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Norvasc

Norvasc

amlodipine

Manufacturer:

Pfizer Global Supply Japan
/
Viatris Pharmaceuticals

Distributor:

Viatris
Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing
Concise Prescribing Info
Contents
Amlodipine
Indications/Uses
1st-line treatment of HTN. Reduces risk of fatal CHD, non-fatal MI & stroke. Reduces risk of coronary revascularization & the need for hospitalization due to angina in patients w/ CAD. 1st-line treatment of myocardial ischemia, whether due to fixed obstruction (stable angina) &/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of coronary vasculature.
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Dosage/Direction for Use
Adult & elderly HTN 2.5-10 mg once daily. Angina Initially 5 mg once daily, may be increased to max 10 mg. CAD 5-10 mg once daily. Childn 6-17 yr 2.5-5 mg once daily.
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Overdosage
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Administration
May be taken with or without food.
Contraindications
Hypersensitivity to amlodipine or dihydropyridines.
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Special Precautions
Increased reports of pulmonary edema w/ no significant differences in the incidence of worsening heart failure in patients w/ NYHA class III & IV heart failure of non-ischemic etiology. Patients w/ impaired hepatic function. Pregnancy & lactation. Effect on BP in childn <6 yr is not known.
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Use In Pregnancy & Lactation
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Adverse Reactions
Headaches, dizziness; abdominal pain. Somnolence; palpitations; flushing; nausea; edema, fatigue. Childn (6-17 yr): Vasodilatation; epistaxis; asthenia.
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Drug Interactions
Increased exposure to simvastatin. Increased amlodipine systemic exposure w/ diltiazem in elderly hypertensive patients. Bioavailability may be increased w/ grapefruit or grapefruit juice. Plasma conc may be increased w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir). Increased risk of hypotension w/ clarithromycin. Plasma conc may be decreased w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). May affect trough conc of cyclosporin in renal transplant patients. Risk of increased tacrolimus blood levels. May increase exposure of mTOR inhibitors (eg, sirolimus, temsirolimus, everolimus).
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Storage
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Description
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Action
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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.
Regulatory Classification
Rx
Presentation/Packing
Form
Norvasc tab 10 mg
Packing/Price
100's (P36.5/tab)
Form
Norvasc tab 2.5 mg
Packing/Price
30's (P9.5/tab);100's (P9.5/tab)
Form
Norvasc tab 5 mg
Packing/Price
100's (P21.75/tab)