Clopidol Plus 75mg+75mg

Tablet
Clopidogrel + Aspirin
Alco Pharma

Other Strength:
- Clopidol 75mg

Alternative:
- Odrel Plus 75mg+75mg
- ECOSPRIN PLUS 75mg+75mg
- Lopirel Plus 75mg+75mg
- Anclog Plus 75mg+75mg
- Replet® Plus 75mg+75mg
- Preclot AS 75mg+75mg
- Pladex-A 75mg+75mg
- Clocard-A 75mg+75mg
- Dogrel Plus 75mg+75mg
- Plagrin Plus 75mg+75mg



Clopidol Plus
Description:
Clopidol Plus is a fixed-dose combination drug containing Clopidogrel and Aspirin.

Composition:
Clopidol Plus Tablet: Each film-coated tablet contains Clopidogrel Bisulphate USPequivalent to Clopidogrel 75 mg and Aspirin BP 75 mg.

Pharmacology:
Clopidogrel is a selective ADP receptor antagonist to inhibit platelet aggregation. Clopidogrel selectively inhibits the binding of Adenosine diphosphate (ADP) to its platelet receptor and the subsequent ADP-mediated activation of the glycoprotein IIb/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).

Indication/Use:
Clopidol Plus is indicated for the prevention of ischaemic events, myocardial infarction, stroke and cardiovascular death in patients with acute coronary syndrome.

Dosage Guideline:
The recommended dose is one tablet once daily.

Side Effects:
The drug is generally well tolerated. Side effects that have been reported include abdominal pain, dyspepsia, gastritis, diarrhea, nausea, vomiting, constipation, gastrointestinal hemorrhage, ulceration, neutropenia, rash, palpitation, syncope, drowsiness, asthenia, neuralgia, paresthesia and vertigo.

Contraindication:
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 or bleeding disorders like hemophilia.

Drug Interaction:
Oral anticoagulants: This combination drug should be used with caution when anticoagulants are prescribed concurrently, since both Aspirin and Clopidogrel may depress the concentration of prothrombin in plasma and thereby increase bleeding time.
Hypoglycemic agents: Large doses of salicylates have hypoglycaemic action and may enhance the effect of the oral hypoglycemics. Consequently, they should not be given concomitantly; if however this is necessary, the dosage of the hypoglycemic agent must be reduced while the salicylate is given.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): In healthy volunteers receiving naproxen, concomitant administration of Clopidogrel was associated with increased occult gastrointestinal blood loss. This combination is contraindicated in patients who are hypersensitive to NSAIDs.
Uricosuric agents: Although salicylates in larger doses are uricosuric agents, smaller amounts may decrease the uricosuric effects of probenecid, sulfinpyrazone and phenylbutazone. Aspirin may decrease the effects of probenecid, sulfinpyrazone and phenylbutazone.
Spironolactone: Sodium excretion produced by spironolactone may be decreased in the presence of salicylates, Salicylates can produce changes in thyroid function tests. Salicylates should be used with caution in patients with severe hepatic damage, pre-existing hypoprothrombinemia or Vitamin K deficiency and in those undergoing surgery.
Alcohol: Has a synergistic effect with aspirin in causing gastrointestinal bleeding.
Corticosteroids: Concomitant administration of Aspirin with corticosteroids may increase the risk of gastrointestinal ulceration and may reduce serum salicylate levels.
Pyrazolone derivatives (phenylbutazone, oxyphenbutazone): Concomitant administration may increase the risk of gastrointestinal ulceration.
Urinary alkalinizers: Decrease Aspirin effectiveness by increasing the risk of salicylate renal excretion.
Phenobarbital: Decreases Aspirin effectiveness by enzyme induction phenytoin, tamoxifen, tolbutamide, torasemide, fluvastatin. At high concentrations in vitro, Clopidogrel inhibits P450 (2C9). Accordingly, Clopidogrel may interfere with the metabolism of phenytoin, tamoxifen, tolbutamide, torasemide and fluvastatin, but there are no data with which to predict the magnitude of these interactions. Caution should be used when any of these drugs is coadministered with Clopidogrel. Aspirin may also increase serum levels of phenytoin.
Propranolol: May decrease Aspirin's anti-inflammatory action by competing for the same receptors.

Use in Pregnancy & Lactation:
Pregnancy: Adverse effects are increased in the mother and the fetus following chronic ingestion of Aspirin. Because of possible adverse effects on the neonate and the potential for increased maternal blood loss, Clopidol Plus should be avoided during the last three months of pregnancy.
Lactation: Clopidol Plus should be avoided in nursing mother because of the possible risk 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.

Over Dose:
Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications. Appropriate therapy should be considered if bleeding is observed. No antidote to the pharmacological activity of clopidogrel has been found. If prompt correction of prolonged bleeding time is required, platelet transfusion may reverse the effects of clopidogrel.
Aspirin overdosage is manifested by the following symptoms:
Moderate overdosage: tinnitus, hearing loss, dizziness, headaches, vertigo, confusion and gastrointestinal symptoms (nausea, vomiting and gastric pain).
Severe overdosage: fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiovascular collapse, respiratory failure, severe hypoglycaemia, haemorrhage.
In case of severe aspirin overdose, the following actions should be undertaken: admission to hospital is necessary, control of acid-base balance, possibility of haemodialysis or peritoneal dialysis if necessary.
Apart from general measures, treatment of aspirin overdosage consists chiefly of measures to accelerate the excretion (forced alkaline diuresis) and to restore the acid-base and electrolyte balance. Infusions of sodium bicarbonate and potassium chloride solutions may be given.

Precaution:
General: As with other anti-platelet agents, this combination drug 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 anti-platelet effect is not desired, Clopidogrel and Aspirin 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 ulcers).
Thrombotic thrombocytopenic purpura (TTP): TTP has been reported rarely following use of Clopidogrel.
Reye’s syndrome: Reye’s syndrome may develop in individuals who have chicken pox, influenza or flu symptoms. This combination is not recommended for use in patients with chicken pox, influenza or flu symptoms.
Nasal polyps or nasal allergies: The combination drug of Clopidogrel and Aspirin should be administered with caution in patients with nasal polyps or nasal allergies.
Hepatic or Renal Impairment: This 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.

Therapeutic Class:
Antihypertensive

Dosage Form:
Tablet

Storage:
Store in a cool, dry place & away from light. Keep medicines out of reach of children.



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