Amphastar Pharmaceuticals, Inc.

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Amphastar Pharmaceuticals, Inc. Drugs

Lidocaine Hydrochloride...

Lidocaine Hydrochloride Jelly

When Lidocaine Hydrochloride Jelly USP, 2% 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 Hydrochloride Jelly USP, 2% 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

The outer orifice is washed and disinfected. The plastic tip is introduced into the orifice, where it is firmly held in position. The jelly is instilled by an easy syringe-like action, until the patient has a feeling of tension or until about 15 mL (i.e., 300 mg of lidocaine hydrochloride) is instilled. A penile clamp is then applied for several minutes at the corona and then additional jelly (about 15 mL) is instilled. To save time, the injection is performed against the resistance of the sphincter, possibly assisted by asking the patient to strain as for defecation or to press as in voiding. The jelly will then pass into the posterior urethra. Prior to sounding or cystoscopy, a penile clamp should be applied for 5 to 10 minutes to obtain adequate anesthesia. If the instrument is introduced immediately, a lubricant is unnecessary. Otherwise some jelly can be expressed from the vial and applied to the instrument tip. About 30 mL (i.e., 600 mg) may be required to fill and dilate the male urethra. When it is desired to anesthetize only the anterior male urethra, as prior to catheterization, considerably smaller volumes, such as the contents from a 5 mL (i.e., 100 mg) or 10 mL (i.e., 200 mg) size vial, are usually adequate for lubrication.

For surface anesthesia of the female adult urethra

3 to 5 mL of the jelly is instilled slowly into the urethra by gently expressing the contents of the vial. 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.

MAXIMUM DOSAGE

No more than 600 mg of lidocaine hydrochloride should be given in any 12 hour period.

Children

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children less than ten years who have a normal lean body mass and a normal lean body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in a child of five years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75–100 mg when calculated according to Clark's rule. In any case, the maximum amount of lidocaine administered should not exceed 4.5 mg / kg (2 mg / lb) of body weight.
Phytonadione

Phytonadione

Whenever possible, phytonadione should be given by the subcutaneous or intramuscular route. When intravenous administration is considered unavoidable, the drug should be injected very slowly, not exceeding 1 mg per minute.

Protect from light at all times.

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

Directions for Dilution

Phytonadione may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. Benzyl alcohol as a preservative has been associated with toxicity in newborns. Therefore, all of the above diluents should be preservative-free. Other diluents should not be used. When dilutions are indicated, administration should be started immediately after mixture with the diluent, and unused portions of the dilution should be discarded, as well as unused contents of the vial.

Prophylaxis of Hemorrhagic Disease of the Newborn

The American Academy of Pediatrics recommends that vitamin K1 be given to the newborn. A single intramuscular dose of phytonadione 0.5 to 1 mg within one hour of birth is recommended.

Treatment of Hemorrhagic Disease of the Newborn

Empiric administration of vitamin K1 should not replace proper laboratory evaluation of the coagulation mechanism. A prompt response (shortening of the prothrombin time in 2 to 4 hours) following administration of vitamin K1 is usually diagnostic of hemorrhagic disease of the newborn, and failure to respond indicates another diagnosis or coagulation disorder.

Phytonadione 1 mg should be given either subcutaneously or intramuscularly. Higher doses may be necessary if the mother has been receiving oral anticoagulants.

Whole blood or component therapy may be indicated if bleeding is excessive. This therapy, however, does not correct the underlying disorder and phytonadione should be given concurrently.

Anticoagulant-Induced Prothrombin Deficiency in Adults

To correct excessively prolonged prothrombin time caused by oral anticoagulant therapy — 2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required. Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition (see WARNINGS). If in 6 to 8 hours after parenteral administration the prothrombin time has not been shortened satisfactorily, the dose should be repeated.

In the event of shock or excessive blood loss, the use of whole blood or component therapy is indicated.

Hypoprothrombinemia Due to Other Causes in Adults

A dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained.

If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates, antibiotics) is suggested as an alternative to administering concurrent phytonadione. The severity of the coagulation disorder should determine whether the immediate administration of phytonadione is required in addition to discontinuation or reduction of interfering drugs.
Phytonadione Summary of Dosage Guidelines (See insert text for details) Newborns Dosage Hemorrhagic Disease of the Newborn Prophylaxis 0.5 - 1 mg IM within 1 hour of birth Treatment 1 mg SC or IM (Higher doses may be necessary if the mother has been receiving oral anti-coagulants) Adults Initial Dosage Anticoagulant - induced Prothrombin Deficiency (caused by coumarin or indanedione derivatives) 2.5 mg - 10 mg or up to 25 mg (rarely 50 mg) Hypoprothrombinemia due to other causes (Antibiotics; Salicylates or other drugs; Factors limiting absorption or synthesis) 2.5 mg - 25 mg or more (rarely up to 50 mg)
Morphine Sulfate

Morphine Sulfate

PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE LIFECARE PCA INFUSER BEFORE PRESCRIBING MORPHINE SULFATE INJECTION USP.

When administered intravenously, morphine sulfate should be given very slowly. Rapid intravenous injection increases the incidence of adverse reactions as described above. This drug should be administered intravenously only if a narcotic antagonist (i.e., naloxone) is available. When morphine sulfate is given parenterally, especially intravenously, the patient should be nonambulatory.

For use in a LifeCare PCA Infuser, dosage should be adjusted according to the severity of the pain and the response of the patient. There can be considerable variability in both the dosage requirement and patient response.

Morphine 1 mg/mL

Adults

The usual dose for adults is 1 mg, with a range of 0.1 mg – 5 mg per incremental dose.

