Cab Tablet: Each tablet contains Amlodipine 5 mg as Besilate BP.
Cab (Amlodipine) is a calcium channel blocker of dihydropyridine group having long duration of action and used for the treatment of hypertension and angina pectoris. Cab inhibitsthe transmembrane influx of calcium ions cardiac and smooth muscle. The mechanism of antihypertensive action of Cab is due to a direct relaxant effect on vascular smooth muscle.In angina, Cab reduces total ischaemic burden by dilating peripheral arterioles and probably the main coronary arteries and coronary arteries. After oral administration of therapcutic doses, Cab is well absorbed with peak blood levels between 6-12 hours post dose. The terminal plasma elimination half-life is about 35-50 hours and is consistent with once-daily administration. Steady-state plasma levels are reached after 7-8 days.
Uses Hypertension: Cab is indicated for the first line treatment of hypertension and can be used as sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of Cab which has been used in combination with a thiazide diuretic, beta-adrenoceptor blocking agent or an angiotensin converting inhibitor. Chronic stable angina: Cab is indicated for the first line therapy of stable angina. It may be used in combination with other antianginal drugs. Vasospastic angina: Cab is indicated where clinical presentation suggests a possible vasospastic angina. Cab may be used as monotherapy, or in combination with other antianginal drugs in patients with angina that is refractory to nitrates and / or adequate doses of beta-adrenoceptor blocking agents.
No Data
For both hypertension and angina, the recommended initial dose is 5mg Cab orally once daily which may be increased to a maximum dose of 10mg depending on the patient's response. Small, fragile or elderly individuals or patients with hepatic insufficiency may be started on 2.5mg once daily dose and this dose may be used when adding Cab to other antihypertensive therapy. The recommended dose for chronic stable or vasospastic angina is 5-10mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Paediatric Use Since there is no clinical experience in patients of less than 18 years, use in children is not currently recommended.
Strong CYP3A4 inhibitors (ketoconazole, itraconazole, diltiazem) increase amlodipine systemic exposure; simvastatin exposure is increased (limit simvastatin to 20 mg daily); tacrolimus and cyclosporine blood levels may increase; CYP3A4 inducers (rifampin, carbamazepine) decrease amlodipine efficacy.
Hypersensitivity to amlodipine, other dihydropyridines, or any of the excipients; severe hypotension; cardiogenic shock.
Common: Headache, peripheral edema, fatigue, skin erythema, nausea, flushing, dizziness.
Overdose
There is no well documented experience with Cab overdosage. Since Amlodipine absorption is slow, gastric lavage may be worthwhile in some cases. Gross overdosage could result in excessive peripheral vasodilation with subsequent marked and probably prolonged systemic hypotension. Clinically significant hypotension due to Cab overdosage calls for active cardiovascular support including monitoring of cardiac and respiratory function, evaluation of extremities and attention to circulating fluid volume and urine output. A vasoconstrictor agent may be helpful in restoring vascular tone and blood pressure provided that there is no contraindication to its use. Since amlodipine is highly protein-bound, dialysis isunlikely to be of benefit.
Category B. Safety in pregnancy has not been established; discontinue upon confirmation of pregnancy. Lactation: Inhibits lactation (dopamine agonist); contraindicated in nursing mothers.
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.