Akorn, Inc.

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Akorn, Inc. Drugs

Lortab

Lortab

Dosage should be adjusted according to severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

The usual adult dosage is 11.25 milliliters every 4 to 6 hours as needed for pain. The total daily dosage for adults should not exceed 67.5 milliliters.

The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.20 mL/kg of LORTAB ELIXIR (providing 0.135 mg/kg of hydrocodone bitartrate and 4.0 mg/kg of acetaminophen). Dosing should be based on weight whenever possible.
BODY WEIGHT APPROXIMATE AGE DOSE every 4 to 6 hours MAXIMUM TOTAL DAILY DOSE (6 doses per day) 12 to 15 kg (27 to 34 lbs.) 2 to 3 years 2.8 mL 16.8 mL 16 to 22 kg (35 to 50 lbs.) 4 to 6 years 3.75 mL 22.5 mL 23 to 31 kg (51 to 69 lbs.) 7 to 9 years 5.6 mL 33.6 mL 32 to 45 kg (70 to 100 lbs.) 10 to 13 years 7.5 mL 45 mL 46 kg and up (101 lbs. and up) 14 years to adult 11.25 mL 67.5 mL
The total daily dosage for children should not exceed 6 doses per day.

It is of utmost importance that the dose of LORTAB ELIXIR be administered accurately. It is strongly recommended that care givers obtain and use a calibrated measuring device. Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct care givers to use extreme caution in measuring the dosage.
Colgate Minions Mild Bu...

Colgate Minions Mild Bubble Fruit Fluoride

The recommended dosage regimen for the treatment of bacterial conjunctivitis is:

Instill 1 drop in the affected eye(s) twice daily, eight to twelve hours apart for the first two days and then instill 1 drop in the affected eye(s) once daily for the next five days.
Xopenex

Xopenex

XOPENEX Inhalation Solution is for oral inhalation only. Administer by nebulization using with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. Do not exceed recommended dose.

Children 6-11 years old: The recommended dosage of XOPENEX Inhalation Solution for patients 6-11 years old is 0.31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0.63 mg three times a day.

Adults and Adolescents ≥12 years old: The recommended starting dosage of XOPENEX Inhalation Solution for patients 12 years of age and older is 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization.

Patients 12 years of age and older with more severe asthma or patients who do not respond adequately to a dose of 0.63 mg of XOPENEX Inhalation Solution may benefit from a dosage of 1.25 mg three times a day.

Patients receiving the highest dose of XOPENEX Inhalation Solution should be monitored closely for adverse systemic effects, and the risks of such effects should be balanced against the potential for improved efficacy.

The use of XOPENEX Inhalation Solution can be continued as medically indicated to help control recurring bouts of bronchospasm. During this time, most patients gain optimal benefit from regular use of the inhalation solution.

If a previously effective dosage regimen fails to provide the usual response this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

The drug compatibility (physical and chemical), efficacy, and safety of XOPENEX Inhalation Solution when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of XOPENEX Inhalation Solution have been established in clinical trials when administered using the PARI LC Jet™ and PARI LC Plus™ nebulizers, and the PARI Master® Dura-Neb® 2000 and Dura-Neb® 3000 compressors. The safety and efficacy of XOPENEX Inhalation Solution when administered using other nebulizer systems have not been established.
Xopenex

Xopenex

XOPENEX Inhalation Solution Concentrate is for oral inhalation only. Dilute with sterile normal saline before administration. Administer by nebulization using with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. Do not exceed recommended dose. For dosages less than 1.25 mg, the non-concentrate (i.e., XOPENEX Inhalation Solution, 3 mL) formulation must be used.

Children 6-11 years old: The recommended dosage of XOPENEX Inhalation Solution for patients 6-11 years old is 0.31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0.63 mg three times a day.

Adults and Adolescents ≥12 years old: The recommended starting dosage of XOPENEX Inhalation Solution for patients 12 years of age and older is 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization.

Patients 12 years of age and older with more severe asthma or patients who do not respond adequately to a dose of 0.63 mg of XOPENEX Inhalation Solution may benefit from a dosage of 1.25 mg three times a day.

Patients receiving the highest dose of XOPENEX Inhalation Solution should be monitored closely for adverse systemic effects, and the risks of such effects should be balanced against the potential for improved efficacy.

The use of XOPENEX Inhalation Solution can be continued as medically indicated to help control recurring bouts of bronchospasm. During this time, most patients gain optimal benefit from regular use of the inhalation solution.

If a previously effective dosage regimen fails to provide the usual response this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

The drug compatibility (physical and chemical), efficacy, and safety of XOPENEX Inhalation Solution when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of XOPENEX Inhalation Solution have been established in clinical trials when administered using the PARI LC Jet™ and PARI LC Plus™ nebulizers, and the PARI Master® Dura-Neb® 2000 and Dura-Neb® 3000 compressors. The safety and efficacy of XOPENEX Inhalation Solution when administered using other nebulizer systems have not been established.
Zioptan

Zioptan

The recommended dose is one drop of ZIOPTAN® in the conjunctival sac of the affected eye(s) once daily in the evening.

The dose should not exceed once daily since it has been shown that more frequent administration of prostaglandin analogs may lessen the intraocular pressure lowering effect.

Reduction of the intraocular pressure starts approximately 2 to 4 hours after the first administration with the maximum effect reached after 12 hours.

ZIOPTAN® may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is being used, each one should be administered at least 5 minutes apart.

The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration.
Aurum Ferrum Sidereum 1...

Aurum Ferrum Sidereum 1010 Special Order

Rifampin for injection is administered by IV infusion (see INDICATIONS AND USAGE). IV doses are the same as those for oral.

See CLINICAL PHARMACOLOGY for dosing information in patients with renal failure.

Tuberculosis

Adults: 10 mg/kg, in a single daily administration, not to exceed 600 mg/day, IV.

Pediatric Patients: 10–20 mg/kg, not to exceed 600 mg/day, IV.

Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide [e.g., RIFATER®]5 is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered.

Following the initial phase, treatment should be continued with rifampin and isoniazid [e.g., RIFAMATE®]6 for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive.

Preparation of Solution for IV Infusion: Reconstitute the lyophilized powder by transferring 10 mL of sterile water for injection to a vial containing 600 mg of rifampin for injection. Swirl vial gently to completely dissolve the antibiotic. The reconstituted solution contains 60 mg rifampin per mL and is stable at room temperature for 24 hours. Prior to administration, withdraw from the reconstituted solution a volume equivalent to the amount of rifampin calculated to be administered and add to 500 mL of infusion medium. Mix well and infuse at a rate allowing for complete infusion within 3 hours. Alternatively, the amount of rifampin calculated to be administered may be added to 100 mL of infusion medium and infused in 30 minutes.

Dilutions in dextrose 5% for injection (D5W) are stable at room temperature for up to 4 hours and should be prepared and used within this time. Precipitation of rifampin from the infusion solution may occur beyond this time. Dilutions in normal saline are stable at room temperature for up to 24 hours and should be prepared and used within this time. Other infusion solutions are not recommended.

Incompatibilities: Physical incompatibility (precipitate) was observed with undiluted (5 mg/mL) and diluted (1 mg/mL in normal saline) diltiazem hydrochloride and rifampin (6 mg/mL in normal saline) during simulated Y-site administration.

Meningococcal Carriers

Adults: For adults, it is recommended that 600 mg rifampin be administered twice daily for two days.

Pediatric Patients: Pediatric patients 1 month of age or older: 10 mg/kg (not to exceed 600 mg per dose) every 12 hours for two days.

Pediatric patients under 1 month of age: 5 mg/kg every 12 hours for two days.
Cholografin Meglumine

Cholografin Meglumine

2.1 General Dosing Recommendations

In patients 1 year of age or greater, apply one drop of either phenylephrine hydrochloride ophthalmic solution 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops per eye per day.

In order to obtain a greater degree of mydriasis, phenylephrine hydrochloride ophthalmic solution 10% may be needed.

2.2 Dosing in Pediatric Patients Less Than 1 Year of Age

In pediatric patients less than 1 year of age, one drop of phenylephrine hydrochloride ophthalmic solution 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye.
Tetracaine

Tetracaine

As with all anesthetics, the dosage varies and depends upon the area to be anesthetized, the number of neuronal segments to be blocked, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. For specific techniques and procedures, refer to standard textbooks.
Suggested Dosage for Spinal Anesthesia Using 1% Tetracaine HCl Injection, USP
* For vaginal delivery (saddle block), from 2 mg to 5 mg in dextrose.

† Doses exceeding 15 mg are rarely required and should be used only in exceptional cases. Inject solution at rate of about 1 mL per 5 seconds.
Extent of Dose of solution Volume of spinal fluid Site of injection Anesthesia (mL) (mL) (lumbar interspace) Perineum 0.5 (= 5 mg)* 0.5 4th Perineum and 1.0 (= 10 mg) 1.0 3rd or 4th lower extremities Up to costal 1.5 to 2.0 1.5 to 2.0 2nd, 3rd, or 4th margin(= 15 mg to 20 mg)†
The extent and degree of spinal anesthesia depend upon dosage, specific gravity of the anesthetic solution, volume of solution used, force of the injection, level of puncture, position of the patient during and immediately after injection, etc.

When spinal fluid is added to 1% tetracaine hydrochloride injection, some turbidity results, the degree depending on the pH of the spinal fluid, the temperature of the solution during mixing, as well as the amount of drug and diluent employed. Liberation of base (which is completed within the spinal canal) is held to be essential for satisfactory results with any spinal anesthetic.

The specific gravity of spinal fluid at 25°C/25°C varies under normal conditions from 1.0063 to 1.0075. The 1% concentration in saline solution has a specific gravity of 1.0060 to 1.0074 at 25°C/25°C.

A hyperbaric solution may be prepared by mixing equal volumes of the 1% solution and Dextrose Solution 10%.

Examine ampules carefully before use. Do not use solution if crystals, cloudiness, or discoloration is observed.

This formulation of tetracaine hydrochloride does not contain antimicrobial or bacteriostatic agents; therefore, unused portions should be discarded.

Sterilization of Ampules

The tetracaine hydrochloride injection is sterile within an undamaged ampule. To destroy bacteria on the exterior of ampules use heat sterilization (autoclaving) before opening. Immersion in antiseptic solution is not recommended.

Autoclave at 15-pounds pressure, at 121°C (250°F), for 15 minutes.

Autoclaving increases likelihood of crystal formation. Unused autoclaved ampules should be discarded. Under no circumstances should unused ampules which have been autoclaved be returned to stock.
Myochrysine

Myochrysine

Gold Sodium Thiomalate should be administered only by intramuscular injection, preferably intragluteally. It should be given with the patient lying down. He should remain recumbent for approximately 10 minutes after the injection.

Therapeutic effects from Gold Sodium Thiomalate occur slowly. Early improvement, often limited to a reduction in morning stiffness, may begin after six to eight weeks of treatment, but beneficial effects may not be observed until after months of therapy.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if material has darkened. Color should not exceed pale yellow.

For the adult of average size the following dosage schedule is suggested:

Weekly Injections:1st injection………………………………………………………………………………………….10 mg2nd injection…………………………………………………………………………………………25 mg

3rd and sub sequent injections, 25 to 50 mg until there is toxicity or major clinical improvement, or, in the absence of either of these, the cumulative dose of Gold Sodium Thiomalate reaches one gram.

Gold Sodium Thiomalate is continued until the cumulative dose reaches one gram unless toxicity or major clinical improvement occurs. If significant clinical improvement occurs before a cumulative dose of one gram has been administered, the dose may be decreased or the interval between injections increased as with maintenance therapy. Maintenance doses of 25 to 50 mg every other week for two to 20 weeks are recommended. If the clinical course remains stable, injections of 25 to 50 mg may be given every third and subsequently every fourth week indefinitely. Some patients may require maintenance treatment at intervals of one to three weeks. Should the arthritis exacerbate during maintenance therapy, weekly injections may be resumed temporarily until disease activity is suppressed.

Should a patient fail to improve during initial therapy (cumulative dose of one gram), several options are available.
the patient may be considered to be unresponsive and Gold Sodium Thiomalate is discontinued. the same dose (25 to 50 mg) of Gold Sodium Thiomalate may be continued for approximately ten additional weeks. the dose of Gold Sodium Thiomalate may be increased by increments of 10 mg every one to four weeks, not to exceed 100 mg in single injection.
If significant clinical improvement occurs using option 2 or 3, the maintenance schedule described above should be initiated. If there is no significant improvement or if toxicity occurs, therapy with Gold Sodium Thiomalate should be stopped. The higher the individual dose of Gold Sodium Thiomalate, the greater the risk of gold toxicity. Selection of one of these options for chrysotherapy should be based upon a number of factors, including the physician's experience with gold salt therapy, the course of the patient's condition, the choice of alternative treatments, and the availability of the patient for the close supervision required.

Juvenile Rheumatoid Arthritis

The pediatric dose of Gold Sodium Thiomalate is proportional to the adult dose on a weight basis. After the initial test dose of 10 mg, the recommended dose for children is one mg per kilo gram body weight, not to exceed 50 mg for a single injection. Otherwise, the guidelines given above for administration to adults also apply to children.

Concomitant Drug Therapy—Gold salts should not be used concomitantly with penicillamine.

The safety of coadministration with cytotoxic drugs has not been established. Other measures, such as salicylates, other nonsteroidal anti-inflammatory drugs, or systemic corticosteroids, may be continued when Gold Sodium Thiomalate is initiated. After improvement commences, analgesic and anti-inflammatory drugs may be discontinued slowly as symptoms permit.
Apraclonidine Ophthalmi...

Apraclonidine Ophthalmic

One to two drops of Apraclonidine Ophthalmic Solution should be instilled in the affected eye(s) three times daily. Since Apraclonidine Ophthalmic Solution will be used with other ocular glaucoma therapies, an approximate 5 minute interval between instillation of each medication should be practiced to prevent washout of the previous dose. NOT FOR INJECTION INTO THE EYE. NOT FOR ORAL INGESTION.
Erythromycin Ointment

Erythromycin Ointment

In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Opthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection.

For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.
Levofloxacin Solution

Levofloxacin Solution

Days 1 and 2

Instill one to two drops in the affected eye(s) every 2 hours while awake, up to 8 times per day.

Days 3 through 7

Instill one to two drops in the affected eye(s) every 4 hours while awake, up to 4 times per day.
Monurol

Monurol

2.1 Prevention of Chemotherapy-Induced Nausea and Vomiting

Adult Patients

The recommended dosage for granisetron hydrochloride injection is 10 mcg/kg administered intravenously within 30 minutes before initiation of chemotherapy, and only on the day(s) chemotherapy is given.

Infusion Preparation

Granisetron hydrochloride injection may be administered intravenously either undiluted over 30 seconds, or diluted with 0.9% Sodium Chloride or 5% Dextrose and infused over 5 minutes.

Stability

Intravenous infusion of granisetron hydrochloride injection should be prepared at the time of administration. However, granisetron hydrochloride injection has been shown to be stable for at least 24 hours when diluted in 0.9% Sodium Chloride or 5% Dextrose and stored at room temperature under normal lighting conditions.

As a general precaution, granisetron hydrochloride injection should not be mixed in solution with other drugs. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

Pediatric Patients

The recommended dose in pediatric patients 2 to 16 years of age is 10 mcg/kg [see Clinical Studies (14)].

Pediatric patients under 2 years of age have not been studied.
Levofloxacin

Levofloxacin

2.1 Dosage in Adult Patients with Normal Renal Function

The usual dose of Levofloxacin Injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.

These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)
1 Due to the designated pathogens [see Indications and Usage (1)].

2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

3 Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].

4 Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].

5 This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.

6 This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.

7 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].

8 The safety of Levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged Levofloxacin therapy should only be used when the benefit outweighs the risk.

9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of Levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
Type of Infection1 Dosed Every 24 hours Duration (days)2 Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia3 500 mg 7 to 14 Community Acquired Pneumonia4 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 10 Chronic Bacterial Prostatitis 500 mg 28 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5 750 mg 5 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6 250 mg 10 Uncomplicated Urinary Tract Infection 250 mg 3 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg7,8 Pediatric patients < 50 kg and≥6 months of age7,8 500 mgsee Table 2 below (2.2) 608 608 Plague, adult and pediatric patients> 50 kg9 Pediatric patients < 50 kg and≥6 months of age 500 mgsee Table 2 below (2.2) 10 to 1410 to 14
2.2 Dosage in Pediatric Patients

The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age
1 Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

3 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].

4 The safety of Levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged Levofloxacin therapy should only be used when the benefit outweighs the risk.

5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Type of Infection1 Dose Freq. Once every Duration2 Inhalational Anthrax (post-exposure)3, 4 Pediatric patients> 50 kg 500 mg 24 hr 60 days4 Pediatric patients< 50 kg and ≥6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 60 days4 Plague5 Pediatric patients> 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients< 50 kg and ≥6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 10 to 14 days
2.3 Dosage Adjustment in Adults with Renal Impairment

Administer Levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.

No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.

In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].

Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min) Dosage in Normal Renal Function Every 24 hours Creatinine Clearance 20 to 49 mL/min Creatinine Clearance 10 to 19 mL/min Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD) 750 mg 750 mg every 48 hours 750 mg initial dose, then 500 mg every 48 hours 750 mg initial dose, then 500 mg every 48 hours 500 mg 500 mg initialdose, then 250mg every 24 hours 500 mg initial dose, then 250 mg every 48 hours 500 mg initial dose, then 250 mg every 48 hours 250 mg No dosage adjustment required 250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required No information on dosing adjustment is available
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

Levofloxacin Injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].

2.5 Administration Instructions

Levofloxacin Injection

Caution: Rapid or bolus intravenous infusion of Levofloxacin Injection has been associated with hypotension and must be avoided. Levofloxacin Injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin Injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

Hydration for Patients Receiving Levofloxacin Injection

Adequate hydration of patients receiving intravenous Levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

2.6 Preparation of Intravenous Product

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Because only limited data are available on the compatibility of Levofloxacin Injection with other intravenous substances, additives or other medications should not be added to Levofloxacin Injection in Single-Use Vials, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of Levofloxacin Injection with an infusion solution compatible with Levofloxacin Injection and with any other drug(s) administered via this common line.

LEVOFLOXACIN Injection in Single-Use Vials

Single-use vials require dilution prior to administration.

Levofloxacin Injection is supplied in single-use vials containing a concentrated levofloxacin solution with the equivalent of 500 mg (20 mL vial) and 750 mg (30 mL vial) of levofloxacin in Water for Injection, USP. The 20 mL and 30 mL vials each contain 25 mg of levofloxacin/mL. These Levofloxacin Injection single-use vials must be further diluted with an appropriate solution prior to intravenous administration [see Table 4]. The concentration of the resulting diluted solution should be 5 mg/mL prior to administration.

Compatible Intravenous Solutions: Any of the following intravenous solutions may be used to prepare a 5 mg/mL levofloxacin solution with the approximate pH values:
Table 4: Compatible Intravenous Solutions Intravenous Fluids Final pH of Levofloxacin Injection Solution 0.9% Sodium Chloride Injection, USP 4.71 5% Dextrose Injection, USP 4.58 5% Dextrose/0.9% NaCl Injection 4.62 5% Dextrose in Lactated Ringers 4.92 Plasma-Lyte®56/5% Dextrose Injection 5.03 5% Dextrose, 0.45% Sodium Chloride, and 0.15% Potassium Chloride Injection 4.61 Sodium Lactate Injection (M/6) 5.54
Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final intravenous solution. Since the vials are for single-use only, any unused portion remaining in the vial should be discarded. When used to prepare two 250 mg doses from the 20 mL vial containing 500 mg of levofloxacin, the full content of the vial should be withdrawn at once using a single-entry procedure, and a second dose should be prepared and stored for subsequent use [see Stability of Levofloxacin Injection Following Dilution].

Prepare the desired dosage of levofloxacin according to Table 5:
Table 5: Preparation of Levofloxacin Injection Intravenous Solution Desired Dosage Strength From Appropriate Vial, Withdraw Volume Volume of Diluent Infusion Time 250 mg 10 mL (20 mL Vial) 40 mL 60 min 500 mg 20 mL (20 mL Vial) 80 mL 60 min 750 mg 30 mL (30 mL Vial) 120 mL 90 min
For example, to prepare a 500 mg dose using the 20 mL vial (25 mg/mL), withdraw 20 mL and dilute with a compatible intravenous solution to a total volume of 100 mL.

This intravenous drug product should be inspected visually for particulate matter prior to administration. Samples containing visible particles should be discarded.