Occasionally, it may be necessary to exceed the usual dosage recommended in cases of exceptionally severe pain or in those patients who become tolerant.

Incompatibility

Morphine Sulfate Injection USP, is incompatible with admixtures of soluble barbiturates, chlorothiazide, aminophylline, heparin, meperidine, methicillin, phenytoin, sodium bicarbonate, iodide, sulfadiazine and sulfisoxazole.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use unless solution is clear and package is undamaged. Morphine products may discolor over a period of time. No loss of analgesic potency and no increase in toxicity has ever been demonstrated for such discolored solutions. Do not use the injection if it is darker than pale yellow or discolored in any other way, or if it contains a precipitate.
Epinephrine

Epinephrine

Subcutaneously or intramuscularly — 0.2 to 1 mL (mg). Start with a small dose and increase if required.

Note: The subcutaneous is the preferred route of administration. If given intramuscularly, injection into the buttocks should be avoided.

For bronchial asthma and certain allergic manifestations, e.g., angioedema, urticaria, serum sickness, anaphylactic shock, use epinephrine subcutaneously. For bronchial asthma in pediatric patients, administer 0.01 mg/kg or 0.3 mg/m2 to a maximum of 0.5 mg subcutaneously, repeated every four hours if required.

For cardiac resuscitation - A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride injection, can be administered intravenously or intracardially to restore myocardial contractility. External cardiac massage should follow intracardial administration to permit the drug to enter coronary circulation. The drug should be used secondarily to unsuccessful attempts with physical or electromechanical methods.

Parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.
Epinephrine

Epinephrine

Please note that the optional STICK-GARD® Safety Needle, featured with stock number 2016 is interchangeable with a standard needle.

EPINEPHRINE 1:10,000

As Cardiac Stimulant

Intravenous or Intracardiac Injection

Administer by I.V. injection and/or in cardiac arrest, by intracardiac injection into the left ventricular chamber. Intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route.

Adult Dosage

1–10 mL (0.1 – 1 mg of epinephrine), repeated every five minutes, if necessary.

Pediatric Dosage

0.05 – 0.1 mL/ kg of body weight (0.005 – 0.01 mg/ kg) e.g., 2 kg infant would receive 0.1 – 0.2 mL of epinephrine 1:10,000.

NOTE: Do not inject if fibrillation is occurring.

As Vasopressor (Anaphylaxis)

Intravenous Injection

Adult Dosage

1–2.5 mL (0.1 – 0.25 mg of epinephrine), administered slowly. May be repeated every 5 to 15 minutes as needed.

Pediatric Dosage

3 mL (0.3 mg of epinephrine), repeated every 15 minutes for 3 or 4 doses, if necessary.

EPINEPHRINE 1:1000

Anaphylactic shock - due to insect stings, etc.

Intramuscular or Subcutaneous Injection

Adult Dosage

0.2 mL – 0.5 mL (0.2 mg – 0.5 mg), repeated every 10 to 15 minutes as needed. As much as 1 mL (1 mg) per dose may be administered if necessary.

Subcutaneous Injection

Pediatric Dosage

0.01 mL/ kg of body weight (0.01 mg/ kg of body weight) or 0.3 mg per square meter of body surface, up to a maximum of 0.5 mg per dose, repeated every 15 minutes for 2 doses, then every 4 hours as needed.

Cardiopulmonary Resuscitation

Adult Dosage

The effect of the I.V. administration of epinephrine 1:10,000 may last only a few minutes, so the I.V. epinephrine may be followed with 0.3 mL of 1:1000 (0.3 mg) subcutaneously.

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

Lidocaine Hydrochloride

Please note that the optional STICK-GARD® Safety Needle, featured with stock number 2190 is interchangeable with a standard needle.

Adults

Single Direct Intravenous Injection (bolus)

ONLY THE 50 AND 100 MG DOSAGE SIZES should be used for direct intravenous injection. The usual dose is 50 to 100 mg of lidocaine hydrochloride (0.70 to 1.4 mg/kg; 0.32 to 0.63 mg/lb) administered intravenously under ECG monitoring. This dose may be administered at the rate of approximately 25 to 50 mg/min (0.35 to 0.70 mg/kg/min; 0.16 to 0.32 mg/lb/min). Sufficient time should be allowed to enable a slow circulation to carry the drug to the site of action. If the initial injection of 50 to 100 mg does not produce a desired response, a second dose may be injected after 5 minutes. (See illustrated instructions for use.) NO MORE THAN 200 TO 300 MG OF LIDOCAINE HYDROCHLORIDE SHOULD BE ADMINISTERED DURING A ONE HOUR PERIOD.

Continuous Intravenous Infusion

Following bolus administration, intravenous infusions of lidocaine hydrochloride may be initiated at the rate of 1 to 4 mg/min of lidocaine hydrochloride (0.014 to 0.057 mg/kg/min; 0.006 to 0.026 mg/lb/min). The rate of intravenous infusions should be reassessed as soon as the patient's basic cardiac rhythm appears to be stable or at the earliest signs of toxicity. It should rarely be necessary to continue intravenous infusions of lidocaine for prolonged periods.

Solutions for intravenous infusion may be prepared by the addition of one gram (or two grams) of lidocaine hydrochloride to one liter of 5% dextrose in water using aseptic technique. Approximately a 0.1% (or 0.2% ) solution will result from this procedure; that is, each milliliter will contain approximately 1 (or 2) mg of lidocaine hydrochloride. In those cases in which fluid restriction is medically appropriate, a more concentrated solution may be prepared.

