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Ambesyl

Ambesyl

amlodipine

Manufacturer:

Sandoz

Distributor:

Sandoz
Concise Prescribing Info
Contents
Amlodipine besilate
Indications/Uses
HTN, chronic stable angina pectoris & vasospastic (Prinzmetal's) angina.
Dosage/Direction for Use
Adult HTN, angina Initially 5 mg once daily. Max daily dose: 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 amlodipine & dihydropyridines. Severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle (eg, high grade aortic stenosis), haemodynamically unstable heart failure after acute MI.
Special Precautions
Hypertensive crisis. Patients w/ heart failure & CHF. Hepatic & renal impairment. Minor or moderate influence on the ability to drive & use machines. Pregnancy & lactation. Childn <6 yr. Elderly.
Adverse Reactions
Oedema. Somnolence, dizziness, headache (especially at beginning of treatment); visual disturbance (including diplopia); palpitations; flushing; dyspnoea; abdominal pain, nausea, dyspepsia, altered bowel habits (including diarrhoea & constipation); ankle swelling, muscle cramps; fatigue, asthenia.
Drug Interactions
Increased exposure & risk of hypotension w/ strong or moderate CYP3A4 inhibitors (PIs, azole antifungals, macrolides eg, erythromycin or clarithromycin, verapamil or diltiazem). Lower plasma conc w/ strong CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Increased BP lowering effects w/ grapefruit or grapefruit juice & medicinal products w/ antihypertensive properties. Risk of hyperkalemia w/ dantrolene infusion. Increase tacrolimus blood levels. May increase exposure of mTOR inhibitors (eg, sirolimus, temsirolimus & everolimus). Increase trough conc of ciclosporin in renal transplant patients. Increased exposure w/ 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
Ambesyl tab 10 mg
Packing/Price
100's;30's (P401.25/pack)
Form
Ambesyl tab 5 mg
Packing/Price
100's;30's (P215.25/pack)
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