Incepta Pharmaceuticals | Product details

Parinox (Enoxaparin Sodium)

Therapeutic Group: Cardiovascular » Anti Coagulant

Presentation
Descriptions
Indications
Dosage & Administration
Side Effects
Precautions
Contraindications
Use in Pregnancy & Lactation
Overdose
Storage
Commercial Packaging

Presentation

Active ingredient: Enoxaparin Sodium BP.

Solvent: Water for injections BP.

Each ml of the solution contains: 10000 anti-Xa IU equivalent to 100 mg Enoxaparin Sodium.

Parinox 40: Each pre-filled syringe (0.4ml) contains 4000 anti-Xa IU is equivalent to 40 mg Enoxaparin Sodium BP.

Parinox 60: Each pre-filled syringe (0.6ml) contains 6000 anti-Xa IU is equivalent to 60 mg Enoxaparin Sodium BP.

Parinox 80: Each pre-filled syringe (0.8ml) contains 8000 anti-Xa IU is equivalent to 80 mg Enoxaparin Sodium BP.

Descriptions

Enoxaparin is a low molecular weight heparin with a high anti-Xa activity and with a low anti-lla or anti- thrombin activity. At doses required for the various indications, Enoxaparin does not increase bleeding time. At preventive doses, Enoxaparin causes no notable modification of activated Partial Thromboplastin Time (aPTT). It neither influences platelet aggregation nor binding of fibrinogen to platelets. Enoxaparin is primarily metabolized in the liver.

Indications

Enoxaparin is indicated for:

Treatment of deep vein thrombosis, with or without pulmonary embolism.

Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with

aspirin.

Prevention of thrombus formation in the extra-corporal circulation during haemodialysis.

Prophylaxis of venous thromboembolic disease (prevention of blood clot formation in the veins), in

particular those which may be associated with orthopedic or general surgery.

Prophylaxis of venous thromboembolic disease in medical patients bedridden due to acute illness,

including cardiac insufficiency, respiratory failure, severe infections, rheumatic diseases.

Dosage & Administration

Dosage adjustment in renal impairment
No dosage adjustment is required in patients with moderate (creatinine clearance 30-50 ml/min) and mild (creatinine clearance 50-80 ml/min) renal impairment. But, all such patients should be observed carefully for signs and symptoms of bleeding.

For patients with severe (creatinine clearance <30 ml/min) renal impairment the dosage adjustment for Prophylactic dose is: 2000 IU once daily and Therapeutic dose is: 100 IU/kg once daily.
Elderly: No dosage adjustment is necessary, unless kidney function is impaired.
Children: Safety and effectiveness of Enoxaparin in pediatric patients have not been established.

Side Effects

Haemorrhage (bleeding), Thrombocytopenia, elevations of serum aminotransferase. Pain, bluish marks at injection sites to skin rash at injection sites. Cases of neuraxial hematomas with the concurrent use of Enoxaparin and spinal/epidural anesthesia or spinal puncture have resulted in varying degrees of neurologic injuries.

Precautions

Enoxaparin injection should not be administered by intramuscular route. Enoxaparin should be used with caution in conditions with increased potential for bleeding, such as impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy, recent neuro or opthalmologic surgery and low weight patients. It is recommended that the platelet count be measured befored the initiation of the treatment and regularly thereafter during treatment.

Contraindications

Hyper-sensitivity to either Enoxaparin, heparin or other low molecular weight heparins; major clotting disorders like history of thrombocytopenia, active gastro-intestinal ulcer or organic lesion likely to bleed, recent haemorrhagic vascular cerebral stroke. Although rare, cutaneous or systemic allergic reactions may occur.

Use in Pregnancy & Lactation

Pregnancy
Pregnancy category B. In humans, there is no evidence that Enoxaparin crosses the placental barrier Enoxaparin should be used during pregnancy only if the physician has established a clear need. Enoxaparin is not recommended for use in pregnant women with prosthetic heart valves.

Lactation
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Enoxaparin injection is administered to nursing women.

Overdose

Accidental overdosage following administration of Enoxaparin may lead to hemorrhagic complications. Injected Enoxaparin may be largely neutralized by the slow i.v. injection of protamine sulfate (1% solution) The dose of protamine sulfate should be equal to the dose of Enoxaparin injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Enoxaparin.

Storage

Enoxaparin should be stored below 25° C. Do not freeze.

Commercial Packaging

Parinox 40: Each box contains 1 pre-filled syringe containing 4000 anti-Xa IU is equivalent to 40 mg

Enoxaparin Sodium BP (0.4 ml) in a blister pack.

Parinox 60: Each box contains 1 pre-filled syringe containing 6000 anti-Xa IU is equivalent to 60 mg

Enoxaparin Sodium BP (0.6 ml) in a blister pack.

Parinox 80: Each box contains 1 pre-filled syringe containing 8000 anti-Xa IU is equivalent to 80 mg

Enoxaparin Sodium BP (0.8 ml) in a blister pack.

Cardiovascular

Anti Anginal