Stability of Levofloxacin Injection Following Dilution: Levofloxacin Injection, when diluted in a compatible intravenous fluid to a concentration of 5 mg/mL, is stable for 72 hours when stored at or below 25°C (77°F) and for 14 days when stored under refrigeration at 5°C (41°F) in plastic intravenous containers. Solutions that are diluted in a compatible intravenous solution and frozen in glass bottles or plastic intravenous containers are stable for 6 months when stored at - 20°C (- 4°F). Thaw frozen solutions at room temperature 25°C (77°F) or in a refrigerator 8°C (46°F). Do not force thaw by microwave irradiation or water bath immersion. Do not refreeze after initial thawing.
Methylene Blue

Methylene Blue

0.1 to 0.2 mL per kilogram of body weight (0.045 to 0.09 mL per pound of body weight). Inject Methylene Blue intravenously very slowly over a period of several minutes.
Diltiazem Hydrochloride...

Diltiazem Hydrochloride

Direct Intravenous Single Injections (Bolus)

The initial dose of diltiazem hydrochloride injection should be 0.25 mg/kg actual body weight as a bolus administered over 2 minutes (20 mg is a reasonable dose for the average patient). If response is inadequate, a second dose may be administered after 15 minutes. The second bolus dose of diltiazem hydrochloride injection should be 0.35 mg/kg actual body weight administered over 2 minutes (25 mg is a reasonable dose for the average patient). Subsequent intravenous bolus doses should be individualized for each patient. Patients with low body weights should be dosed on a mg/kg basis. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. Experience with this dose is limited.

Continuous Intravenous Infusion

For continued reduction of the heart rate (up to 24 hours) in patients with atrial fibrillation or atrial flutter, an intravenous infusion of diltiazem hydrochloride injection may be administered. Immediately following bolus administration of 20 mg (0.25 mg/kg) or 25 mg (0.35 mg/kg) diltiazem hydrochloride injection and reduction of heart rate, begin an intravenous infusion of diltiazem hydrochloride injection. The recommended initial infusion rate of diltiazem hydrochloride injection is 10 mg/h. Some patients may maintain response to an initial rate of 5 mg/h. The infusion rate may be increased in 5 mg/h increments up to 15 mg/h as needed, if further reduction in heart rate is required, the infusion may be maintained for up to 24 hours.

Diltiazem shows dose-dependent, non-linear pharmacokinetics. Duration of infusion longer than 24 hours and infusion rates greater than 15 mg/h have not been studied. Therefore, infusion duration exceeding 24 hours and infusion rates exceeding 15 mg/h are not recommended.

Dilution: To prepare diltiazem hydrochloride injection for continuous intravenous infusion aseptically transfer the appropriate quantity (see chart) of diltiazem hydrochloride injection to the desired volume of either Normal Saline, D5W, or D5W/0.45% NaCl. Mix thoroughly. Use within 24 hours. Keep refrigerated until use.

* 5 mg/h may be appropriate for some patients.
Diluent Volume Quantity of Diltiazem Hydrochloride Injection to Add Final Concentration Administration Dose* Infusion Rate 100 mL 125 mg (25 mL) 1 mg/mL 10 mg/h15 mg/h 10 mL/h15 mL/h 250 mL 250 mg (50 mL) 0.83 mg/mL 10 mg/h15 mg/h 12 mL/h18 mL/h 500 mL 250 mg (50 mL) 0.45 mg/mL 10 mg/h15 mg/h 22 mL/h33 mL/h
Diltiazem hydrochloride injection was tested for compatibility with three commonly used intravenous fluids at a maximal concentration of 1 mg diltiazem hydrochloride per milliliter. Diltiazem hydrochloride injection was found to be physically compatible and chemically stable in the following parenteral solutions for at least 24 hours when stored in glass or polyvinylchloride (PVC) bags at controlled room temperature 15° to 30°C (59° to 86°F) or under refrigeration 2° to 8°C (36° to 46°F).
dextrose (5%) injection USP sodium chloride (0.9%) injection USP dextrose (5%) and sodium chloride (0.45%) injection USP
Because of potential physical incompatibilities, it is recommended that diltiazem hydrochloride injection not be mixed with any other drugs in the same container.

If possible, it is recommended that diltiazem hydrochloride injection not be co-infused in the same intravenous line. Physical incompatibilities (precipitate formation or cloudiness) were observed when diltiazem hydrochloride injection was infused in the same intravenous line with the following drugs: acetazolamide, acyclovir, aminophylline, ampicillin, ampicillin sodium/sulbactam sodium, cefamandole, cefoperazone, diazepam, furosemide, hydrocortisone, sodium succinate, insulin (regular: 100 units/mL), methylprednisolone sodium succinate, mezlocillin, nafcillin, phenytoin, rifampin, and sodium bicarbonate.

Parental drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Transition to Further Antiarrhythmic Therapy

Transition to other antiarrhythmic agents following administration of diltiazem hydrochloride injection is generally safe. However, reference should be made to the respective agent manufacturer's package insert for information relative to dosage and administration.

In controlled clinical trials, therapy with antiarrhythmic agents to maintain reduced heart rate in atrial fibrillation or atrial flutter or for prophylaxis of PSVT was generally started within 3 hours after bolus administration of diltiazem hydrochloride injection. These antiarrhythmic agents were intravenous or oral digoxin, Class I antiarrhythmics (eg, quinidine, procainamide), calcium channel blockers, and oral beta-blockers.

Experience in the use of antiarrhythmic agents following maintenance infusion of diltiazem hydrochloride injection is limited. Patients should be dosed on an individual basis and reference should be made to respective manufacturer's package insert for information relative to dosage and administration.
Gonak Hypromellose

Gonak Hypromellose

Directions: Fill gonioscopic prism with solution as necessary.
Little Ones Vitamin A A...

Little Ones Vitamin A And D

The recommended dose of Ketorolac Tromethamine Ophthalmic Solution, 0.4% is one drop four times a day in the operated eye as needed for pain and burning/stinging for up to 4 days following corneal refractive surgery.

Ketorolac tromethamine ophthalmic solution has been safely administered in conjunction with other ophthalmic medications such as antibiotics, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.
Phenylephrine Hydrochlo...

Phenylephrine Hydrochloride Solution Drops

Vasoconstriction and Pupil Dilatation: Phenylephrine Hydrochloride Ophthalmic Solution is especially useful when rapid and powerful dilatation of the pupil without cycloplegia and reduction of congestion in the capillary bed are desired. A drop of a suitable topical anesthetic may be applied, followed in a few minutes by 1 drop of Phenylephrine Hydrochloride Ophthalmic Solution to the upper limbus. The anesthetic prevents stinging and consequent dilution of the solution by lacrimation. It may occasionally be necessary to repeat the instillation after one hour, again preceded by the use of the topical anesthetic.

Uveitis: Posterior Synechiae: Phenylephrine Hydrochloride Ophthalmic Solution may be used in patients with uveitis when synechiae are present or may develop. The formation of synechiae may be prevented by the use of this solution and atropine or other cycloplegics to produce wide dilation of the pupil. For recently formed posterior synechiae one drop of Phenylephrine Hydrochloride Ophthalmic Solution may be applied to the upper surface of the cornea and be repeated as necessary, not to exceed three times. Treatment may be continued the following day, if necessary. Atropine sulfate and the application of hot compresses should also be used if indicated.

Glaucoma: Phenylephrine Hydrochloride Ophthalmic Solution may be used with miotics in patients with open angle glaucoma. It reduces the difficulties experienced by the patient because of the small field produced by miosis, and still it permits and often supports the effect of the miotic in lowering the intraocular pressure in open angle glaucoma. Hence, there may be marked improvement in visual acuity after using Phenylephrine Hydrochloride Ophthalmic Solution in conjunction with miotic drugs.

Surgery: When a short-acting mydriatic is needed for wide dilation of the pupil before intraocular surgery, Phenylephrine Hydrochloride Ophthalmic Solution may be applied topically from 30 to 60 minutes before the operation.

Refraction: Phenylephrine Hydrochloride Ophthalmic Solution may be used effectively to increase mydriasis with homatropine hydrobromide, cyclopentolate hydrochloride, tropicamide hydrochloride and atropine sulfate.

FOR ADULTS: One drop of the preferred cycloplegic is placed in each eye, followed in 5 minutes by one drop of Phenylephrine Hydrochloride Ophthalmic Solution. Since adequate cycloplegia is achieved at different time intervals after the instillation of the necessary number of drops, different cycloplegics will require different waiting periods to achieve adequate cycloplegia.

FOR CHILDREN: For a “one application method,” Phenylephrine Hydrochloride Ophthalmic Solution may be combined with one of the preferred rapid acting cycloplegics to produce adequate cycloplegia.

Opthalmoscopic Examination: One drop of Phenylephrine Hydrochloride Ophthalmic Solution is placed in each eye. Sufficient mydriasis to permit examination is produced in 15 to 30 minutes. Dilation lasts one to three hours.

Diagnostic Procedures:

Provocative Test for Angle Closure Glaucoma:

Phenylephrine Hydrochloride Ophthalmic Solution may be used cautiously as a provocative test when interval narrow angle closure glaucoma is suspected. Intraocular tension and gonioscopy are performed prior to and after dilation of the pupil with phenylephrine hydrochloride. A “significant” intraocular pressure (IOP) rise combined with gonioscopic evidence of angle closure indicates an anterior segment anatomy capable of angle closure. A negative test does not rule this out. This pharmacologically induced angle closure glaucoma may not simulate real life conditions and other causes for transient elevations of IOP should be excluded.

Retinoscopy (Shadow Test): When dilation of the pupil without cycloplegic action is desired for retinoscopy, Phenylephrine Hydrochloride Ophthalmic Solution may be used.

NOTE: Heavily pigmented irides may require larger doses in all of the above procedures.

Blanching Test: One or two drops of Phenylephrine Hydrochloride Ophthalmic Solution should be applied to the injected eye. After five minutes, examine for perilimbal blanching. If blanching occurs, the congestion is superficial and probably does not indicate iridocyclitis.
Tropicamide Solution Dr...

Tropicamide Solution Drops

For refraction, instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. For examination of fundus, instill one or two drops of 0.5% solution 15 to 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses. Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.
Phenylephrine Hydrochlo...

Phenylephrine Hydrochloride Solution Drops

Vasoconstriction and Pupil Dilatation: Phenylephrine Hydrochloride Ophthalmic Solution is especially useful when rapid and powerful dilatation of the pupil without cycloplegia and reduction of congestion in the capillary bed are desired. A drop of a suitable topical anesthetic may be applied, followed in a few minutes by 1 drop of Phenylephrine Hydrochloride Ophthalmic Solution to the upper limbus. The anesthetic prevents stinging and consequent dilution of the solution by lacrimation. It may occasionally be necessary to repeat the instillation after one hour, again preceded by the use of the topical anesthetic.

Uveitis: Posterior Synechiae: Phenylephrine Hydrochloride Ophthalmic Solution may be used in patients with uveitis when synechiae are present or may develop. The formation of synechiae may be prevented by the use of this solution and atropine or other cycloplegics to produce wide dilatation of the pupil. It should be emphasized, however, that the vasoconstrictor effect of Phenylephrine Hydrochloride Ophthalmic Solution may be antagonistic to the increase of local blood flow in uveal infection.

To free recently formed posterior synechiae, one drop of Phenylephrine Hydrochloride Ophthalmic Solution may be applied to the upper surface of the cornea. On the following day, treatment may be continued if necessary. In the interim, hot compresses should be applied for five or ten minutes three times a day, with one drop of a 1% or 2% solution of atropine sulfate before and after each series of compresses.

Glaucoma: In certain patients with glaucoma, temporary reduction of intraocular tension may be attained by producing vasoconstriction of the intraocular vessels; this may be accomplished by placing 1 drop of Phenylephrine Hydrochloride Ophthalmic Solution on the upper surface of the cornea. This treatment may be repeated as often as necessary.

Phenylephrine Hydrochloride Ophthalmic Solution may be used with miotics in patients with wide angle glaucoma. It reduces the difficulties experienced by the patient because of the small field produced by miosis, and still it permits and often supports the effect of the miotic in lowering the intraocular pressure. Hence, there may be marked improvement in visual acuity after using Phenylephrine Hydrochloride Ophthalmic Solution in conjunction with miotic drugs.

Surgery: When a short-acting mydriatic is needed for wide dilation of the pupil before intraocular surgery, Phenylephrine Hydrochloride Ophthalmic Solution may be applied topically from 30 to 60 minutes before the operation.
Trimethoprim Sulfate An...

Trimethoprim Sulfate And Polymyxin B Sulfate Solution

Adults: In mild to moderate infections, instill one drop in the affected eye(s) every three hours (maximum of 6 doses per day) for a period of 7 to 10 days.

Pediatric Use: Clinical studies have shown Trimethoprim and Polymyxin B Sulfate Ophthalmic Solution to be safe and effective for use in pediatric patients over two months of age. The dosage regimen is the same as for adults.
Cyclopentolate Hydrochl...

Cyclopentolate Hydrochloride Solution Drops

Adults: Instill one or two drops of 1% or 2% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days. Children: Instill one or two drops of 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 1% solution if necessary.
Ciprofloxacin

Ciprofloxacin

Corneal Ulcers

The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.

Bacterial Conjunctivitis

The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
Dehydrated Alcohol

Dehydrated Alcohol

The dosage of Dehydrated Alcohol Injection, USP for therapeutic nerve or ganglion block varies from as little as 0.05 to 0.5 mL in trigeminal neuralgia to 0.5 to 1.0 mL per interspace for subarachnoid injections. Doses larger than 1.5 mL are seldom required. All injections should be made slowly and only after all steps have been taken to insure precise placement of the alcohol. A 1.0 mL tuberculin syringe is desirable to facilitate accurate measurement of the dose. Separate needles should be used for injection of successive interspaces or other sites. Since Dehydrated Alcohol Injection, USP is hypobaric as compared to spinal fluid, proper positioning of the patient is essential to control localization of injections into the subarachnoid space.

When lesser concentrations of alcohol are used, larger volumes are usually injected. A dose of 2 mL of 45% alcohol has been used for injecting individual motor nerves, or from 1.5 to 4.0 mL for epidural injection in children with spastic cerebral palsy; 50 mL of 50% alcohol has been used for celiac plexus blockade.

The LD50 oral dose in rats is 13.7 g/kg.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.
Betaxolol

Betaxolol

The recommended dose is one to two drops of Betaxolol Ophthalmic Solution in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering responses to Betaxolol may require a few weeks to stabilize. As with any new medication, careful monitoring of patients is advised.

If the intraocular pressure of the patient is not adequately controlled on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine and/or carbonic anhydrase inhibitors can be instituted.
Lidocaine

Lidocaine

When Lidocaine HCl 2% Jelly is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.

The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. Although the incidence of adverse effects with Lidocaine HCl 2% Jelly is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

For Surface Anesthesia of the Male Adult Urethra: When using Lidocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube. The cone may be gas sterilized or cold sterilized, as preferred. Slowly instill approximately 15 mL (300 mg of lidocaine HCl) into the urethra or until the patient has a feeling of tension. A penile clamp is then applied for several minutes at the corona. An additional dose of not more than 15 mL (300mg) can be instilled for adequate anesthesia.

Prior to sounding or cystoscopy, a penile clamp should be applied for 5 to 10 minutes to obtain adequate anesthesia. A total dose of 30 mL (600 mg) is usually required to fill and dilate the male urethra.

Prior to catheterization, smaller volumes of 5 to 10 mL(100 to 200 mg) are usually adequate for lubrication.

For Surface Anesthesia of the Female Adult Urethra: When using Lidocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube. The cone may be gas sterilized or cold sterilized, as preferred. Slowly instill 3 to 5 mL (60 to 100 mg of lidocaine HCl) of the jelly into the urethra. If desired, some jelly may be deposited on a cotton swab and introduced into the urethra. In order to obtain adequate anesthesia, several minutes should be allowed prior to performing urological procedures.

Lubrication for Endotracheal Intubation: Apply a moderate amount of jelly to the external surface of the endotracheal tube shortly before use. Care should be taken to avoid introducing the product into the lumen of the tube. Do not use the jelly to lubricate endotracheal stylettes. See WARNINGS and ADVERSE REACTIONS concerning rare reports of inner lumen occlusion. It is also recommended that use of endotracheal tubes with dried jelly on the external surface be avoided for lack of lubricating effect.
Proparacaine Hydrochlor...

Proparacaine Hydrochloride Solution Drops

Deep anesthesia as in cataract extraction:
Instill 1 drop to the eye every 5 to 10 minutes for 5 to 7 doses.
Removal of sutures:
Instill 1 or 2 drops to the eye 2 or 3 minutes before removal of stitches.
Removal of foreign bodies:
Instill 1 or 2 drops to the eye prior to operating.
Tonometry:
Instill 1 or 2 drops to the eye immediately before measurement.
Inapsine

Inapsine

Dosage should be individualized. Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used and the surgical procedure involved.

Vital signs and ECG should be monitored routinely.

Adult dosage: The maximum recommended initial dose of INAPSINE is 2.5 mg IM or slow IV. Additional 1.25 mg doses of INAPSINE may be administered to achieve the desired effect. However, additional doses should be administered with caution, and only if the potential benefit outweighs the potential risk.

Children's dosage: For children two to 12 years of age, the maximum recommended initial dose is 0.1 mg/kg. taking into account the patient's age and other clinical factors. However, additional doses should be administered with caution, and only if the potential benefit outweighs the potential risk.

See WARNINGS and PRECAUTIONS for use of INAPSINE with other CNS depressants and in patients with altered response.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If such abnormalities are observed, the drug should not be administered.
Balanced Salt

Balanced Salt

18 mL bottle

The adaptor plug is designed to accept an irrigating needle. Tissues may be irrigated by attaching the needle to the bottle as explained below. External irrigation may be done without the irrigating needle.

Method for Using Adaptor Plug for Ophthalmic Irrigating Needle
Aseptically remove bottle from pouch by peeling backing. Snap-on surgeon's irrigating needle. Push until firmly in place. Test assembly for proper function before use.
Ofloxacin Solution Drop...

Ofloxacin Solution Drops

The recommended dosage regimen for the treatment of bacterial conjunctivitis is:
Days 1 and 2 Instill one to two drops every two to four hours in the affected eye(s). Days 3 through 7 Instill one to two drops four times daily.
The recommended dosage regimen for the treatment of bacterial corneal ulcer is:
Days 1 and 2 Instill one to two drops into the affected eye every 30 minutes while awake. Awaken at approximately four and six hours after retiring and instill one to two drops. Days 3 through 7 to 9 Instill one to two drops hourly while awake. Days 7 to 9 through treatment completion Instill one to two drops four times daily.
Brimonidine

Brimonidine

The recommended dose is one drop of Brimonidine Tartrate Ophthalmic Solution in the affected eye(s) three times daily, approximately 8 hours apart.

Brimonidine Tartrate Ophthalmic Solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.
Artificial Tears

Artificial Tears

Instill 1 or 2 drops in the affected eye(s) as needed.
Labetalol Hydrochloride...

Labetalol Hydrochloride

Labetalol HCl Injection is intended for intravenous use in hospitalized patients. DOSAGE MUST BE INDIVIDUALIZED depending upon the severity of hypertension and the response of the patient during dosing.

Patients should always be kept in a supine position during the period of intravenous drug administration. A substantial fall in blood pressure on standing should be expected in these patients. The patient's ability to tolerate an upright position should be established before permitting any ambulation, such as using toilet facilities.

Either of two methods of administration of labetalol HCl injection may be used: a) repeated intravenous injections, b) slow continuous infusion.

Repeated Intravenous Injection

Initially, labetalol HCl injection should be given in a dose of 20 mg labetalol HCl (which corresponds to 0.25 mg/kg for an 80 kg patient) by slow intravenous injection over a 2-minute period.

Immediately before the injection and at 5 and 10 minutes after injection, supine blood pressure should be measured to evaluate response. Additional injections of 40 mg or 80 mg can be given at 10-minute intervals until a desired supine blood pressure is achieved or a total of 300 mg labetalol HCl has been injected. The maximum effect usually occurs within 5 minutes of each injection.

Slow Continuous Infusion

Labetalol HCl Injection is prepared for continuous intravenous infusion by diluting the vial contents with commonly used intravenous fluids (see below). Examples of two methods of preparing the infusion solution are:

The contents of either two 20-mL vials (40 mL), or one 40-mL vial, are added to 160 mL of a commonly used intravenous fluid such that the resultant 200 mL of solution contains 200 mg of labetalol HCl, 1 mg/mL. The diluted solution should be administered at a rate of 2 mL/min to deliver 2 mg/min.

Alternatively, the contents of either two 20-mL vials (40 mL), or one 40-mL vial, of labetalol HCl injection are added to 250 mL of a commonly used intravenous fluid. The resultant solution will contain 200 mg of labetalol HCl, approximately 2 mg/3 mL. The diluted solution should be administered at a rate of 3 mL/min to deliver approximately 2 mg/min.

The rate of infusion of the diluted solution may be adjusted according to the blood pressure response, at the discretion of the physician. To facilitate a desired rate of infusion, the diluted solution can be infused using a controlled administration mechanism, eg, graduated burette or mechanically driven infusion pump.

