West-ward Pharmaceuticals Corp

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West-ward Pharmaceuticals Corp Drugs

Captopril

Captopril

Captopril tablets should be taken one hour before meals. Dosage must be individualized.

Hypertension: Initiation of therapy requires consideration of recent antihypertensive drug treatment, the extent of blood pressure elevation, salt restriction, and other clinical circumstances. If possible, discontinue the patient’s previous antihypertensive drug regimen for one week before starting captopril tablets.

The initial dose of captopril tablets is 25 mg b.i.d. or t.i.d. If satisfactory reduction of blood pressure has not been achieved after one or two weeks, the dose may be increased to 50 mg b.i.d. or t.i.d. Concomitant sodium restriction may be beneficial when captopril tablets are used alone.

The dose of captopril tablets in hypertension usually does not exceed 50 mg t.i.d. Therefore, if the blood pressure has not been satisfactorily controlled after one to two weeks at this dose, (and the patient is not already receiving a diuretic), a modest dose of a thiazide-type diuretic (e.g., hydrochlorothiazide, 25 mg daily), should be added. The diuretic dose may be increased at one to two-week intervals until its highest usual antihypertensive dose is reached.

If captopril tablets are being started in a patient already receiving a diuretic, captopril tablets therapy should be initiated under close medical supervision (See WARNINGS and PRECAUTIONS: Drug Interactions regarding hypotension), with dosage and titration of captopril tablet as noted above.

If further blood pressure reduction is required, the dose of captopril tablets may be increased to 100 mg b.i.d. or t.i.d. and then, if necessary, to 150 mg b.i.d. or t.i.d. (while continuing the diuretic). The usual dose range is 25 to 150 mg b.i.d. or t.i.d. A maximum daily dose of 450 mg captopril tablets should not be exceeded.

For patients with severe hypertension (e.g., accelerated or malignant hypertension), when temporary discontinuation of current antihypertensive therapy is not practical or desirable, or when prompt titration to more normotensive blood pressure levels is indicated, diuretic should be continued but other current antihypertensive medication stopped and captopril tablets dosage promptly initiated at 25 mg b.i.d. or t.i.d., under close medical supervision.

When necessitated by the patient’s clinical condition, the daily dose of captopril tablets may be increased every 24 hours or less under continuous medical supervision until a satisfactory blood pressure response is obtained or the maximum dose of captopril tablets is reached. In this regimen, addition of a more potent diuretic, e.g., furosemide, may also be indicated.

Beta-blockers may also be used in conjunction with captopril tablets therapy (See PRECAUTIONS: Drug Interactions), but the effects of the two drugs are less than additive.

Heart Failure: Initiation of therapy requires consideration of recent diuretic therapy and the possibility of severe salt/volume depletion. In patients with either normal or low blood pressure, who have been vigorously treated with diuretics and who may be hyponatremic and/or hypovolemic, a starting dose of 6.25 or 12.5 mg t.i.d. may minimize the magnitude or duration of the hypotensive effect (See WARNINGS: Hypotension); for these patients, titration to the usual daily dosage can then occur within the next several days.

For most patients the usual initial daily dosage is 25 mg t.i.d. After a dose of 50 mg t.i.d. is reached, further increases in dosage should be delayed, where possible, for at least two weeks to determine if a satisfactory response occurs. Most patients studied have had a satisfactory clinical improvement at 50 or 100 mg t.i.d. A maximum daily dose of 450 mg of captopril tablets should not be exceeded.

Captopril tablets should generally be used in conjunction with a diuretic and digitalis. Captopril tablets therapy must be initiated under very close medical supervision.

Left Ventricular Dysfunction After Myocardial Infarction: The recommended dose for long-term use in patients following a myocardial infarction is a target maintenance dose of 50 mg t.i.d.

Therapy may be initiated as early as three days following a myocardial infarction. After a single dose of 6.25 mg, captopril tablets therapy should be initiated at 12.5 mg t.i.d. Captopril tablets should then be increased to 25 mg t.i.d. during the next several days and to a target dose of 50 mg t.i.d. over the next several weeks as tolerated (See CLINICAL PHARMACOLOGY).

Captopril tablets may be used in patients treated with other post-myocardial infarction therapies, e.g., thrombolytics, aspirin, beta blockers.

Diabetic Nephropathy: The recommended dose of captopril tablets for long term use to treat diabetic nephropathy is 25 mg t.i.d.

Other antihypertensives such as diuretics, beta blockers, centrally acting agents or vasodilators may be used in conjunction with captopril tablets if additional therapy is required to further lower blood pressure.

Dosage Adjustment in Renal Impairment: Because captopril tablets are excreted primarily by the kidneys, excretion rates are reduced in patients with impaired renal function. These patients will take longer to reach steady-state captopril levels and will reach higher steady-state levels for a given daily dose than patients with normal renal function. Therefore, these patients may respond to smaller or less frequent doses.

Accordingly, for patients with significant renal impairment, initial daily dosage of captopril tablets should be reduced, and smaller increments utilized for titration, which should be quite slow (one- to two-week intervals). After the desired therapeutic effect has been achieved, the dose should be slowly back-titrated to determine the minimal effective dose. When concomitant diuretic therapy is required, a loop diuretic (e.g., furosemide), rather than a thiazide diuretic, is preferred in patients with severe renal impairment. (See WARNINGS: Anaphylactoid reactions during membrane exposure and PRECAUTIONS: Hemodialysis.)
Sumavel Dosepro

Sumavel Dosepro

Morphine sulfate injection is intended for intravenous administration.

2.1 General Dosing Considerations

Morphine sulfate injection is available in three concentrations for direct injection. Take care when prescribing and administering morphine sulfate injection to avoid dosing errors due to confusion between 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 total dose in volume.

Administration of morphine sulfate injection should be limited to use by those familiar with the management of respiratory depression. Morphine must be injected slowly; rapid intravenous administration may result in chest wall rigidity.

Selection of patients for treatment with morphine sulfate injection should be governed by the same principles that apply to the use of similar opioid analgesics. 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.

2.2 Individualization of Dosage

Adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of morphine sulfate injection, give attention to the following:
the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent morphine sulfate injection dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient’s pain; risk factors for abuse, addiction or diversion, including prior history of abuse, addiction or diversion
The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Continual reevaluation of the patient receiving morphine sulfate injection is important, with special attention to the management of pain and the relative incidence of side effects associated with therapy.

During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between the physician, other members of the healthcare team, the patient, and the caregiver/family.

2.3 Direct Intravenous Injection

The usual starting dose in adults is 0.1 mg to 0.2 mg per kg every 4 hours as needed to manage pain. Administer the injection slowly.

