ENOXAPARIN SODIUM injection ENOXAPARIN SODIUM injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Enoxaparin sodium (UNII: 8NZ41MIK1O) (enoxaparin - UNII:E47C0NF7LV)

Available from:

Amphastar Pharmaceuticals, Inc.

INN (International Name):

Enoxaparin sodium

Composition:

Enoxaparin sodium 100 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ENOXAPARIN SODIUM- ENOXAPARIN SODIUM INJECTION
AMPHASTAR PHARMACEUTICALS, INC.
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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