Prosp Pharma
Full Prescribing Info
Amlodipine besylate.
Each tablet contains Amlodipine besylate 6.94 mg equivalent to Amlodipine 5 mg.
Pharmacology: Pharmacodynamics: Amlodipine is a calcium channel blocker (slow channel blockers or calcium antagonist) which inhibits the movement of calcium ions across cardiac and vascular smooth muscle. The effects on the cardiovascular system include depression of mechanical contraction of myocardial and smooth muscle as well as depression of both impulse formation and conduction velocity. Amlodipine dilates the coronary arteries and arterioles in normal and ischemic regions and inhibits coronary artery spasm and vasospastic (Prinzmetal's or variant) angina. This reduces myocardial energy consumption and oxygen requirements and probably accounts for efficacy in chronic stable angina. The drug reduces arterial blood pressure at rest and with exercise by dilating peripheral arterioles and reducing total peripheral resistance (afterload).
Pharmacokinetics: Absorption/Distribution: Amlodipine is slowly and almost completely absorbed from the gastrointestinal tract, absorption not affected by food. Highly protein bound. Absolute bioavailability is approximately 64-90%. Time to peak concentration is about 6-12 hours. 
Metabolism/Excretion: Amlodipine undergoes slow but extensive hepatic metabolism producing non-pharmacologically active metabolites. The elimination half-life is about 30-65 hours. Amlodipine is excreted by renal (about 59-62%) and biliary/fecal (about 20-25%).
For the treatment of hypertension, chronic stable angina, and confirmed or suspected vasospastic angina (Prinzmetal's or variant angina). Amlodipine may be used alone or in combination with other antihypertensive or other antianginal drugs.
Dosage/Direction for Use
Hypertension: The usual initial antihypertensive oral dose of amlodipine is 5 mg once daily with a maximum dose of 10 mg once daily. The elderly or patients with hepatic insufficiency may be started on 2.5 mg once daily, and this dose may be used when adding amlodipine to other antihypertensive therapy. Dosage should be adjusted according to each patient’s need. The titration should proceed over 7 to 14 days so that the physician can fully assess the patient’s response to each dose level.
Chronic stable or vasospastic angina: The recommended dose is 5 to 10 mg with the lower dose suggested in the elderly and in patients with hepatic insufficiency.
Mode of Administration: AMPINE-5 is administered orally once daily without regard to meals.
Overdosage could result in excessive peripheral vasodilatation with subsequent marked and probably prolonged systemic hypotension. Clinically significant hypotension calls for active cardiovascular support including monitoring of cardiac and respiratory function, elevation of extremities, attention to circulating fluid volume and urine output, or vasoconstrictor may be used.
If the patient is seen shortly after oral ingestion, employ emetics or lavage and cathartics. Treatment is supportive. General management of calcium channel blocker overdosage is shown as follows. (See Table.)

Click on icon to see table/diagram/image
Patients with known hypersensitivity to amlodipine or any component of the formulation.
Special Precautions
Use in patients with congestive heart failure: Amlodipine should be used with caution in patient with congestive heart failure because of the slight risk of negative inotropic effect.
Use in patients with hepatic function impairment: Clearance of amlodipine may be reduced since it undergoes extensive hepatic metabolism, elimination half-life may be prolonged. The drug should therefore be administered with caution in these patients.
Use in Elderly: The half-life of amlodipine may be increased in the elderly. These patients may be more sensitive to the hypotensive effects of amlodipine and may require a lower initial dose.
Use In Pregnancy & Lactation
Pregnancy: Category C. There are no well-controlled studies in pregnant woman. Use during pregnancy only when clearly needed and when potential benefits outweigh potential hazards to the fetus.
Lactation: It is not known whether amlodipine is excreted in breast milk. Discontinue nursing while taking amlodipine.
Adverse Reactions
Adverse effects need medical attention.
Adverse effects with more frequent incidence were edema peripheral, abdominal pain, flushing, headache and somnolence.
Adverse effects with less frequent incidence were dizziness, palpitations, fatigue, rash, pruritus, male sexual dysfunction, nausea, dyspepsia, muscle cramps, weakness, dyspnea, pulmonary edema.
Rare adverse effects were angina, bradycardia, hypotension, jaundice, orthostatic hypotension.
Drug Interactions
Anesthetics, hydrocarbon inhalation: Concurrent use with amlodipine may produce additive hypotension; although calcium channel blocking agents may be useful to prevent supraventricular tachycardias, hypertension, or coronary spasm during surgery, caution is recommended during use.
Anti-inflammatory drugs; nonsteroidal (NSAIDs), especially indomethacin: NSAIDs may reduce the antihypertensive effects of amlodipine by inhibiting renal prostaglandin synthesis and/or causing sodium and fluid retention.
Beta-adrenergic blocking agents: Although reports of adverse effects resulting from concurrent use of amlodipine with the beta-adrenergic blocking agents are lacking, caution is recommended given the similarity of amlodipine to nifedipine; concurrent use of nifedipine with the beta-adrenergic blocking agents may produce excessive hypotension and, in rare cases, may increase the possibility of congestive heart failure.
Estrogens: Estrogen-induced fluid retention may tend to increase blood pressure; the patient should be carefully monitored to confirm that the desired effect is being obtained.
Hypotension-producing medications: Antihypertensive effects may be potentiated when amlodipine is used concurrently with hypotension-producing medications; although some antihypertensive and/or diuretic combinations are frequently used for therapeutic advantage, when any of these medications are used concurrently, dosage adjustments may be necessary.
Lithium: Concurrent use with amlodipine may potentially result in neurotoxicity in the form of nausea, vomiting, diarrhea, ataxia, tremors, and/or tinnitus, caution is recommended.
Sympathomimetics: Concurrent use may reduce antihypertensive effects of amlodipine; the patient should be carefully monitored to confirm that the desired effect is being obtained.
Highly protein bound drugs: Caution is advised when using concurrently with amlodipine, changes of the unbound serum concentration of those drugs may occur.
Store below 30°C and protect from light.
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 (white, oval, biconvex, with cut-edge at both ends. One side engraved with "MLM" and the other side engraved with "V" and "5" on each part of the bisecting line) x 100 x 10's.
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