Lidocaine hydrochloride injection has been found to be chemically stable for 24 hours after dilution in 5% dextrose in water. However, as with all intravenous admixtures, dilution of the solution should be made just prior to its administration.

It is very important that after adding lidocaine hydrochloride, or any other medication, to an I.V. container, the contents be thoroughly mixed before beginning the infusion.

When administering by continuous I.V. infusion, it is advisable to use a precision volume control I.V. set.

Pediatric

Controlled clinical studies in the pediatric population to establish dosing schedules have not been conducted. The American Heart Association's Standards and Guidelines recommends a bolus dose of 1 mg/kg, and an infusion rate of between 20 to 50 mcg/kg/min for prolonged therapy. When drug clearance is reduced, as in patients with shock, congestive heart failure or cardiac arrest, the infusion rate should not exceed 20 mcg/kg/min.

Note Regarding Prolonged Infusion

There are data that indicate the half-life may be 3 hours or longer following infusions of greater than 24 hours in duration.

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

Calcium Chloride

FOR INTRACARDIAC OR INTRAVENOUS USE ONLY

Please note that the optional STICK-GARD® Safety Needle, featured with stock number 2004 is interchangeable with a standard needle.

INJECT SLOWLY

Calcium Chloride Injection, USP, 10%, is administered only by slow intravenous injection (not to exceed 1 mL/min) and / or in cardiac resuscitation, by injection into the ventricular cavity. It must not be injected into the myocardium.

The usual precautions for intravenous therapy should be observed. If time permits, the solution should be warmed to body temperature. The injection should be halted if the patient complains of any discomfort; it may be resumed when symptoms disappear. Following injection, the patient should remain recumbent for a short time.

INTRACARDIAC USE

For cardiac resuscitation, inject into the ventricular cavity, not into the heart muscle.

Usual Adult Dosage

200 to 800 mg (2 to 8 mL) when injected into the ventricular cavity.

Pediatric Dosage

0.2 mL/kg of body weight.

INTRAVENOUS USE

Hypocalcemic Disorders

Usual Adult Dosage

500 mg to 1 g (5 to 10 mL) at intervals of 1 to 3 days, depending on the response of the patient and / or results of serum calcium determinations. Repeated injections may be required because of rapid excretion of calcium.

Pediatric Dosage

0.2 mL /kg of body weight. Maximum 1-10 mL/day.

Magnesium Intoxication

Initial Adult Dose

500 mg (5 mL) administered promptly and the patient observed for signs of recovery before further doses are given.

Hyperkalemic ECG Disturbances of Cardiac Function

Dosage should be adjusted by constant monitoring of ECG changes during administration.
Bethanechol Chloride

Bethanechol Chloride

All patients should be evaluated for a bleeding disorder before administration of Enoxaparin Sodium Injection, unless the medication is needed urgently. Since coagulation parameters are unsuitable for monitoring Enoxaparin Sodium Injection activity, routine monitoring of coagulation parameters is not required [see Warnings and Precautions (5.9)].

For subcutaneous use, Enoxaparin Sodium Injection should not be mixed with other injections or infusions.

For intravenous use (i.e., for treatment of acute STEMI), Enoxaparin Sodium Injection can be mixed with normal saline solution (0.9%) or 5% dextrose in water.

Enoxaparin Sodium Injection is not intended for intramuscular administration.

2.1 Adult Dosage

Abdominal Surgery: In patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of Enoxaparin Sodium Injection is 40 mg once a day administered by SC injection with the initial dose given 2 hours prior to surgery. The usual duration of administration is 7 to 10 days; up to 12 days administration has been administered in clinical trials.

Hip or Knee Replacement Surgery: In patients undergoing hip or knee replacement surgery, the recommended dose of Enoxaparin Sodium Injection is 30 mg every 12 hours administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery. For hip replacement surgery, a dose of 40 mg once a day SC, given initially 12 (±3) hours prior to surgery, may be considered. Following the initial phase of thromboprophylaxis in hip replacement surgery patients, it is recommended that continued prophylaxis with Enoxaparin Sodium Injection 40 mg once a day be administered by SC injection for 3 weeks. The usual duration of administration is 7 to 10 days; up to 14 days administration has been administered in clinical trials.

Medical Patients During Acute Illness: In medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of Enoxaparin Sodium Injection is 40 mg once a day administered by SC injection. The usual duration of administration is 6 to 11 days; up to 14 days of Enoxaparin Sodium Injection has been administered in the controlled clinical trial.

Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism: In outpatient treatment, patients with acute deep vein thrombosis without pulmonary embolism who can be treated at home, the recommended dose of Enoxaparin Sodium Injection is 1 mg/kg every 12 hours administered SC. In inpatient (hospital) treatment, patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of Enoxaparin Sodium Injection is 1 mg/kg every 12 hours administered SC or 1.5 mg/kg once a day administered SC at the same time every day. In both outpatient and inpatient (hospital) treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of Enoxaparin Sodium Injection). Enoxaparin Sodium Injection should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2.0 to 3.0). The average duration of administration is 7 days; up to 17 days of Enoxaparin Sodium Injection administration has been administered in controlled clinical trials.

Unstable Angina and Non-Q-Wave Myocardial Infarction: In patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of Enoxaparin Sodium Injection is 1 mg/kg administered SC every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily). Treatment with Enoxaparin Sodium Injection should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days; up to 12.5 days of Enoxaparin Sodium Injection has been administered in clinical trials [see Warnings and Precautions (5.2) and Clinical Studies (14.5)].