Since the half-life of labetalol is 5 to 8 hours, steady-state blood levels (in the face of a constant rate of infusion) would not be reached during the usual infusion time period. The infusion should be continued until a satisfactory response is obtained and should then be stopped and oral labetalol HCl started (see below). The effective intravenous dose is usually in the range of 50 to 200 mg. A total dose of up to 300 mg may be required in some patients.

Blood Pressure Monitoring

The blood pressure should be monitored during and after completion of the infusion or intravenous injections. Rapid or excessive falls in either systolic or diastolic blood pressure during intravenous treatment should be avoided. In patients with excessive systolic hypertension, the decrease in systolic pressure should be used as indicator of effectiveness in addition to the response of the diastolic pressure.

Initiation of Dosing with Labetalol HCl Tablets

Subsequent oral dosing with labetalol HCl tablets should begin when it has been established that the supine diastolic blood pressure has begun to rise. The recommended initial dose is 200 mg, followed in 6 - 12 hours by an additional dose of 200 or 400 mg, depending on the blood pressure response. Thereafter, inpatient titration with Labetalol HCl Tablets may proceed as follows:
Inpatient Titration Instructions Regimen Daily Dose* * If needed, the total daily dose may be given in three divided doses. 200 mg b.i.d. 400 mg 400 mg b.i.d. 800 mg 800 mg b.i.d. 1600 mg 1200 mg b.i.d. 2400 mg
While in the hospital, the dosage of labetalol HCl tablets may be increased at 1-day intervals to achieve the desired blood pressure reduction.

For subsequent outpatient titration or maintenance dosing see DOSAGE AND ADMINISTRATION in the labetalol HCl tablets product information for additional recommendations.

Compatibility with commonly used intravenous fluids

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Labetalol HCl Injection was tested for compatibility with commonly used intravenous fluids at final concentrations of 1.25 mg to 3.75 mg labetalol HCl per mL of the mixture. Labetalol HCl Injection was found to be compatible with and stable (for 24 hours refrigerated or at room temperature) in mixtures with the following solutions:

Ringers Injection, USPLactated Ringers Injection, USP5% Dextrose and Ringers Injection5% Lactated Ringers and 5% Dextrose Injection5% Dextrose Injection, USP0.9% Sodium Chloride Injection, USP5% Dextrose and 0.2% Sodium Chloride Injection, USP2.5% Dextrose and 0.45% Sodium Chloride Injection, USP5% Dextrose and 0.9% Sodium Chloride Injection, USP5% Dextrose and 0.33% Sodium Chloride Injection, USP

Labetalol HCl Injection was NOT compatible with 5% Sodium Bicarbonate Injection, USP.
Indigo Carmine

Indigo Carmine

Indigo Carmine solution is injected either by the intravenous or intramuscular route, and its appearance at the ureteral orifices is watched with the cystoscope in place. The intravenous method is preferred because a 5 mL injection is sufficient. A lesser dosage in infants, children and underweight patients will prevent skin coloration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

PROTECT FROM LIGHT

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Ephedrine Sulfate

Ephedrine Sulfate

ADULTS - The usual parenteral dose is 25 to 50 mg given subcutaneously or intramuscularly. Intravenously, 5 to 25 mg may be administered slowly, repeated in 5 to 10 minutes, if necessary.

CHILDREN - The usual subcutaneous or intramuscular dose is 0.5 mg/kg of body weight or 16.7 mg/square meter of body surface every 4 to 6 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Fluress

Fluress

Removal of foreign bodies and sutures, and for tonometry: 1 to 2 drops (in single instillations) in each eye before operating.

Deep ophthalmic anesthesia: 2 drops in each eye at 90 second intervals for 3 instillations.

NOTE: The use of an eye patch is recommended.
Lidocaine

Lidocaine

When Lidocaine HCI 2% Jelly is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.

The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. Although the incidence of adverse effects with Lidocaine HCI 2% Jelly is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

For Surface Anesthesia of the Male Adult Urethra: When using Lidocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube. The cone may be gas sterilized or cold sterilized, as preferred. Slowly instill approximately 15 mL (300 mg of lidocaine HCI) into the urethra or until the patient has a feeling of tension. A penile clamp is then applied for several minutes at the corona. An additional dose of not more than 15 mL (300 mg) can be instilled for adequate anesthesia.

Prior to sounding or cystoscopy, a penile clamp should be applied for 5 to 10 minutes to obtain adequate anesthesia. A total dose of 30 mL (600 mg) is usually required to fill and dilate the male urethra.

Prior to catheterization, smaller volumes of 5 to 10 mL (100 to 200 mg) are usually adequate for lubrication.

For Surface Anesthesia of the Female Adult Urethra: When using Lidocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube. The cone may be gas sterilized or cold sterilized, as preferred. Slowly instill 3 to 5 mL (60 to 100 mg of lidocaine HCI) of the jelly into the urethra. If desired, some jelly may be deposited on a cotton swab and introduced into the urethra. In order to obtain adequate anesthesia, several minutes should be allowed prior to performing urological procedures.

Lubrication for Endotracheal Intubation: Apply a moderate amount of jelly to the external surface of the endotracheal tube shortly before use. Care should be taken to avoid introducing the product into the lumen of the tube. Do not use the jelly to lubricate endotracheal stylettes. See WARNINGS and ADVERSE REACTIONS concerning rare reports of inner lumen occlusion. It is also recommended that use of endotracheal tubes with dried jelly on the external surface be avoided for lack of lubricating effect.
Tobramycin Solution Dro...

Tobramycin Solution Drops

In mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe infections, instill two drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.
Sodium Chloride Solutio...

Sodium Chloride Solution Drops

Instill 1 or 2 drops in the affected eye(s) as needed.
Gentak

Gentak

Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.
Naphazoline

Naphazoline

Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.
Neomycin And Polymyxin ...

Neomycin And Polymyxin B Sulfates

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.
Ful-glo

Ful-glo

To ensure full fluorescence and patient comfort, the Ful-Glo impregnated tip should be moistened before application. One or two drops of sterile irrigation solution should be used for this purpose. Touch conjunctiva or fornix as required with moistened tip. It is recommended that the patient blink several times after application.

NOTE: Contents may not be sterile if individual strip package has been damaged or previously opened. Store below 30°C.
Ful-glo

Ful-glo

To ensure full fluorescence and patient comfort, the Ful-Glo impregnated tip should be moistened before application. One or two drops of sterile irrigation solution should be used for this purpose. Touch conjunctiva or fornix as required with moistened tip. It is recommended that the patient blink several times after application.

NOTE: Contents may not be sterile if individual strip package has been damaged or previously opened. Store below 30°C.
Hydralazine Hydrochlori...

Hydralazine Hydrochloride

When there is urgent need, therapy in the hospitalized patient may be initiated intramuscularly or as a rapid intravenous bolus injection directly into the vein. Hydralazine hydrochloride injection should be used only when the drug cannot be given orally. The usual dose is 20-40 mg, repeated as necessary.

Certain patients (especially those with marked renal damage) may require a lower dose. Blood pressure should be checked frequently. It may begin to fall within a few minutes after injection, with the average maximal decrease occurring in 10-80 minutes. In cases where there has been increased intracranial pressure, lowering the blood pressure may increase cerebral ischemia. Most patients can be transferred to oral hydralazine hydrochloride within 24-48 hours.

The product should be used immediately after the vial is opened. It should not be added to infusion solutions. Hydralazine hydrochloride injection may discolor upon contact with metal; discolored solutions should be discarded.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Bal

Bal

By deep intramuscular injection only. For mild arsenic or gold poisoning, 2.5 mg/kg of body weight four times daily for two days, two times on the third day, and once daily thereafter for ten days; for severe arsenic or gold poisoning, 3 mg/kg every four hours for two-days, four times on the third day, then twice daily thereafter for ten days. For mercury poisoning, 5 mg/kg initially, followed by 2.5 mg/kg one or two times daily for ten days. For acute lead encephalopathy, 4 mg/kg body weight is given alone in the first dose and thereafter at four-hour intervals in combination with Edetate Calcium Disodium Injection USP administered at a separate site. For less severe poisoning the dose can be reduced to 3 mg/kg after the first dose. Treatment is maintained for two to seven days depending on clinical response. Successful treatment depends on beginning injections at the earliest possible moment and on the use of adequate amounts at frequent intervals. Other supportive measures should always be used in conjunction with BAL in Oil (Dimercaprol Injection USP) therapy.

BAL in Oil should be inspected visually for particulate matter and discoloration prior to administration.
Ketotifen Fumarate Solu...

Ketotifen Fumarate Solution Drops

Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day. Children under 3 years of age: Consult a doctor.
Sodium Chloride Ointmen...

Sodium Chloride Ointment

Apply small amount (one-fourth inch) to the inside of affected eye(s) every 3 to 4 hours, or as directed by a doctor.
Orphenadrine Citrate

Orphenadrine Citrate

INJECTION: Adults - One 2 mL vial (60 mg) intravenously or intramuscularly; may be repeated every 12 hours.
A3670 Spinal

A3670 Spinal

2.1 General Dosing Considerations

Take care when prescribing and administering Hydromorphone Hydrochloride Injection (HPF) to avoid dosing errors due to confusion between the different concentrations and between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total volume of the dose.

Selection of patients and administration of hydromorphone hydrochloride injection (HPF) should be governed by the same principles that apply to the use of similar opioid analgesics to treat patients with acute or chronic pain, and depends upon a comprehensive assessment of the patient. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

The nature of the pain (severity, frequency, etiology, and pathophysiology), as well as the medical status of the patient, will affect selection of the starting dosage. Opioid analgesics, including hydromorphone hydrochloride injection (HPF), have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks.

2.2 Individualization of Dosing

Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment. Give attention to the following:
the age, general condition, and medical status of the patient; the patient's degree of opioid tolerance; the daily dose, potency, and specific characteristics of the opioid the patient has been taking previously; concurrent medications the type and severity of the patient's pain risk factors for abuse or addiction; including whether the patient has a previous or current substance abuse problem, a family history of substance abuse, or a history of mental illness or depression; the balance between pain control and adverse reactions.
Periodic reassessment after the initial dosing of hydromorphone hydrochloride injection (HPF) is required. If pain management is not satisfactory, and opioid-induced adverse events are tolerable, the hydromorphone dose may be increased gradually. If excessive opioid side effects are observed early in the dosing interval, reduce the hydromorphone hydrochloride dose. If this results in breakthrough pain at the end of the dosing interval, the dosing interval may need to be shortened. Dose titration should be guided more by the need for analgesia and the severity of adverse events than the absolute dose of opioid employed.

2.3 Initiation of Therapy in Opioid-Naïve Patients

Always initiate dosing in opioid-naïve patients using hydromorphone hydrochloride injection. Never administer hydromorphone hydrochloride injection (HPF) to opioid-naïve patients.

2.3.1 Subcutaneous or Intramuscular Administration

The usual starting dose of hydromorphone hydrochloride injection is 1 mg to 2 mg every 2 to 3 hours as necessary. Depending on the clinical situation, the initial starting dose may be lowered in patients who are opioid naïve. Adjust the dose according to the severity of pain, the severity of adverse events, as well as the patient's underlying disease and age.

2.3.2 Intravenous Administration

The initial starting dose is 0.2 to 1 mg every 2 to 3 hours. Intravenous administration should be given slowly, over at least 2 to 3 minutes, depending on the dose. Titrate the dose to achieve acceptable analgesia and tolerable adverse events. The initial dose should be reduced in the elderly or debilitated and may be lowered to 0.2 mg.

2.3.3 Hepatic Impairment

Start patients with hepatic impairment on one-fourth to one-half the usual hydromorphone hydrochloride injection starting dose depending on the extent of impairment [see CLINICAL PHARMACOLOGY, Pharmacokinetics (12.2)].

2.3.4 Renal Impairment

Start patients with renal impairment on one-fourth to one-half the usual hydromorphone hydrochloride injection starting dose depending on the degree of impairment [see CLINICAL PHARMACOLOGY, Pharmacokinetics (12.2)].

2.4 Conversion From Prior Opioid

Use the equianalgesic dose table below (Table 1) as a guide to determine the appropriate dose of hydromorphone hydrochloride injection (HPF). Convert the current total daily amount(s) of opioid(s) received to an equivalent total daily dose of hydromorphone hydrochloride injection (HPF) and reduce by one-half due to the possibility of incomplete cross tolerance. Divide the new total amount by the number of doses permitted based on dosing interval (e.g., 8 doses for every-three-hour dosing). Titrate the dose according to the patient's response. For opioids not in Table 1, first estimate the daily amount of morphine that is equivalent to the current total daily amount of other opioid(s) received, then use Table 1 to find the approximate equivalent total daily dose of hydromorphone hydrochloride injection (HPF).
Table 1. OPIOID ANALGESIC EQUIVALENTS WITH APPROXIMATELY EQUIANALGESIC POTENCY FOR CONVERSION TO HYDROMORPHONE HCl INJECTION*
*Dosages, and ranges of dosages represented, are a compilation of estimated equipotent dosages from published references comparing opioid analgesics in cancer and severe pain.
DRUG SUBSTANCE PARENTERAL DOSE ORAL DOSE Morphine sulfate 10 mg 40 to 60 mg Hydromorphone HCl 1.3 to 2 mg 6.5 to 7.5 mg Oxymorphone HCl 1 to 1.1 mg 6.6 mg Levorphanol tartrate 2 to 2.3 mg 4 mg Meperidine HCl (Pethidine HCl) 75 to 100 mg 300 to 400 mg Methadone HCl 10 mg 10 to 20 mg Nalbuphine HCl 10 to 12 mg - Butorphanol tartrate 1.5 to 2.5 mg -
2.5 Hydromorphone Hydrochloride Injection (HPF) (for use in opioid-tolerant patients only)

Do not use Hydromorphone Hydrochloride Injection (HPF) for patients who are not tolerant to the respiratory depressant or sedating effects of opioids.

Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

Use Hydromorphone Hydrochloride Injection (HPF) ONLY for patients who require the higher concentration and lower total volume of Hydromorphone Hydrochloride Injection (HPF).

Because of its high concentration, the delivery of precise doses of hydromorphone hydrochloride injection (HPF) may be difficult if low doses of hydromorphone are required. Therefore, use hydromorphone hydrochloride injection (HPF) only if the amount of hydromorphone required can be delivered accurately with this formulation.

Base the starting dose for hydromorphone hydrochloride injection (HPF) on the prior dose of hydromorphone hydrochloride injection or on the prior dose of an alternate opioid as described above in Section 2.4 Conversion From Prior Opioid and Table 1.

2.6 Administration and Reconstitution

Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. A slight yellowish discoloration may develop in hydromorphone hydrochloride injection (HPF) ampules. No loss of potency has been demonstrated. Hydromorphone hydrochloride injection (HPF) are physically compatible and chemically stable for at least 24 hours at 25°C, protected from light in most common large-volume parenteral solutions.

500 mg/50 mL Vial

To use this single dose presentation, do not penetrate the stopper with a syringe. Instead, remove both the aluminum flipseal and rubber stopper in a suitable work area, such as under a laminar flow hood (or equivalent clean air compounding area). The contents may then be withdrawn for preparation of a single, large-volume parenteral solution. Discard any unused portion in an appropriate manner.
Ak-poly-bac

Ak-poly-bac

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.
Neomycin And Polymyxin ...

Neomycin And Polymyxin B Sulfates

Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition.

Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
Gentamicin Sulfate Solu...

Gentamicin Sulfate Solution Drops

Gentamicin Sulfate sterile ophthalmic solution; Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops once every hour.
Chlorothiazide Sodium

Chlorothiazide Sodium

Chlorothiazide Sodium for Injection should be reserved for patients unable to take oral medication or for emergency situations.

Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.

Intravenous use in infants and children has been limited and is not generally recommended.

When medication can be taken orally, therapy with chlorothiazide tablets or oral suspension may be substituted for intravenous therapy, using the same dosage schedule as for the parenteral route.

Chlorothiazide Sodium for Injection may be given slowly by direct intravenous injection or by intravenous infusion.

Extravasation must be rigidly avoided. Do not give subcutaneously or intramuscularly.

The usual adult dosage is 500 mg to 1 g once or twice a day. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.

Directions for Reconstitution

Use aseptic technique. Because Chlorothiazide Sodium for Injection contains no preservative, a fresh solution should be prepared immediately prior to each administration, and the unused portion should be discarded.

Add 18 mL of Sterile Water for Injection to the vial to form an isotonic solution for intravenous injection. Never add less than 18 mL. When reconstituted with 18 mL of Sterile Water, the final concentration of chlorothiazide sodium is 28 mg/mL. The reconstituted solution is clear and essentially free from visible particles. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit. The solution is compatible with dextrose or sodium chloride solutions for intravenous infusion. Avoid simultaneous administration of solutions of chlorothiazide with whole blood or its derivatives.
Midazolam

Midazolam

Midazolam injection is a potent sedative agent that requires slow administration and individualization of dosage. Clinical experience has shown midazolam to be 3 to 4 times as potent per mg as diazepam. BECAUSE SERIOUS AND LIFE-THREATENING CARDIORESPIRATORY ADVERSE EVENTS HAVE BEEN REPORTED, PROVISION FOR MONITORING, DETECTION AND CORRECTION OF THESE REACTIONS MUST BE MADE FOR EVERY PATIENT TO WHOM MIDAZOLAM INJECTION IS ADMINISTERED, REGARDLESS OF AGE OR HEALTH STATUS. Excessive single doses or rapid intravenous administration may result in respiratory depression, airway obstruction and/or arrest. The potential for these latter effects is increased in debilitated patients, those receiving concomitant medications capable of depressing the CNS, and patients without an endotracheal tube but undergoing a procedure involving the upper airway such as endoscopy or dental (see Boxed WARNING and WARNINGS).

Reactions such as agitation, involuntary movements, hyperactivity and combativeness have been reported in adult and pediatric patients. Should such reactions occur, caution should be exercised before continuing administration of midazolam (see WARNINGS).

Midazolam injection should only be administered IM or IV (see WARNINGS).

Care should be taken to avoid intra-arterial injection or extravasation (see WARNINGS).

Midazolam injection may be mixed in the same syringe with the following frequently used premedications: morphine sulfate, meperidine, atropine sulfate or scopolamine. Midazolam, at a concentration of 0.5 mg/mL, is compatible with 5% dextrose in water and 0.9% sodium chloride for up to 24 hours and with lactated Ringer's solution for up to 4 hours. Both the 1 mg/mL and 5 mg/ mL formulations of midazolam may be diluted with 0.9% sodium chloride or 5% dextrose in water.

MONITORING:

Patient response to sedative agents, and resultant respiratory status, is variable. Regardless of the intended level of sedation or route of administration, sedation is a continuum; a patient may move easily from light to deep sedation, with potential loss of protective reflexes. This is especially true in pediatric patients. Sedative doses should be individually titrated, taking into account patient age, clinical status and concomitant use of other CNS depressants. Continuous monitoring of respiratory and cardiac function is required (i.e., pulse oximetry).

Adults and Pediatrics: Sedation guidelines recommend a careful presedation history to determine how a patient's underlying medical conditions or concomitant medications might affect their response to sedation/analgesia as well as a physical examination including a focused examination of the airway for abnormalities. Further recommendations include appropriate presedation fasting.

Titration to effect with multiple small doses is essential for safe administration. It should be noted that adequate time to achieve peak central nervous system effect (3 to 5 minutes) for midazolam should be allowed between doses to minimize the potential for oversedation. Sufficient time must elapse between doses of concomitant sedative medications to allow the effect of each dose to be assessed before subsequent drug administration. This is an important consideration for all patients who receive intravenous midazolam.

Immediate availability of resuscitative drugs and age- and size-appropriate equipment and personnel trained in their use and skilled in airway management should be assured (see WARNINGS).

Pediatrics: For deeply sedated pediatric patients a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedure.

