MEDIVASC
(Amlodipine Besilate)
MEDIVASC is THE IDEAL AMLODIPINE, effective yet affordable
FORMULATION:
Each tablet contains:
Amlodipine (as besilate) …………………………………. 5 mg/ 10mg
PHARMACOKINETICS:
Amlodipine is well absorbed following oral administrations with peak blood concentrations occurring after 6 to 12 hours. The bioavailability is about 60-65%. Amlodipine is reported to be about 97.5% bound to plasma proteins. It has a prolonged terminal elimination half-life of 35 to 50 hours and steady state plasma concentrations are not achieved until after 7 to 8 days of administration. Amlodipine is extensively metabolized in the liver; metabolites are mostly excreted in the urine together with less that 10% of a dose as unchanged drug.
INDICATIONS:
Amlodipine is used in the management of hypertension and angina pectoris. It may be used in combination with other antihypertensive and anti-anginal drugs.
DOSAGE AND ADMINISTRATION:
The usual initial antihypertensive dose of Amlodipine is 5 mg once daily with a maximum dose of 10 mg once daily.
Small, fragile or elderly individuals or patients with hepatic insufficient may be started on 2.5 mg once daily and this 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.
The recommended dose for chronic stable or vasospastic angina is 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.
Amlodipine is given by mouth as the besilate, but doses are usually expressed in terms of the base.
PRECAUTIONS:
Amlodipine should be used with caution in patients with hypotension, in patients whose cardiac reserve is poor, and those with heart failure since deterioration of heart failure has been noted. Amlodipine should not be used in cardiogenic shock, in patients who have recently suffered a myocardial infarction, or in acute unstable angina. Amlodipine should not be used to treat and angina attack in chronic stable 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 ischaemic pain following its administration and should be avoided in pregnancy.
CONTRAINDICATIONS:
Amlodipine is contraindicated in patients with known sensitivity to amlodipine. Cardiogenic shock, unstable angina, significant aortic stenosis and obesity.
ADVERSE EFFECTS:
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, hepatitis, jaundice, cholestasis, gingival hyperplasia, myocardial infarction, arrhythmia, vasculitis, hyperglycaemia, thrombocytopenia, angioedema and urticaria.
OVERDOSAGE:
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 intravenously. If hypotension persists, intravenous administration of a sympathomimetic agent such as isoprenaline, dopamine or noradrenergic (norepinephrine) may be given. Dialysis is not useful as amlodipine is highly protein bound.
INTERACTIONS:
Amlodipine may enhance the antihypertensive effects of other hypertensive drugs such as beta 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.
CAUTION:
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
AVAILABILITY:
Amlodipine 5 mg Tablet: Blister Pack x 10’s (Box of 100’s)
Amlodipine 10 mg Tablet: Blister Pack x 10’s (Box of 100’s)
STORE AT TEMPERATURES NOT EXCEEDING 30°C.
Manufactured by:
HIZON LABORATORIES, INC.
Assumption Road, Sumulong Highway,Antipolo City
Distributed by:
METRO DRUG INC.
Mañalac Avenue, Bagumbayan,Taguig City
Under the Authority of:
MEDLINK PHARMA PHILS., INC.
Suite 2002 20th Floor, Prestige Tower
Emerald Ave., Ortigas Center,Pasig City
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