2.4 Dosing with Hepatic and Renal Impairment

Morphine sulfate pharmacokinetics have been reported to be significantly altered in patients with cirrhosis and renal failure. Start these patients cautiously with lower doses of morphine sulfate injection and titrate slowly while carefully monitoring for side effects. [See Use in Specific Populations (8.7 and 8.8).]
Perindopril Erbumine

Perindopril Erbumine

2.1 Dosing for Partial Onset Seizures

Adults 16 Years and OlderInitiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

Pediatric Patients1 Month to < 6 Months Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

6 Months to < 4 Years Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

4 Years to < 16 Years Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

2.2 Dosing for Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy

Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

2.3 Dosing for Primary Generalized Tonic-Clonic Seizures

Adults 16 Years and OlderInitiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

Pediatric Patients Ages 6 to <16 YearsInitiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg (10 mg/kg twice daily) to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied.

2.4 Switching from Oral Dosing

When switching from oral levetiracetam, the initial total daily intravenous dosage of levetiracetam should be equivalent to the total daily dosage and frequency of oral levetiracetam.

2.5 Switching to Oral Dosing

At the end of the intravenous treatment period, the patient may be switched to levetiracetam oral administration at the equivalent daily dosage and frequency of the intravenous administration.

2.6 Preparation and Administration Instructions

Levetiracetam injection is for intravenous use only and should be diluted in 100 mL of a compatible diluent prior to administration. If a smaller volume is required (e.g. pediatric patients), the amount of diluent should be calculated to not exceed a maximum levetiracetam concentration of 15 mg per mL of diluted solution. Consideration should also be given to the total daily fluid intake of the patient. Levetiracetam injection should be administered as a 15-minute IV infusion. One vial of levetiracetam injection contains 500 mg levetiracetam (500 mg/5 mL).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Product with particulate matter or discoloration should not be used.

Any unused portion of the levetiracetam injection vial contents should be discarded.

AdultsSee Table 1 for the recommended preparation and administration of levetiracetam injection to achieve a dose of 500 mg, 1000 mg, or 1500 mg.
Table 1: Preparation and Administration of Levetiracetam Injection for Adults Dose Withdraw Volume Volume of Diluent Infusion Time 500 mg 5 mL (5 mL vial) 100 mL 15 minutes 1000 mg 10 mL (two 5 mL vials) 100 mL 15 minutes 1500 mg 15 mL (three 5 mL vials) 100 mL 15 minutes
For example, to prepare a 1000 mg dose, dilute 10 mL of levetiracetam injection in 100 mL of a compatible diluent and administer intravenously as a 15-minute infusion.

Pediatric PatientsWhen using levetiracetam injection for pediatric patients, dosing is weight-based (mg per kg).

The following calculation should be used to determine the appropriate daily dose of levetiracetam injection for pediatric patients:
Total daily dose (mL/day) = Daily dose (mg/kg/day) x patient weigh (kg) 100 mg/mL
2.7 Dosage Adjustments in Adult Patients with Renal Impairment

Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults with renal impairment are shown in Table 2. Information is unavailable for dosage adjustments in pediatric patients with renal impairment. In order to calculate the dose recommended for adult patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

CLcr = [140-age (years)] x weight (kg) (x 0.85 for female patients) 72 x serum creatinine (mg/dL)

Then CLcr is adjusted for body surface area (BSA) as follows:

CLcr (mL/min/1.73m2) = CLcr (mL/min) x 1.73 BSA subject (m2)

Table 2:Dosage Adjustment Regimen for Adult Patients withRenal Impairment

Group

Creatinine Clearance (mL/min/1.73 m2)

Dosage (mg)

Frequency

Normal

> 80

500 to 1,500

Every 12 hours

Mild

50 – 80

500 to 1,000

Every 12 hours

Moderate

30 – 50

250 to 750

Every 12 hours

Severe

< 30

250 to 500

Every 12 hours

ESRD patients using dialysis

-----

500 to 1,000*

Every 24 hours*

2.8 Compatibility and Stability

Levetiracetam injection was found to be physically compatible and chemically stable when mixed with the following diluents and antiepileptic drugs for at least 24 hours and stored in polyvinyl chloride (PVC) bags at controlled room temperature 15º to 30°C (59º to 86°F).

Diluents Sodium chloride (0.9%) injection, USP Lactated Ringer’s injection Dextrose 5% injection, USP

Other Antiepileptic Drugs Lorazepam Diazepam Valproate sodium

There is no data to support the physical compatibility of levetiracetam injection with antiepileptic drugs that are not listed above.
Preferred Plus Day Time...

Preferred Plus Day Time Cold And Flu

2.1 General Dosing Information

Nicardipine hydrochloride injection is intended for intravenous use. DOSAGE MUST BE INDIVIDUALIZED depending upon the severity of hypertension and the response of the patient during dosing. Blood pressure and heart rate should be monitored both during and after the infusion to avoid tachycardia or too rapid or excessive reduction in either systolic or diastolic blood pressure.

2.2 Preparation

Warning: Dilute vials before infusion. Dilution

Nicardipine hydrochloride injection is administered by slow continuous infusion at a CONCENTRATION OF 0.1 MG/ML. Each vial (25 mg) should be diluted with 240 mL of compatible intravenous fluid (see below), resulting in 250 mL of solution at a concentration of 0.1 mg/mL.

Nicardipine hydrochloride injection has been found compatible and stable in polyvinyl chloride containers for 24 hours at controlled room temperature with:

Dextrose (5%) Injection, USPDextrose (5%) and Sodium Chloride (0.45%) Injection, USPDextrose (5%) and Sodium Chloride (0.9%) Injection, USPDextrose (5%) with 40 mEq Potassium, USPSodium Chloride (0.45%) Injection, USPSodium Chloride (0.9%) Injection, USP

Nicardipine hydrochloride injection is not compatible with Sodium Bicarbonate (5%) Injection, USP or Lactated Ringer’s Injection, USP.

The diluted solution is stable for 24 hours at room temperature.

Inspection

Visually inspect nicardipine hydrochloride injection for particulate matter and discoloration prior to administration, whenever solution and container permit. Nicardipine hydrochloride injection is normally light yellow in color.

Do not use the solution if particulate matter, precipitate or crystallization is present, or if the container appears damaged.

2.3 Dosage as a Substitute for Oral Nicardipine Therapy

The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:
Oral Nicardipine Dose Equivalent Intravenous Infusion Rate 20 mg q8h 0.5 mg/hr 30 mg q8h 1.2 mg/hr 40 mg q8h 2.2 mg/hr
2.4 Dosage for Initiation of Therapy in a Drug-Free Patient

The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. Nicardipine hydrochloride injection is administered by slow continuous infusion at a concentration of 0.1 mg/mL. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes.

When treating acute hypertensive episodes in patients with chronic hypertension, discontinuation of infusion is followed by a 50% offset of action in 30 minutes ± 7 minutes but plasma levels of drug and gradually decreasing antihypertensive effects exist for many hours.

Titration

For a gradual reduction in blood pressure, initiate therapy at a rate of 50 mL/hr (5 mg/hr). If desired blood pressure reduction is not achieved at this dose, increase the infusion rate by 25 mL/hr (2.5 mg/hr) every 15 minutes up to a maximum of 150 mL/hr (15 mg/hr), until desired blood pressure reduction is achieved. For more rapid blood pressure reduction, titrate every 5 minutes.

