Seaclop™

Composition and Strengths

Seaclop 75mg: Each film coated tablet contains: Clopidogrel (as bisulphate) U.S.P 75 mg. Seaclop-AP 75/75 mg: Each film coated tablet contains: Clopidogrel (as bisulphate) U.S.P 75mg Aspirin U.S.P 75mg.

Seaclop-AP 75/150 mg: Each film coated tablet contains: Clopidogrel (as bisulphate) U.S.P 75mg Aspirin U.S.P 150mg.

Pharmacokinetics Absorption and Distribution

Clopidogrel is rapidly absorbed after oral administration of repeated doses of 75mg clopidogrel, with peak plasma levels (3 mg/L) occurring approximately 1 hour after dosing. Clopidogrel and the main circulating metabolite bind reversibly, in vitro, to human plasma proteins (98% and 94% respectively). After absorption Aspirin achieves peak plasma levels within 1-2 hours, Salicylate has a concentration dependent protein binding. Approximately 90 percent of plasma salicylate is protein bound at concentrations lower than 100mcg/ml while at concentration higher than 400mcg/ml the protein binding is about 75 percent.

Metabolism & Elimination
 
Clopidogrel is extensively metabolized by the liver. Excretion is through urine and feces. The elimination half-life is 8 hours after single and repeated administration. Meals do not significantly modify the bioavailability of Clopidogrel. Aspirin, after absorption, is hydrolyzed and converted to salicylic acid, whose rate of elimination is constant in relation to plasma concentration. Renal excretion of free salicylate is dependent upon urine pH. As urinary pH rises above 6.5, the renal clearance increases from < 5 percent to > 80 percent.

Indications

Seaclop & Seaclop-AP are indicated for the prevention of ischemic events, myocardial infarction, stroke and cardiovascular death in patients with Acute Coronary Syndrome (ACS) and or the prevention of stent thrombosis.

Contraindications

Hypersensitivity to Clopidogrel, Hypersensitivity to Aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs). Recent history of gastrointestinal bleeding, Active pathological bleeding such as peptic ulcer or intracranial hemorrhage, or bleeding disorders like hemophilia.

Warning and Precautions

Seaclop&Seaclop-AP 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, drug should be discontinued 7 days prior to surgery. PEDIATRIC USE: Safety and effectiveness of (Seaclop&Seaclop-AP) in the pediatric have not been established.

Over Dosage

In case of over dosage, symptomatic treatment is advised. Platelet transfusion may be appropriate to reverse the pharmacological effects of Seaclop&Seaclop-AP if quick reversal is required.


Instructions

To be sold on the prescription of a registered medical practitioner only. Protect from moisture, freezing, excessive heat and sunlight. Keep all medicines out of the reach of children.

Dosage And Administration

The recommended dose is one table once daily.

Presentations Available

Seaclop75mg: Pack of 10 film coated tablets. Seaclop-AP75/75: Pack of 10 film coated tablets. Seaclop-AP75/150: Pack of 10 film coated tablets.


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