Norvasc Dosage & Drug Information

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 besilate

Indications/Uses

1st-line treatment of HTN & sole agent to control BP in majority of patients. Reduce risk of fatal CHD, non-fatal MI & stroke. Reduce 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 &/or vasospasm/vasoconstriction of coronary vasculature. Monotherapy or in combination w/ other anti-anginal drugs in patients w/ angina that is refractory to nitrates &/or adequate doses of β-blockers.

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Dosage/Direction for Use

HTN 2.5-10 mg once daily. Angina Initially 5 mg once daily, may be increased to a max of 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 dihydropyridines.

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Special Precautions

Increased risk of pulmonary edema. Hepatic impairment. Pregnancy & lactation. Childn <6 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headaches, dizziness; abdominal pain. Somnolence; palpitations; flushing; nausea; edema, fatigue. Ped: Vasodilatation; epistaxis; asthenia.

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Drug Interactions

Increase in exposure to simvastatin. Increase in amlodipine systemic exposure w/ diltiazem. May increase exposure of mTOR inhibitors (eg, sirolimus, temsirolimus, everolimus). Increased bioavailability w/ grapefruit or grapefruit juice. May increase plasma conc w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir). Increased risk of hypotension w/ clarithromycin. May decrease plasma conc w/ CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). May affect the trough conc of cyclosporin in renal transplant patients. Increased risk of tacrolimus blood levels.

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Storage

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Description

View Norvasc description for details of the chemical structure and excipients (inactive components).

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

Presentation/Packing

Form

Norvasc tab 10 mg

Packing/Price

100's (P3,657.5/pack)

Form

Norvasc tab 2.5 mg

Packing/Price

100's;30's

Form

Norvasc tab 5 mg

Packing/Price

100's (P2,170.75/pack)

Norvasc

amlodipine

Manufacturer:

Pfizer USA

Distributor:

Viatris