Maintenance

Adjust the rate of infusion as needed to maintain desired response.

2.5 Conditions Requiring Infusion Adjustment

Hypotension or Tachycardia: In case of hypotension or tachycardia, discontinue infusion. When blood pressure and heart rate stabilize, restart infusion at low doses such as 30 mL/hr to 50 mL/hr (3 mg/hr to 5 mg/hr) and titrate to maintain desired blood pressure.

Infusion Site Changes: Change infusion site every 12 hours if administered via peripheral vein.

Impaired Cardiac, Hepatic, or Renal Function: Monitor closely when titrating nicardipine hydrochloride injection in patients with congestive heart failure or impaired hepatic or renal function [see Warnings and Precautions (5.4, 5.5 and 5.6)].

2.6 Transfer to Oral Antihypertensive Agents

If treatment includes transfer to an oral antihypertensive agent other than nicardipine capsules, initiate oral therapy upon discontinuation of nicardipine hydrochloride injection.

When switching to a TID regimen of nicardipine capsules, administer the first dose 1 hour prior to discontinuation of the infusion.
Mecell Red Ginseng Coll...

Mecell Red Ginseng Collagen 3d Mask Pack

2.1 General Dosing Information

Nicardipine hydrochloride injection is intended for intravenous use. DOSAGE MUST BE INDIVIDUALIZED depending upon the severity of hypertension and the response of the patient during dosing. Blood pressure and heart rate should be monitored both during and after the infusion to avoid tachycardia or too rapid or excessive reduction in either systolic or diastolic blood pressure.

2.2 Preparation

Warning: Dilute vials before infusion. Dilution

Nicardipine hydrochloride injection is administered by slow continuous infusion at a CONCENTRATION OF 0.1 MG/ML. Each vial (25 mg) should be diluted with 240 mL of compatible intravenous fluid (see below), resulting in 250 mL of solution at a concentration of 0.1 mg/mL.

Nicardipine hydrochloride injection has been found compatible and stable in polyvinyl chloride containers for 24 hours at controlled room temperature with:

Dextrose (5%) Injection, USPDextrose (5%) and Sodium Chloride (0.45%) Injection, USPDextrose (5%) and Sodium Chloride (0.9%) Injection, USPDextrose (5%) with 40 mEq Potassium, USPSodium Chloride (0.45%) Injection, USPSodium Chloride (0.9%) Injection, USP

Nicardipine hydrochloride injection is not compatible with Sodium Bicarbonate (5%) Injection, USP or Lactated Ringer’s Injection, USP.

The diluted solution is stable for 24 hours at room temperature.

Inspection

Visually inspect nicardipine hydrochloride injection for particulate matter and discoloration prior to administration, whenever solution and container permit. Nicardipine hydrochloride injection is normally light yellow in color.

Do not use the solution if particulate matter, precipitate or crystallization is present, or if the container appears damaged.

2.3 Dosage as a Substitute for Oral Nicardipine Therapy

The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:
Oral Nicardipine Dose Equivalent Intravenous Infusion Rate 20 mg q8h 0.5 mg/hr 30 mg q8h 1.2 mg/hr 40 mg q8h 2.2 mg/hr
2.4 Dosage for Initiation of Therapy in a Drug-Free Patient

The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. Nicardipine hydrochloride injection is administered by slow continuous infusion at a concentration of 0.1 mg/mL. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes.

When treating acute hypertensive episodes in patients with chronic hypertension, discontinuation of infusion is followed by a 50% offset of action in 30 minutes ± 7 minutes but plasma levels of drug and gradually decreasing antihypertensive effects exist for many hours.

Titration

For a gradual reduction in blood pressure, initiate therapy at a rate of 50 mL/hr (5 mg/hr). If desired blood pressure reduction is not achieved at this dose, increase the infusion rate by 25 mL/hr (2.5 mg/hr) every 15 minutes up to a maximum of 150 mL/hr (15 mg/hr), until desired blood pressure reduction is achieved. For more rapid blood pressure reduction, titrate every 5 minutes.

Maintenance

Adjust the rate of infusion as needed to maintain desired response.

2.5 Conditions Requiring Infusion Adjustment

Hypotension or Tachycardia: In case of hypotension or tachycardia, discontinue infusion. When blood pressure and heart rate stabilize, restart infusion at low doses such as 30 mL/hr to 50 mL/hr (3 mg/hr to 5 mg/hr) and titrate to maintain desired blood pressure.

Infusion Site Changes: Change infusion site every 12 hours if administered via peripheral vein.

Impaired Cardiac, Hepatic, or Renal Function: Monitor closely when titrating nicardipine hydrochloride injection in patients with congestive heart failure or impaired hepatic or renal function [see Warnings and Precautions (5.4, 5.5 and 5.6)].

2.6 Transfer to Oral Antihypertensive Agents

If treatment includes transfer to an oral antihypertensive agent other than nicardipine capsules, initiate oral therapy upon discontinuation of nicardipine hydrochloride injection.

When switching to a TID regimen of nicardipine capsules, administer the first dose 1 hour prior to discontinuation of the infusion.
Pain Reliever Pm Extra ...

Pain Reliever Pm Extra Strength

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

2.1 Hypercalcemia of Malignancy

The maximum recommended dose of zoledronic acid in hypercalcemia of malignancy (albumin‑corrected serum calcium greater than or equal to 12 mg/dL [3 mmol/L]) is 4 mg. The 4-mg dose must be given as a single-dose intravenous infusion over no less than 15 minutes. Patients who receive zoledronic acid should have serum creatinine assessed prior to each treatment.

Dose adjustments of zoledronic acid are not necessary in treating patients for hypercalcemia of malignancy presenting with mild-to-moderate renal impairment prior to initiation of therapy (serum creatinine less than 400 mcmol/L or less than 4.5 mg/dL).

Patients should be adequately rehydrated prior to administration of zoledronic acid [see Warnings and Precautions (5.2)].

Consideration should be given to the severity of, as well as the symptoms of, tumor‑induced hypercalcemia when considering use of zoledronic acid. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. Diuretic therapy should not be employed prior to correction of hypovolemia.

Retreatment with zoledronic acid 4 mg may be considered if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. Renal function must be carefully monitored in all patients receiving zoledronic acid and serum creatinine must be assessed prior to retreatment with zoledronic acid [see Warnings and Precautions (5.2)].

2.2 Multiple Myeloma and Metastatic Bone Lesions of Solid Tumors

The recommended dose of zoledronic acid in patients with multiple myeloma and metastatic bone lesions from solid tumors for patients with creatinine clearance (CrCl) greater than 60 mL/min is 4 mg infused over no less than 15 minutes every 3 to 4 weeks. The optimal duration of therapy is not known.

