DESCRIPTION

Clas. is a fixed-dose combination formula comprising Clopidogrel and Aspirin; both are acting as antiplatelet agent. Clopidogrel is aninhibitor 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 (GP•)•complex, thereby  inhibiting platelet aggregation. Asp1nn is also an antiplatelet agent. It acts by causing irrversible inhibition of the cyclo-oxygenase enzyme , which leads to decrease formation of thromboxane A2•

INDICATIONS

• Clas is indicated for:
• Recent myocardial infarction
• Recent stroke
• lschemic events
• Peripheral arterial diseases
• Peripheral vascular diseases
• Acute coronary syndrome
• (unstable angina/non-0-wave Ml)

DOSAGE & ADMINISTRATION

Recent MI, recent stroke or established peripheral arterial diseases:

The recommended daily dose of this combined preparation is one tablet daily

Acute coronary syndrome: In Acute coronary syndrome (unstable angina/non-Q-wave Ml), the dose should be initiated with 4 tablets as loading dose and then continued at one tablet daily.

CONTRAINDICATIONS

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 hemorrhage and hemophilia.

PRECAUTIONS

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 patients are to go under elective surgery and an anti-platelet effect is not desired this drug should be discontinued 7 days prior to surgery.

GI bleeding: The combination of Clopidogrel and Aspirin prolongs the bleeding time. So, it should be used with caution in patients who have lesions with a propensity to bleed (such as ulcer).

 Hepatic and 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.

Pregnancy and lactation: Adverse effects are increased in mother and fetus following chronic ingestion of Aspirin. Because of possible adverse effects on the neonate and the potential for increase maternal blood loss, this combination should be avoided during the last three months of pregnancy.This product should be avoided in nursing mothers because of the possible risks of developing Reye's syndrome. Regular use of high doses of Aspirin could  impair platelet function and produce hypoprothrombinemia in infants if neonatal vitamin K levels are low.

Pediatric use: Not recommended.

ADVERSE REACTIONS

The drug is generally well tolerated. Adverse effects that have been reported about Clopidogrel are gastrointestinal disturbances and skin rashes. Neutropenia and thrombotic thrombocytopenic purpura have also occurred. The most common adverse effects with therapeutic doses or Aspirin are nausea, dyspepsia, vomiting. Irritation of the gastric mucosa with erosion, ulceration may occur.

DRUG INTERACTIONS

Aspirin may enhance the effects of  anticoagulants, oral hypoglycemia and Methotrexate and decreases the action of Uricosuria drugs. Aspirin does not modify the Clop1dogrel mediated inhibition of ADP-induced platelet aggregation. Concomitant administration of Clopidogrel with NSAIDs such as Naproxen is associated with gastrointestinal blood loss. No clinically significant interactions have been observed when Clopidogrel is co-administered with Atenolol, Nifedipine or both Atenolol and Nifedipine

PACKAGING

Clas tablet: Each box contains 3 x 1o film coated tablets in alu-alu blister pack. Each film-coated tablet contains

Clopidogrel Bisulfate USP equivalent to 75 mg Clop1dogrel and Aspirin USP 75 mg.

PHARMACEUTICAL PRECAUTION

Store in a cool (below 30'c) and dry place, also away from hght. Keep out of reach of children.

Manufactured by
Delta Pharma Limited, Bangladesh.