Treatment of Acute ST-Segment Elevation Myocardial Infarction:

In patients with acute ST-segment elevation myocardial infarction, the recommended dose of Enoxaparin Sodium Injection is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses). Dosage adjustments are recommended in patients ≥75 years of age [see Dosage and Administration (2.3)]. All patients should receive aspirin as soon as they are identified as having STEMI and maintained with 75 to 325 mg once daily unless contraindicated.

When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), Enoxaparin Sodium Injection should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. In the pivotal clinical study, the Enoxaparin Sodium Injection treatment duration was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days.

For patients managed with percutaneous coronary intervention (PCI): If the last Enoxaparin Sodium Injection SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last Enoxaparin Sodium Injection SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of Enoxaparin Sodium Injection should be administered [see Warnings and Precautions (5.2)].

2.2 Renal Impairment

Although no dose adjustment is recommended in patients with moderate (creatinine clearance 30–50 mL/min) and mild (creatinine clearance 50–80 mL/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding.

The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance <30 mL/min) are described in Table 1 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Table 1 Dosage Regimens for Patients with Severe Renal Impairment(creatinine clearance <30 mL/minute) Indication Dosage Regimen Prophylaxis in abdominal surgery 30 mg administered SC once daily Prophylaxis in hip or knee replacement surgery 30 mg administered SC once daily Prophylaxis in medical patients during acute illness 30 mg administered SC once daily Inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered SC once daily Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered SC once daily Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin 1 mg/kg administered SC once daily Treatment of acute ST-segment elevation myocardial infarction in patients <75 years of age, when administered in conjunction with aspirin 30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC once daily Treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, when administered in conjunction with aspirin 1 mg/kg administered SC once daily (no initial bolus)
2.3 Geriatric Patients with Acute ST-Segment Elevation Myocardial Infarction

For treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg dosing for the remaining doses) [see Use in Specific Populations (8.5) and Clinical Phamacology (12.3)].

No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired [see Dosage and Administration (2.2)].

2.4 Administration

Enoxaparin Sodium Injection is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.

Enoxaparin Sodium Injection must not be administered by intramuscular injection.

Enoxaparin Sodium Injection is intended for use under the guidance of a physician.

For subcutaneous administration, patients may self-inject only if their physicians determine that it is appropriate and with medical follow-up, as necessary. Proper training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided.

Subcutaneous Injection Technique: Patients should be lying down and Enoxaparin Sodium Injection administered by deep SC injection. To avoid the loss of drug when using the 30 and 40 mg prefilled syringes, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. The whole length of the needle should be introduced into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.

Enoxaparin Sodium Injection prefilled syringes and graduated prefilled syringes are for single, one-time use only and are available with a system that shields the needle after injection.

Remove the prefilled syringe from the blister packaging by peeling at the arrow as directed on the blister. Do not remove by pulling on the plunger as this may damage the syringe.
Remove needle cover by pulling straight off of needle (see Figure 1). If adjusting the dose is required, the adjustment must be done prior to injecting the prescribed dose into the patient.

See Administration: Subcutaneous Injection Technique for a description of the Standard Protocol for administration.

Depress the plunger while grasping the finger flange until the entire dose has been given. The Passive needle guard should not activate unless the entire dose has been given.

Remove needle from patient, then let go of the plunger and allow syringe to move up until the entire needle is guarded.

Dispose of syringe/needle guard assembly in approved sharps container.

NOTE:
The safety system should only activate once the syringe has been emptied. Activation of the safety system must be done only after removing the needle from the patient's skin. Do not replace the needle shield after injection. The safety system should not be sterilized.
Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.

Intravenous (Bolus) Injection Technique

For intravenous injection, the multiple-dose vial should be used. Enoxaparin Sodium Injection should be administered through an intravenous line. Enoxaparin Sodium Injection should not be mixed or co-administered with other medications. To avoid the possible mixture of Enoxaparin Sodium Injection with other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the intravenous bolus administration of Enoxaparin Sodium Injection to clear the port of drug. Enoxaparin Sodium Injection may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
Phytonadione

Phytonadione

Whenever possible, phytonadione should be given by the subcutaneous route (see Box WARNING). When intravenous or intramuscular administration is considered unavoidable, the drug should be injected very slowly, not exceeding 1 mg per minute.

Protect from light at all times.

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

Directions for Dilution

Phytonadione may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. Benzyl alcohol as a preservative has been associated with toxicity in newborns. Therefore, all of the above diluents should be preservative-free. (See WARNINGS) Other diluents should not be used. When dilutions are indicated, administration should be started immediately after mixture with the diluent, and unused portions of the dilution should be discarded, as well as unused contents of the vial.

Prophylaxis of Hemorrhagic Disease of the Newborn

The American Academy of Pediatrics recommends that vitamin K1 be given to the newborn. A single intramuscular dose of phytonadione 0.5 to 1 mg within one hour of birth is recommended.

Treatment of Hemorrhagic Disease of the Newborn

Empiric administration of vitamin K1 should not replace proper laboratory evaluation of the coagulation mechanism. A prompt response (shortening of the prothrombin time in 2 to 4 hours) following administration of vitamin K1 is usually diagnostic of hemorrhagic disease of the newborn, and failure to respond indicates another diagnosis or coagulation disorder.

Phytonadione 1 mg should be given either subcutaneously or intramuscularly. Higher doses may be necessary if the mother has been receiving oral anticoagulants.

Whole blood or component therapy may be indicated if bleeding is excessive. This therapy, however, does not correct the underlying disorder and phytonadione should be given concurrently.