Upon treatment initiation, the recommended zoledronic acid doses for patients with reduced renal function (mild and moderate renal impairment) are listed in Table 1. These doses are calculated to achieve the same area under the curve (AUC) as that achieved in patients with creatinine clearance of 75 mL/min. CrCl is calculated using the Cockcroft-Gault formula [see Warnings and Precautions (5.2)].
Table 1: Reduced Doses for Patients with Baseline CrCl Less than or Equal to 60 mL/min Baseline Creatinine Clearance (mL/min) Zoledronic Acid Injection Recommended Dose*
greater than 6050 to 6040 to 4930 to 39

4 mg3.5 mg3.3 mg3 mg
* Doses calculated assuming target AUC of 0.66 (mg•hr/L) (CrCl = 75 mL/min)
During treatment, serum creatinine should be measured before each zoledronic acid dose and treatment should be withheld for renal deterioration. In the clinical studies, renal deterioration was defined as follows:

For patients with normal baseline creatinine, increase of 0.5 mg/dL

For patients with abnormal baseline creatinine, increase of 1 mg/dL

In the clinical studies, zoledronic acid treatment was resumed only when the creatinine returned to within 10% of the baseline value. Zoledronic acid should be reinitiated at the same dose as that prior to treatment interruption.

Patients should also be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily.

2.3 Preparation of Solution

Zoledronic acid must not be mixed with calcium or other divalent cation-containing infusion solutions, such as Lactated Ringer’s solution, and should be administered as a single intravenous solution in a line separate from all other drugs.

4 mg/5 mL Single-Dose VialVials of zoledronic acid concentrate for infusion contain overfill allowing for the withdrawal of 5 mL of concentrate (equivalent to 4 mg zoledronic acid). This concentrate should immediately be diluted in 100 mL of sterile 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, following proper aseptic technique, and administered to the patient by infusion. Do not store undiluted concentrate in a syringe, to avoid inadvertent injection.

To prepare reduced doses for patients with baseline CrCl less than or equal to 60 mL/min, withdraw the specified volume of the zoledronic acid concentrate from the vial for the dose required (see Table 2).
Table 2: Preparation of Reduced Doses - Zoledronic Acid Injection Concentrate Remove and Use Zoledronic Acid Injection Volume (mL) Dose (mg)
4.44.13.8

3.53.33

The withdrawn concentrate must be diluted in 100 mL of sterile 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP.

If not used immediately after dilution with infusion media, for microbiological integrity, the solution should be refrigerated at 2° to 8°C (36° to 46°F). The refrigerated solution should then be equilibrated to room temperature prior to administration. The total time between dilution, storage in the refrigerator, and end of administration must not exceed 24 hours.

2.4 Method of Administration

Due to the risk of clinically significant deterioration in renal function, which may progress to renal failure, single doses of zoledronic acid should not exceed 4 mg and the duration of infusion should be no less than 15 minutes [see Warnings and Precautions (5.3)]. In the trials and in post marketing experience, renal deterioration, progression to renal failure and dialysis, have occurred in patients, including those treated with the approved dose of 4 mg infused over 15 minutes. There have been instances of this occurring after the initial zoledronic acid dose.
Cefaclor

Cefaclor

Cefaclor is administered orally.

Adults–The usual adult dosage is 250 mg every 8 hours. For more severe infections (such as pneumonia) or those caused by less susceptible organisms, doses may be doubled.

Pediatric patients–The usual recommended daily dosage for children is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day.

Cefaclor may be administered in the presence of impaired renal function. Under such a condition, the dosage usually is unchanged (see PRECAUTIONS).

In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cefaclor should be administered for at least 10 days.
Levetiracetam

Levetiracetam

2.1 Dosing for Partial Onset Seizures

Adults 16 Years and OlderInitiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

Pediatric Patients1 Month to < 6 MonthsInitiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

6 Months to < 4 YearsInitiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

4 Years to < 16 YearsInitiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

2.2 Dosing for Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy

Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

2.3 Dosing for Primary Generalized Tonic-Clonic Seizures

Adults 16 Years and OlderInitiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

Pediatric Patients Ages 6 to <16 YearsInitiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg (10 mg/kg twice daily) to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied.

2.4 Switching from Oral Dosing

When switching from oral levetiracetam, the initial total daily intravenous dosage of levetiracetam should be equivalent to the total daily dosage and frequency of oral levetiracetam.

2.5 Switching to Oral Dosing

At the end of the intravenous treatment period, the patient may be switched to levetiracetam oral administration at the equivalent daily dosage and frequency of the intravenous administration.

2.6 Preparation and Administration Instructions

Levetiracetam injection is for intravenous use only and should be diluted in 100 mL of a compatible diluent prior to administration. If a smaller volume is required (e.g. pediatric patients), the amount of diluent should be calculated to not exceed a maximum levetiracetam concentration of 15 mg per mL of diluted solution. Consideration should also be given to the total daily fluid intake of the patient. Levetiracetam injection should be administered as a 15-minute IV infusion. One vial of levetiracetam injection contains 500 mg levetiracetam (500 mg/5 mL).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Product with particulate matter or discoloration should not be used.

Any unused portion of the levetiracetam injection vial contents should be discarded.

Adults See Table 1 for the recommended preparation and administration of levetiracetam injection to achieve a dose of 500 mg, 1000 mg, or 1500 mg.
Table 1: Preparation and Administration of Levetiracetam Injection for Adults Dose Withdraw Volume Volume of Diluent Infusion Time   500 mg   5 mL (5 mL vial)   100 mL   15 minutes   1000 mg   10 mL (two 5 mL vials)   100 mL   15 minutes   1500 mg   15 mL (three 5 mL vials)   100 mL   15 minutes
For example, to prepare a 1000 mg dose, dilute 10 mL of levetiracetam injection in 100 mL of a compatible diluent and administer intravenously as a 15-minute infusion.

Pediatric PatientsWhen using levetiracetam injection for pediatric patients, dosing is weight-based (mg per kg).

The following calculation should be used to determine the appropriate daily dose of levetiracetam injection for pediatric patients:
Total daily dose (mL/day) =
Daily dose (mg/kg/day) x patient weigh (kg)
100 mg/mL
2.7 Dosage Adjustments in Adult Patients with Renal Impairment

Levetiracetam dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults with renal impairment are shown in Table 2. Information is unavailable for dosage adjustments in pediatric patients with renal impairment. In order to calculate the dose recommended for adult patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

CLcr =       [140-age (years)] x weight (kg)     (x 0.85 for female patients)                 72 x serum creatinine (mg/dL)

Then CLcr is adjusted for body surface area (BSA) as follows:

CLcr (mL/min/1.73m2) = CLcr (mL/min)    x 1.73                                        BSA subject (m2)
Table 2: Dosage Adjustment Regimen for Adult Patients with Renal Impairment *
Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Group   Creatinine Clearance(mL/min/1.73 m2)   Dosage (mg)   Frequency Normal   > 80   500 to 1500   Every 12 hours Mild   50 – 80   500 to 1000   Every 12 hours Moderate   30 – 50   250 to 750   Every 12 hours Severe   < 30   250 to 500   Every 12 hours ESRD patients using dialysis -----   500 to 1000*   Every 24 hours*
2.8 Compatibility and Stability

Levetiracetam injection was found to be physically compatible and chemically stable when mixed with the following diluents and antiepileptic drugs for at least 24 hours and stored in polyvinyl chloride (PVC) bags at controlled room temperature 15º to 30°C (59º to 86°F).

