Norvask

Norvask

amlodipine

Manufacturer:

Pfizer
Concise Prescribing Info
Contents
Amlodipine besylate
Indications/Uses
1st-line treatment of HTN & can be used as a sole agent to control BP in the majority of patients. Patients not adequately controlled on a single antihypertensive agent (other than amlodipine) may benefit from the addition of amlodipine, which has been used in combination w/ thiazide diuretic, α blockers, β adrenoceptor blocking agent, or an ACE inhibitor. 1st-line treatment of myocardial ischemia whether due to fixed obstruction (stable angina) &/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) or coronary vasculature. May be used where the clinical presentation suggests a possible vasospastic/vasoconstriction has not been confirmed. As monotherapy or in combination w/ other antianginal drugs in patients w/ angina that is refractory to nitrates &/or adequate doses of β-blockers.
Dosage/Direction for Use
HTN & angina Initially 5 mg once daily which may be increased to max dose of 10 mg. Childn 6-17 yr 2.5-5 mg once daily.
Administration
May be taken with or without food.
Contraindications
Known hypersensitivity to dihydropyridines, amlodipine, or any of the inert ingredients.
Special Precautions
Heart failure. Prolonged t½ in patients w/ impaired liver function. Pregnancy & lactation.
Adverse Reactions
Headache, dizziness, somnolence; palpitation; flushing; abdominal pain, nausea; oedema, fatigue. Ped patients (6-17 yr): Vasodilatation; epistaxis; asthenia.
Drug Interactions
Increased exposure of simvastatin. Increased bioavailability w/ grapefruit or grapefruit juice. CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir) may increase plasma conc of amlodipine. Increased risk of hypotension w/ clarithromycin. May decrease plasma conc of amlodipine w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Cyclosporine, tacrolimus. Amlodipine may increase exposure of mTOR inhibitors.
MIMS Class
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
Norvask tab 10 mg
Packing/Price
3 × 10's (Rp598,414/boks)
Form
Norvask tab 5 mg
Packing/Price
10 × 10's (Rp1,113,044/boks);3 × 10's (Rp333,912/boks)
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