Amvasc BE Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Amlodipine besilate

Indications/Uses

Treatment of HTN & prophylaxis of angina.

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Dosage/Direction for Use

Adult 5 mg once daily. Max: 10 mg once daily. HTN, stable angina & Prinzmetal's angina 5 mg once daily, increased to 10 mg once daily if necessary. Chronic stable or vasospastic angina 5-10 mg once daily, w/ lower dose (5 mg) suggested in the elderly & patients w/ hepatic impairment. CAD 5-10 mg once daily. Childn 6-17 yr 2.5-5 mg once daily.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity to amlodipine besilate or dihydropyridines. Severe hypotension; shock including cardiogenic shock; obstruction of the outflow tract of the left ventricle eg, high grade aortic stenosis; hemodynamically unstable heart failure after MI.

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Special Precautions

Worsening angina & acute MI may develop, particularly in patients w/ severe obstructive CAD after initiating or increasing dose. Possible symptomatic hypotension, particularly in patients w/ severe aortic stenosis. Patients w/ heart failure. Hepatic impairment. May have minor or moderate influence on ability to drive & use machines. Pregnancy. Not recommended during lactation. Childn <6 yr. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, edema & fatigue.

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Drug Interactions

Bioavailability may be increased resulting in increased BP lowering effects w/ grapefruit juice. Increased exposure to simvastatin. Plasma conc may be increased w/ strong or moderate CYP3A4 inhibitors eg, PIs (eg, ritonavir), azole antifungals (eg, ketoconazole, itraconazole), macrolides (eg, erythromycin, clarithromycin), verapamil or diltiazem. Plasma conc may be lowered w/ CYP3A4 inducers eg, rifampicin, St. John's wort. Increased trough levels of ciclosporin. May increase blood levels of tacrolimus.

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Storage

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Description

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Action

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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.

Regulatory Classification

Presentation/Packing

Form

Amvasc BE tab 10 mg

Packing/Price

50's (P33.92/tab)

Form

Amvasc BE tab 5 mg

Packing/Price

50's (P19.79/tab)

Amvasc BE

amlodipine

Manufacturer:

Therapharma

Distributor:

United Lab