Diluents Sodium chloride (0.9%) injection, USPLactated Ringer’s injection Dextrose 5% injection, USP

Other Antiepileptic Drugs LorazepamDiazepamValproate sodium

There is no data to support the physical compatibility of levetiracetam injection with antiepileptic drugs that are not listed above.
Metoprolol Tartrate

Metoprolol Tartrate

Myocardial Infarction

Early Treatment: During the early phase of definite or suspected acute myocardial infarction, initiate treatment with metoprolol as soon as possible after the patient’s arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized.

Begin treatment in this early phase with the intravenous administration of three bolus injections of 5 mg of metoprolol each; give the injections at approximately 2-minute intervals. During the intravenous administration of metoprolol, monitor blood pressure, heart rate, and electrocardiogram.

In patients who tolerate the full intravenous dose (15 mg), initiate metoprolol tablets, 50 mg every 6 hours, 15 minutes after the last intravenous dose and continue for 48 hours. Thereafter, the maintenance dosage is 100 mg orally twice daily.

Start patients who appear not to tolerate the full intravenous dose on metoprolol tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, discontinue metoprolol (see WARNINGS).

Special populations

Pediatric patients: No pediatric studies have been performed. The safety and efficacy of metoprolol in pediatric patients have not been established.

Renal impairment: No dose adjustment of metoprolol is required in patients with renal impairment.

Hepatic impairment: Metoprolol blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, metoprolol should be initiated at low doses with cautious gradual dose titration according to clinical response.

Geriatric patients (> 65 years): In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Method of administration:

Parenteral administration of metoprolol should be done in a setting with intensive monitoring.

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

Hydrocortisone Maximum Strength

The reconstituted solution should be used upon preparation and should not be stored.
1.Prevention or control of hypertensive episodes in the patient with pheochromo-cytoma. For preoperative reduction of elevated blood pressure, 5 mg of phentolamine mesylate (1 mg for children) is injected intravenously or intramuscularly 1 or 2 hours before surgery, and repeated if necessary. During surgery, phentolamine mesylate (5 mg for adults, 1 mg for children) is administered intravenously as indicated, to help prevent or control paroxysms of hypertension, tachycardia, respiratory depression, convulsions, or other effects of epinephrine intoxication. (Postoperatively, norepinephrine may be given to control the hypotension that commonly follows complete removal of a pheochromocytoma.) 2.Prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine. For Prevention: 10 mg of phentolamine mesylate is added to each liter of solution containing norepinephrine. The pressor effect of norepinephrine is not affected.For Treatment: 5 to 10 mg of phentolamine mesylate in 10 mL of saline is injected into the area of extravasation within 12 hours. 3.Diagnosis of pheochromocytoma - phentolamine blocking test.The test is most reliable in detecting pheochromocytoma in patients with sustained hypertension and least reliable in those with paroxysmal hypertension. False-positive tests may occur in patients with hypertension without pheochromocytoma.
a. Intravenous

Preparation

The CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections should be reviewed. Sedatives, analgesics, and all other medications except those that might be deemed essential (such as digitalis and insulin) are withheld for at least 24 hours, and preferably 48 to 72 hours, prior to the test. Antihypertensive drugs are withheld until blood pressure returns to the untreated, hypertensive level. This test is not preformed on a patient who is normotensive.

Procedure

The patient is kept at rest in a supine position throughout the test, preferably in a quiet, darkened room. Injection of phentolamine is delayed until blood pressure is stabilized, as evidenced by blood pressure readings taken every 10 minutes for at least 30 minutes.

Five milligrams of phentolamine mesylate is dissolved in 1 mL of Sterile Water for Injection. The dose for adults is 5 mg; for children, 1 mg.

The syringe needle is inserted into the vein, and injection is delayed until pressor response to venipuncture has subsided.

Phentolamine is injected rapidly. Blood pressure is recorded immediately after injection, at 30-second intervals for the first 3 minutes, and at 60-second intervals for the next 7 minutes.

Interpretation

A positive response, suggestive of pheochromocytoma, is indicated when the blood pressure is reduced more than 35 mm Hg systolic and 25 mm Hg diastolic. A typical positive response is a reduction in pressure of 60 mm Hg systolic and 25 mm Hg diastolic. Usually, maximal effect is evident within 2 minutes after injection. A return to preinjection pressure commonly occurs within 15 to 30 minutes but may occur more rapidly.

If blood pressure decreases to a dangerous level, the patient should be treated as outlined under OVERDOSAGE.

A positive response should always be confirmed by other diagnostic procedures, preferably by measurement of urinary catecholamines or their metabolites.

A negative response is indicated when the blood pressure is elevated, unchanged, or reduced less than 35 mm Hg systolic and 25 mm Hg diastolic after injection of phentolamine. A negative response to this test does not exclude the diagnosis of pheo-chromocytoma, especially in patients with paroxysmal hypertension in whom the incidence of false-negative responses is high.

b. Intramuscular

If the intramuscular test for pheochromocytoma is preferred, preparation is the same as for the intravenous test. Five milligrams of phentolamine mesylate is then dissolved in 1 mL of Sterile Water for Injection. The dose for adults is 5 mg intramuscularly; for children, 3 mg. Blood pressure is recorded every 5 minutes for 30 to 45 minutes following injection. A positive response is indicated when the blood pressure is reduced 35 mm Hg systolic and 25 mm Hg diastolic, or more, within 20 minutes following injection.

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

Ciprofloxacin

Ciprofloxacin Tablets, USP, should be administered orally to adults as described in the appropriate Dosage Guidelines table.

2.1 Dosage in Adults

The determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.
Table 1: Adult Dosage Guidelines Infection Dose Frequency Usual Durations1 Urinary Tract 250–500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500–750 mg every 12 hours 7 to 14 days Acute Sinusitis 500 mg every 12 hours 10 days Skin and Skin Structure 500–750 mg every 12 hours 7 to 14 days Bone and Joint 500–750 mg every 12 hours 4 to 8 weeks Complicated Intra–Abdominal2 500 mg every 12 hours 7 to 14 days Infectious Diarrhea 500 mg every 12 hours 5 to 7 days Typhoid Fever 500 mg every 12 hours 10 days Uncomplicated Urethral and Cervical Gonococcal Infections 250 mg single dose single dose Inhalational anthrax (postexposure)3 500 mg every 12 hours 60 days Plague 3 500–750 mg every 12 hours 14 days Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). Used in conjunction with metronidazole. Begin drug administration as soon as possible after suspected or confirmed exposure.
Conversion of IV to Oral Dosing in Adults

