Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets)

Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets)
© The Swiss Pharmacy

Clopivas (Generic Clopidogrel Bisulfate tablets) is used to treat
patients with Acute coronary syndrome. For patients with non-
ST-segment elevation ACS (unstable angina [UA]/non-ST-
elevation myocardial infarction [NSTEMI]), Clopidogrel tablets
have been shown to reduce the rate of myocardial infarction (MI)
and stroke.
For patients with ST-elevation myocardial infarction (STEMI),
clopidogrel tablets have been shown to reduce the rate of MI and
stroke.
This medicine is also used to treat patients with recent MI, recent
stroke, or established peripheral arterial disease. Clopidogrel
tablets have been shown to reduce the rate of MI and stroke.

Clopivas Tablets are manufactured
by Cipla Limited, India in the
strength of 75 mg and 300 mg.

Chemical Structure

The active ingredient contained in Clopivas
tablets is Clopidogrel Bisulfate.
Each film-coated Clopivas tablet contains
Clopidogrel Bisulfate eqivalent to 75 mg or 300
mg of Clopidogrel.

Uses of Clopivas 75 mg and 300 mg Tablets:
Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets) are used alone
or together with aspirin to lessen the chance of a heart attack or stroke.
It is given to patients with acute coronary syndrome (ACS), to patients
who have already had a heart attack, severe chest pain, or a stroke, or
to patients with other circulation problems (eg, peripheral arterial
disease) that could cause a stroke or heart attack. Acute coronary
syndrome is a condition where the blood flow to the heart is blocked.
A heart attack or stroke may occur when a blood vessel is blocked by a
blood clot. Clopidogrel is a platelet inhibitor. It reduces the chance that
a harmful blood clot will form by preventing platelets from clumping
together in the blood. Clopidogrel may also increase the chance of
serious bleeding in some people.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9590_Clopidogrel-Tablets.html

Recommended Adult Dosage
Acute Coronary Syndrome:
Clopivas tablets (Generic Clopidogrel Bisulfate tablets) can be
administered with or without food.
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate with a
single oral loading dose of Clopivas 300 and then continue at
Clopivas 75 once daily. Initiate aspirin (75 to 325 mg once daily) and
continue in combination with Clopivas.
For patients with STEMI, the recommended dose is Clopivas 75
once daily orally, administered in combination with aspirin (75 to 325
mg once daily), with or without thrombolytics. Clopivas may be
initiated with or without a loading dose.

Recommended Adult Dosage
Recent MI, Recent Stroke or Established PAD:
The recommended dose is Clopivas 75 once daily orally, with or
without food.

Contraindications
➔
Clopivas is contraindicated in patients with a known
hypersensitivity to Clopidogrel Bisulfate or any component of
the tablet.
➔
Active pathological bleeding, such as peptic ulcer or intracranial
hemorrhage

Storage Instructions
Clopivas (Generic Clopidogrel Bisulfate tablets) have
to be stored at controlled room temperature i.e. from
20°C to 25°C (68°F to 77°F) with excursions permitted
between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away from
children and pets.

Warnings
Reduced effectiveness in impaired CYP2C19 function: Avoid
concomitant use with medicines that are strong or moderate CYP2C19
inhibitors (e.g., Omeprazole).
Bleeding: Clopidogrel tablets increases risk of bleeding. Discontinue 5
days prior to elective surgery.
Discontinuation of Clopidogrel tablets: Premature discontinuation of
Clopivas increases risk of cardiovascular events.
Recent transient ischemic attack or stroke: Combination use of
Clopidogrel tablets and Aspirin in these patients was not shown to be
more effective than Clopivas tablets alone, but was shown to increase
major bleeding.

Warnings
Thrombotic thrombocytopenic purpura (TTP): TTP has been reported
with Clopidogrel Bisulfate tablets, including fatal cases.
Patients should be evaluated for history of hypersensitivity to another
thienopyridine (such as Ticlopidine, Prasugrel) since cross-reactivity
among thienopyridines has been reported.
Thienopyridines may cause mild to severe allergic reactions such as
rash, angioedema, or haematological reactions such as
thrombocytopaenia and neutropaenia.