Intravenous access is not thought to be necessary for all pediatric patients sedated for a diagnostic or therapeutic procedure because in some cases the difficulty of gaining IV access would defeat the purpose of sedating the child; rather, emphasis should be placed upon having the intravenous equipment available and a practitioner skilled in establishing vascular access in pediatric patients immediately available.
USUAL ADULT DOSE INTRAMUSCULARLYFor preoperative sedation/anxiolysis/amnesia (induction of sleepiness or drowsiness and relief of apprehension and to impair memory of perioperative events).For intramuscular use, midazolam should be injected deep in a large muscle mass. The recommended premedication dose of midazolam for good risk (ASA Physical Status I & II) adult patients below the age of 60 years is 0.07 to 0.08 mg/kg IM (approximately 5 mg IM) administered up to 1 hour before surgery.The dose must be individualized and reduced when IM midazolam is administered to patients with chronic obstructive pulmonary disease, other higher risk surgical patients, patients 60 or more years of age, and patients who have received concomitant narcotics or other CNS depressants (see ADVERSE REACTIONS). In a study of patients 60 years or older, who did not receive concomitant administration of narcotics, 2 to 3 mg (0.02 to 0.05 mg/kg) of midazolam produced adequate sedation during the preoperative period. The dose of 1 mg IM midazolam may suffice for some older patients if the anticipated intensity and duration of sedation is less critical. As with any potential respiratory depressant, these patients require observation for signs of cardiorespiratory depression after receiving IM midazolam.Onset is within 15 minutes, peaking at 30 to 60 minutes. It can be administered concomitantly with atropine sulfate or scopolamine hydrochloride and reduced doses of narcotics. INTRAVENOUSLYSedation /anxiolysis/amnesia for procedures (see INDICATIONS): Narcotic premedication results in less variability in patient response and a reduction in dosage of midazolam. For peroral procedures, the use of an appropriate topical anesthetic is recommended. When used for sedation/anxiolysis/amnesia for a procedure, dosage must be individualized and titrated.Midazolam should always be titrated slowly; administer over at least 2 minutes and allow an additional 2 or more minutes to fully evaluate the sedative effect. Individual response will vary with age, physical status and concomitant medications, but may also vary independent of these factors. (See WARNINGS concerning cardiac/respiratory arrest/airway obstruction/hypoventilation.) For bronchoscopic procedures, the use of narcotic premedication is recommended. Midazolam 1 mg/mL formulation is recommended for sedation/anxiolysis/amnesia for procedures to facilitate slower injection.Both the 1 mg/mL and the 5 mg/mL formulations may be diluted with 0.9% sodium chloride or 5% dextrose in water. Healthy Adults Below the Age of 60: Titrate slowly to the desired effect, e.g., the initiation of slurred speech. Some patients may respond to as little as 1 mg. No more than 2.5 mg should be given over a period of at least 2 minutes. Wait an additional 2 or more minutes to fully evaluate the sedative effect. If further titration is necessary, continue to titrate, using small increments, to the appropriate level of sedation. Wait an additional 2 or more minutes after each increment to fully evaluate the sedative effect. A total dose greater than 5 mg is not usually necessary to reach the desired endpoint. If narcotic premedication or other CNS depressants are used, patients will require approximately 30% less midazolam than unpremedicated patients. Patients Age 60 or Older, and Debilitated or Chronically Ill Patients: Because the danger of hypoventilation, airway obstruction, or apnea is greater in elderly patients and those with chronic disease states or decreased pulmonary reserve, and because the peak effect may take longer in these patients, increments should be smaller and the rate of injection slower. Titrate slowly to the desired effect, e.g, the initiation of slurred speech. Some patients may respond to as little as 1 mg. No more than 1.5 mg should be given over a period of no less than 2 minutes. Wait an additional 2 or more minutes to fully evaluate the sedative effect. If additional titration is necessary, it should be given at a rate of no more than 1 mg over a period of 2 minutes, waiting an additional 2 or more minutes each time to fully evaluate the sedative effect. Total doses greater than 3.5 mg are not usually necessary. If concomitant CNS depressant premedications are used in these patients, they will require at least 50% less midazolam than healthy young unpremedicated patients. Maintenance Dose: Additional doses to maintain the desired level of sedation may be given in increments of 25% of the dose used to first reach the sedative endpoint, but again only by slow titration, especially in the elderly and chronically ill or debilitated patient. These additional doses should be given only after a thorough clinical evaluation clearly indicates the need for additional sedation. Induction of Anesthesia:For induction of general anesthesia, before administration of other anesthetic agents. Individual response to the drug is variable, particularly when a narcotic premedication is not used. The dosage should be titrated to the desired effect according to the patient's age and clinical status.When midazolam is used before other intravenous agents for induction of anesthesia, the initial dose of each agent may be significantly reduced, at times to as low as 25% of the usual initial dose of the individual agents.Unpremedicated Patients: In the absence of premedication, an average adult under the age of 55 years will usually require an initial dose of 0.3 to 0.35 mg/kg for induction, administered over 20 to 30 seconds and allowing 2 minutes for effect. If needed to complete induction, increments of approximately 25% of the patient's initial dose may be used; induction may instead be completed with inhalational anesthetics. In resistant cases, up to 0.6 mg/kg total dose may be used for induction, but such larger doses may prolong recovery.Unpremedicated patients over the age of 55 years usually require less midazolam for induction; an initial dose of 0.3 mg/kg is recommended. Unpremedicated patients with severe systemic disease or other debilitation usually require less midazolam for induction. An initial dose of 0.2 to 0.25 mg/kg will usually suffice; in some cases, as little as 0.15 mg/kg may suffice. Premedicated Patients: When the patient has received sedative or narcotic premedication, particularly narcotic premedication, the range of recommended doses is 0.15 to 0.35 mg/kg.In average adults below the age of 55 years, a dose of 0.25 mg/kg, administered over 20 to 30 seconds and allowing 2 minutes for effect, will usually suffice.The initial dose of 0.2 mg/kg is recommended for good risk (ASA I & II) surgical patients over the age of 55 years.In some patients with severe systemic disease or debilitation, as little as 0.15 mg/kg may suffice.Narcotic premedication frequently used during clinical trials included fentanyl (1.5 to 2 mcg/kg IV, administered 5 minutes before induction), morphine (dosage individualized, up to 0.15 mg/kg IM), and meperidine (dosage individualized, up to 1 mg/kg IM). Sedative premedications were hydroxyzine pamoate (100 mg orally) and sodium secobarbital (200 mg orally). Except for intravenous fentanyl, administered 5 minutes before induction, all other premedications should be administered approximately 1 hour prior to the time anticipated for midazolam induction. Injectable midazolam can also be used during maintenance of anesthesia, for surgical procedures, as a component of balanced anesthesia.Effective narcotic premedication is especially recommended in such cases. Incremental injections of approximately 25% of the induction dose should be given in response to signs of lightening of anesthesia and repeated as necessary. CONTINUOUS INFUSIONFor continuous infusion, midazolam 5 mg/mL formulation is recommended diluted to a concentration of 0.5 mg/mL with 0.9% sodium chloride or 5% dextrose in water. Usual Adult Dose: If a loading dose is necessary to rapidly initiate sedation, 0.01 to 0.05 mg/kg (approximately 0.5 to 4 mg for a typical adult) may be given slowly or infused over several minutes. This dose may be repeated at 10 to 15 minute intervals until adequate sedation is achieved. For maintenance of sedation, the usual initial infusion rate is 0.02 to 0.1 mg/kg/hr (1 to 7 mg/hr). Higher loading or maintenance infusion rates may occasionally be required in some patients. The lowest recommended doses should be used in patients with residual effects from anesthetic drugs, or in those concurrently receiving other sedatives or opioids.Individual response to midazolam is variable. The infusion rate should be titrated to the desired level of sedation, taking into account the patient's age, clinical status and current medications. In general, midazolam should be infused at the lowest rate that produces the desired level of sedation. Assessment of sedation should be performed at regular intervals and the midazolam infusion rate adjusted up or down by 25% to 50% of the initial infusion rate so as to assure adequate titration of sedation level.Larger adjustments or even a small incremental dose may be necessary if rapid changes in the level of sedation are indicated. In addition, the infusion rate should be decreased by 10% to 25% every few hours to find the minimum effective infusion rate. Finding the minimum effective infusion rate decreases the potential accumulation of midazolam and provides for the most rapid recovery once the infusion is terminated. Patients who exhibit agitation, hypertension, or tachycardia in response to noxious stimulation, but who are otherwise adequately sedated, may benefit from concurrent administration of an opioid analgesic. Addition of an opioid will generally reduce the minimum effective midazolam infusion rate. PEDIATRIC PATIENTS UNLIKE ADULT PATIENTS, PEDIATRIC PATIENTS GENERALLY RECEIVE INCREMENTS OF MIDAZOLAM ON A MG/KG BASIS. As a group, pediatric patients generally require higher dosages of midazolam (mg/kg) than do adults. Younger (less than six years) pediatric patients may require higher dosages (mg/kg) than older pediatric patients, and may require close monitoring (see tables below). In obese PEDIATRIC PATIENTS, the dose should be calculated based on ideal body weight. When midazolam is given in conjunction with opioids or other sedatives, the potential for respiratory depression, airway obstruction, or hypoventilation is increased. For appropriate patient monitoring, see Boxed WARNING, WARNINGS Monotoring subsection of DOSAGE AND ADMINISTRATION. The health care practitioner who uses this medication in pediatric patients should be aware of and follow accepted professional guidelines for pediatric sedation appropriate to their situation. OBSERVER'S ASSESSMENT OF ALERTNESS/SEDATION (OAA/S) Assessment Categories Responsiveness Speech Facial Expression Eyes Composite Score Responds readily to name spoken in normal tone normal normal clear, no ptosis 5 (alert) Lethargic response to name spoken in normal tone mild slowing or thickening mild relaxation glazed or mild ptosis (less than half the eye) 4 Responds only after name is called loudly and/or repeatedly slurring or prominent slowing marked relaxation (slack jaw) glazed and marked ptosis (half the eye or more) 3 Responds only after mild prodding or shaking few recognizable words ----- ----- 2 Does not respond to mild prodding or shaking ----- ----- ----- 1 (deep sleep) FREQUENCY OF OBSERVER'S ASSESSMENT OF ALERTNESS/SEDATION COMPOSITE SCORES IN ONE STUDY OF CHILDREN UNDERGOING PROCEDURES WITH INTRAVENOUS MIDAZOLAM FOR SEDATION Age Range (years) n OAA/S Score 1 2 3 4 5 (deep sleep) (alert) 1-2 16 6 4 3 3 0 (38%) (25%) (19%) (19%) >2-5 22 9 5 8 0 0 (41%) (23%) (36%) >5-12 34 1 6 22 5 0 (3%) (18%) (65%) (15%) >12-17 18 0 4 14 0 0 (22%) (78%) Total (1-17) 90 16 19 47 8 0 (18%) (21%) (52%) (9%) INTRAMUSCULARLY USUAL PEDIATRIC DOSE (NON-NEONATAL) For sedation/anxiolysis/amnesia prior to anesthesia or for procedures, intramuscular midazolam can be used to sedate pediatric patients to facilitate less traumatic insertion of an intravenous catheter for titration of additional medication. Sedation after intramuscular midazolam is age and dose dependent: higher doses may result in deeper and more prolonged sedation.Doses of 0.1 to 0.15 mg/kg are usually effective and do not prolong emergence from general anesthesia. For more anxious patients, doses up to 0.5 mg/kg have been used. Although not systematically studied, the total dose usually does not exceed 10 mg.If midazolam is given with an opioid, the initial dose of each must be reduced. INTRAVENOUSLY BY INTERMITTENT INJECTIONFor sedation/anxiolysis/amnesia prior to and during procedures or prior to anesthesia. USUAL PEDIATRIC DOSE(NON-NEONATAL)It should be recognized that the depth of sedation/anxiolysis needed for pediatric patients depends on the type of procedure to be performed. For example, simple light sedation/anxiolysis in the preoperative period is quite different from the deep sedation and analgesia required for an endoscopic procedure in a child. For this reason, there is a broad range of dosage. For all pediatric patients, regardless of the indications for sedation/anxiolysis, it is vital to titrate midazolam and other concomitant medications slowly to the desired clinical effect. The initial dose of midazolam should be administered over 2 to 3 minutes. Since midazolam is water soluble, it takes approximately three times longer than diazepam to achieve peak EEG effects; therefore one must wait an additional 2 to 3 minutes to fully evaluate the sedative effect before initiating a procedure or repeating a dose. If further sedation is necessary, continue to titrate with small increments until the appropriate level of sedation is achieved. If other medications capable of depressing the CNS are coadministered, the peak effect of those concomitant medications must be considered and the dose of midazolam adjusted. The importance of drug titration to effect is vital to the safe sedation/anxiolysis of the pediatric patient. The total dose of midazolam will depend on patient response, the type and duration of the procedure, as well as the type and dose of concomitant medications. Pediatric patients Less Than 6 months of age: Limited information is available in non-intubated pediatric patients less than 6 months of age. It is uncertain when the patient transfers from neonatal physiology to pediatric physiology, therefore the dosing recommendations are unclear. Pediatric patients less than 6 months of age are particularly vulnerable to airway obstruction and hypoventilation, therefore titration with small increments to clinical effect and careful monitoring are essential. Pediatric patients 6 months to 5 years of age: Initial dose 0.05 to 0.1 mg/kg; A total dose up to 0.6 mg/kg may be necessary to reach the desired endpoint but usually does not exceed 6 mg. Prolonged sedation and risk of hypoventilation may be associated with the higher doses. Pediatric patients 6 to 12 years of age: Initial dose 0.025 to 0.05 mg/kg; total dose up to 0.4 mg/kg may be needed to reach the desired endpoint but usually does not exceed 10 mg. Prolonged sedation and risk of hypoventilation may be associated with the higher doses. Pediatric patients 12 to 16 years of age: Should be dosed as adults. Prolonged sedation may be associated with higher doses; some patients in this age range will require higher than recommended adult doses but the total dose usually does not exceed 10 mg.
The dose of midazolam must be reduced in patients premedicated with opioid or other sedative agents including midazolam. Higher risk or debilitated patients may require lower dosages whether or not concomitant sedating medications have been administered (see WARNINGS).
CONTINUOUS INTRAVENOUS INFUSIONFor sedation/anxiolysis/amnesia in critical care settings. USUAL PEDIATRIC DOSE (NON-NEONATAL)To initiate sedation, an intravenous loading dose of 0.05 to 0.2 mg/kg administered over at least 2 to 3 minutes can be used to establish the desired clinical effect IN PATIENTS WHOSE TRACHEA IS INTUBATED. (Midazolam should not be administered as a rapid intravenous dose.) This loading dose may be followed by a continuous intravenous infusion to maintain the effect. An infusion of midazolam has been used in patients whose trachea was intubated but who were allowed to breathe spontaneously.Assisted ventilation is recommended for pediatric patients who are receiving other central nervous system depressant medications such as opioids. Based on pharmacokinetic parameters and reported clinical experience, continuous intravenous infusions of midazolam should be initiated at a rate of 0.06 to 0.12 mg/kg/hr (1 to 2 mcg/kg/min). The rate of infusion can be increased or decreased (generally by 25% of the initial or subsequent infusion rate) as required, or supplemental intravenous doses of midazolam can be administered to increase or maintain the desired effect. Frequent assessment at regular intervals using standard pain/sedation scales is recommended. Drug elimination may be delayed in patients receiving erythromycin and/or other P450-3A4 enzyme inhibitors (see PRECAUTIONS: Drug Interactions) and in patients with liver dysfunction, low cardiac output (especially those requiring inotropic support), and in neonates. Hypotension may be observed in patients who are critically ill, particularly those receiving opioids and/or when midazolam is rapidly administered. When initiating an infusion with midazolam in hemodynamically compromised patients, the usual loading dose of midazolam should be titrated in small increments and the patient monitored for hemodynamic instability, e.g., hypotension. These patients are also vulnerable to the respiratory depressant effects of midazolam and require careful monitoring of respiratory rate and oxygen saturation. CONTINUOUS INTRAVENOUS INFUSIONFor sedation in critical care settings. USUAL NEONATAL DOSEBased on pharmacokinetic parameters and reported clinical experience in preterm and term neonates WHOSE TRACHEA WAS INTUBATED, continuous intravenous infusions of midazolam injection should be initiated at a rate of 0.03 mg/kg/hr (0.5 mcg/kg/min) in neonates <32 weeks and 0.06 mg/kg/hr (1 mcg/kg/min) in neonates >32 weeks.Intravenous loading doses should not be used in neonates, rather the infusion may be run more rapidly for the first several hours to establish therapeutic plasma levels. The rate of infusion should be carefully and frequently reassessed, particularly after the first 24 hours so as to administer the lowest possible effective dose and reduce the potential for drug accumulation. This is particularly important because of the potential for adverse effects related to metabolism of the benzyl alcohol (see WARNINGS: Usage in Preterm Infants and Neonates). Hypotension may be observed in patients who are critically ill and in preterm and term infants, particularly those receiving fentanyl and/or when midazolam is administered rapidly. Due to an increased risk of apnea, extreme caution is advised when sedating preterm and former preterm patients whose trachea is not intubated.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Paremyd

Paremyd

One to two drops in the conjunctival sac. The onset of action with PAREMYD® Solution occurs within 15 minutes followed by maximum effect within 60 minutes. Clinically significant dilation, inhibition of pupillary light response, and partial cycloplegia last 3 hours.

Mydriasis will reverse spontaneously with time, typically in 6 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.
A3661-20 Single Shot Ep...

A3661-20 Single Shot Epidural 20g Tuohy

Adult Administration:

For intravenous use only. The optimal dose of doxercalciferol injection must be carefully determined for each patient.

The recommended initial dose of doxercalciferol injection is 4 mcg administered intravenously as a bolus dose three times weekly at the end of dialysis (approximately every other day). The initial dose should be adjusted, as needed, in order to lower blood iPTH into the range of 150 to 300 pg/mL. The dose may be increased at 8-week intervals by 1 to 2 mcg if iPTH is not lowered by 50% and fails to reach the target range. Dosages higher than 18 mcg weekly have not been studied. Drug administration should be suspended if iPTH falls below 100 pg/mL and restarted one week later at a dose that is at least 1 mcg lower than the last administered dose. During titration, iPTH, serum calcium, and serum phosphorus levels should be obtained weekly. If hypercalcemia, hyperphosphatemia, or a serum calcium times phosphorus product greater than 55 mg2/dL2 is noted, the dose of doxercalciferol should be decreased or suspended and/or the dose of phosphate binders should be appropriately adjusted. If suspended, the drug should be restarted at a dose that is 1 mcg lower.

Dosing must be individualized and based on iPTH levels with monitoring of serum calcium and serum phosphorus levels. Table 5 presents a suggested approach in dose titration.
Table 5: Initial Dosing iPTH Level Doxercalciferol Injection Dose >400 pg/mL 4 mcg three times per week at the end of dialysis, or approximately every other day Dose Titration iPTH Level Doxercalciferol Injection Dose Decrease by <50% and above 300 pg/mL Increase by 1 to 2 mcg at eight-week intervals as necessary Decrease by >50% and above 300 pg/mL Maintain 150 to 300 pg/mL Maintain <100 pg/mL Suspend for one week, then resume at a dose that is at least 1 mcg lower
Nedocromil Sodium Solut...

Nedocromil Sodium Solution Drops

The recommended dosage is one or two drops in each eye twice a day. Nedocromil Ophthalmic Solution 2% should be used at regular intervals.

Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.
Green Guard Ibupro Reli...

Green Guard Ibupro Relief

The recommended Adenosine Injection dose is 0.14 mg/kg/min infused over six minutes (total dose of 0.84 mg/kg) (Table 1).
Administer adenosine only as a continuous peripheral intravenous infusion Inject Thallium-201 at the midpoint of the adenosine infusion (i.e., after the first three minutes of adenosine) Thallium-201 is physically compatible with adenosine and may be injected directly into the adenosine infusion set Inject Thallium-201 as close to the venous access as possible to prevent an inadvertent increase in the dose of adenosine (the contents of the intravenous tubing) being administered
Visually inspect adenosine for particulate matter and discoloration prior to administration. Do not administer adenosine if it contains particulate matter or is discolored.

There are no data on the safety or efficacy of alternative adenosine infusion protocols. The safety and efficacy of adenosine administered by the intracoronary route have not been established.
Table 1 Dosage Chart for Adenosine Injection Patient Weight (kilograms) Infusion Rate (mL per minute over 6 minutes for total dose of 0.84 mg/kg) 45 2.1 50 2.3 55 2.6 60 2.8 65 3 70 3.3 75 3.5 80 3.8 85 4 90 4.2
The nomogram displayed in Table 1 was derived from the following general formula:

0.14 (mg/kg/min) x total body weight (kg) = Infusion rate Adenosine concentration (mL/min) (3 mg/mL)
Lubricant Eye

Lubricant Eye

Pull down lower lid of the affected eye(s) and apply small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a doctor.
Naphazoline Hydrochlori...

Naphazoline Hydrochloride And Pheniramine Maleate Solution Drops

adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to four times a day children under 6 years of age: consult a doctor
Hydralazine Hydrochlori...

Hydralazine Hydrochloride

When there is urgent need, therapy in the hospitalized patient may be initiated intramuscularly or as a rapid intravenous bolus injection directly into the vein. Hydralazine Hydrochloride Injection should be used only when the drug cannot be given orally. The usual dose is 20 to 40 mg, repeated as necessary.

Certain patients (especially those with marked renal damage) may require a lower dose. Blood pressure should be checked frequently. It may begin to fall within a few minutes after injection, with the average maximal decrease occurring in 10 to 80 minutes. In cases where there has been increased intracranial pressure, lowering the blood pressure may increase cerebral ischemia. Most patients can be transferred to oral hydralazine hydrochloride within 24 to 48 hours.

