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Amlodisan

Amlodisan

amlodipine

Manufacturer:

Hiral Labs

Distributor:

Sannovex
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, may be increased to a max dose of 10 mg depending on individual patient's response. Childn & adolescent 6-17 yr HTN 2.5 mg once daily as starting dose, 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 outflow tract of left ventricle eg, high grade aortic stenosis. Haemodynamically unstable heart failure after acute MI.
Special Precautions
Safety & efficacy of amlodipine in hypertensive crisis has not been established. Caution in patients w/ cardiac failure; may increase risk of future CV events & mortality. Cautious dose selection & start at the lower end of dosing range in patients w/ mild to moderate hepatic impairment. Initiate treatment at the lowest dose & slowly titrate in patients w/ severe hepatic impairment. Use in pregnancy is only recommended when there is no safer alternative. Continue/discontinue breast-feeding or continue/discontinue therapy during lactation. No data are available in childn <6 yr. Increase dose w/ care in elderly.
Adverse Reactions
Somnolence, dizziness, headache (especially at the beginning of treatment); palpitations; flushing; abdominal pain, nausea; ankle swelling; oedema, fatigue.
Drug Interactions
Increased exposure w/ strong or moderate CYP3A4 inhibitors [eg, PIs, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil or diltiazem]. Possible decreased plasma conc w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Increased bioavailability w/ grapefruit or grapefruit juice. Additive BP-lowering effects w/ other antihypertensives. Due to risk of hyperkalemia, avoid co-administration of Ca channel blockers eg, amlodipine in patients susceptible to malignant hyperthermia & in the management of malignant hyperthermia (dantrolene infusion).
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
Amlodisan tab 10 mg
Packing/Price
100's
Form
Amlodisan tab 5 mg
Packing/Price
100's
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