Patients whose therapy is started with ciprofloxacin IV may be switched to Ciprofloxacin tablets, USP when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].
Table 2: Equivalent AUC Dosing Regimens Ciprofloxacin Tablets, USP Oral Dosage Equivalent ciprofloxacin IV Dosage 250 mg Tablet every 12 hours 200 mg intravenous every 12 hours 500 mg Tablet every 12 hours 400 mg intravenous every 12 hours 750 mg Tablet every 12 hours 400 mg intravenous every 8 hours
2.2 Dosage in Pediatric Patients

Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin tablets, USP should be administered as described in Table 3.
Table 3 : Pediatric Dosage Guidelines Guidelines Infection Dose Frequency Total Duration Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg) Every 12 hours 10–21 days1 Inhalational Anthrax(PostExposure)2 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 days Plague2,3 15 mg/kg (maximum 500 mg per dose) Every 12 to 8 hours 10–21 days The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). Begin drug administration as soon as possible after suspected or confirmed exposure. Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.
2.3 Dosage Modifications in Patients with Renal Impairment

Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.
Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal Function Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30–50 250–500 mg every12 hours 5–29 250–500 mg every 18 hours Patients on hemodialysis or Peritoneal dialysis 250–500 mg every 24 hours (after dialysis)
When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:

Men -Creatinine clearance (mL/min) = Weight (kg) x (140–age)

72 x serum creatinine (mg/dL)

Women -0.85 x the value calculated for men.

The serum creatinine should represent a steady state of renal function.

In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.

Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).

2.4 Important Administration Instructions

With Multivalent Cations

Administer Ciprofloxacin Tablets, USP at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.

With Dairy Products

Concomitant administration of Ciprofloxacin Tablets, USP with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, Ciprofloxacin Tablets, USP may be taken with a meal that contains these products.

Hydration of Patients Receiving Ciprofloxacin Tablets, USP

Assure adequate hydration of patients receiving Ciprofloxacin Tablets, USP to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.

Instruct the patient of the appropriate Ciprofloxacin Tablets, USP administration [see Patient Counseling Information (17)].
Ofirmev

Ofirmev

As noted under CLINICAL PHARMACOLOGY, multiple-dose studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for isosorbide dinitrate tablets must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release ISDN, it appears that one daily dose-free interval must be at least 14 hours long.

As also noted under CLINICAL PHARMACOLOGY, the effects of the second and later doses have been smaller and shorter-lasting than the effects of the first.

Large controlled studies with other nitrates suggest that no dosing regimen with isosorbide dinitrate tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day.

As with all titratable drugs, it is important to administer the minimum dose which produces the desired clinical effect. The usual starting dose of isosorbide dinitrate tablets is 5 mg to 20 mg, two or three times daily. For maintenance therapy, 10 mg to 40 mg, two or three times daily is recommended. Some patients may require higher doses. A daily dose-free interval of at least 14 hours is advisable to minimize tolerance. The optimal interval will vary with the individual patient, dose and regimen.
Hydrocodone Bitartrate ...

Hydrocodone Bitartrate And Acetaminophen

The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Butalbital

Butalbital

one or two capsules every four hours. Total daily dosage should not exceed 6 capsules.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.
Diclofenac Sodium

Diclofenac Sodium

500 mg – Adults: Initial dosage, 3 tablets q.i.d.; maintenance dosage, 2 tablets q.i.d.750 mg – Adults: Initial dosage, 2 tablets q.i.d.; maintenance dosage, 1 tablet q.4h. or 2 tablets t.i.d.

Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered.) Thereafter, the dosage can usually be reduced to approximately 4 grams a day.
Lithium Carbonate

Lithium Carbonate

Acute Mania - Optimal patient response to Lithium Carbonate usually can be established and maintained with 600 mg t.i.d. Such doses will normally produce an effective serum lithium level ranging between 1 and 1.5 mEq/L. Dosage must be individualized according to serum levels and clinical response. Regular monitoring of the patient's clinical state and of serum lithium levels is necessary. Serum levels should be determined twice per week during the acute phase, and until the serum level and clinical condition of the patient have been stabilized.

Long-Term Control - The desirable serum lithium levels are 0.6 to 1.2 mEq/L. Dosage will vary from one individual to another, but usually 300 mg of Lithium Carbonate t.i.d. or q.i.d. will maintain this level. Serum lithium levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months.

Patients abnormally sensitive to lithium may exhibit toxic signs at serum levels of 1 to 1.5 mEq/L. Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels ordinarily tolerated by other patients.

N.B.: Blood samples for serum lithium determination should be drawn immediately prior to the next dose when lithium concentrations are relatively stable (i.e., 8-12 hours after the previous dose). Total reliance must not be placed on serum levels alone. Accurate patient evaluation requires both clinical and laboratory analysis.
Cyclobenzaprine Hydroch...

Cyclobenzaprine Hydrochloride

2.1 Important Dosing and Administration Information

In selecting a digoxin dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only slightly higher than therapeutic levels. Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading dose.

Parenteral administration of digoxin should be used only when the need for rapid digitalization is urgent or when the drug cannot be taken orally. Intramuscular injection can lead to severe pain at the injection site, thus intravenous administration is preferred. If the drug must be administered by the intramuscular route, it should be injected deep into the muscle followed by massage. For adults, no more than 500 mcg of Digoxin Injection should be injected into a single site. For pediatric patients, see the full prescribing information for pediatric digoxin injection (not available from West-Ward) for specific recommendations.

Administer the dose over a period of 5 minutes or longer and avoid bolus administration to prevent systemic and coronary vasoconstriction. Mixing of Digoxin Injection with other drugs in the same container or simultaneous administration in the same intravenous line is not recommended.

Digoxin Injection can be administered undiluted or diluted with a 4-fold or greater volume of Sterile Water for Injection, 0.9% Sodium Chloride Injection, or 5% Dextrose Injection. The use of less than a 4-fold volume of diluent could lead to precipitation of the digoxin. Immediate use of the diluted product is recommended.

If tuberculin syringes are used to measure very small doses do not flush with the parenteral solution after its contents are expelled into an indwelling vascular catheter to avoid overadministration of digoxin.

Consider interruption or reduction in digoxin dose prior to electrical cardioversion [see Warnings and Precautions (5.4)].

2.2 Loading Dosing Regimen in Adult Patients
Table 1. Recommended Digoxin Injection Loading Dose mcg = microgram Age Total IV Loading Dose (mcg/kg)      Administer half the total loading dose initially,     then ¼ the loading dose every 6-8 hours twice Adult patients      8-12
2.3 Maintenance Dosing in Adult Patients

The maintenance dose is based on lean body weight, renal function, age, and concomitant products [see Clinical Pharmacology (12.3)].

