GX Amlodipine Besilate

GX Amlodipine Besilate





Metro Drug
Full Prescribing Info
Amlodipine besilate.
Pharmacology: Pharmacokinetics: Amlodipine is well absorbed following oral administration with peak blood concentrations occurring after 6-12 hrs. The bioavailability is 60-65%. Amlodipine is reported to be about 97.5% bound to plasma proteins. It has a prolonged terminal elimination t½ of 35-50 hrs and steady-state plasma concentrations are not achieved until after 7-8 days of administration. Amlodipine is extensively metabolized in the liver; metabolites are mostly excreted in the urine together with <10% of a dose as unchanged drug.
Management of hypertension and angina pectoris. It may be used in combination with other antihypertensive and antianginal agents.
Dosage/Direction for Use
Hypertension: Usual Initial Dose: 5 mg once daily with a maximum dose of 10 mg once daily.
Small, Fragile or Elderly Individuals or Patients with Hepatic Insufficiency: Start on 2.5 mg once daily and this dose may be used when adding amlodipine to other antihypertensive therapy or as prescribed by a physician. Dose may be increased depending on the patient's response.
Chronic Stable or Vasospastic Angina: Recommended Dose: 5-10 mg with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effects or as prescribed by a physician.
Administration: Amlodipine is given by mouth as the besilate, but doses are usually expressed in terms of the base.
Activated charcoal may be administered in case of overdosage. Hypotension may respond to placing the patient in supine position with the feet raised and the administration of plasma expanders. If hypotension is not corrected, calcium gluconate or calcium chloride should be given IV. If hypotension persists, IV administration of a sympathomimetic agent eg, isoprenaline, dopamine or noradrenaline (norepinephrine) may be given. Dialysis is not useful as amlodipine is highly protein bound.
Patients with known sensitivity to amlodipine. Cardiogenic shock, unstable angina, significant aortic stenosis and obesity.
Special Precautions
Patients with hypotension, poor cardiac reserve, and those with heart failure since deterioration of heart failure has been noted. In patients who have recently suffered a myocardial infarction or in acute unstable angina. Amlodipine should not be used to treat an anginal attack in chronic unstable angina. In patients with severe aortic stenosis, amlodipine may increase the risk of developing heart failure. The dose may need to be reduced in patients with hepatic impairment. Amlodipine should be discontinued in patients who experience ischemic pain following its administration and should be avoided in pregnancy.
Use In Pregnancy & Lactation
Use in Pregnancy: Amlodipine should be avoided in pregnancy.
Adverse Reactions
Abdominal pain, nausea, palpitations, flushing, edema, headache, dizziness, sleep disturbances, fatigue, gastrointestinal disturbances, dry mouth, taste disturbances, hypotension, syncope, chest pain, dyspnea, mood changes, tremor, paresthesia, urinary disturbances, impotence, gynecomastia, weight change, myalgia, visual disturbances, pruritus, rashes (including erythema multiforme), alopecia, purpura, pancreatitis, jaundice, cholestasis, gingival hyperplasia, myocardial infarctions, arrhythmia, vasculitis, hyperglycemia, thrombocytopenia, angioedema and urticaria.
Drug Interactions
Amlodipine may enhance the antihypertensive effects of other antihypertensive drugs eg, β-blockers, although the combination is generally tolerated. It may modify insulin and glucose response and therefore, diabetic patients may need to adjust their antidiabetic treatment.
Store at temperatures not exceeding 30°C.
MIMS Class
Calcium Antagonists / Anti-Anginal Drugs
ATC Classification
C08CA01 - amlodipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
Tab 5 mg x 30's. 10 mg x 30's.
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