APT Plus is a fixed-dose combination drug 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.
Clopidogrel also inhibits platelet aggregation induced by agonists other than
ADP by blocking the amplification of platelet activation released by ADP.
Aspirin is also an antiplatelet agent. Aspirin acts by causing irreversible
inhibition of the cyclooxygenase enzyme, which leads to decreased formation of
thromboxane A2 and ultimate inhibition of platelet aggregation.
Recent MI, Recent Stroke, or Established Peripheral
Arterial Disease The recommended daily dose of APT Plus one tablet daily.
Acute Coronary Syndrome
For patients with acute coronary syndrome (unstable
angina/non-Q-wave MI), APT Plus should be initiated with a 4 tablet stat
loading dose and then continued at one tablet daily.
Use caution with phenytoin, tamoxifen, tolbutamide,
warfarin, torsemide, fluvastatin and non-steroidal anti-inflammatory drugs.
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.
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, APT Plus should be avoided during
the last three months of pregnancy.
Lactation: APT 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 hypoprothrombinemia in infants if neonatal vitamin K
levels are low.
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[1]platelet effect is not desired, APT Plus 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.
Anti-platelet drugs
Store at a cool and dry place, protected from light
& moisture. Keep out of reach of children