The recommended starting maintenance dose in adult patients with normal renal function is given in Table 2. Doses may be increased every 2 weeks according to clinical response, serum drug levels, and toxicity.
Table 2. Recommended Starting Digoxin Injection Maintenance Dosage in Adult Patients mcg = microgram Age       Total Intravenous Maintenance Dose,     mcg/kg/day(given once daily) Adult patients 2.4-3.6
Table 3 provides the recommended (once daily) maintenance dose for adult patients according to lean body weight and renal function. The doses are based on studies in adult patients with heart failure. Alternatively, the maintenance dose may be estimated by the following formula (peak body stores lost each day through elimination):

Total Maintenance Dose = Loading Dose (i.e., Peak Body Stores) x % Daily Loss/100(% Daily Loss = 14 + Creatinine clearance/5)

Reduce the dose of digoxin in patients whose lean weight is an abnormally small fraction of their total body mass because of obesity or edema.
Table 3. Recommended Maintenance Dose (in micrograms given once daily) of Digoxin Injection in Adult Patients by Lean Body Weight and by Renal Function a  For adults, creatinine clearance was corrected to 70-kg body weight or 1.73 m2 body surface area. If only serum creatinine concentrations (Scr) are available, a corrected Ccr may be estimated in men as (140 – Age)/Scr. For women, this result should be multiplied by 0.85.GFR (mL/min/1.73 m2) = (k x Height)/Scrb  If no loading dose administeredc  The doses listed assume average body composition.       Corrected     Creatinine Clearancea Lean Body Weightc       Number of Days Before SteadyState Achievedb    kg       40        50        60        70        80        90        100          10 mL/min 64 80 96 112 128 144 160 19 20 mL/min 72 90 108 126 144 162 180 16 30 mL/min 80 100 120 140 160 180 200 14 40 mL/min 88 110 132 154 176 198 220 13 50 mL/min 96 120 144 168 192 216 240 12 60 mL/min 104 130 156 182 208 234 260 11 70 mL/min 112 140 168 196 224 252 280 10 80 mL/min 120 150 180 210 240 270 300 9 90 mL/min 128 160 192 224 256 288 320 8 100 mL/min 136 170 204 238 272 306 340 7
2.4 Monitoring to Assess Safety, Efficacy, and Therapeutic Blood Levels

Monitor for signs and symptoms of digoxin toxicity and clinical response. Adjust dose based on toxicity, efficacy, and blood levels.

Serum digoxin levels less than 0.5 ng/mL have been associated with diminished efficacy, while levels above 2 ng/mL have been associated with increased toxicity without increased benefit.

Interpret the serum digoxin concentration in the overall clinical context, and do not use an isolated measurement of serum digoxin concentration as the basis for increasing or decreasing the digoxin dose. Serum digoxin concentrations may be falsely elevated by endogenous digoxin-like substances [see Drug Interactions (7.4)]. If the assay is sensitive to these substances, consider obtaining a baseline digoxin level before starting digoxin and correct post-treatment values by the reported baseline level.

Obtain serum digoxin concentrations just before the next scheduled digoxin dose or at least 6 hours after the last dose. The digoxin concentration is likely to be 10-25% lower when sampled right before the next dose (24 hours after dosing) compared to sampling 8 hours after dosing (using once-daily dosing). However, there will be only minor differences in digoxin concentrations using twice daily dosing whether sampling is done at 8 or 12 hours after a dose.

2.5 Switching from Intravenous Digoxin to Oral Digoxin

When switching from intravenous to oral digoxin formulations, make allowances for differences in bioavailability when calculating maintenance dosages (see Table 4).
Table 4. Comparison of the Systemic Availability and Equivalent Doses of Oral and Intravenous Digoxin Absolute      Bioavailability      Equivalent Doses (mcg) Digoxin Tablets 60-80%     62.5        125        250        500    Digoxin Intravenous Injection      100% 50 100 200 400
Prednisone

Prednisone

Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk.

The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day.

Dietary salt restriction may be advisable in patients.

Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy.

The initial dosage of prednisone may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, prednisone should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of prednisone for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Multiple Sclerosis

In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)

Alternate Day Therapy

Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.

The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.

A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.

The diurnal rhythm of the HPA axis is lost in Cushing’s disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.

During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1 1/4 to 1 1/2 days following a single dose) and thus are recommended for alternate day therapy.

The following should be kept in mind when considering alternate day therapy:

1. Basic principles and indications for corticosteroid therapy should apply. The benefits of alternate day therapy should not encourage the indiscriminate use of steroids.

2. Alternate day therapy is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated.

3. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with alternate day therapy. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended. Once control has been established, two courses are available: (a) change to alternate day therapy and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable.

4. Because of the advantages of alternate day therapy, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on alternate day therapy may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum.

5. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone).

6. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am).

7. In using alternate day therapy it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of alternate day therapy will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed.

8. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be re-instituted.

9. Although many of the undesirable features of corticosteroid therapy can be minimized by alternate day therapy, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.

HOW SUPPLIED

Prednisone Tablets, USP 5 mg: White, Round Tablets; Debossed “West-ward 475” on one side and Scored on the other side. Each tablet contains 5 mg of prednisone for oral administration.

Bottles of 100 tablets Bottles of 1000 tablets

Prednisone Tablets, USP 10 mg: White, Round Tablets; Debossed “WEST-WARD 473” on one side and Scored on the other side. Each tablet contains 10 mg of prednisone for oral administration.

Bottles of 100 tablets Bottles of 1000 tablets

Prednisone Tablets, USP 20 mg: Peach, Round Tablets; Debossed “West-ward 477” on one side and Scored on the other side. Each tablet contains 20 mg of prednisone for oral administration.

Bottles of 100 tablets Bottles of 500 tablets Bottles of 1000 tablets

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

REFERENCES

1. Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases.

Philadelphia: WBSaunders Company 1992:1050-1.

2. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63.

Manufactured by:HIKMA Pharmaceuticals P.O. Box 182400Amman 11118 - Jordan

Distributed by:West-Ward Pharmaceutical Corp. Eatontown, NJ 07724 USA

Revised December 2013
Glyburide

Glyburide

Patients should be retitrated when transferred from glyburide tablets (nonmicronized) or other oral hypoglycemic agents.

There is no fixed dosage regimen for the management of diabetes mellitus with glyburide tablets (micronized) or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient’s blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient’s response to therapy.

Short-term administration of glyburide (micronized) may be sufficient during periods of transient loss of control in patients usually controlled well on diet.

Usual Starting Dose:

The suggested starting dose of glyburide tablets (micronized) is 1.5 to 3 mg daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 0.75 mg daily. (See PRECAUTIONS Section for patients at increased risk.) Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy.

Transfer From Other Hypoglycemic Therapy; Patients Receiving Other Oral Antidiabetic Therapy:

Patients should be retitrated when transferred from glyburide tablets (nonmicronized) or other oral hypoglycemic agents. The initial daily dose should be 1.5 to 3 mg. When transferring patients from oral hypoglycemic agents other than chlorpropamide to glyburide tablets (micronized), no transition period and no initial or priming dose are necessary. When transferring patients from chlorpropamide, particular care should be exercised during the first two weeks because the prolonged retention of chlorpropamide in the body and subsequent overlapping drug effects may provoke hypoglycemia.