Anticoagulant-Induced Prothrombin Deficiency in Adults

To correct excessively prolonged prothrombin time caused by oral anticoagulant therapy — 2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required. Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition (see WARNINGS). If in 6 to 8 hours after parenteral administration the prothrombin time has not been shortened satisfactorily, the dose should be repeated.
Phytonadione Summary of Dosage Guidelines (See insert text for details) Newborns Dosage Hemorrhagic Disease of the Newborn Prophylaxis Treatment 0.5 – 1 mg IM within 1 hour of birth1 mg SC or IM(Higher doses may be necessary if the mother has been receiving oral anti-coagulants) Adults Initial Dosage Anticoagulant - Induced Prothrombin Deficiency(caused by coumarin or indanedione derivatives) 2.5 mg – 10 mg or up to 25 mg(rarely 50 mg) Hypoprothrombinemia due to other causes(Antibiotics; Salicylates or other drugs; Factors limiting absorption or synthesis) 2.5 mg – 25 mg or more (rarely up to 50 mg)
In the event of shock or excessive blood loss, the use of whole blood or component therapy is indicated.

Hypoprothrombinemia Due to Other Causes in Adults

A dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained.

If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates, antibiotics) is suggested as an alternative to administering concurrent phytonadione. The severity of the coagulation disorder should determine whether the immediate administration of phytonadione is required in addition to discontinuation or reduction of interfering drugs.
Dextrose Monohydrate

Dextrose Monohydrate

Hypertonic solutions of dextrose are for intravenous use only. The concentration and dose depend upon the patient’s age, weight and clinical condition. Electrolytes should be added based on fluid and electrolyte status. The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg/hour. About 95% is retained when infused at 0.8 g/kg/hour.

Insulin-induced hypoglycemia: Blood glucose is determined before injecting dextrose. In emergencies, dextrose is promptly administered without waiting for pretreatment test results.

Adults: 10 to 25 g (20 to 50 mL of the 50% solution). Repeated doses may be required in severe cases. The number of injections and the interval between them must be determined in each case by clinical judgment. Slow intravenous administration is recommended, e.g. 3 mL of the 50% solution per minute. After 25 grams of dextrose have been given, it is advisable to interrupt the injection and evaluate the effect. The exact number of grams required to relieve hypoglycemia will vary. After the patient responds, supplemental oral feedings are indicated to avoid relapse, especially after insulin shock therapy.

Neonates: 250 to 500 mg/kg/dose (5 to 10 mL of 25% dextrose in a 5 kg infant) to control acute symptomatic hypoglycemia.

Severe cases or older infants: Larger or repeated single doses up to 10 to 12 mL of 25% dextrose may be required. Subsequent continuous I.V. infusion of 10% dextrose may be needed to stabilize blood glucose levels.

In the treatment of acute alcoholism, intravenous dextrose - 50 mL of the 50% solution - is used; unmodified insulin, 20 units, and thiamine hydrochloride, 100 mg, are added to the infusion.

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

Atropine Sulfate

Usual adult dosage:

Antimuscarinic: Intramuscular, intravenous, or subcutaneous, 400 to 600 μg (0.4 to 0.6 mg) every four to six hours.Arrhythmias: Intravenous, 400 μg (0.4 mg) to 1 mg every one to two hours as needed, up to a maximum of 2 mg.Gastrointestinal radiography: Intramuscular, 1 mg.Preanesthesia (antisialagogue): Intramuscular, 200 to 600 μg (0.2 to 0.6 mg) one-half to one hour before surgery.Cholinergic adjunct (curariform block): Intravenous, 600 μg (0.6 mg) to 1.2 mg administered a few minutes before or concurrently with 500 μg (0.5 mg) to 2 mg of neostigmine methylsulfate, using separate syringes.Antidote (to cholinesterase inhibitors): Intravenous, 2 to 4 mg initially, then 2 mg repeated every five to ten minutes until muscarinic symptoms disappear or signs of atropine toxicity appear.Antidote (to muscarine in mushroom poisoning): Intramuscular or intravenous, 1 to 2 mg every hour until respiratory effects subside.Antidote (to organophosphate pesticides): Intramuscular or intravenous 1 to 2 mg, repeated in twenty to thirty minutes as soon as cyanosis has cleared. Continue dosage until definite improvement occurs and is maintained, sometimes for two days or more.

Usual pediatric dosage

Antimuscarinic: Subcutaneous, 10 μg (0.01 mg) per kg of body weight, not to exceed 400 μg (0.4 mg), or 300 μg (0.3 mg) per square meter of body surface, every four to six hours. Arrhythmias: Intravenous, 10 to 30 μg (0.01 to 0.03 mg) per kg of body weight. Preanesthesia (antisialagogue): orPreanesthesia (antiarrhythmic): Subcutaneous– Children weighing up to 3 kg: 100 μg (0.1 mg). Children weighing 7 to 9 kg: 200 μg (0.2 mg). Children weighing 12 to 16 kg: 300 μg (0.3 mg). Children weighing 20 to 27 kg: 400 μg (0.4 mg). Children weighing 32 kg: 500 μg (0.5 mg). Children weighing 41 kg; 600 μg (0.6 mg).Antidote (to cholinesterase inhibitors): Intravenous or intramuscular, 1 mg initially, then 0.5 to 1 mg every five to ten minutes until muscarinic symptoms disappear or signs of atropine toxicity appear.

