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Indications

This capsule is a combination antiplatelet agent indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or a complete ischemic stroke due to thrombosis.

Pharmacology

This is a combination of anti-platelet agents Aspirin & Dipyridamole intended for oral administration. Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibits the generation of thromboxane A2. Dipyridamole inhibits platelet aggregation by inhibiting the uptake of adenosine into platelet, which is a potent mediator of vasodilation. Dipyridamole increases local concentration of adenosine which increases cAMP (cyclic-adenosine monophosphate) level thus decreased ca++ concentration and inhibits platelet aggregation. Dipyridamole also inhibits phosphodiesterase (PDE) especially cyclic-guanosine monophosphate-PDE (cGMP-PDE), which increases cGMP produced by EDRF (endothelium-derived relaxing factor) Nitric oxide a potent vasodilator.

Dosage And Administration

The recommended dose is one capsule given orally twice daily. One in the morning and one in the evening. Capsules should be swallowed whole without chewing. This can be administered with or without food.

Pediatric Use: The safety and effectiveness of this capsule in pediatric patients have not been studied. So, the use of this preparation in the pediatric population is not recommended.

 

Interaction

Co-administration with anticoagulants, antiplatelets or NSAIDS can increase risk of bleeding. Decreased renal function can occur with co-administration with NSAID, beta blockers and diuretics. Dipyridamole may counteract the anticholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis.

Contraindications

Hypersensitivity: This capsule is contraindicated in patients with known hypersensitivity to any of the product components.

Allergy: Aspirin is contraindicated in patients with known allergy to Nonsteroidal anti-inflammatory drugs and in patients with the syndrome of asthma, rhinitis and nasal polyps. Aspirin may cause severe urticaria, angioedema or bronchospasm.

Reye Syndrome: Aspirin should not be used in children or teenagers with viral infections because of the risk of Reye syndrome.

Side Effects

The most frequently reported adverse reactions are headache, dyspepsia, abdominal pain, nausea and diarrhea.

Pregnancy And Lactation

Pregnancy Category D. Aspirin can results in excessive blood loss at delivery as well as prolonged gestation and prolonged labor. So this capsule should be avoided in the third trimester of pregnancy and during labor and delivery. Both Dipyridamole and Aspirin are excreted in human milk. This capsule not to be administered to a nursing woman.

Precautions And Warnings

This is not interchangeable with the individual components of Aspirin and Dipyridamole tablets. This increases the risk of Intracranial Hemorrhage & Gastrointestinal Bleeding. Avoid this in patient with peptic ulcer, coronary artery diseases, hypotension & severe renal failure or hepatic insufficiency.

Overdose Effects

Overdosage of this is likely to be dominated by signs and symptoms of Dipyridamole & Aspirin overdoses. Overdose of Dipyridamole shows hemodynamic effects with various symptoms such as warm feeling, flushes, sweating, restlessness, feeling of weakness, dizziness and a drop in blood pressure and tachycardia might also be observed. The sign of Aspirin overdose includes tinnitus, hyperthermia and hypovolemia. Treatment of overdose consists primarily of supporting vital functions, increasing drug elimination, correcting acid-base disturbances and gastric emptying or lavage as soon as possible after ingestion. Maintain fluid, electrolyte balance and to control the hypoglycemic condition intravenous fluid and infusion of glucose must be administered. Administration of Xanthine derivatives (e.g. aminophylline) may reverse the hemodynamic effects of Dipyridamole overdose.

Therapeutic Class

Anti-platelet drugs

Storage Conditions

Store at cool & dry place. Protect from light. Keep away from reach of children.