Patients Receiving Insulin:

Some Type II diabetic patients being treated with insulin may respond satisfactorily to glyburide tablets (micronized). If the insulin dose is less than 20 units daily, substitution of glyburide tablets (micronized) 1.5 to 3 mg as a single daily dose may be tried. If the insulin dose is between 20 and 40 units daily, the patient may be placed directly on glyburide tablets, (micronized) 3 mg daily as a single dose. If the insulin dose is more than 40 units daily, a transition period is required for conversion to glyburide tablets (micronized). In these patients, insulin dosage is decreased by 50% and glyburide tablets (micronized) 3 mg daily is started. Please refer to Titration to Maintenance Dose for further explanation.

Patients Receiving Colesevelam:

When colesevelam is coadministered with glyburide, maximum plasma concentration and total exposure to glyburide is reduced. Therefore, glyburide tablets (micronized) should be administered at least 4 hours prior to colesevelam.

Titration to Maintenance Dose:

The usual maintenance dose is in the range of 0.75 to 12 mg daily, which may be given as a single dose or in divided doses (See Dosage Interval section). Dosage increases should be made in increments of no more than 1.5 mg at weekly intervals based upon the patient’s blood glucose response.

No exact dosage relationship exists between glyburide tablets (micronized) and the other oral hypoglycemic agents, including glyburide tablets (nonmicronized). Although patients may be transferred from the maximum dose of other sulfonylureas, the maximum starting dose of 3 mg glyburide tablets (micronized) should be observed. A maintenance dose of 3 mg of glyburide tablets (micronized) provides approximately the same degree of blood glucose control as 250 to 375 mg chlorpropamide, 250 to 375 mg tolazamide, 5 mg of glyburide tablets (nonmicronized) 500 to 750 mg acetohexamide, or 1000 to 1500 mg tolbutamide.

When transferring patients receiving more than 40 units of insulin daily, they may be started on a daily dose of glyburide tablets (micronized) 3 mg concomitantly with a 50% reduction in insulin dose. Progressive withdrawal of insulin and increase of glyburide tablets (micronized) in increments of 0.75 to 1.5 mg every 2 to 10 days is then carried out. During this conversion period when both insulin and glyburide tablets (micronized) are being used, hypoglycemia may rarely occur. During insulin withdrawal, patients should test their urine for glucose and acetone at least three times daily and report results to their physician. The appearance of persistent acetonuria with glycosuria indicates that the patient is a Type I diabetic who requires insulin therapy.

Concomitant Glyburide and Metformin Therapy:

Glyburide tablets (micronized) should be added gradually to the dosing regimen of patients who have not responded to the maximum dose of metformin monotherapy after four weeks (see Usual Starting Dose and Titration to Maintenance Dose). Refer to metformin package insert.

With concomitant glyburide and metformin therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the optimal dose of each drug needed to achieve this goal. With concomitant glyburide and metformin therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken (see PRECAUTIONS section).

Maximum Dose:

Daily doses of more than 12 mg are not recommended.

Dosage Interval:

Once-a-day therapy is usually satisfactory. Some patients, particularly those receiving more than 6 mg daily, may have a more satisfactory response with twice-a-day dosage.

Specific Patient Populations:

Glyburide tablets (micronized) are not recommended for use in pregnancy or for use in pediatric patients.

In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions. (See PRECAUTIONS Section.)
Phenytoin

Phenytoin

2.1 General Dosing Information

Nicardipine hydrochloride injection is intended for intravenous use. DOSAGE MUST BE INDIVIDUALIZED depending upon the severity of hypertension and the response of the patient during dosing. Blood pressure and heart rate should be monitored both during and after the infusion to avoid tachycardia or too rapid or excessive reduction in either systolic or diastolic blood pressure.

2.2 Preparation

Warning: Dilute vials before infusion.

Dilution

Nicardipine hydrochloride injection is administered by slow continuous infusion at a CONCENTRATION OF 0.1 MG/ML. Each vial (25 mg) should be diluted with 240 mL of compatible intravenous fluid (see below), resulting in 250 mL of solution at a concentration of 0.1 mg/mL.

Nicardipine hydrochloride injection has been found compatible and stable in polyvinyl chloride containers for 24 hours at controlled room temperature with:

Dextrose (5%) Injection, USPDextrose (5%) and Sodium Chloride (0.45%) Injection, USPDextrose (5%) and Sodium Chloride (0.9%) Injection, USPDextrose (5%) with 40 mEq Potassium, USPSodium Chloride (0.45%) Injection, USPSodium Chloride (0.9%) Injection, USP

Nicardipine hydrochloride injection is not compatible with Sodium Bicarbonate (5%) Injection, USP or Lactated Ringer’s Injection, USP.

The diluted solution is stable for 24 hours at room temperature.

Inspection

Visually inspect nicardipine hydrochloride injection for particulate matter and discoloration prior to administration, whenever solution and container permit. Nicardipine hydrochloride injection is normally light yellow in color.

Do not use the solution if particulate matter, precipitate or crystallization is present, or if the container appears damaged.

2.3 Dosage as a Substitute for Oral Nicardipine Therapy

The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table:
Oral Nicardipine Dose Equivalent Intravenous Infusion Rate 20 mg q8h 0.5 mg/hr 30 mg q8h 1.2 mg/hr 40 mg q8h 2.2 mg/hr
2.4 Dosage for Initiation of Therapy in a Drug-Free Patient

The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. Nicardipine hydrochloride injection is administered by slow continuous infusion at a concentration of 0.1 mg/mL. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes.

When treating acute hypertensive episodes in patients with chronic hypertension, discontinuation of infusion is followed by a 50% offset of action in 30 minutes ± 7 minutes but plasma levels of drug and gradually decreasing antihypertensive effects exist for many hours.

Titration

For a gradual reduction in blood pressure, initiate therapy at a rate of 50 mL/hr (5 mg/hr). If desired blood pressure reduction is not achieved at this dose, increase the infusion rate by 25 mL/hr (2.5 mg/hr) every 15 minutes up to a maximum of 150 mL/hr (15 mg/hr), until desired blood pressure reduction is achieved. For more rapid blood pressure reduction, titrate every 5 minutes.

Maintenance

Adjust the rate of infusion as needed to maintain desired response.

2.5 Conditions Requiring Infusion Adjustment

Hypotension or Tachycardia:

In case of hypotension or tachycardia, discontinue infusion. When blood pressure and heart rate stabilize, restart infusion at low doses such as 30 mL/hr to 50 mL/hr (3 mg/hr to 5 mg/hr) and titrate to maintain desired blood pressure.

Infusion Site Changes:

Change infusion site every 12 hours if administered via peripheral vein.

Impaired Cardiac, Hepatic, or Renal Function:

Monitor closely when titrating nicardipine hydrochloride injection in patients with congestive heart failure or impaired hepatic or renal function [see Warnings and Precautions (5.4, 5.5 and 5.6)].

2.6 Transfer to Oral Antihypertensive Agents

If treatment includes transfer to an oral antihypertensive agent other than nicardipine capsules, initiate oral therapy upon discontinuation of nicardipine hydrochloride injection.

When switching to a TID regimen of nicardipine capsules, administer the first dose 1 hour prior to discontinuation of the infusion.

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