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

Naloxone Hydrochloride

Naloxone hydrochloride injection may be administered intravenously, intramuscularly, or subcutaneously. The most rapid onset of action is achieved by intravenous administration, and it is recommended in emergency situations. Since the duration of action of some narcotics may exceed that of naloxone, the patient should be kept under continued surveillance and repeated doses of naloxone should be administered, as necessary.

Intravenous Infusion: Naloxone hydrochloride injection may be diluted for intravenous infusion in Sodium Chloride Injection 0.9% or Dextrose Injection 5%. The addition of 2 mg of naloxone in 500 mL of either solution provides a concentration of 0.004 mg/mL. Mixtures should be used within 24 hours. After 24 hours, the remaining unused solution must be discarded. The rate of administration should be titrated in accordance with the patient’s response. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Naloxone hydrochloride injection should not be mixed with preparations containing bisulfite, metabisulfite, long-chain or high-molecular-weight anions, or any solution having an alkaline pH. No drug or chemical agent should be added to naloxone hydrochloride injection unless its effect on the chemical and physical stability of the solution has first been established.
Laryng-o-jet

Laryng-o-jet

When Lidocaine HCI Topical Solution 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 Topical Solution is quite low, caution should be exercised, particularly when employing large volumes and concentrations of Lidocaine HCI Topical Solution since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered. For specific techniques and procedures refer to standard textbooks. The dosages below are for normal, healthy adults.Topical Application: For laryngoscopy, bronchoscopy and endotracheal intubation, the pharynx may be sprayed with 1-5 mL (40-200 mg lidocaine HCI), i.e., 0.6-3 mg/kg or 0.3-1.5 mg/lb body weight. For local anesthesia by the transtracheal route, it may be occasionally necessary to spray the pharynx by oropharyngeal spray to achieve complete analgesia.Maximum Recommended Dosages:Normal Healthy Adults:The maximum recommended dose of Lidocaine HCI Topical Solution, should be such that the dose of lidocaine HCI is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight. Children: It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g. Clark’s rule). For example, in a child of five years weighing 50 Ibs., the dose of lidocaine HCI should not exceed 75-100 mg when calculated according to Clark’s rule. The amount of Lidocaine HCI Topical Solution administered should be such that the dose of lidocaine is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2.0 mg/lb) of body weight.

Directions for UseDESCRIPTION The LARYNG-O-JET® is a disposable kit for producing rapid, effective topical anesthesia of the interior of the larynx and trachea. The kit contains (1) a sterile, anatomically-curved plastic cannula with attached vial injector, and (2) a single-dose vial prefilled with 4 mL of a 4% sterile aqueous solution of lidocaine hydrochloride. Medication, cannula and fluid pathway are sterile in original, unopened package. The kit is designed for one-time use only. After use, it may be discarded without disassembly.

USE The LARYNG-O-JET® Kit is used to instill a jet spray of lidocaine hydrochloride topical solution into the interior of the larynx and trachea for local anesthesia in the unconscious patient just prior to endotracheal intubation. This form of application also is effective as a final stage of topical anesthesia in the conscious patient (after initial use of an atomizer spray or other appropriate technique for applying topical anesthetic to the pharynx and epiglottis) prior to laryngeal or tracheobronchial endoscopic procedures.

DIRECTIONS Use Aseptic Technique DO NOT ASSEMBLE UNTIL READY TO USE IMPORTANT: Use of the LARYNG-O-JET® Kit requires strict observance of precautions appropriate to use of topical anesthesia in the respiratory tract.For Use Prior to Intubation During Anesthesia Induction (Unconscious Patient): 1. Open kit following peel pouch directions.2. Remove vial and vial injector from bag.3. Aseptically remove vial and vial injector caps and insert vial into injector.4. Rotate vial about three turns clockwise or until resistance is felt. DO NOT PUSH VIAL INTO INJECTOR; THIS MAY CAUSE MISALIGNMENT. Needle will then be in contact with medication (Fig. 1). Assembled unit should remain in field until laryngoscopy has been completed.5. Before instillation, manually ventilate the patient with 5 or 6 deep breaths of 100% oxygen (denitrogenate with at least 5 minutes of high flow semi-closed 100% oxygen administration in patients with low cardio-respiratory, circulatory, or hematologic reserve).6. Predetermine dose (volume) of anesthetic to be instilled and expel excess solution.7. After hypnosis and muscle relaxation have developed fully and oxygenation has been accomplished as above, perform laryngoscopy in conventional manner. See Fig. 2.

Figure 2. Laryngoscopist’s view showing cannula in place in adult larynx and trachea, with blackguide mark just proximal to cords.

8. Hold injector in manner of holding a pen, and insert tip of cannula between vocal cords and into trachea to the proper depth for instillation of local anesthetic. The black guide mark is positioned just proximal to vocal cords. At this depth, interior of larynx will be bathed with anesthetic solution from upper jet orifices and entire tracheal wall by lower jet openings. (NOTE: Black mark on cannula shaft indicates approximate depth for insertion in most normal patients without touching carina with distal tip.) Caution and gentleness during insertion should be observed and the cannula advanced a proportionately shorter distance in those persons suspected of having a high tracheal bifurcation or tracheobronchial anomaly.9. With cannula at proper depth, depress syringe plunger rapidly to produce a jet-like instillation for bathing walls of larynx and trachea. NOTE: Depression of syringe plunger too slowly may fail to eject solution with sufficient velocity to reach all parts of the larynx and trachea.10. Withdraw unit and discard.11. Proceed with intubation.For Use in Endoscopic Procedures to Supplement Initial Atomizer Spray of Local Anesthetic (Conscious Patient): 1. Predetermine dose and assemble unit as in steps 1, 2, 3, 4 and 6 (above).2. Before instillation apply an initial local anesthetic to the pharynx and epiglottis using an atomizer spray or other appropriatetechnique.3. Follow steps 8, 9 and 10 (above) for instillation.4. Proceed with desired laryngeal or tracheobronchial endoscopy.
Cortrosyn

Cortrosyn

CORTROSYN® (cosyntropin) for Injection may be administered intramuscularly or as a direct intravenous injection when used as a rapid screening test of adrenal function. It may also be given as an intravenous infusion over a 4 to 8 hour period to provide a greater stimulus to the adrenal glands. Doses of CORTROSYN® 0.25 to 0.75 mg have been used in clinical studies and a maximal response noted with the smallest dose.