The product should be used immediately after the vial is opened. It should not be added to infusion solutions. Hydralazine Hydrochloride Injection may discolor upon contact with metal; discolored solutions should be discarded.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Lidocaine And Prilocain...

Lidocaine And Prilocaine

Adult Patients-Intact Skin

A thick layer of lidocaine and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION).

Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine and prilocaine cream (1/2 the 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.

Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.

Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream.

Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.

Adult Female Patients-Genital Mucous Membranes

For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of lidocaine and prilocaine cream for 5 to 10 minutes.

Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine and prilocaine cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream.

Pediatric Patients-Intact Skin

The following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream based on a child's age and weight:
Age and Body WeightRequirements Maximum TotalDose of Lidocaine andPrilocaine Cream MaximumApplication Area MaximumApplication Time 0 up to 3 months or < 5 kg 1 g 10 cm2 1 hour 3 up to 12 months and > 5 kg 2 g 20 cm2 4 hours 1 to 6 years and > 10 kg 10 g 100 cm2 4 hours 7 to 12 years and 20 kg 20 g 200 cm2 4 hours
Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream should be restricted to that which corresponds to the patient's weight (see INSTRUCTIONS FOR APPLICATION).

Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream (see PRECAUTIONS).

When applying lidocaine and prilocaine cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.

Lidocaine and prilocaine cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).

When lidocaine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine and prilocaine cream is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).

Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
Erythromycin Ointment

Erythromycin Ointment

In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Opthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection.

For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.
Dehydrated Alcohol

Dehydrated Alcohol

The dosage of Dehydrated Alcohol Injection, USP for therapeutic nerve or ganglion block varies from as little as 0.05 to 0.5 mL in trigeminal neuralgia to 0.5 to 1.0 mL per interspace for subarachnoid injections. Doses larger than 1.5 mL are seldom required. All injections should be made slowly and only after all steps have been taken to insure precise placement of the alcohol. A 1.0 mL tuberculin syringe is desirable to facilitate accurate measurement of the dose. Separate needles should be used for injection of successive interspaces or other sites. Since Dehydrated Alcohol Injection, USP is hypobaric as compared to spinal fluid, proper positioning of the patient is essential to control localization of injections into the subarachnoid space.

When lesser concentrations of alcohol are used, larger volumes are usually injected. A dose of 2 mL of 45% alcohol has been used for injecting individual motor nerves, or from 1.5 to 4.0 mL for epidural injection in children with spastic cerebral palsy; 50 mL of 50% alcohol has been used for celiac plexus blockade.

The LD50 oral dose in rats is 13.7 g/kg.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.
Gentak

Gentak

Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.
Ephedrine Sulfate

Ephedrine Sulfate

ADULTS - The usual parenteral dose is 25 to 50 mg given subcutaneously or intramuscularly. Intravenously, 5 to 25 mg may be administered slowly, repeated in 5 to 10 minutes, if necessary.

CHILDREN - The usual subcutaneous or intramuscular dose is 0.5 mg/kg of body weight or 16.7 mg/square meter of body surface every 4 to 6 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Gentamicin Sulfate Solu...

Gentamicin Sulfate Solution Drops

Gentamicin Sulfate sterile ophthalmic solution; Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops once every hour.
Indigo Carmine

Indigo Carmine

Indigo Carmine solution is injected either by the intravenous or intramuscular route, and its appearance at the ureteral orifices is watched with the cystoscope in place. The intravenous method is preferred because a 5 mL injection is sufficient. A lesser dosage in infants, children and underweight patients will prevent skin coloration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

PROTECT FROM LIGHT

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Diltiazem Hydrochloride...

Diltiazem Hydrochloride

Direct Intravenous Single Injections (Bolus)

The initial dose of diltiazem hydrochloride injection should be 0.25 mg/kg actual body weight as a bolus administered over 2 minutes (20 mg is a reasonable dose for the average patient). If response is inadequate, a second dose may be administered after 15 minutes. The second bolus dose of diltiazem hydrochloride injection should be 0.35 mg/kg actual body weight administered over 2 minutes (25 mg is a reasonable dose for the average patient). Subsequent intravenous bolus doses should be individualized for each patient. Patients with low body weights should be dosed on a mg/kg basis. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. Experience with this dose is limited.

Continuous Intravenous Infusion

For continued reduction of the heart rate (up to 24 hours) in patients with atrial fibrillation or atrial flutter, an intravenous infusion of diltiazem hydrochloride injection may be administered. Immediately following bolus administration of 20 mg (0.25 mg/kg) or 25 mg (0.35 mg/kg) diltiazem hydrochloride injection and reduction of heart rate, begin an intravenous infusion of diltiazem hydrochloride injection. The recommended initial infusion rate of diltiazem hydrochloride injection is 10 mg/h. Some patients may maintain response to an initial rate of 5 mg/h. The infusion rate may be increased in 5 mg/h increments up to 15 mg/h as needed, if further reduction in heart rate is required, the infusion may be maintained for up to 24 hours.

Diltiazem shows dose-dependent, non-linear pharmacokinetics. Duration of infusion longer than 24 hours and infusion rates greater than 15 mg/h have not been studied. Therefore, infusion duration exceeding 24 hours and infusion rates exceeding 15 mg/h are not recommended.

Dilution: To prepare diltiazem hydrochloride injection for continuous intravenous infusion aseptically transfer the appropriate quantity (see chart) of diltiazem hydrochloride injection to the desired volume of either Normal Saline, D5W, or D5W/0.45% NaCl. Mix thoroughly. Use within 24 hours. Keep refrigerated until use.

* 5 mg/h may be appropriate for some patients.
Diluent Volume Quantity of Diltiazem Hydrochloride Injection to Add Final Concentration Administration Dose* Infusion Rate 100 mL 125 mg (25 mL) 1 mg/mL 10 mg/h 10 mL/h 15 mg/h 15 mL/h 250 mL 250 mg (50 mL) 0.83 mg/mL 10 mg/h 12 mL/h 15 mg/h 18 mL/h 500 mL 250 mg (50 mL) 0.45 mg/mL 10 mg/h 22 mL/h 15 mg/h 33 mL/h
Diltiazem hydrochloride injection was tested for compatibility with three commonly used intravenous fluids at a maximal concentration of 1 mg diltiazem hydrochloride per milliliter. Diltiazem hydrochloride injection was found to be physically compatible and chemically stable in the following parenteral solutions for at least 24 hours when stored in glass or polyvinylchloride (PVC) bags at controlled room temperature 15° to 30°C (59° to 86°F) or under refrigeration 2° to 8°C (36° to 46°F).
dextrose (5%) injection USP sodium chloride (0.9%) injection USP dextrose (5%) and sodium chloride (0.45%) injection USP
Because of potential physical incompatibilities, it is recommended that diltiazem hydrochloride injection not be mixed with any other drugs in the same container.

If possible, it is recommended that diltiazem hydrochloride injection not be co-infused in the same intravenous line.

Physical incompatibilities (precipitate formation or cloudiness) were observed when diltiazem hydrochloride injection was infused in the same intravenous line with the following drugs: acetazolamide, acyclovir, aminophylline, ampicillin, ampicillin sodium/sulbactam sodium, cefamandole, cefoperazone, diazepam, furosemide, hydrocortisone, sodium succinate, insulin (regular: 100 units/mL), methylprednisolone sodium succinate, mezlocillin, nafcillin, phenytoin, rifampin, and sodium bicarbonate.

Parental drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Transition to Further Antiarrhythmic Therapy

Transition to other antiarrhythmic agents following administration of diltiazem hydrochloride injection is generally safe. However, reference should be made to the respective agent manufacturer's package insert for information relative to dosage and administration.

In controlled clinical trials, therapy with antiarrhythmic agents to maintain reduced heart rate in atrial fibrillation or atrial flutter or for prophylaxis of PSVT was generally started within 3 hours after bolus administration of diltiazem hydrochloride injection. These antiarrhythmic agents were intravenous or oral digoxin, Class I antiarrhythmics (eg, quinidine, procainamide), calcium channel blockers, and oral beta-blockers.

Experience in the use of antiarrhythmic agents following maintenance infusion of diltiazem hydrochloride injection is limited. Patients should be dosed on an individual basis and reference should be made to respective manufacturer's package insert for information relative to dosage and administration.
Progesterone

Progesterone

Prevention of Endometrial Hyperplasia

Progesterone Capsules should be given as a single daily dose at bedtime, 200 mg orally for 12 days sequentially per 28-day cycle, to a postmenopausal woman with a uterus who is receiving daily conjugated estrogens tablets.

Treatment of Secondary Amenorrhea

Progesterone Capsules may be given as a single daily dose of 400 mg at bedtime for 10 days.

Some women may experience difficulty swallowing Progesterone Capsules. For these women, Progesterone Capsules should be taken with a glass of water while in the standing position.
Clindamycin

Clindamycin

If diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).

Adults

Parenteral (IV Administration): Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens):

600 to 1200 mg/day in 2, 3 or 4 equal doses.

More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens:

1200 to 2700 mg/day in 2, 3 or 4 equal doses.

For more serious infections, these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Infusion Rates section below.

Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:
To maintain serum Maintenance clindamycin levels Rapid infusion rate infusion rate Above 4 mcg/mL 10 mg/min for 30 min 0.75 mg/min Above 5 mcg/mL 15 mg/min for 30 min 1.00 mg/min Above 6 mcg/mL 20 mg/min for 30 min 1.25 mg/min
Neonates (less than 1 month)

15 to 20 mg/kg/day in 3 to 4 equal doses. The lower dosage may be adequate for small prematures.

Pediatric patients 1 month of age to 16 years

Parenteral (IV) Administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.

Parenteral therapy may be changed to oral clindamycin palmitate hydrochloride for oral solution or clindamycin hydrochloride capsules when the condition warrants and at the discretion of the physician.

In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

Infusion Rates

Infusion rates for Clindamycin in 5% Dextrose Injection should not exceed 30 mg per minute. The usual infusion rates are as follows:
Dose Strength Time 300 mg/50 mL 6 mg/mL 10 min 600 mg/50 mL 12 mg/mL 20 min 900 mg/50 mL 18 mg/mL 30 min
Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Compatibility

Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of clindamycin in 5% dextrose injection in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.
Latanoprost Solution Dr...

Latanoprost Solution Drops

The recommended dosage is one drop (1.5 μg) in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal.

The dosage of Latanoprost Ophthalmic Solution, 0.005% should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including Latanoprost Ophthalmic Solution, 0.005% is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the Intraocular pressure lowering effect or cause paradoxical elevations in IOP.

Reduction of the intraocular pressure starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours.

Latanoprost Ophthalmic Solution, 0.005% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.
Calcitriol

Calcitriol

Calcitriol injection is for intravenous injection only.

The optimal dose of calcitriol injection must be carefully determined for each patient.

The effectiveness of calcitriol injection therapy is predicated on the assumption that each patient is receiving an adequate and appropriate daily intake of calcium. The RDA for calcium in adults is 800 mg. To ensure that each patient receives an adequate daily intake of calcium, the physician should either prescribe a calcium supplement or instruct the patient in proper dietary measures.

The recommended initial dose of Calcitriol Injection, depending on the severity of the hypocalcemia and/or secondary hyperparathyroidism, is 1 mcg (0.02 mcg/kg) to 2 mcg administered intravenously three times weekly, approximately every other day. Doses as small as 0.5 mcg and as large as 4 mcg three times weekly have been used as an initial dose. If a satisfactory response is not observed, the dose may be increased by 0.5 to 1 mcg at two to four week intervals. During this titration period, serum calcium and phosphorus levels should be obtained at least twice weekly. If hypercalcemia or a serum calcium times phosphate product greater than 70 is noted, the drug should be immediately discontinued until these parameters are appropriate. Then, the calcitriol injection dose should be reinitiated at a lower dose. Doses may need to be reduced as the PTH levels decrease in response to the therapy. Thus, incremental dosing must be individualized and commensurate with PTH, serum calcium and phosphorus levels. The following is a suggested approach in dose titration:
PTH Levels Calcitriol Injection Dose the same or increasing increase decreasing by < 30% increase decreasing by > 30%, < 60% maintain decreasing by > 60% decrease one and one-half to three times the upper limit of normal maintain
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Discard unused portion.
Ic-green

Ic-green

2.1 Indicator-Dilution Studies

In the performance of dye dilution curves, a known amount of dye is injected as a single bolus as rapidly as possible via a cardiac catheter into selected sites in the vascular system. A recording instrument (oximeter or densitometer) is attached to a needle or catheter for sampling of the dye-blood mixture from a systemic arterial sampling site.

Under sterile conditions, the IC-GREEN® powder should be dissolved with the Sterile Water for Injection, USP provided for this product, and the solution used within 6 hours after it is prepared. If a precipitate is present, discard the solution.

The usual doses of IC-GREEN® for dilution curves are as follows:

Adults - 5.0 mg

Children - 2.5 mg

Infants - 1.25 mg

These doses of the dye are usually injected in 1 mL volume. An average of five dilution curves are recommended in the performance of a diagnostic cardiac catheterization. The total dose of dye injected should be kept below 2 mg/kg.

While sterile water for injection may be used to rinse the syringe, isotonic saline should be used to flush the residual dye from the cardiac catheter into the circulation so as to avoid hemolysis. With the exception of the rinsing of the dye injection syringe, saline should be used in all other parts of the catheterization procedure.

Calibrating Dye Curves: To quantitate the dilution curves, standard dilutions of IC-GREEN® in whole blood are made as follows. It is strongly recommended that the same dye that was used for the injections be used in the preparation of these standard dilutions. The most concentrated dye solution is made by accurately diluting 1 mL of the 5 mg/mL dye with 7 mL of distilled water. This concentration is then successively halved by diluting 4 mL of the previous concentration with 4 mL of distilled water.

If a 2.5 mg/mL concentration was used for the dilution curves, 1 mL of the 2.5 mg/mL dye is added to 3 mL of distilled water to make the most concentrated “standard” solution. This concentration is then successively halved by diluting 2 mL of the previous concentration with 2 mL of distilled water.

Then 0.2 mL portions (accurately measured from a calibrated syringe) of these dye solutions are added to 5 mL aliquots of the subject's blood, giving final concentrations of the dye in blood beginning with 24.0 mg/liter, approximately (actual concentration depends on the exact volume of dye added). This concentration is, of course, successively halved in the succeeding aliquots of the subject's blood. These aliquots of blood containing known amounts of dye, as well as a blank sample to which 0.2 mL of saline containing no dye has been added, are then passed through the detecting instrument and a calibration curve is constructed from the deflections recorded.

2.2 Hepatic Function Studies

Due to its absorption spectrum, changing concentrations of IC-GREEN® (indocyanine green for injection) in the blood can be monitored by ear densitometry or by obtaining blood specimens at timed intervals. The technique for both methods is as follows.

The patient should be studied in a fasting, basal state. The patient should be weighed and the dosage calculated on the basis of 0.5 mg/kg of body weight.

Under sterile conditions, the IC-GREEN® powder should be dissolved with the Sterile Water for Injection, USP provided. Exactly 5 mL of Sterile Water for Injection, USP should be added to the 25 mg vial giving 5 mg of dye per mL of solution.

Inject the calculated amount of dye (0.5 mg/kg of body weight) into the lumen of an arm vein as rapidly as possible, without allowing the dye to escape outside the vein. (If the photometric method is used, prior to injecting IC-GREEN®, withdraw 6 mL of venous blood from the patient's arm for serum blank and standard curve construction, and through the same needle, inject the correct amount of dye.)

Ear Densitometry: Ear oximetry has also been used and makes it possible to monitor the appearance and disappearance of IC-GREEN® without the necessity of withdrawal and spectrophotometric analysis of blood samples for calibration. An ear densitometer which has a compensatory photo-electric cell to correct for changes in blood volume and hematocrit, and a detection photo cell which registers levels should be used. This device permits simultaneous measurement of cardiac output, blood volume and hepatic clearance of IC-GREEN®*. This technique has been employed in newborn infants, healthy adults and in children and adults with liver disease. The normal subject has a removal rate of 18 to 24% per minute. Due to the absence of extra-hepatic removal, IC-GREEN® was found to be suited for serial study of severe chronic liver disease and to provide a stable measurement of hepatic blood flow. In larger doses, IC-GREEN® can be used in detecting drug-induced alterations of hepatic function and in the detection of mild liver injury.

Using the ear densitometer, a dosage of 0.5 mg/kg in normal subjects gives the following clearance pattern.

*Dichromatic earpiece densitometer supplied by The Waters Company, Rochester, Minnesota.

Photometric Method -

Determination Using Percentage Retention of Dye:

A typical curve obtained by plotting dye concentration versus optical density is shown. The percent retention can be read from this plot. If more accurate results are desired, a curve using the patient's blood and the vial of IC-GREEN® being used in the determination can be constructed as follows:
Take 6 mL of non-dye-containing venous blood from the patient's arm. Place in a test tube and allow the blood to clot. The serum should be separated by centrifugation. Pipette 1 mL of the serum into a microcuvette. Add 1 lambda (λ) of the 5 mg/mL aqueous IC-GREEN® (sterile indocyanine green) solution to the serum, giving a dilution of 5 mg/liter, the standard for 50% retention. (The addition of 2 lambda (λ) of the 5 mg/mL IC-GREEN® solution would give 100% retention; however, this concentration cannot be read on the spectrophotometer.) The optical density of this solution should be read at 805 nm, using normal serum as the blank. Using graph paper similar to that used in the illustration, plot the 50% figure obtained in Step 4, and draw a line connecting this point with the zero coordinates.
Percentage Retention: A single 20-minute sample (withdrawn from a vein in the opposite arm to that injected) should be collected and allowed to clot, centrifuged and its optical density determined at 805 nm using the patient's normal serum as the blank. The dye concentration can be read from the curve above. A single 20-minute sample of serum in healthy subjects should contain no more than 4% of the initial concentration of the dye. The use of percentage retention is less accurate than percentage disappearance rate. Hemolysis is not expected to interfere with a reading.

Determination Using Disappearance Rate of Dye: To calculate the percentage disappearance rate, obtain samples at 5, 10, 15 and 20 minutes after injecting the dye. Prepare the sample as in the previous section and measure the optical densities at 805 nm, using the patient's normal serum as the blank. The IC-GREEN® concentration in each timed specimen should be determined by using the concentration curve illustrated. Values should be plotted on semilogarithmic paper.

Specimens containing IC-GREEN® should be read at the same temperature since its optical density is influenced by temperature variations.

Normal Values: Percentage disappearance rate in healthy subjects is 18 to 24% per minute. Normal biological half-time is 2.5 to 3.0 minutes.

2.3 Ophthalmic Angiography Studies

The excitation and emission spectra (Figure 1) and the absorption spectra (Figure 2) of IC-GREEN® make it useful in ophthalmic angiography.

Dosages up to 40 mg IC-GREEN® dye in 2 mL of Sterile Water for Injection, USP should be used, depending on the imaging equipment and technique used. The antecubital vein can be injected with an IC-GREEN® dye bolus and should immediately be followed by a 5 mL bolus of normal saline.
Pantoprazole Sodium

Pantoprazole Sodium

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to and during administration whenever solution and container permit.

Parenteral routes of administration other than intravenous are not recommended.

Pantoprazole Sodium for Injection may be administered intravenously through a dedicated line or through a Y-site. The intravenous line should be flushed before and after administration of Pantoprazole Sodium for Injection with either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP. When administered through a Y-site, Pantoprazole Sodium for Injection is compatible with the following solutions: 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP.

Midazolam HCl has been shown to be incompatible with Y-site administration of Pantoprazole Sodium for Injection. Pantoprazole Sodium for Injection may not be compatible with products containing zinc. When Pantoprazole Sodium for Injection is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.

2.1 Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis

Recommended Dosage

The recommended adult dose is 40 mg pantoprazole given once daily by intravenous infusion for 7 to 10 days.

Treatment with Pantoprazole Sodium for Injection should be discontinued as soon as the patient is able to receive treatment with Pantoprazole Sodium Delayed-Release Tablets or Oral Suspension.

Administration and Preparation Instructions

Data on the safe and effective dosing for conditions other than those described [see Indications and Usage (1)] such as life-threatening upper gastrointestinal bleeds, are not available.

Pantoprazole Sodium for Injection 40 mg once daily dose not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions.

Fifteen Minute Infusion

Pantoprazole Sodium for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, and further diluted (admixed) with 100 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a final concentration of approximately 0.4 mg/mL. The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The admixed solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the admixed solution do not need to be protected from light.

Pantoprazole Sodium for Injection admixtures should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.

Two Minute Infusion

Pantoprazole Sodium for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, to a final concentration of approximately 4 mg/mL. The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light. Pantoprazole Sodium for Injection should be administered intravenously over a period of at least 2 minutes.

