Amlodipine Sandoz

Amlodipine Sandoz

amlodipine

Manufacturer:

Sandoz

Distributor:

Zuellig
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. Paed patient 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 or to dihydropyridine derivatives. 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
Patients w/ heart failure; hepatic impairment; elderly. Minor or moderate influence on the ability to drive & use machines. Safety & efficacy in hypertensive crisis has not been established. Pregnancy & lactation.
Adverse Reactions
Somnolence, dizziness, headache (especially at the beginning of treatment), palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema, fatigue. Visual disturbance (including diplopia), dyspnoea, dyspepsia, altered bowel habits (including diarrhoea & constipation), muscle cramps, asthenia.
Drug Interactions
Increased risk of hypotension w/ strong or moderate CYP3A4 inhibitors (eg, PIs, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem). Increased bioavailability w/ grapefruit or grapefruit juice. Varied effect on plasma conc w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Due to risk of hyperkalaemia, avoid co-administration of Ca channel blockers in patients susceptible to malignant hyperthermia & in the management of malignant hyperthermia (dantrolene infusion). Additive effect w/ other antihypertensives. Increased exposure of simvastatin. Risk of increased blood levels of tacrolimus. May increase exposure of mTOR inhibitors. Increased trough conc of ciclosporin in renal transplant patients.
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
Amlodipine Sandoz tab 10 mg
Packing/Price
30's
Form
Amlodipine Sandoz tab 5 mg
Packing/Price
30's
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