Warnings
As with other antiplatelet agents, when considering prescribing
Clopidogrel, physicians should inquire whether the patient has a
history of bleeding.
Clopidogrel should be used with caution in patients who may be at risk
of increased bleeding from recent trauma, surgery or other
pathological condition(s), and in patients receiving treatment with
acetylsalicylic acid, heparin, glycoprotein IIb/IIIa inhibitors, non-
steroidal anti-inflammatory drugs (NSAIDs), or selective serotonin
reuptake inhibitors (SSRIs).

Possible Side Effects
Bleeding, including life-threatening and fatal bleeding, is the most
commonly reported side effect.
Another serious side effect is Thrombotic thrombocytopenic purpura.
Some other side effects that were reported include –
thrombocytopenia, leucopenia, neutropenia (including severe
neutropenia), granulocytopenia, anemia, cross-reactive drug
hypersensitivity among thienopyridines (such as ticlopidine,
prasugrel), paresthesia, dizziness, vertigo, abdominal pain, dyspepsia,
gastritis, vomiting, nausea, constipation, flatulence, gynecomastia,
glomerulonephritis, hematuria.

The following side effects were reported post marketing:
Blood and Lymphatic System Disorders: Agranulocytosis, aplastic
anemia/pancytopenia, TTP, acquired hemophilia A
Eye Disorders: Eye (conjunctival, ocular, retinal) bleeding
Gastrointestinal Disorders: Gastrointestinal and retroperitoneal hemorrhage with
fatal outcome, colitis (including ulcerative or lymphocytic colitis), pancreatitis,
stomatitis , gastric/duodenal ulcer, diarrhea
General Disorders and Administration Site Conditions: Fever, hemorrhage of
operative wound
Hepato-Biliary Disorders: Acute liver failure, hepatitis (non-infectious), abnormal
liver function test
Immune System Disorders: Hypersensitivity reactions, anaphylactoid reactions,
serum sickness

The following side effects were reported post marketing:
Musculoskeletal, Connective Tissue and Bone Disorders: Musculoskeletal bleeding,
myalgia, arthralgia, arthritis
Nervous System Disorders: Taste disorders, fatal intracranial bleeding, headache
Psychiatric Disorders: Confusion, hallucinations
Respiratory, Thoracic and Mediastinal Disorders: Bronchospasm, interstitial
pneumonitis, respiratory tract bleeding, eosinophilic pneumonia
Renal and Urinary Disorders: Increased creatinine levels
Skin and Subcutaneous Tissue Disorders: Maculopapular or erythematous rash,
urticaria, bullous dermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson
syndrome, angioedema, drug-induced hypersensitivity syndrome, drug rash with
eosinophilia and systemic symptoms (DRESS), erythema multiforme, skin bleeding,
lichen planus, generalized pruritus
Vascular Disorders: Vasculitis, hypotension

Clopivas Tablets Overdosage
Platelet inhibition by Clopidogrel (Clopivas tablets) is irreversible and
will last for the life of the platelet. Overdose following Clopidogrel
administration may result in bleeding complications.
A single oral dose of Clopidogrel at 1,500 or 2,000 mg/kg was lethal to
mice and to rats and at 3,000 mg/kg to baboons.
Symptoms of acute toxicity were vomiting, prostration, difficult
breathing, and gastrointestinal hemorrhage in animals.
Based on biological plausibility, platelet transfusion may restore
clotting ability.

Treatment of Clopivas Tablets Overdosage
Based on biological plausibility, platelet transfusion may restore
clotting ability

Clopivas Tablets During Pregnancy
Clopidogrel Bisulfate (Clopivas tablets) has been classified by the US
FDA as Pregnancy Category B.
Reproduction studies performed in rats and rabbits at doses up to 500
and 300 mg/kg/day, respectively (65 and 78 times the recommended
daily human dose, respectively, on a mg/m2 basis), revealed no
evidence of impaired fertility or fetotoxicity due to Clopidogrel.
There are, however, no adequate and well-controlled studies in
pregnant women. Because animal reproduction studies are not always
predictive of a human response, Clopidogrel (Clopivas tablets) should
be used during pregnancy only if clearly needed.

Clopivas Tablets (Generic Clopidogrel Bisulfate
Tablets) are manufactured by Cipla Limited, India.

Clopivas Tablets (Generic Clopidogrel Bisulfate Tablets)

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