Sampine

Sampine

amlodipine

Manufacturer:

Kusum

Distributor:

JDS
Concise Prescribing Info
Contents
Amlodipine besylate
Indications/Uses
HTN & chronic stable angina pectoris.
Dosage/Direction for Use
Adult Individualized dosage. Initially 2.5 mg once daily. Max: 5 mg once daily.
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.
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.
Adverse Reactions
Constipation; dizziness, headache; orthostatic hypotension, pedal edema, flushing; fatigability.
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.
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.
Presentation/Packing
Form
Sampine tab 2.5 mg
Packing/Price
2 × 14's
Form
Sampine tab 5 mg
Packing/Price
2 × 14's
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