2.2 Pathological Hypersecretion Including Zollinger-Ellison Syndrome

Recommended Dosage

The dosage of Pantoprazole Sodium for Injection in patients with pathological hypersecretory conditions including Zollinger-Ellison Syndrome varies with individual patients. The recommended adult dosage is 80 mg intravenously every 12 hours. The frequency of dosing can be adjusted to individual patient needs based on acid output measurements. In those patients who need a higher dosage, 80 mg intravenously every 8 hours is expected to maintain acid output below 10 mEq /h. Daily doses higher than 240 mg or administered for more than 6 days have not been studied [see Clinical Studies (14)]. Transition from oral to intravenous and from intravenous to oral formulations of gastric acid inhibitors should be performed in such a manner to ensure continuity of effect of suppression of acid secretion. Patients with Zollinger-Ellison Syndrome may be vulnerable to serious clinical complications of increased acid production even after a short period of loss of effective inhibition.

Administration and Preparation Instructions

Fifteen Minute Infusion

Each vial of Pantoprazole Sodium for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP. The contents of the two vials should be combined and further diluted (admixed) with 80 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a total volume of 100 mL with a final concentration of approximately 0.8 mg/mL. The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The admixed solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the admixed solution do not need to be protected from light.

Pantoprazole Sodium for Injection should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.

Two minute Infusion

Pantoprazole Sodium for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, per vial to a final concentration of approximately 4 mg/mL. The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light. The total volume from both vials should be administered intravenously over a period of at least 2 minutes.
Fenofibrate

Fenofibrate

Timolol Maleate Ophthalmic Solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of 0.25 percent timolol in the affected eye(s) twice a day. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5 percent solution in the affected eye(s) twice a day.

Since in some patients the pressure-lowering response to timolol may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with timolol.

If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eye(s). Because of diurnal variations in intraocular pressure, satisfactory response to the once-a-day dose is best determined by measuring the intraocular pressure at different times during the day.

Dosages above one drop of 0.5 percent timolol twice a day generally have not been shown to produce further reduction in intraocular pressure. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy with other agent(s) for lowering intraocular pressure can be instituted. The concomitant use of two topical beta-adrenergic blocking agents is not recommended. (See PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents.)
Vancomycin Hydrochlorid...

Vancomycin Hydrochloride

2.1 Adults

Vancomycin HCl Capsules are used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.
C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.
2.2 Pediatric Patients

The usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.
Alfentanil

Alfentanil

The dosage of Alfentanil HCl injection should be individualized and titrated to the desired effect in each patient according to body weight, physical status, underlying pathological condition, use of other drugs, and type and duration of surgical procedure and anesthesia. In obese patients (more than 20% above ideal total body weight), the dosage of Alfentanil HCl injection should be determined on the basis of lean body weight. The dose of Alfentanil HCl injection should be reduced in elderly or debilitated patients (see PRECAUTIONS).

Vital signs should be monitored routinely.

See Dosage Guidelines for the use of Alfentanil HCl injection: 1) by incremental injection as an analgesic adjunct to anesthesia with barbiturate/nitrous oxide/oxygen for short surgical procedures (expected duration of less than one hour); 2) by continuous infusion as a maintenance analgesic with nitrous oxide/oxygen for general surgical procedures; and 3) by intravenous injection in anesthetic doses for the induction of anesthesia for general surgical procedures with a minimum expected duration of 45 minutes; and 4) by intravenous injection as the analgesic component for monitored anesthesia care (MAC).

DOSAGE GUIDELINES DOSAGE SHOULD BE INDIVIDUALIZED AND TITRATED
FOR USE DURING GENERAL ANESTHESIA SPONTANEOUSLY BREATHING/ ASSISTED VENTILATION Induction of Analgesia: 8 to 20 mcg/kgMaintenance of Analgesia: 3 to 5 mcg/kg q 5 to 20 min or 0.5 to 1 mcg/kg/minTotal dose: 8 to 40 mcg/kg ASSISTED OR CONTROLLED VENTILATION Induction of Analgesia: 20 to 50 mcg/kgMaintenance of Analgesia: 5 to 15 mcg/kg q 5 to 20 minTotal dose: Up to 75 mcg/kg Incremental Injection (To attenuate response to laryngoscopy and intubation) Continuous Infusion (To provide attenuation of response to intubation and incision) Infusion rates are variable and should be titrated to the desired clinical effect.SEE INFUSION DOSAGE GUIDELINES BELOW.Induction of Analgesia: 50 to 75 mcg/kgMaintenance of Analgesia: 0.5 to 3 mcg/kg/min (Average rate 1 to 1.5 mcg/kg/min)Total dose: Dependent on duration of procedure Anesthetic Induction Induction of Anesthesia: 130 to 245 mcg/kgMaintenance of Anesthesia: 0.5 to 1.5 mcg/kg/min or general anestheticTotal dose: Dependent on duration of procedureAt these doses, truncal rigidity should be expected and a muscle relaxant should be utilized. Administer slowly (over 3 minutes). Concentration of inhalation agents reduced by 30 to 50% for initial hour. MONITORED ANESTHESIA CARE (MAC) (For sedated and responsive spontaneously breathing patients) Induction of MAC: 3 to 8 mcg/kgMaintenance of MAC: 3 to 5 mcg/kg q 5 to 20 min or 0.25 to 1 mcg/kg/minTotal dose: 3 to 40 mcg/kg INFUSION DOSAGE Continuous Infusion: 0.5 to 3 mcg/kg/min administered with nitrous oxide/oxygen in patients undergoing general surgery. Following an anesthetic induction dose of Alfentanil HCl injection, infusion rate requirements are reduced by 30 to 50% for the first hour of maintenance.Changes in vital signs that indicate a response to surgical stress or lightening of anesthesia may be controlled by increasing the alfentanil to a maximum of 4 mcg/kg/min and/or administration of bolus doses of 7 mcg/kg. If changes are not controlled after three bolus doses given over a five minute period, a barbiturate, vasodilator, and/or inhalation agent should be used. Infusion rates should always be adjusted downward in the absence of these signs until there is some response to surgical stimulation.Rather than an increase in infusion rate, 7 mcg/kg bolus doses of Alfentanil HCl injection or a potent inhalation agent should be administered in response to signs of lightening of anesthesia within the last 15 minutes of surgery. Alfentanil HCl injection infusion should be discontinued at least 10 to 15 minutes prior to the end of surgery.
Usage in Children: Clinical data to support the use of Alfentanil HCl injection in patients under 12 years of age are not presently available. Therefore, such use is not recommended.

Premedication: The selection of preanesthetic medications should be based upon the needs of the individual patient.

Neuromuscular Blocking Agents: The neuromuscular blocking agent selected should be compatible with the patient's condition, taking into account the hemodynamic effects of a particular muscle relaxant and the degree of skeletal muscle relaxation required (see CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS sections).

In patients administered anesthetic (induction) dosages of Alfentanil HCl injection, it is essential that qualified personnel and adequate facilities are available for the management of intraoperative and postoperative respiratory depression.

Also see WARNINGS and PRECAUTIONS sections.

For purposes of administering small volumes of Alfentanil HCl injection accurately, the use of a tuberculin syringe or equivalent is recommended.

The physical and chemical compatibility of Alfentanil HCl injection have been demonstrated in solution with normal saline, 5% dextrose in normal saline, 5% dextrose in water and Lactated Ringers. Clinical studies of Alfentanil HCl injection infusion have been conducted with Alfentanil HCl injection diluted to a concentration range of 25 mcg/mL to 80 mcg/mL.

As an example of the preparation of Alfentanil HCl injection for infusion, 20 mL of Alfentanil HCl injection added to 230 mL of diluent provides 40 mcg/mL solution of Alfentanil HCl injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Fentanyl Citrate

Fentanyl Citrate

50 mcg = 0.05 mg = 1 mL

Dosage should be individualized. Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used and the surgical procedure involved. Dosage should be reduced in elderly or debilitated patients (see PRECAUTIONS).

Vital signs should be monitored routinely.
Premedication — Premedication (to be appropriately modified in the elderly, debilitated and those who have received other depressant drugs) — 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL) may be administered intramuscularly 30 to 60 minutes prior to surgery. Adjunct to General Anesthesia — See Dosage Range Chart Adjunct to Regional Anesthesia - 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL) may be administered intramuscularly or slowly intravenously, over one to two minutes, when additional analgesia is required. Postoperatively (recovery room) - 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 mL) may be administered intramuscularly for the control of pain, tachypnea and emergence delirium. The dose may be repeated in one to two hours as needed.
Usage in Children: For induction and maintenance in children 2 to 12 years of age, a reduced dose as low as 2 to 3 mcg/kg is recommended.
DOSAGE RANGE CHART TOTAL DOSAGE Low Dose — 2 mcg/kg(0.002 mg/kg) (0.04 mL/kg) fentanyl. Fentanyl in small doses is most useful for minor, but painful, surgical procedures. In addition to the analgesia during surgery, fentanyl may also provide some pain relief in the immediate postoperative period. Moderate Dose — 2 to 20 mcg/kg (0.002 to 0.02 mg/kg) (0.04 to 0.4 mL/kg). Where surgery becomes more major, a larger dose is required. With this dose, in addition to adequate analgesia, one would expect to see some abolition of the stress response. However, respiratory depression will be such that artificial ventilation during anesthesia is necessary and careful observation of ventilation postoperatively is essential. High Dose — 20 to 50 mcg/kg (0.02 to 0.05 mg/kg) (0.4 to 1 mL/kg). During open heart surgery and certain more complicated neurosurgical and orthopedic procedures where surgery is more prolonged, and in the opinion of the anesthesiologist, the stress response to surgery would be detrimental to the well being of the patient, dosages of 20 to 50 mcg/kg (0.02 to 0.05 mg) (0.4 to 1 mL) of fentanyl with nitrous oxide/oxygen have been shown to attenuate the stress response as defined by increased levels of circulating growth hormone, catecholamine, ADH and prolactin. When dosages in this range have been used during surgery, postoperative ventilation and observation are essential due to extended postoperative respiratory depression. The main objective of this technique would be to produce “stress free” anesthesia. DOSAGE RANGE CHART MAINTENANCE DOSAGE Low Dose — 2 mcg/kg (0.002 mg/kg) (0.04 mL/kg).Additional dosages of fentanyl are infrequently needed in these minor procedures. Moderate Dose — 2 to 20 mcg/kg(0.002 to 0.02 mg/kg) (0.04 to 0.4 mL/kg).25 to 100 mcg (0.025 to 0.1 mg) (0.5 to 2.0 mL) may be administered intravenously or intramuscularly when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. High Dose — 20 to 50 mcg/kg (0.02 to 0.05 mcg/kg) (0.4 to 1.0 mL/kg). Maintenance dosage (ranging from 25 mcg (0.025 mg) (0.5 mL) to one half the initial loading dose) will be dictated by the changes in vital signs which indicate stress and lightening of analgesia. However, the additional dosage selected must be individualized especially if the anticipated remaining operative time is short.
As a General Anesthetic

When attenuation of the responses to surgical stress is especially important, doses of 50 to 100 mcg/kg (0.05 to 0.1 mg/kg) (1 to 2 mL/kg) may be administered with oxygen and a muscle relaxant. This technique has been reported to provide anesthesia without the use of additional anesthetic agents. In certain cases, doses up to 150 mcg/kg (0.15 mg/kg) (3 mL/kg) may be necessary to produce this anesthetic effect. It has been used for open heart surgery and certain other major surgical procedures in patients for whom protection of the myocardium from excess oxygen demand is particularly indicated, and for certain complicated neurological and orthopedic procedures.

As noted above, it is essential that qualified personnel and adequate facilities be available for the management of respiratory depression.

See WARNINGS and PRECAUTIONS for use of fentanyl with other CNS depressants, and in patients with altered response.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Lidocaine

Lidocaine

When Lidocaine HCI 2% Jelly is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.

The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. Although the incidence of adverse effects with Lidocaine HCI 2% Jelly is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

For Surface Anesthesia of the Male Adult Urethra: When using Lidocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube. The cone may be gas sterilized or cold sterilized, as preferred. Slowly instill approximately 15 mL (300 mg of lidocaine HCI) into the urethra or until the patient has a feeling of tension. A penile clamp is then applied for several minutes at the corona. An additional dose of not more than 15 mL (300 mg) can be instilled for adequate anesthesia.

Prior to sounding or cystoscopy, a penile clamp should be applied for 5 to 10 minutes to obtain adequate anesthesia. A total dose of 30 mL (600 mg) is usually required to fill and dilate the male urethra.

Prior to catheterization, smaller volumes of 5 to 10 mL (100 to 200 mg) are usually adequate for lubrication.

For Surface Anesthesia of the Female Adult Urethra: When using Lidocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube. The cone may be gas sterilized or cold sterilized, as preferred. Slowly instill 3 to 5 mL (60 to 100 mg of lidocaine HCI) of the jelly into the urethra. If desired, some jelly may be deposited on a cotton swab and introduced into the urethra. In order to obtain adequate anesthesia, several minutes should be allowed prior to performing urological procedures.

Lubrication for Endotracheal Intubation: Apply a moderate amount of jelly to the external surface of the endotracheal tube shortly before use. Care should be taken to avoid introducing the product into the lumen of the tube. Do not use the jelly to lubricate endotracheal stylettes. See WARNINGS and ADVERSE REACTIONS concerning rare reports of inner lumen occlusion. It is also recommended that use of endotracheal tubes with dried jelly on the external surface be avoided for lack of lubricating effect.
Benztropine Mesylate

Benztropine Mesylate

Since there is no significant difference in onset of effect after intravenous or intramuscular injection, usually there is no need to use the intravenous route. The drug is quickly effective after either route, with improvement sometimes noticeable a few minutes after injection. In emergency situations, when the condition of the patient is alarming, 1 to 2 mL of the injection normally will provide quick relief. If the parkinsonian effect begins to return, the dose can be repeated.

Because of cumulative action, therapy should be initiated with a low dose which is increased gradually at five or six-day intervals to the smallest amount necessary for optimal relief. Increases should be made in increments of 0.5 mg, to a maximum of 6 mg, or until optimal results are obtained without excessive adverse reactions.

Postencephalitic and Idiopathic Parkinsonism: The following dosing guidelines were written in reference to both benztropine mesylate tablets and COGENTIN Injection. Benztropine mesylate tablets should be used when patients are able to take oral medication.

The usual daily dose is 1 to 2 mg, with a range of 0.5 to 6 mg parenterally.

As with any agent used in parkinsonism, dosage must be individualized according to age and weight, and the type of parkinsonism being treated. Generally, older patients, and thin patients cannot tolerate large doses. Most patients with postencephalitic parkinsonism need fairly large doses and tolerate them well. Patients with a poor mental outlook are usually poor candidates for therapy.

In idiopathic parkinsonism, therapy may be initiated with a single daily dose of 0.5 to 1 mg at bedtime. In some patients, this will be adequate; in others 4 to 6 mg a day may be required.

In postencephalitic parkinsonism, therapy may be initiated in most patients with 2 mg a day in one or more doses. In highly sensitive patients, therapy may be initiated with 0.5 mg at bedtime, and increased as necessary.

Some patients experience greatest relief when given the entire dose at bedtime; others react more favorably to divided doses, two to four times a day. Frequently, one dose a day is sufficient, and divided doses may be unnecessary or undesirable.

The long duration of action of this drug makes it particularly suitable for bedtime medication when its effects may last throughout the night, enabling patients to turn in bed during the night more easily, and to rise in the morning.

When benztropine mesylate injection, USP is started, do not terminate therapy with other antiparkinsonian agents abruptly. If the other agents are to be reduced or discontinued, it must be done gradually. Many patients obtain greatest relief with combination therapy.

Benztropine mesylate injection, USP may be used concomitantly with, SINEMET (Ccarbidopa-Levodopalevodopa), or with levodopa, in which case dosage adjustment may be required in order to maintain optimum response.

Drug-Induced Extrapyramidal Disorders: In treating extrapyramidal disorders due to neuroleptic drugs (e.g., phenothiazines), the recommended dosage is 1 to 4 mg once or twice a day parenterally. Dosage must be individualized according to the need of the patient. Some patients require more than recommended; others do not need as much.

In acute dystonic reactions, 1 to 2 mL of the injection usually relieves the condition quickly.

When extrapyramidal disorders develop soon after initiation of treatment with neuroleptic drugs (e.g., phenothiazines), they are likely to be transient. One to 2 mg of benztropine mesylate injection, USP two or three times a day usually provides relief within one or two days. If such disorders recur, COGENTIN can be reinstituted.

Certain drug-induced extrapyramidal disorders that develop slowly may not respond to benztropine mesylate injection, USP.
Calcitriol

Calcitriol

Calcitriol injection is for intravenous injection only.

The optimal dose of calcitriol injection must be carefully determined for each patient.

The effectiveness of calcitriol injection therapy is predicated on the assumption that each patient is receiving an adequate and appropriate daily intake of calcium. The RDA for calcium in adults is 800 mg. To ensure that each patient receives an adequate daily intake of calcium, the physician should either prescribe a calcium supplement or instruct the patient in proper dietary measures.

The recommended initial dose of Calcitriol Injection, depending on the severity of the hypocalcemia and/or secondary hyperparathyroidism, is 1 mcg (0.02 mcg/kg) to 2 mcg administered intravenously three times weekly, approximately every other day. Doses as small as 0.5 mcg and as large as 4 mcg three times weekly have been used as an initial dose. If a satisfactory response is not observed, the dose may be increased by 0.5 to 1 mcg at two to four week intervals. During this titration period, serum calcium and phosphorus levels should be obtained at least twice weekly. If hypercalcemia or a serum calcium times phosphate product greater than 70 is noted, the drug should be immediately discontinued until these parameters are appropriate. Then, the calcitriol injection dose should be reinitiated at a lower dose. Doses may need to be reduced as the PTH levels decrease in response to the therapy. Thus, incremental dosing must be individualized and commensurate with PTH, serum calcium and phosphorus levels. The following is a suggested approach in dose titration:
PTH Levels Calcitriol Injection Dose the same or increasing increase decreasing by < 30% increase decreasing by > 30%, < 60% maintain decreasing by > 60% decrease one and one-half to three times the upper limit of normal maintain
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Discard unused portion.
Adenosine

Adenosine

For rapid bolus intravenous use only.

Adenosine injection should be given as a rapid bolus by the peripheral intravenous route. To be certain the solution reaches the systemic circulation, it should be administered either directly into a vein or, if given into an IV line, it should be given as close to the patient as possible and followed by a rapid saline flush.

Adult Patients

The dose recommendation is based on clinical studies with peripheral venous bolus dosing. Central venous (CVP or other) administration of adenosine injection has not been systematically studied.

The recommended intravenous doses for adults are as follows:

Initial dose: 6 mg given as a rapid intravenous bolus (administered over a 1-2 second period).

Repeat administration: If the first dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes, 12 mg should be given as a rapid intravenous bolus. This 12 mg dose may be repeated a second time if required.

Pediatric Patients

The dosages used in neonates, infants, children and adolescents were equivalent to those administered to adults on a weight basis.

Pediatric Patients with a Body Weight < 50 kg:

Initial dose: Give 0.05 to 0.1 mg/kg as a rapid IV bolus given either centrally or peripherally. A saline flush should follow.

Repeat administration: If conversion of PSVT does not occur within 1-2 minutes, additional bolus injections of adenosine can be administered at incrementally higher doses, increasing the amount given by 0.05 to 0.1 mg/kg. Follow each bolus with a saline flush. This process should continue until sinus rhythm is established or a maximum single dose of 0.3 mg/kg is used.

Pediatric Patients with a Body Weight ≥ 50 kg: Administer the adult dose.

Doses greater than 12 mg are not recommended for adult and pediatric patients.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Diltiazem Hydrochloride...

Diltiazem Hydrochloride

Direct Intravenous Single Injections (Bolus)

The initial dose of diltiazem hydrochloride injection should be 0.25 mg/kg actual body weight as a bolus administered over 2 minutes (20 mg is a reasonable dose for the average patient). If response is inadequate, a second dose may be administered after 15 minutes. The second bolus dose of diltiazem hydrochloride injection should be 0.35 mg/kg actual body weight administered over 2 minutes (25 mg is a reasonable dose for the average patient). Subsequent intravenous bolus doses should be individualized for each patient. Patients with low body weights should be dosed on a mg/kg basis. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. Experience with this dose is limited.

Continuous Intravenous Infusion

For continued reduction of the heart rate (up to 24 hours) in patients with atrial fibrillation or atrial flutter, an intravenous infusion of diltiazem hydrochloride injection may be administered. Immediately following bolus administration of 20 mg (0.25 mg/kg) or 25 mg (0.35 mg/kg) diltiazem hydrochloride injection and reduction of heart rate, begin an intravenous infusion of diltiazem hydrochloride injection. The recommended initial infusion rate of diltiazem hydrochloride injection is 10 mg/h. Some patients may maintain response to an initial rate of 5 mg/h. The infusion rate may be increased in 5 mg/h increments up to 15 mg/h as needed, if further reduction in heart rate is required, the infusion may be maintained for up to 24 hours.

