Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
Enoxaparin sodium (UNII: 8NZ41MIK1O) (enoxaparin - UNII:E47C0NF7LV)
Amphastar Pharmaceuticals, Inc.
Enoxaparin sodium
Enoxaparin sodium 100 mg in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
Enoxaparin Sodium Injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): - in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies (14.1) ] - in patients undergoing hip replacement surgery, during and following hospitalization - in patients undergoing knee replacement surgery - in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness Enoxaparin Sodium Injection is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium - the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium Enoxaparin Sodium Injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently adminis
Enoxaparin Sodium Injection USP is available in two concentrations (see Tables 26 and 27) Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [See USP Controlled Room Temperature]. Store in the original carton or packaging until ready to use. Do not store the multiple-dose vials for more than 28 days after the first use.
Abbreviated New Drug Application
ENOXAPARIN SODIUM- ENOXAPARIN SODIUM INJECTION AMPHASTAR PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ENOXAPARIN SODIUM INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ENOXAPARIN SODIUM INJECTION.ENOXAPARIN SODIUM INJECTION, FOR SUBCUTANEOUS AND INTRAVENOUS USE INITIAL U.S. APPROVAL: 1993 WARNING: SPINAL/EPIDURAL HEMATOMAS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR IN PATIENTS WHO ARE ANTICOAGULATED WITH LOW MOLECULAR WEIGHT HEPARINS (LMWH) OR HEPARINOIDS AND ARE RECEIVING NEURAXIAL ANESTHESIA OR UNDERGOING SPINAL PUNCTURE. THESE HEMATOMAS MAY RESULT IN LONGTERM OR PERMANENT PARALYSIS. CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS FOR SPINAL PROCEDURES. FACTORS THAT CAN INCREASE THE RISK OF DEVELOPING EPIDURAL OR SPINAL HEMATOMAS IN THESE PATIENTS INCLUDE: USE OF INDWELLING EPIDURAL CATHETERS CONCOMITANT USE OF OTHER DRUGS THAT AFFECT HEMOSTASIS, SUCH AS NON-STEROIDAL ANTI- INFLAMMATORY DRUGS (NSAIDS), PLATELET INHIBITORS, AND OTHER ANTICOAGULANTS A HISTORY OF TRAUMATIC OR REPEATED EPIDURAL OR SPINAL PUNCTURES A HISTORY OF SPINAL DEFORMITY OR SPINAL SURGERY OPTIMAL TIMING BETWEEN THE ADMINISTRATION OF ENOXAPARIN SODIUM INJECTION AND NEURAXIAL PROCEDURES IS NOT KNOWN. MONITOR PATIENTS FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGICAL IMPAIRMENT. IF NEUROLOGICAL COMPROMISE IS NOTED, URGENT TREATMENT IS NECESSARY. (5.1, 7) INDICATIONS AND USAGE Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH) indicated for: Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1) Inpatient treatment of acute DVT with or without pulmonary embolism (1.2) Outpatient treatment of acute DVT without pulmonary embolism (1.2) Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarc Baca dokumen lengkap