ENOXAPARIN SODIUM INJECTION 40MG/0.4ML

ENOXAPARIN SODIUM INJECTION 40MG/0.4ML

  • Documents: GMP,COPP,CTD

ENOXAPARIN SODIUM INJECTION 40MG/0.4ML

Indications:

Enoxaparin sodium injection is a low molecular weight heparin 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

Inpatient treatment of acute DVT with or without pulmonary embolism

Outpatient treatment of acute DVT without pulmonary embolism

Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction.

Treatment of acute ST-segment elevation myocardial infarction [STEMI] managed medically or with subsequent percutaneous coronary intervention [PCI]

Dosage and Administration:

Evaluate all patients for a bleeding disorder before starting enoxaparin sodium injection treatment, unless treatment is urgently needed.

Do not administer enoxaparin sodium injection by intramuscular injection.

Administer enoxaparin sodium injection by intravenous or subcutaneous injection only.

Precautions & Warning:

1 Increased Risk of Hemorrhage

2 Increased Risk of Bleeding following Percutaneous Coronary 3 Increased Risk of Bleeding in Patients with Concomitant Medical Conditions

4 Risk of Heparin-Induced Thrombocytopenia with or without Thrombosis

5 Thrombocytopenia

6 Interchangeability with Other Heparins

7 Increased Risk of Thrombosis in Pregnant Women with Mechanical

8 Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative

Contra-indications:

Enoxaparin sodium injection is contraindicated in patients with:

Active major bleeding.

History of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies.

Known hypersensitivity to enoxaparin sodium (e.g., pruritus, urticaria, anaphylactic/anaphylactoid reactions).

Known hypersensitivity to heparin.

Drug interactions:

Whenever possible, agents which may enhance the risk of hemorrhage should be discontinued prior to initiation of enoxaparin sodium injection therapy. These agents include medications such as: anticoagulants, platelet inhibitors including acetylsalicylic acid, salicylates, NSAIDs (including ketorolac tromethamine), dipyridamole, or sulfinpyrazone. If coadministration is essential, conduct close clinical and laboratory monitoring.

Storage instructions:

Store in a cool and dry place,below 25°C.