A suggested method for a rapid screening test of adrenal function has been described by Wood and Associates (1). A control blood sample of 6 to 7 mL is collected in a heparinized tube. Reconstitute 0.25 mg of CORTROSYN® with 1mL of 0.9% Sodium Chloride Injection, USP and inject intramuscularly. The reconstituted drug product should be inspected visually for particulate matter and discoloration prior to injection. Reconstituted CORTROSYN® should not be retained. In the pediatric population, aged 2 years or less, a dose of 0.125 mg will often suffice. A second blood sample is collected exactly 30 minutes later. Both blood samples should be refrigerated until sent to the laboratory for determination of the plasma cortisol response by some appropriate method. If it is not possible to send them to the laboratory or perform the fluorimetric procedure within 12 hours, then the plasma should be separated and refrigerated or frozen according to need.

Two alternative methods of administration are intravenous injection and infusion. CORTROSYN® can be injected intravenously in 2 to 5 mL of saline over a 2-minute period. When given as an intravenous infusion: CORTROSYN®, 0.25 mg may be added to glucose or saline solutions and given at the rate of approximately 40 micrograms per hour over a 6-hour period. It should not be added to blood or plasma as it is apt to be inactivated by enzymes. Adrenal response may be measured in the usual manner by determining urinary steroid excretion before and after treatment or by measuring plasma cortisol levels before and at the end of the infusion. The latter is preferable because the urinary steroid excretion does not always accurately reflect the adrenal or plasma cortisol response to ACTH.

The usual normal response in most cases is an approximate doubling of the basal level, provided that the basal level does not exceed the normal range. Patients receiving cortisone, hydrocortisone or spironolactone should omit their pre-test doses on the day selected for testing. Patients taking inadvertent doses of cortisone or hydrocortisone on the test day and patients taking spironolactone or women taking drugs which contain estrogen may exhibit abnormally high basal plasma cortisol levels.A paradoxical response may be noted in the cortisone or hydrocortisone group as seen in a decrease in plasma cortisol values following a stimulating dose of CORTROSYN®.

In the spironolactone or estrogen group only a normal incremental response is to be expected. Many patients with normal adrenal function, however, do not respond to the expected degree so that the following criteria have been established to denote a normal response:

1. The control plasma cortisol level should exceed 5 micrograms/100 mL. 2. The 30-minute level should show an increment of at least 7 micrograms/100 mL above the basal level. 3. The 30-minute level should exceed 18 micrograms/100 mL. Comparable figures have been reported by Greig and co-workers (2).

Plasma cortisol levels usually peak about 45 to 60 minutes after an injection of CORTROSYN® and some prefer the 60-minute interval for testing for this reason. While it is true that the 60-minute values are usually higher than the 30-minute values, the difference may not be significant enough in most cases to outweigh the disadvantage of a longer testing period. If the 60-minute test period is used, the criterion for a normal response is an approximate doubling of the basal plasma cortisol value.

In patients with a raised plasma bilirubin or in patients where the plasma contains free hemoglobin, falsely high fluorescence measurements will result. The test may be performed at any time during the day but because of the physiological diurnal variation of plasma cortisol the criteria listed by Wood cannot apply. It has been shown that basal plasma cortisol levels and the post CORTROSYN® increment exhibit diurnal changes. However, the 30-minute plasma cortisol level remains unchanged throughout the day so that only this single criterion should be used (3).

Parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit. Reconstituted CORTROSYN® should not be retained.
Up And Up Childrens Ace...

Up And Up Childrens Acetaminophen

All patients should be evaluated for a bleeding disorder before administration of Enoxaparin Sodium Injection, unless the medication is needed urgently. Since coagulation parameters are unsuitable for monitoring Enoxaparin Sodium Injection activity, routine monitoring of coagulation parameters is not required [see Warnings and Precautions (5.9)].

For subcutaneous use, Enoxaparin Sodium Injection should not be mixed with other injections or infusions.

For intravenous use (i.e., for treatment of acute STEMI), Enoxaparin Sodium Injection can be mixed with normal saline solution (0.9%) or 5% dextrose in water.

Enoxaparin Sodium Injection is not intended for intramuscular administration.

2.1 Adult Dosage

Abdominal Surgery: In patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of Enoxaparin Sodium Injection is 40 mg once a day administered by SC injection with the initial dose given 2 hours prior to surgery. The usual duration of administration is 7 to 10 days; up to 12 days administration has been administered in clinical trials.

Hip or Knee Replacement Surgery: In patients undergoing hip or knee replacement surgery, the recommended dose of Enoxaparin Sodium Injection is 30 mg every 12 hours administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery. For hip replacement surgery, a dose of 40 mg once a day SC, given initially 12 (±3) hours prior to surgery, may be considered. Following the initial phase of thromboprophylaxis in hip replacement surgery patients, it is recommended that continued prophylaxis with Enoxaparin Sodium Injection 40 mg once a day be administered by SC injection for 3 weeks. The usual duration of administration is 7 to 10 days; up to 14 days administration has been administered in clinical trials.

