Amlodipine Besylate

Drug Name

Amlodipine besylate [USAN:USP]

DESCRIPTION

Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.

CLINICAL PHARMACOLOGY

Mechanism of ActionAmlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. 

CLINICAL STUDIES

Effects in HypertensionAdult PatientsThe antihypertensive efficacy of amlodipine has been demonstrated in a total of 15 double-blind, placebo-controlled, randomized studies involving 800 patients on amlodipine and 538 on placebo. Once daily administration produced statistically significant placebo-corrected reductions in supine and standing blood pressures at 24 hours postdose, averaging about 12/6 mmHg in the standing position and 13/7 mmHg in the supine position in patients with mild to moderate hypertension. Maintenance of the blood pressure effect over the 24-hour dosing interval was observed, with little difference in peak and trough effect. Tolerance was not demonstrated in patients studied for up to 1 year. The 3 parallel, fixed dose, dose response studies showed that the reduction in supine and standing blood pressures was dose-related within the recommended dosing range. Effects on diastolic pressure were similar in young and older patients. The effect on systolic pressure was greater in older patients, perhaps because of greater baseline systolic pressure. Effects were similar in black patients and in white patients.

INDICATIONS AND USAGE

1.  Hypertension - Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

CONTRAINDICATIONS

Amlodipine is contraindicated in patients with known sensitivity to amlodipine.

WARNINGS

Increased Angina and/or Myocardial Infarction - Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed documented increased.

PRECAUTIONS

General - Since the vasodilation induced by amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration.

ADVERSE REACTIONS

Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine was well-tolerated at doses up to 10 mg

OVERDOSAGE

Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses

DOSAGE AND ADMINISTRATION

Adults - The usual initial antihypertensive oral dose of amlodipine is 5 mg once daily with a maximum dose of 10 mg once daily.

HOW SUPPLIED

Amlodipine besylate tablets, 2.5 mg are white to off-white colored, diamond-shaped, flat-faced, beveled-edge tablets, debossed with 568 on one side and plain on the other side

Synonyms

Synonyms of Amlodipine besylate [USAN:USP]

• Amcard
• Amdepin
• Amdipin
• Amlodin
• Amlodipine benzenesulfonate
• Amlodipine besilate
• Amlodipine besylate
• Amlogard
• Amlopin
• Amlosyn
• Antacal
• Astudar
• Cardiorex
• Cordarene
• Istin
• Monopina
• Myodura
• Norlopin
• Norvas
• Norvasc
• Norvask
• Pelmec
• Stamlo
• Tensivask
• Terloc
• UK 48340-26
• UK-48,340-26
• UNII-864V2Q084H

• Dailymed label info on Amlodipine Besylate
• FDA Amlodipine Besylate

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