Sampine 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 besylate

Indications/Uses

HTN & chronic stable angina pectoris.

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Dosage/Direction for Use

Adult Individualized dosage. Initially 2.5 mg once daily. Max: 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 & dihydropyridine derivatives. Severe hypotension; shock (including cardiogenic shock); obstruction of left ventricular outflow tract (eg, high grade aortic stenosis); haemodynamically unstable heart failure after acute MI.

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Special Precautions

Hypertensive crisis. Heart failure; increased risk of future CV events & mortality in patients w/ CHF. Avoid in patients susceptible to malignant hyperthermia & in management of malignant hyperthermia due to risk of hyperkalemia. Minor or moderate influence on the ability to drive & use machines. Patients w/ mild to moderate hepatic impairment (start w/ a lower dose); slowly titrate dose & carefully monitor patients w/ severe hepatic impairment. Pregnancy & lactation. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Constipation; dizziness, headache; orthostatic hypotension, pedal edema, flushing; fatigability.

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Drug Interactions

Increased exposure w/ concomitant use of strong or moderate CYP3A4 inhibitors [protease inhibitors, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil or diltiazem]. May decrease plasma conc w/ CYP3A4 inducers (rifampicin, Hypericum perforatum). Bioavailability may be increased w/ grapefruit juice resulting in increased BP lowering effects. Potentially, lethal ventricular fibrillation & CV collapse associated w/ hyperkalemia after co-administration w/ dantrolene IV. Additive BP-lowering effects w/ other antihypertensives. Limit simvastatin dose to 20 mg daily in concomitant use.

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Storage

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Description

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Action

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MIMS Class

Calcium Antagonists

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

POM

Presentation/Packing

Form

Sampine tab 2.5 mg

Packing/Price

2 × 14's

Form

Sampine tab 5 mg

Packing/Price

2 × 14's

Sampine

amlodipine

Manufacturer:

Kusum

Distributor:

JDS