Medical Patients During Acute Illness: In medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of Enoxaparin Sodium Injection is 40 mg once a day administered by SC injection. The usual duration of administration is 6 to 11 days; up to 14 days of Enoxaparin Sodium Injection has been administered in the controlled clinical trial.

Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism: In outpatient treatment, patients with acute deep vein thrombosis without pulmonary embolism who can be treated at home, the recommended dose of Enoxaparin Sodium Injection is 1 mg/kg every 12 hours administered SC. In inpatient (hospital) treatment, patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of Enoxaparin Sodium Injection is 1 mg/kg every 12 hours administered SC or 1.5 mg/kg once a day administered SC at the same time every day. In both outpatient and inpatient (hospital) treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of Enoxaparin Sodium Injection). Enoxaparin Sodium Injection should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2.0 to 3.0). The average duration of administration is 7 days; up to 17 days of Enoxaparin Sodium Injection administration has been administered in controlled clinical trials.

Unstable Angina and Non-Q-Wave Myocardial Infarction: In patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of Enoxaparin Sodium Injection is 1 mg/kg administered SC every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily). Treatment with Enoxaparin Sodium Injection should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days; up to 12.5 days of Enoxaparin Sodium Injection has been administered in clinical trials [see Warnings and Precautions (5.2) and Clinical Studies (14.5)].

Treatment of Acute ST-Segment Elevation Myocardial Infarction:

In patients with acute ST-segment elevation myocardial infarction, the recommended dose of Enoxaparin Sodium Injection is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses). Dosage adjustments are recommended in patients ≥75 years of age [see Dosage and Administration (2.3)]. All patients should receive aspirin as soon as they are identified as having STEMI and maintained with 75 to 325 mg once daily unless contraindicated.

When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), Enoxaparin Sodium Injection should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. In the pivotal clinical study, the Enoxaparin Sodium Injection treatment duration was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days.

For patients managed with percutaneous coronary intervention (PCI): If the last Enoxaparin Sodium Injection SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last Enoxaparin Sodium Injection SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of Enoxaparin Sodium Injection should be administered [see Warnings and Precautions (5.2)].

2.2 Renal Impairment

Although no dose adjustment is recommended in patients with moderate (creatinine clearance 30–50 mL/min) and mild (creatinine clearance 50–80 mL/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding.

The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance <30 mL/min) are described in Table 1 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Table 1 Dosage Regimens for Patients with Severe Renal Impairment(creatinine clearance <30 mL/minute) Indication Dosage Regimen Prophylaxis in abdominal surgery 30 mg administered SC once daily Prophylaxis in hip or knee replacement surgery 30 mg administered SC once daily Prophylaxis in medical patients during acute illness 30 mg administered SC once daily Inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered SC once daily Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered SC once daily Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin 1 mg/kg administered SC once daily Treatment of acute ST-segment elevation myocardial infarction in patients <75 years of age, when administered in conjunction with aspirin 30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC once daily Treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, when administered in conjunction with aspirin 1 mg/kg administered SC once daily (no initial bolus)
2.3 Geriatric Patients with Acute ST-Segment Elevation Myocardial Infarction

For treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg dosing for the remaining doses) [see Use in Specific Populations (8.5) and Clinical Phamacology (12.3)].

No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired [see Dosage and Administration (2.2)].

2.4 Administration

Enoxaparin Sodium Injection is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.

Enoxaparin Sodium Injection must not be administered by intramuscular injection.

Enoxaparin Sodium Injection is intended for use under the guidance of a physician.

For subcutaneous administration, patients may self-inject only if their physicians determine that it is appropriate and with medical follow-up, as necessary. Proper training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided.

Subcutaneous Injection Technique: Patients should be lying down and Enoxaparin Sodium Injection administered by deep SC injection. To avoid the loss of drug when using the 30 and 40 mg prefilled syringes, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. The whole length of the needle should be introduced into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.

Enoxaparin Sodium Injection prefilled syringes and graduated prefilled syringes are for single, one-time use only and are available with a system that shields the needle after injection.

Remove the prefilled syringe from the blister packaging by peeling at the arrow as directed on the blister. Do not remove by pulling on the plunger as this may damage the syringe.
Remove needle cover by pulling straight off of needle (see Figure 1). If adjusting the dose is required, the adjustment must be done prior to injecting the prescribed dose into the patient.

See Administration: Subcutaneous Injection Technique for a description of the Standard Protocol for administration.

Depress the plunger while grasping the finger flange until the entire dose has been given. The Passive needle guard should not activate unless the ENTIRE dose has been given.

Remove needle from patient, then let go of the plunger and allow syringe to move up until the entire needle is guarded.

Dispose of syringe/needle guard assembly in approved sharps container.

NOTE:
The safety system should only activate once the syringe has been emptied. Activation of the safety system must be done only after removing the needle from the patient's skin. Do not replace the needle shield after injection. The safety system should not be sterilized.
Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.

Intravenous (Bolus) Injection Technique

For intravenous injection, the multiple-dose vial should be used. Enoxaparin Sodium Injection should be administered through an intravenous line. Enoxaparin Sodium Injection should not be mixed or co-administered with other medications. To avoid the possible mixture of Enoxaparin Sodium Injection with other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the intravenous bolus administration of Enoxaparin Sodium Injection to clear the port of drug. Enoxaparin Sodium Injection may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.

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