Diltiazem shows dose-dependent, non-linear pharmacokinetics. Duration of infusion longer than 24 hours and infusion rates greater than 15 mg/h have not been studied. Therefore, infusion duration exceeding 24 hours and infusion rates exceeding 15 mg/h are not recommended.

Dilution: To prepare diltiazem hydrochloride injection for continuous intravenous infusion aseptically transfer the appropriate quantity (see chart) of diltiazem hydrochloride injection to the desired volume of either Normal Saline, D5W, or D5W/0.45% NaCl. Mix thoroughly. Use within 24 hours. Keep refrigerated until use.

* 5 mg/h may be appropriate for some patients.
DiluentVolume Quantity ofDiltiazem HydrochlorideInjection to Add FinalConcentration Administration Dose* Infusion Rate 100 mL 125 mg (25 mL) 1 mg/mL 10 mg/h15 mg/h 10 mg/h15 mg/h 250 mL 250 mg (50 mL) 0.83 mg/mL 10 mg/h15 mg/h 12 mL/h18 mL/h 500 mL 250 mg (50 mL) 0.45 mg/mL 10 mg/h15 mg/h 22 mL/h33 mL/h
Diltiazem hydrochloride injection was tested for compatibility with three commonly used intravenous fluids at a maximal concentration of 1 mg diltiazem hydrochloride per milliliter. Diltiazem hydrochloride injection was found to be physically compatible and chemically stable in the following parenteral solutions for at least 24 hours when stored in glass or polyvinylchloride (PVC) bags at controlled room temperature 15° to 30°C (59° to 86°F) or under refrigeration 2° to 8°C (36° to 46°F).
dextrose (5%) injection USP sodium chloride (0.9%) injection USP dextrose (5%) and sodium chloride (0.45%) injection USP
Because of potential physical incompatibilities, it is recommended that diltiazem hydrochloride injection not be mixed with any other drugs in the same container.

If possible, it is recommended that diltiazem hydrochloride injection not be co-infused in the same intravenous line.

Physical incompatibilities (precipitate formation or cloudiness) were observed when diltiazem hydrochloride injection was infused in the same intravenous line with the following drugs: acetazolamide, acyclovir, aminophylline, ampicillin, ampicillin sodium/sulbactam sodium, cefamandole, cefoperazone, diazepam, furosemide, hydrocortisone, sodium succinate, insulin (regular: 100 units/mL), methylprednisolone sodium succinate, mezlocillin, nafcillin, phenytoin, rifampin, and sodium bicarbonate.

Parental drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Transition to Further Antiarrhythmic Therapy

Transition to other antiarrhythmic agents following administration of diltiazem hydrochloride injection is generally safe. However, reference should be made to the respective agent manufacturer's package insert for information relative to dosage and administration.

In controlled clinical trials, therapy with antiarrhythmic agents to maintain reduced heart rate in atrial fibrillation or atrial flutter or for prophylaxis of PSVT was generally started within 3 hours after bolus administration of diltiazem hydrochloride injection. These antiarrhythmic agents were intravenous or oral digoxin, Class I antiarrhythmics (eg, quinidine, procainamide), calcium channel blockers, and oral beta-blockers.

Experience in the use of antiarrhythmic agents following maintenance infusion of diltiazem hydrochloride injection is limited. Patients should be dosed on an individual basis and reference should be made to respective manufacturer's package insert for information relative to dosage and administration.

How Supplied:

Diltiazem Hydrochloride Injection, 0.5% (5 mg/mL) is supplied:
5 mL vials NDC 17478-817-05 10 mL vials NDC 17478-817-10 25 mL vials NDC 17478-817-25
SINGLE-USE CONTAINERS. DISCARD UNUSED PORTION.

Storage: Store under refrigeration 2° to 8°C (36° to 46°F). DO NOT FREEZE. May be stored at room temperature for up to 1 month. Destroy after 1 month at room temperature.

PREMIERPro™ RxManufactured by: Akorn, Inc.Lake Forest, IL 60045

PREMIERPro™Rx is a trademark of Premier, Inc., used under license.

PDH00NRev. 08/13
Artificial Tears

Artificial Tears

Pull down lower lid of the affected eye(s) and apply small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a doctor.
Haloperidol Decanoate

Haloperidol Decanoate

Cataract Surgery: One drop of Diclofenac Sodium Ophthalmic Solution, 0.1% should be applied to the affected eye, 4 times daily beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the post operative period.

Corneal Refractive Surgery: One or two drops of Diclofenac Sodium Ophthalmic Solution, 0.1% should be applied to the operative eye within the hour prior to corneal refractive surgery. Within 15 minutes after surgery, one or two drops should be applied to the operative eye and continued 4 times daily for up to 3 days.
Careone Childrens Pain ...

Careone Childrens Pain And Fever

The total dose of Acetylcysteine Injection is 300 mg/kg given as 3 separate doses and administered over a total of 21 hours. Please refer to the guidelines below for dose preparation based upon patient weight. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction (see Tables 1 and 2).

2.1 Administration Instructions (Three-Bag Method: Loading, Second and Third Dose)

Dosing for patients who weigh 5 kg to 20 kg (Table 1):

Loading Dose: 150 mg/kg diluted in 3 mL/kg of diluent* administered over 1 hr

Second Dose: 50 mg/kg diluted in 7 mL/kg of diluent* administered over 4 hrs

Third Dose: 100 mg/kg diluted in 14 mL/kg of diluent* administered over 16 hrs
Table 1. Three Bag Method Dosage Guide by Weight in Patients 5 kg to 20 kg
*Acetylcysteine injection is compatible with the following diluents; 5% Dextrose in Water, 0.45% Sodium Chloride Injection, and Sterile Water for Injection.
BodyWeight(kg) Bag 1 (loading dose):150 mg/kg in 3 mL/kg of diluent* infused over 1 hour Bag 2 (second dose):50 mg/kg in 7 mL/kg of diluent* infused over 4 hours Bag 3 (third dose):100 mg/kg diluted in 14 mL/kg of diluent* infused over 16 hours Acetylcysteine InjectionTotal Dose Diluentvolume Acetylcysteine InjectionTotal Dose Diluentvolume Acetylcysteine InjectionTotal Dose Diluentvolume 5 kg 750 mg 15 mL 250 mg 35 mL 500 mg 70 mL 10 kg 1,500 mg 30 mL 500 mg 70 mL 1,000 mg 140 mL 15 kg 2,250 mg 45 mL 750 mg 105 mL 1,500 mg 210 mL 20 kg 3,000 mg 60 mL 1,000 mg 140 mL 2,000 mg 280 mL
See also Section 2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction

Dosing for patients who weigh 21 kg to 40 kg (Table 2):

Loading Dose: 150 mg/kg diluted in 100 mL of diluent* administered over 1 hr

Second Dose: 50 mg/kg diluted in 250 mL of diluent* administered over 4 hrs

Third Dose: 100 mg/kg diluted in 500 mL of diluent* administered over 16 hrs
Table 2. Three-Bag Method Dosage Guide by Weight in Patients 21 kg to 40 kg
*Acetylcysteine injection is compatible with the following diluents; 5% Dextrose in Water 0.45% Sodium Chloride Injection, and Sterile Water for Injection.
Body Weight(kg) Bag 1 (loading dose):150 mg/kg in 100 mL of diluent* infused over 1 hr Bag 2 (second dose):50 mg/kg in 250 mL of diluent* infused over 4 hrs Bag 3 (third dose):100 mg/kg in 500 mL of diluent* infused over 16 hrs Acetylcysteine InjectionTotal Dose (mg) Acetylcysteine InjectionTotal Dose (mg) Acetylcysteine InjectionTotal Dose (mg) 21 kg 3,150 mg 1,050 mg 2,100 mg 30 kg 4,500 mg 1,500 mg 3,000 mg 40 kg 6,000 mg 2,000 mg 4,000 mg
See also Section 2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction.

Dosing for patients who weigh 41 kg to 100 kg (Table 3):

Loading Dose: 150 mg/kg diluted in 200 mL of diluent* administered over 1 hr

Second Dose: 50 mg/kg diluted in 500 mL of diluent* administered over 4 hrs

Third Dose: 100 mg/kg diluted in 1000 mL of diluent* administered over 16 hrs
Table 3. Three-Bag Method Dosage Guide by Weight in Patients 41 kg to 100 kg
*Acetylcysteine injection is compatible with the following diluents; 5% Dextrose 0.45% Sodium Chloride Injection, and Sterile Water for Injection.
Body Weight(kg) Bag 1 (loading dose):150 mg/kg diluted in 200 mL of diluent* infused over 1 hr Bag 2 (second dose):50 mg/kg diluted in 500 mL of diluent* infused over 4 hrs Bag 3 (third dose):100 mg/kg diluted in 1000 mL of diluent* infused over 16 hrs Acetylcysteine InjectionTotal Dose (mg) Acetylcysteine InjectionTotal Dose (mg) Acetylcysteine InjectionTotal Dose (mg) 41 kg 6,150 mg 2,050 mg 4,100 mg 50 kg 7,500 mg 2,500 mg 5,000 mg 60 kg 9,000 mg 3,000 mg 6,000 mg 70 kg 10,500 mg 3,500 mg 7,000 mg 80 kg 12,000 mg 4,000 mg 8,000 mg 90 kg 13,500 mg 4,500 mg 9,000 mg 100 kg 15,000 mg 5,000 mg 10,000 mg
Patients Weighing More Than 100 kg

No specific studies have been conducted to evaluate the use of or necessity of dosing adjustments in patients weighing over 100 kg. Limited information is available regarding the dosing requirements of patients that weigh more than 100 kg. The dose of acetylcysteine injection recommended in these patients should be a loading dose of 15,000 mg infused over a period of one hour followed by a first maintenance dose of 5,000 mg over 4 hours and a second maintenance dose of 10,000 mg over 16 hours (See Table 3).

Continued Therapy beyond 21 Hours

While there is no clinical trial data to support infusions beyond 21 hours there is literature that supports continued infusion of acetylcysteine in some rare instances. In cases of suspected massive overdose, or with concomitant ingestion of other substances, or in patients with preexisting liver disease, the absorption and/or the half-life of acetaminophen may be prolonged, in such cases consideration should be given to the need for continued infusion of N-acetylcysteine beyond 21 hours. Acetaminophen levels and ALT/AST & INR should be checked before the end of the 21-hour infusion. If acetaminophen levels are still detectable, or in cases in which the ALT/AST are still increasing or the INR remains elevated, the infusion should be continued, and the treating physician should contact a US regional poison center at 1-800-222-1222, or alternatively, a “special health professional assistance line for acetaminophen overdose” at 1-800-525-6115 for assistance with dosing recommendations.

2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction

The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as clinically needed. If the volume of the infusion is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure and death. [see Dosage and Administration (2)].

As acetylcysteine injection is hyperosmolar (2600 mOsmol/L), caution is advised when the diluent volume is decreased as the hyperosmolarity of the solution is increased. See Table 4 below for examples.
Table 4. Acetylcysteine Injection Concentration and Osmolarity
*Osmolarity should be adjusted to a physiologically safe level (generally not less than 150 mOsmol/L in children).
Acetylcysteine Injection Concentration (mg/mL) Osmolarity in ½ Normal Saline Osmolarity in D5W Osmolarity in Sterile Water for Injection 7 mg/mL 245 mOsmol/L 343 mOsmol/L 91 mOsmol/L* 24 mg/mL 466 mOsmol/L 564 mOsmol/L 312 mOsmol/L
Single dose vial, preservative-free, discard unused portion. If vial was previously opened, do not use for intravenous administration.

Stability studies indicate that the diluted solution is stable for 24 hours at controlled room temperature.

Note: The color of Acetylcysteine Injection may turn from essentially colorless to a slight pink or purple once the stopper is punctured. The color change does not affect the quality of the product.

2.3 Renal Impairment

No data are available to determine if a dose adjustment in patients with moderate or severe renal impairment is required.

2.4 Hepatic Impairment

Although there was a threefold increase in acetylcysteine plasma concentrations in patients with hepatic cirrhosis, no data are available to determine if a dose adjustment in these patients is required. The published medical literature does not indicate that the dose of acetylcysteine in patients with hepatic impairment should be reduced.
Sufentanil Citrate

Sufentanil Citrate

The dosage of sufentanil should be individualized in each case according to body weight, physical status, underlying pathological condition, use of other drugs, and type of surgical procedure and anesthesia. In obese patients (more than 20% above ideal total body weight), the dosage of sufentanil should be determined on the basis of lean body weight. Dosage should be reduced in elderly and debilitated patients (see PRECAUTIONS).

Vital signs should be monitored routinely.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Because the clearance of sufentanil is reduced in neonates, especially those with cardiovascular disease, the dose of sufentanil should be reduced accordingly (see PRECAUTIONS).

Intravenous use

Sufentanil citrate may be administered intravenously by slow injection or infusion 1) in doses of up to 8 mcg/kg as an analgesic adjunct to general anesthesia, and 2) in doses ≥8 mcg/kg as a primary anesthetic agent for induction and maintenance of anesthesia (see Dosage Range Chart). If benzodiazepines, barbiturates, inhalation agents, other opioids or other central nervous system depressants are used concomitantly, the dose of sufentanil and/or these agents should be reduced (see PRECAUTIONS). In all cases dosage should be titrated to individual patient response.

Usage in Children: For induction and maintenance of anesthesia in children less than 12 years of age undergoing cardiovascular surgery, an anesthetic dose of 10 to 25 mcg/kg administered with 100% oxygen is generally recommended. Supplemental dosages of up to 25 to 50 mcg are recommended for maintenance, based on response to initial dose and as determined by changes in vital signs indicating surgical stress or lightening of anesthesia.

Premedication: The selection of preanesthetic medications should be based upon the needs of the individual patient.

Neuromuscular Blocking Agents: The neuromuscular blocking agent selected should be compatible with the patient's condition, taking into account the hemodynamic effects of a particular muscle relaxant and the degree of skeletal muscle relaxation required (see CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS).
ADULT DOSAGE RANGE CHART for Intravenous use ANALGESIC COMPONENT TO GENERAL ANESTHESIA •TOTAL DOSAGE REQUIREMENTS OF 1 MCG/KG/HR OR LESS ARE RECOMMENDED TOTAL DOSAGE MAINTENANCE DOSAGE ANALGESIC DOSAGES Incremental or Infusion: 1 to 2 mcg/kg (expected duration of anesthesia 1 to 2 hours). Approximately 75% or more of total sufentanil dosage may be administered prior to intubation by either slow injection or infusion titrated to individual patient response. Dosages in this range are generally administered with nitrous oxide/oxygen in patients undergoing general surgery in which endotracheal intubation and mechanical ventilation are required. Incremental: 10 to 25 mcg (0.2 to 0.5 mL) may be administered in increments as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. Supplemental dosages should be individualized and adjusted to remaining operative time anticipated.Infusion: Sufentanil citrate may be administered as an intermittent or continuous infusion as needed in response to signs of lightening of analgesia. In absence of signs of lightening of analgesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation. Maintenance infusion rates should be adjusted based upon the induction dose of sufentanil so that the total dose does not exceed 1 mcg/kg/hr of expected surgical time. Dosage should be individualized and adjusted to remaining operative time anticipated. ANALGESIC DOSAGES Incremental or Infusion: 2 to 8 mcg/kg (expected duration of anesthesia 2 to 8 hours). Approximately 75% or less of the total calculated sufentanil dosage may be administered by slow injection or infusion prior to intubation, titrated to individual patient response. Dosages in this range are generally administered with nitrous oxide/oxygen in patients undergoing more complicated major surgical procedures in which endotracheal intubation and mechanical ventilation are required. At dosages in this range, sufentanil has been shown to provide some attenuation of sympathetic reflex activity in response to surgical stimuli, provide hemodynamic stability, and provide relatively rapid recovery. Incremental: 10 to 50 mcg (0.2 to 1 mL) may be administered in increments as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. Supplemental dosages should be individualized and adjusted to the remaining operative time anticipated.Infusion: Sufentanil citrate may be administered as an intermittent or continuous infusion as needed in response to signs of lightening of analgesia. In the absence of signs of lightening of analgesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation. Maintenance infusion rates should be adjusted based upon the induction dose of sufentanil so that the total dose does not exceed 1 mcg/kg/hr of expected surgical time. Dosage should be individualized and adjusted to remaining operative time anticipated. ANESTHETIC DOSAGES Incremental or Infusion: 8 to 30 mcg/kg (anesthetic doses). At this anesthetic dosage range sufentanil is generally administered as a slow injection, as an infusion, or as an injection followed by an infusion. Sufentanil with 100% oxygen and a muscle relaxant has been found to produce sleep at dosages ≥8 mcg/kg and to maintain a deep level of anesthesia without the use of additional anesthetic agents. The addition of N2O to these dosages will reduce systolic blood pressure. At dosages in this range of up to 25 mcg/kg, catecholamine release is attenuated. Dosages of 25 to 30 mcg/kg have been shown to block sympathetic response including catecholamine release. High doses are indicated in patients undergoing major surgical procedures, in which endotracheal intubation and mechanical ventilation are required, such as cardiovascular surgery and neurosurgery in the sitting position with maintenance of favorable myocardial and cerebral oxygen balance. Postoperative observation is essential and postoperative mechanical ventilation may be required at the higher dosage range due to extended postoperative respiratory depression. Dosage should be titrated to individual patient response. Incremental: Depending on the initial dose, maintenance doses of 0.5 to 10 mcg/kg may be administered by slow injection in anticipation of surgical stress such as incision, sternotomy or cardiopulmonary bypass.Infusion: Sufentanil citrate may be administered by continuous or intermittent infusion as needed in response to signs of lightening of anesthesia. In the absence of lightening of anesthesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation. The maintenance infusion rate for sufentanil should be based upon the induction dose so that the total dose for the procedure does not exceed 30 mcg/kg.
In patients administered high doses of sufentanil, it is essential that qualified personnel and adequate facilities are available for the management of postoperative respiratory depression.

Also see WARNINGS and PRECAUTIONS sections.

For purposes of administering small volumes of Sufentanil Citrate Injection accurately, the use of a tuberculin syringe or equivalent is recommended.
Epidural use in Labor and Delivery Proper placement of the needle or catheter in the epidural space should be verified before sufentanil citrate is injected to assure that unintentional intravascular or intrathecal administration does not occur. Unintentional intravascular injection of sufentanil could result in a potentially serious overdose, including acute truncal muscular rigidity and apnea. Unintentional intrathecal injection of the full sufentanil, bupivacaine epidural doses and volume could produce effects of high spinal anesthesia including prolonged paralysis and delayed recovery. If analgesia is inadequate, the placement and integrity of the catheter should be verified prior to the administration of any additional epidural medications. Sufentanil should be administered by slow injection. Respiration should be closely monitored following each administration of an epidural injection of sufentanil. Dosage for Labor and Delivery: The recommended dosage is sufentanil 10 to 15 mcg administered with 10 mL bupivacaine 0.125% with or without epinephrine. Sufentanil and bupivacaine should be mixed together before administration. Doses can be repeated twice (for a total of three doses) at not less than one-hour intervals until delivery.
Akten

Akten

The recommended dose of Akten® is 2 drops applied to the ocular surface in the area of the planned procedure. Akten® may be reapplied to maintain anesthetic effect.
Tetanus And Diphtheria ...

Tetanus And Diphtheria Toxoids Adsorbed

PRIMARY IMMUNIZATIONMassBiologics' Td may be used in persons 7 years of age and older who have not been previously immunized against tetanus and diphtheria, as a primary immunization series consisting of three 0.5 ml doses. The first two doses are administered 4-8 weeks apart and the third dose is administered 6-12 months after the second dose.

MassBiologics' Td may be used to complete the primary immunization series for tetanus and diphtheria, following one or two doses of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (whole cell DTP), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and/or Diphtheria and Tetanus Toxoids Adsorbed (DT) vaccine. However, the safety and efficacy of MassBiologics' Td in such regimens have not been evaluated.

ROUTINE BOOSTER IMMUNIZATIONMassBiologics' Td may be used for routine booster immunization against tetanus and diphtheria in persons 7 years of age and older who have completed primary immunization against tetanus and diphtheria. Routine booster immunization against tetanus and diphtheria is recommended in children 11-12 years of age and every 10 years thereafter.10

The Advisory Committee on Immunization Practices (ACIP) has specific recommendations on booster immunization against tetanus and diphtheria for adolescents and adults.10,13,14

TETANUS PROPHYLAXIS IN WOUND MANAGEMENT For active tetanus immunization in wound management of patients 7 years of age and older, a preparation containing tetanus and diphtheria toxoids is preferred instead of single-antigen tetanus toxoid to enhance diphtheria protection.15 MassBiologics' Td is approved for wound management of patients 7 years of age and older.

