Drug reference

Amlodipine

Calcium Channel Blocker · Antihypertensive

Also known as Amlodipine besylate, Amlodipine maleate, Amlodipine camsylate

START

5 mg PO once daily

TYPICAL MAX

10 mg/day

STOP IF

Severe aortic stenosis · cardiogenic shock

WATCH

Peripheral edema · gingival hyperplasia

CDSCO approvedSchedule HJan AushadhiNPPA price-controlledATC C08CA01

Dose laddermg/d

Renal dose adjustmenteGFR mL/min/1.73m²

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours

ONSET: 6h · BP effect onset
PEAK: 8h · Cmax
t½: 1.5d · plasma t½ (long)
DURATION: 1d · once-daily dosing window

EXCRETION

Hepatic CYP3A4 · 10% renal unchanged

route + CYP

INTERACTIONS

12 major

SEVERE in our sources

PREGNANCY

Category C — use if maternal benefit > fetal risk

FDA category + note

Top interactionssee all 12 →

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Available in India

552 branded formulations and 2,177 fixed-dose combinations. Look up specific brands in the Drugs workspace.

Jan Aushadhi — generic available at GoI pharmacies

Mechanism

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Its primary effect is direct vasodilation of peripheral arterioles and coronary arteries, leading to a reduction in peripheral vascular resistance and myocardial oxygen demand, thus lowering blood pressure and relieving angina.

Indications

Hypertension (as monotherapy or in combination)Chronic stable anginaVasospastic angina (Prinzmetal's or variant angina)Coronary artery disease (reduce risk of hospitalization for angina and procedures)PAH patients with positive vasodilator testingHypertensionAnginaAngina pectoris

Dosing

Adult: Hypertension/Angina: Initially 5 mg orally once daily. May be increased to a maximum of 10 mg once daily, usually after 7-14 days. Some patients (e.g., frail, elderly, or those with hepatic impairment) may start with 2.5 mg once daily.
Pediatric: Children 6-17 years (Hypertension): Initially 2.5 mg orally once daily. May be increased to 5 mg once daily after 4 weeks if blood pressure not controlled.
Renal adjustment: No dosage adjustment is required for patients with renal impairment.
Hepatic adjustment: In patients with hepatic impairment, initiate amlodipine at 2.5 mg orally once daily. Dose titration should be done slowly with careful monitoring.
Geriatric: Initiate with 2.5 mg orally once daily. Increase dose slowly with careful monitoring.
Max dose: 10 mg orally once daily

Pharmacokinetics

Onset

6-12 hours (antihypertensive effect)

Peak effect

6-12 hours (plasma concentration); 6-9 hours (blood pressure reduction)

Duration

24 hours

Half-life

30-50 hours

Bioavailability

64-90% (oral)

Protein binding

Approximately 97.5%

Metabolism

Extensively hepatic, primarily via CYP3A4 to inactive metabolites

Excretion

Primarily renal (approximately 60% as inactive metabolites, 10% as unchanged drug); 20-25% via feces

Contraindications

Hypersensitivity to amlodipine or other dihydropyridines
Cardiogenic shock
Severe aortic stenosis (relative)
Unstable angina (acute phase, relative)

Side effects

Common

Peripheral edema (dose-dependent)HeadacheFlushingPalpitationsFatigue/AstheniaDizzinessNauseaAbdominal painSomnolencesystemic hypotensionedemafatiguePeripheral edema (ankle edema)less peripheral edema (for S-amlodipine)palpitation (largely avoided)flushing (largely avoided)headache (largely avoided)postural dizziness (largely avoided)Gingival hyperplasia

Serious

Symptomatic hypotension
Bradycardia
Angina exacerbation or myocardial infarction (rare, especially during initiation or dose increase)
Hepatic enzyme elevations/Hepatitis (rare)
Gingival hyperplasia (rare, chronic use)
Erythema multiforme/Stevens-Johnson syndrome (rare)
Angioedema (rare)
worsening V/Q mismatch and hypoxemia (due to reduced hypoxic pulmonary vasoconstriction)
deterioration of RV function

Pregnancy & lactation

Pregnancy

Category C — use if maternal benefit > fetal risk

Lactation

Amlodipine is excreted in human milk. The effect of amlodipine on the breastfed infant is unknown. Use with caution during breastfeeding; monitor infants for adverse effects.