ENOXAPARIN SODIUM injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV)

Available from:

Teva Parenteral Medicines, Inc.

INN (International Name):

ENOXAPARIN SODIUM

Composition:

ENOXAPARIN SODIUM 30 mg in 0.3 mL

Administration route:

INTRAVENOUS

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 admin

Product summary:

Enoxaparin Sodium Injection USP is available in two concentrations (see Tables 26 and 27): Dosage Unit/Strength* Anti-Xa Activity † Package Size (per carton) Label Color NDC Number Prefilled Syringes ‡ 30 mg/0.3 mL 3000 IU 10 syringes Medium Blue 0703-8530-23 40 mg/0.4 mL 4000 IU 10 syringes Yellow 0703-8540-23 Graduated Prefilled Syringes ‡ 60 mg/0.6 mL 6000 IU 10 syringes Orange 0703-8560-23 80 mg/0.8 mL 8000 IU 10 syringes Brown 0703-8680-23 100 mg/1 mL 10,000 IU 10 syringes Black 0703-8580-23 Dosage Unit/Strength* Anti-Xa Activity † Package Size  (per carton) Syringe  Label Color NDC Number Graduated Prefilled Syringes ‡ 120 mg/0.8 mL 12,000 IU 10 syringes Purple 0703-8610-23 150 mg/1 mL 15,000 IU 10 syringes Navy Blue 0703-8510-23 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ENOXAPARIN SODIUM- ENOXAPARIN SODIUM INJECTION, SOLUTION
TEVA PARENTERAL MEDICINES, 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 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, 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 myoc