Each uncoated tablet contains: Amlodipine Besilate equivalent to Amlodipine 5mg.
Hypertension: Indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Coronary Artery Disease (CAD): Chronic Stable Angina: Indicated for the symptomatic treatment of chronic stable angina. It may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal's or Variant Angina): It is indicated for the treatment of confirmed or suspected vasospastic angina. It may be used as monotherapy or in combination with other antianginal agents.
For both hypertension and angina, the usual initial dose is 5mg amlodipine once daily which may be increased to a maximum dose of 10mg depending on the individual patient's response.
For patients with coronary artery disease, the recommended dosage range is 5-10 mg once daily. In clinical studies, the majority of patients required 10 mg.
No dose adjustment of amlodipine is required upon concomitant administration of thiazide diuretics, beta-blockers, and angiotensin-converting enzyme inhibitors.
Use in Renal Failure: Amlodipine may be used in such patients at normal doses. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialyzable.
Amlodipine is contraindicated in patients with a known sensitivity to dihydropyridines, amlodipine, or any of the inert ingredients.
Use in Patients with Heart Failure: In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of nonischemic etiology, amlodipine was associated with increased reports of pulmonary edema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
Use in Patients with Impaired Hepatic Function: As with all calcium antagonists, amlodipine half-life is prolonged in patients with impaired liver function and dosage recommendations have not been established in these patients. The drug should therefore be administered with caution in these patients.
Use in Pregnancy & Lactation: Safety of amlodipine in human pregnancy or lactation has not been established. Amlodipine does not demonstrate toxicity in animal reproductive studies other than to delay parturition and prolong labor in rats at a dose level fifty times the maximum recommended dose in humans. Accordingly, use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and fetus.
Safety of amlodipine in human pregnancy or lactation has not been established. Amlodipine does not demonstrate toxicity in animal reproductive studies other than to delay parturition and prolong labor in rats at a dose level fifty times the maximum recommended dose in humans. Accordingly, use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and fetus.
The most commonly observed side effects were headache, oedema, fatigue, somnolence, nausea, flushing, palpitations and dizziness. Vomiting and abdominal pain have occurred.
Less commonly observed side effects include alopecia, altered bowel habits, arthralgia, asthenia, back pain, dyspepsia, dyspnea, gingival hyperplasia, gynecomastia, hyperglycemia, impotence, increased urinary frequency, leucopenia, malaise, mood changes and depression, dry mouth, muscle cramps, myalgia, peripheral neuropathy, pancreatitis, increased sweating, syncope, thrombocytopenia, vasculitis, and visual disturbances. Allergic reactions including pruritus, rash, angioedema and erythema multiforme have also been observed.
The following adverse events have been reported but cannot be distinguished from the natural history of the underlying disease: myocardial infarction, arrhythmia (including ventricular tachycardia and atrial fibrillation) and chest pain.
Hepatitis and jaundice and hepatic enzyme elevations have been reported (mostly consistent with cholestasis). Some cases severe enough to require hospitalisation have been reported in association with use of amlodipine.
Store below 25°C in a dry place.
Protect from light and moisture.
C08CA01 - amlodipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
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