Clotinex Injection 60mg/0.6ml

Clotinex is indicated in:

• 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.

Composition

• Each 0.2 ml pre-filled syringe contains Enoxaparin Sodium BP 20 mg equivalent to 2000 anti-Xa III.
• Each 0.4 ml pre-filled syringe contains Enoxaparin Sodium BP 40 mg equivalent to 4000 anti-Xa III.
• Each 0.6 ml pre-filled syringe contains Enoxaparin Sodium BP 60 mg equivalent to 6000 anti-Xa IU.
• Each 0.8 ml pre-filled syringe contains Enoxaparin Sodium BP 80 mg equivalent to 8000 anti-Xa IU.

Pharmacology

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

Interaction

It is recommended that agents which affect hemostasis should be discontinued prior to Clotinex therapy unless strictly indicated. These agents include medications such as: acetylsalicylic acid (and derivatives), NSAIDs (including ketorolac), ticlopidine,clopidogrel,dextran 40,glucocorticoids, thrombolytics and anticoagulants, other antiplatelet aggregation agents including glycoprotein llb/llla antagonists. If the combination is indicated, should be used with careful clinical and laboratory monitoring.

Contraindications

Patients with known hypersensitivity to Enoxaparin Sodium, heparin or other low molecular weight heparins. Patients with active major bleeding and conditions with a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke.

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 Clotinex and spinal/epidural anesthesia or spinal puncture have resulted in varying degrees of neurologic injuries.

Pregnancy & Lactation

Pregnancy category B. In humans, there is no evidence that Enoxaparin Sodium crosses the placental barrier. As there are no adequate and well-controlled studies in pregnant women, Enoxaparin Sodium should be used during pregnancy only if clearly needed. Pregnant women with mechanical prosthetic heart valves may be at a higher risk for thromboembolism.

Precautions & Warnings

Clotinex should be injected by deep subcutaneous route in prophylactic and curative treatment and by intravascular route during hemodialysis. 

Overdose Effects

Accidental overdosage following administration of Clotinex may lead to hemorrhagic complications. Injected Clotinex 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 Clotinex injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Clotinex.

Therapeutic Class

Parenteral anti-coagulants

Storage Conditions

Store in a cool and dry place, protect from light and moisture. Do not store above 25°C. Do not store in a refrigerator or freezer. Keep out of the reach of children