The need for active immunization with a tetanus toxoid-containing preparation, with or without Tetanus Immune Globulin (TIG) (Human) depends on both the condition of the wound and the patient's vaccination history (Table 1).

When indicated, TIG (Human) should be administered using a separate needle and syringe at a different anatomic site, according to the manufacturer's package insert. If a contraindication to using a tetanus toxoid-containing vaccine exists in a person who has not completed tetanus primary immunization and other than a clean, minor wound is sustained, only passive immunization with TIG (Human) should be given.15

TABLE 1 GUIDE TO TETANUS PROPHYLAXIS IN ROUTINE WOUND MANAGEMENT IN PERSONS AGED 7 YEARS AND OLDER 13,14,15
History of Adsorbed Tetanus Toxoid (Doses) Clean, Minor Wounds All Other Wounds* Td† TIG Td† TIG Unknown or < 3 Yes No Yes Yes ≥ 3 ‡ No§ No No¶ No
* Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns and frostbite.† The ACIP has specific recommendations on use of Td or Tetanus Toxoid, Reduced Diphtheria Toxoids and Acellular Pertussis Vaccine Adsorbed (Tdap) in adolescents and adults.13,14 ‡ If only three doses of fluid tetanus toxoid have been received, then a fourth dose of toxoid, preferably an adsorbed toxoid, should be given.§ Yes, if ≥ 10 years since the last tetanus toxoid-containing vaccine dose.¶ Yes, if ≥ 5 years since the last tetanus toxoid-containing vaccine dose. (More frequent boosters are not needed and can accentuate side effects.)

DIPHTHERIA PROPHYLAXIS FOR CASE CONTACTSMassBiologics' Td may be used for post-exposure diphtheria prophylaxis in persons 7 years of age and older who have not completed primary vaccination, whose vaccination status is unknown, or who have not been vaccinated with diphtheria toxoid within the previous 5 years. Consult ACIP recommendations for additional interventions for post-exposure diphtheria prophylaxis.15

ADMINISTRATIONShake the vial well to resuspend the vaccine before withdrawing the dose. After shaking, MassBiologics' Td is a homogenous milky white suspension. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions exist, MassBiologics' Td should not be administered.

Inject 0.5 ml of MassBiologics' Td intramuscularly. The preferred site is the deltoid muscle. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

Do not administer this vaccine intravenously, subcutaneously, or intradermally.

MassBiologics' Td should not be combined through reconstitution or mixed with any other vaccine.
Cosopt Pf

Cosopt Pf

The dose is one drop of COSOPT PF in the affected eye(s) two times daily.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart [see Drug Interactions (7.3)].

The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration.
Tobramycin Solution

Tobramycin Solution

The recommended dosage for both adults and pediatric patients 6 years of age and older is 1 single-use ampule (300 mg) administered BID for 28 days. Dosage is not adjusted by weight. All patients should be administered 300 mg BID. The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart.

Tobramycin inhalation solution is inhaled while the patient is sitting or standing upright and breathing normally through the mouthpiece of the nebulizer. Nose clips may help the patient breathe through the mouth.

Tobramycin inhalation solution is administered BID in alternating periods of 28 days. After 28 days of therapy, patients should stop tobramycin inhalation solution therapy for the next 28 days, and then resume therapy for the next 28 day on/28 day off cycle.

Tobramycin inhalation solution is supplied as a single-use ampule and is administered by inhalation, using a hand-held PARI LC PLUS™ Reusable Nebulizer with a DeVilbiss® Pulmo-Aide® compressor. Tobramycin inhalation solution is not for subcutaneous, intravenous or intrathecal administration.

Usage

Tobramycin inhalation solution is administered by inhalation over an approximately 15-minute period, using a hand-held PARI LC PLUS™ Reusable Nebulizer with a DeVilbiss® Pulmo-Aide® compressor. Tobramycin inhalation solution should not be diluted or mixed with dornase alfa (PULMOZYME®, Genentech) or other medication in the nebulizer.

During clinical studies, patients on multiple therapies were instructed to take them first, followed by Tobramycin inhalation solution.
Dronabinol

Dronabinol

Antiemetic: Dronabinol Capsules is best administered at an initial dose of 5 mg/m2, given 1 to 3 hours prior to the administration of chemotherapy, then every 2 to 4 hours after chemotherapy is given, for a total of 4 to 6 doses/day. Should the 5 mg/m2 dose prove to be ineffective, and in the absence of significant side effects, the dose may be escalated by 2.5 mg/m2 increments to a maximum of 15 mg/m2 per dose. Caution should be exercised in dose escalation, however, as the incidence of disturbing psychiatric symptoms increases significantly at maximum dose. (See PRECAUTIONS.)
Atropine

Atropine

In individuals from three (3) months of age or greater, 1 drop topically to the cul-de-sac of the conjunctiva, forty minutes prior to the intended maximal dilation time.

In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed.
Xylon 10

Xylon 10

Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of Tranexamic Acid Injection intravenously together with replacement therapy (see PRECAUTIONS). Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.

Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:
Serum Creatinine (μmol/L) Tranexamic Acid I.V. Dosage 120 to 250 (1.36 to 2.83 mg/dL) 10 mg/kg BID 250 to 500 (2.83 to 5.66 mg/dL) 10 mg/kg daily 10 mg/kg every 48 hours > 500 (>5.66 mg/dL) or 5 mg/kg every 24 hours
For intravenous infusion, Tranexamic Acid Injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to Tranexamic Acid Injection. Tranexamic Acid Injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.
Zoledronic Acid Solutio...

Zoledronic Acid Solution

2.1 Important Administration Instructions

Zoledronic acid injection must be administered as an intravenous infusion over no less than 15 minutes.
Patients must be appropriately hydrated prior to administration of zoledronic acid injection [see Warnings and Precautions (5.3)]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Intravenous infusion should be followed by a 10 mL normal saline flush of the intravenous line. Administration of acetaminophen following zoledronic acid injection administration may reduce the incidence of acute-phase reaction symptoms.
Caution: After removing the overwrap check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard container as sterility may be compromised. Use only if solution is clear and the container is undamaged.

2.6 Treatment of Paget's Disease of Bone

The recommended dose is a 5 mg infusion. The infusion time must not be less than 15 minutes given over a constant infusion rate.

Re-treatment of Paget's Disease

After a single treatment with zoledronic acid injection in Paget's disease an extended remission period is observed. Specific re-treatment data are not available. However, re-treatment with zoledronic acid injection may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, or in those patients who failed to achieve normalization of their serum alkaline phosphatase, or in those patients with symptoms, as dictated by medical practice.

2.7 Laboratory Testing and Oral Examination Prior to Administration
Prior to administration of each dose of zoledronic acid injection, obtain a serum creatinine and creatinine clearance should be calculated based on actual body weight using Cockcroft-Gault formula before each zoledronic acid injection dose. Zoledronic acid injection is contraindicated in patients with creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment. A 5 mg dose of zoledronic acid injection administered intravenously is recommended for patients with creatinine clearance greater than 35 mL/min. There are no safety or efficacy data to support the adjustment of the zoledronic acid injection dose based on baseline renal function. Therefore, no dose adjustment is required in patients with CrCl greater than 35 mL/min [see Contraindications (4), Warnings and Precautions (5.3)]. A routine oral examination should be performed by the prescriber prior to initiation of zoledronic acid injection treatment [see Warning and Precautions (5.4)].
2.8 Calcium and Vitamin D Supplementation
Instruct patients being treated for Paget's disease of bone on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels, and on the symptoms of hypocalcemia. All patients should take 1500 mg elemental calcium daily in divided doses (750 mg two times a day, or 500 mg three times a day) and 800 international units vitamin D daily, particularly in the 2 weeks following zoledronic acid injection administration [see Warnings and Precautions (5.2)].
2.9 Method of Administration

The zoledronic acid injection infusion time must not be less than 15 minutes given over a constant infusion rate.

The i.v. infusion should be followed by a 10 mL normal saline flush of the intravenous line.

Zoledronic acid injection solution for infusion must not be allowed to come in contact with any calcium or other divalent cation-containing solutions, and should be administered as a single intravenous solution through a separate vented infusion line.

If refrigerated, allow the refrigerated solution to reach room temperature before administration. After opening, the solution is stable for 24 hours at 2° to 8°C (36° to 46°F) [see How Supplied/Storage and Handling (16)].
Tobramycin

Tobramycin

Tobramycin may be given intramuscularly or intravenously. Recommended dosages are the same for both routes. The patient's pretreatment body weight should be obtained for calculation of correct dosage. It is desirable to measure both peak and trough serum concentrations (see WARNINGS box and PRECAUTIONS).

Administration for Patients with Normal Renal Function

Adults with Serious Infections: 3 mg/kg/day in 3 equal doses every 8 hours (see Table 3).

Adults With Life-Threatening Infections: Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see Table 3). The dosage should be reduced to 3 mg/kg/day as soon as clinically indicated. To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored (see WARNINGS box and PRECAUTIONS).
Table 3 DOSAGE SCHEDULE GUIDE FOR ADULT WITH NORMAL RENAL FUNCTION (Dosage at 8-Hour Intervals) For Patient Weighing Usual Dose for Serious Infections 1 mg/kg q8h (Total, 3 mg /kg/day) kg lb mg/dose mL/dose* q8h 120 264 120 mg 3 mL 115 253 115 mg 2.9 mL 110 242 110 mg 2.75 mL 105 231 105 mg 2.6 mL 100 220 100 mg 2.5 mL 95 209 95 mg 2.4 mL 90 198 90 mg 2.25 mL 85 187 85 mg 2.1 mL 80 176 80 mg 2 mL 75 165 75 mg 1.9 mL 70 154 70 mg 1.75 mL 65 143 65 mg 1.6 mL 60 132 60 mg 1.5 mL 55 121 55 mg 1.4 mL 50 110 50 mg 1.25 mL 45 99 45 mg 1.1 mL 40 88 40 mg 1 mL
* Applicable to all product forms except Tobramycin Injection Pediatric, 10 mg/mL.
DOSAGE SCHEDULE GUIDE FOR ADULTWITH NORMAL RENAL FUNCTION (continued)(Dosage at 8-Hour Intervals) For PatientWeighing Maximum dose for Life-ThreateningInfections(Reduce as soon as possible)1.66 mg/kg q8h(Total 5 mg/kg/day) kg lb mg/dose mL/dose* q8h 120 264 200 mg 5 mL 115 253 191 mg 4.75 mL 110 242 183 mg 4.5 mL 105 231 175 mg 4.4 mL 100 220 166 mg 4.2 mL 95 209 158 mg 4 mL 90 198 150 mg 3.75 mL 85 187 141 mg 3.5 mL 80 176 133 mg 3.3 mL 75 165 125 mg 3.1 mL 70 154 116 mg 2.9 mL 65 143 108 mg 2.7 mL 60 132 100 mg 2.5 mL 55 121 91 mg 2.25 mL 50 110 83 mg 2.1 mL 45 99 75 mg 1.9 mL 40 88 66 mg 1.6 mL
Pediatric Patients (greater than 1 week of age): 6 to 7.5 mg/kg/day in 3 or 4 equally divided doses (2 to 2.5 mg/kg every 8 hours or 1.5 to 1.89 mg/kg every 6 hours).

Premature or Full-Term Neonates 1 Week of Age or Less: Up to 4 mg/kg/day may be administered in 2 equal doses every 12 hours.

It is desirable to limit treatment to a short term. The usual duration of treatment is 7 to 10 days. A longer course of therapy may be necessary in difficult and complicated infections. In such cases, monitoring of renal, auditory, and vestibular functions is advised, because neurotoxicity is more likely to occur when treatment is extended longer than 10 days.

Dosage in Patients with Cystic Fibrosis

In patients with cystic fibrosis, altered pharmacokinetics may result in reduced serum concentrations of aminoglycosides. Measurement of tobramycin serum concentration during treatment is especially important as a basis for determining appropriate dose. In patients with severe cystic fibrosis, an initial dosing regimen of 10 mg/kg/day in 4 equally divided doses is recommended. This dosing regimen is suggested only as a guide. The serum levels of tobramycin should be measured directly during treatment due to wide interpatient variability.

Administration for Patients with Impaired Renal Function

Whenever possible, serum tobramycin concentrations should be monitored during therapy.

Following a loading dose of 1 mg/kg, subsequent dosage in these patients must be adjusted, either with reduced doses administered at 8-hour intervals or with normal doses given at prolonged intervals. Both of these methods are suggested as guides to be used when serum levels of tobramycin cannot be measured directly. They are based on either the creatinine clearance level or the serum creatinine level of the patient because these values correlate with the half-life of tobramycin. The dosage schedule derived from either method should be used in conjunction with careful clinical and laboratory observations of the patient and should be modified as necessary. Neither method should be used when dialysis is being performed.

Reduced dosage at 8-hour intervals: When the creatinine clearance rate is 70 mL or less per minute or when the serum creatinine value is known, the amount of the reduced dose can be determined by multiplying the normal dose from Table 3 by the percent of normal dose from the accompanying nomogram.

*Scales have been adjusted to facilitate dosage calculations.

An alternate rough guide for determining reduced dosage at 8-hour intervals (for patients whose steady-state serum creatinine values are known) is to divide the normally recommended dose by the patient's serum creatinine.

Normal dosage at prolonged intervals: If the creatinine clearance rate is not available and the patient's condition is stable, a dosage frequency in hours for the dosage given in Table 3 can be determined by multiplying the patient's serum creatinine by 6.

Dosage in Obese Patients

The appropriate dose may be calculated by using the patient's estimated lean body weight plus 40% of the excess as the basic weight on which to figure mg/kg.

Intramuscular Administration

Tobramycin may be administered by withdrawing the appropriate dose directly from a vial.

Intravenous Administration

For intravenous administration, the usual volume of diluent (0.9% Sodium Chloride Injection or 5% Dextrose Injection) is 50 to 100 mL for adult doses. For pediatric patients, the volume of diluent should be proportionately less than that for adults. The diluted solution usually should be infused over a period of 20 to 60 minutes. Infusion periods of less than 20 minutes are not recommended because peak serum levels may exceed 12 mcg/mL (see WARNINGS box).

Tobramycin injection should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

Prior to administration, parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.
Renew Body Cleanser

Renew Body Cleanser

Lorazepam must never be used without individualization of dosage particularly when used with other medications capable of producing central-nervous-system depression.

EQUIPMENT NECESSARY TO MAINTAIN A PATENT AIRWAY SHOULD BE IMMEDIATELY AVAILABLE PRIOR TO INTRAVENOUS ADMINISTRATION OF LORAZEPAM (see WARNINGS).

Status Epilepticus

General Advice

Status epilepticus is a potentially life-threatening condition associated with a high risk of permanent neurological impairment, if inadequately treated. The treatment of status, however, requires far more than the administration of an anticonvulsant agent. It involves observation and management of all parameters critical to maintaining vital function and the capacity to provide support of those functions as required. Ventilatory support must be readily available. The use of benzodiazepines, like Lorazepam injection, is ordinarily only an initial step of a complex and sustained intervention which may require additional interventions, (e.g., concomitant intravenous administration of phenytoin). Because status epilepticus may result from a correctable acute cause such as hypoglycemia, hyponatremia, or other metabolic or toxic derangement, such an abnormality must be immediately sought and corrected. Furthermore, patients who are susceptible to further seizure episodes should receive adequate maintenance antiepileptic therapy.

Any health care professional who intends to treat a patient with status epilepticus should be familiar with this package insert and the pertinent medical literature concerning current concepts for the treatment of status epilepticus. A comprehensive review of the considerations critical to the informed and prudent management of status epilepticus cannot be provided in drug product labeling. The archival medical literature contains many informative references on the management of status epilepticus, among them the report of the working group on status epilepticus of the Epilepsy Foundation of America “Treatment of Convulsive Status Epilepticus” (JAMA 1993; 270:854-859). As noted in the report just cited, it may be useful to consult with a neurologist if a patient fails to respond (e.g., fails to regain consciousness).

Intravenous Injection

For the treatment of status epilepticus, the usual recommended dose of Lorazepam injection is 4 mg given slowly (2 mg/min) for patients 18 years and older. If seizures cease, no additional Lorazepam injection is required. If seizures continue or recur after a 10 to 15 minute observation period, an additional 4 mg intravenous dose may be slowly administered. Experience with further doses of Lorazepam is very limited. The usual precautions in treating status epilepticus should be employed. An intravenous infusion should be started, vital signs should be monitored, an unobstructed airway should be maintained, and artificial ventilation equipment should be available.

Intramuscular Injection

IM Lorazepam is not preferred in the treatment of status epilepticus because therapeutic lorazepam levels may not be reached as quickly as with IV administration. However, when an intravenous port is not available, the IM route may prove useful (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism).

Pediatric

The safety of Lorazepam in pediatric patients has not been established.

Preanesthetic

Intramuscular Injection

For the designated indications as a premedicant, the usual recommended dose of lorazepam for intramuscular injection is 0.05 mg/kg up to a maximum of 4 mg. As with all premedicant drugs, the dose should be individualized (see also CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS). Doses of other central-nervous-system-depressant drugs ordinarily should be reduced (see PRECAUTIONS). For optimum effect, measured as lack of recall, intramuscular lorazepam should be administered at least 2 hours before the anticipated operative procedure. Narcotic analgesics should be administered at their usual preoperative time.

There are insufficient data to support efficacy or make dosage recommendations for intramuscular lorazepam in patients less than 18 years of age; therefore, such use is not recommended.

Intravenous Injection

For the primary purpose of sedation and relief of anxiety, the usual recommended initial dose of lorazepam for intravenous injection is 2 mg total, or 0.02 mg/lb (0.044 mg/kg), whichever is smaller. This dose will suffice for sedating most adult patients and ordinarily should not be exceeded in patients over 50 years of age. In those patients in whom a greater likelihood of lack of recall for perioperative events would be beneficial, larger doses as high as 0.05 mg/kg up to a total of 4 mg may be administered (see CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS). Doses of other injectable central-nervous-system-depressant drugs ordinarily should be reduced (see PRECAUTIONS). For optimum effect, measured as lack of recall, intravenous lorazepam should be administered 15 to 20 minutes before the anticipated operative procedure.

There are insufficient data to support efficacy or make dosage recommendations for intravenous lorazepam in patients less than 18 years of age; therefore, such use is not recommended.

Dose Administration in Special Populations

Elderly Patients and Patients with Hepatic Disease No dosage adjustments are needed in elderly patients and in patients with hepatic disease.

Patients with Renal Disease

For acute dose administration, adjustment is not needed for patients with renal disease. However, in patients with renal disease, caution should be exercised if frequent doses are given over relatively short periods of time (see also CLINICAL PHARMACOLOGY).

Dose Adjustment Due to Drug Interactions

The dose of Lorazepam should be reduced by 50% when coadministered with probenecid or valproate (see PRECAUTIONS, Drug Interactions).

It may be necessary to increase the dose of Lorazepam in female patients who are concomitantly taking oral contraceptives.

Administration

When given intramuscularly, Lorazepam injection, undiluted, should be injected deep in the muscle mass.

Injectable Lorazepam can be used with atropine sulfate, narcotic analgesics, other parenterally used analgesics, commonly used anesthetics, and muscle relaxants.

Immediately prior to intravenous use, Lorazepam injection must be diluted with an equal volume of compatible solution. Contents should be mixed thoroughly by gently inverting the container repeatedly until a homogenous solution results. Do not shake vigorously, as this will result in air entrapment. When properly diluted, the drug may be injected directly into a vein or into the tubing of an existing intravenous infusion. The rate of injection should not exceed 2.0 mg per minute.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if solution is discolored or contains a precipitate.

Lorazepam injection is compatible for dilution purposes with the following solutions: Sterile Water for Injection, USP; Sodium Chloride Injection, USP; 5% Dextrose Injection, USP.
Sulfacetamide Sodium So...

Sulfacetamide Sodium Solution Drops

For conjunctivitis and other superficial ocular infections:

Solution: Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.

For Trachoma:

Solution: Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.
Milk Of Magnesia

Milk Of Magnesia

The dose is 1 or 2 drops in each eye 4 to 6 times a day at regular intervals. One drop contains approximately 1.6 mg cromolyn sodium.

Patients should be advised that the effect of Cromolyn Sodium Ophthalmic Solution therapy is dependent upon its administration at regular intervals, as directed.

Symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.

If required, corticosteroids may be used concomitantly with Sodium Chloride Ophthalmic Solution.
Dorzolamide Hcl And Tim...

Dorzolamide Hcl And Timolol Maleate

The dose is one drop of Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution in the affected eye(s) two times daily.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart (see also PRECAUTIONS, Drug Interactions).

Akorn, Inc.

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