Aforbes

Aforbes

amlodipine

Manufacturer:

Merck

Distributor:

Merck
Concise Prescribing Info
Contents
Amlodipine besilate
Indications/Uses
HTN, as monotherapy or in combination w/ thiazide diuretic, β-adrenoceptor blocking agent or ACE inhibitor. 1st-line treatment of myocardial ischemia due to fixed obstruction (stable angina) &/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of the coronary vasculature, as monotherapy or in combination w/ other anti-anginal drugs in patients w/ angina refractory to nitrates &/or adequate doses of β-blockers.
Dosage/Direction for Use
Adult HTN & angina Initially 5 mg once daily. Max: 10 mg. Childn & adolescent 6-17 yr HTN Initially 2.5 mg once daily, up-titrated to 5 mg once daily if BP goal is not achieved after 4 wk.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to dihydropyridine derivatives or amlodipine. 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 acute MI.
Special Precautions
Hypertensive crisis. CHF. Impaired hepatic & renal function. Amlodipine is not dialyzable. Severe hepatic impairment. Minor or moderate influence on the ability to drive & use machines. Amlodipine is excreted in human milk. Pregnancy & lactation. Childn <6 yr. Elderly.
Adverse Reactions
Edema. Somnolence, dizziness, headache (especially at the beginning of the treatment); visual disturbance (including diplopia); palpitations; flushing; dyspnea; abdominal pain, nausea, dyspepsia, altered bowel habits (including diarrhea & constipation); ankle swelling, muscle cramps; fatigue, asthenia.
Drug Interactions
May increase risk of hypotension w/ strong or moderate CYP3A4 inhibitors (PIs, azole antifungals, macrolides eg, erythromycin or clarithromycin, verapamil or diltiazem). Monitor BP & dose regulations w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Increased BP lowering effects w/ grapefruit or grapefruit juice. Risk of hyperkalemia w/ dantrolene. Increased blood levels of tacrolimus. Increased exposure of mTOR inhibitors (eg, sirolimus, temsirolimus & everolimus). Increased variable trough conc of cyclosporine in renal transplant patients. Increased exposure to simvastatin.
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.
Presentation/Packing
Form
Aforbes tab 10 mg
Packing/Price
100's
Form
Aforbes tab 5 mg
Packing/Price
100's
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