Each film-coated tablet contains Clopidogrel bisulfate USP 97.88 mg equivalent to Clopidogrel 75 mg and Aspirin BP 75 mg.
Pedolip Plus is a fixed dose combination containing Clopidogrel and Aspirin. Clopidogrel is an inhibitor of platelet aggregation. Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Aspirin is also an antiplatelet agent. It acts by causing irreversible inhibition of the cyclo-oxygenase enzyme, which leads to decreased formation of thromboxane A2. Since platelets do not synthesise new enzyme, the action of Aspirin on platelet cyclo-oxygenase is permanent, lasting for the life of the platelets (7-10 days).
Pedolip Plus is indicated for the prevention of ischaemic events, myocardial infarction, stroke and cardiovascular death in patients with acute coronary syndrome.
The recommended dose is one tablet once daily.
No adverse events were reported after single oral administration of 600 mg (equivalent to 8 standard 75-mg tablets) of Clopidogrel in healthy volunteers. The bleeding time was prolonged by a factor of 1.7, which is similar to that typically observed with the therapeutic dose of 75 mg of Clopidogrel per day.
Hypersensitivity to Clopidogrel.
Hypersensitivity to Aspirin and/or non-steroidal anti-inflammatory drugs.
Recent history of gastrointestinal bleeding.
Active pathological bleeding such as peptic ulcer or intracranial haemorrhage, or bleeding disorders like haemophilia.
General: Like other anti-platelet agents, Clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions. If a patient is to undergo elective surgery and an antiplatelet effect is not desired, Clopidogrel should be discontinued 7 days prior to surgery.
Hepatic or renal impairment: Should be avoided in patients with impaired hepatic and renal function. Aspirin causes sodium and water retention in patients with renal impairment, and increases the risk of gastrointestinal bleeding.
Use in Children: Safety and efficacy of Pedolip Plus in the paediatric population have not been established.
Pregnancy: Adverse effects are increased in the mother and the foetus following chronic ingestion of Aspirin. Because of possible adverse effects on the neonate and the potential for increased maternal blood loss. Pedolip Plus should be avoided during the last trimester of pregnancy.
Lactation: Pedolip Plus should be avoided in nursing mothers because of the possible risk of developing Reye's syndrome. Regular use of high doses of Aspirin could impair platelet function and produce hypoprothrombinaemia in infants if neonatal vitamin K levels are low.
The drug is generally well tolerated. Adverse effects that have been reported about Clopidogrel are gastro-intestinal disturbances and skin rashes. Neutropenia and thrombotic thrombocytopenic purpura have also occurred. The most common adverse effects with therapeutic doses of aspirin are nausea, dyspepsia, vomiting. Irritation of the gastric mucosa with erosion, ulceration may occur.
The safety of chronic concomitant administration of Aspirin, Heparin, Nonsteroidal anti-inflammatory drugs (NSAIDs), Warfarin, Phenytoin, Tamoxifen, Tolbutamide, Torsemide, Fluvastatin with Clopidogrel has not been established. However, concomitant use should be undertaken with caution.
Store at temperature not exceeding 30°C in a dry place. Protect from light.
B01AC30 - combinations ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
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