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:

Watson Pharma, Inc.

INN (International Name):

ENOXAPARIN SODIUM

Composition:

ENOXAPARIN SODIUM 30 mg in 0.3 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ENOXAPARIN SODIUM- ENOXAPARIN SODIUM INJECTION
WATSON PHARMA, 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
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 LONG-TERM 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, OTHER ANTICOAGULANTS
A HISTORY OF TRAUMATIC OR REPEATED EPIDURAL OR SPINAL PUNCTURES
A HISTORY OF SPINAL DEFORMITY OR SPINAL SURGERY.
MONITOR PATIENTS FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGICAL
IMPAIRMENT. IF NEUROLOGICAL
COMPROMISE IS NOTED, URGENT TREATMENT IS NECESSARY. CONSIDER THE
BENEFITS AND RISKS BEFORE NEURAXIAL
INTERVENTION IN PATIENTS ANTICOAGULATED OR TO BE ANTICOAGULATED FOR
THROMBOPROPHYLAXIS [SEE _WARNINGS_
_AND PRECAUTIONS (5.1)_ AND _DRUG INTERACTIONS (7)_].
RECENT MAJOR CHANGES
Administration (2.4) (08/2011)
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 compli