Amlodipine

Treatment of hypertension, alone or with other antihypertensives. Coronary indications include chronic stable angina and vasospastic angina, alone or with other antianginal medicines.

In angiographically documented coronary artery disease without heart failure or ejection fraction below 40%, Norvasc is indicated to reduce hospitalization for angina and the risk of coronary revascularization. This indication does not establish a mortality benefit.

Regular therapy helps prevent angina but does not relieve an attack already in progress. Follow the prescribed rescue plan. This profile covers single-ingredient oral amlodipine; combination products require their own labels.

2.5–5 mg orally once daily. Doses above 5 mg daily have not been studied for this pediatric indication. Effects below age 6 are not established; the adult 10 mg maximum is not a pediatric recommendation.

Katerzia suspension and Norliqva solution each contain 1 mg/mL and have formulation-specific directions. Measure the prescribed dose with an oral syringe or dosing cup, never a household spoon. Shake Katerzia before every dose. Their storage requirements differ; see Product identification.

Renal impairment does not significantly alter amlodipine pharmacokinetics; the usual initial dose can be used, subject to the patient’s other risks. Hepatic impairment reduces clearance: use a lower starting dose when appropriate and titrate slowly, especially in severe impairment.

Known sensitivity to amlodipine is a contraindication. Review the exact formulation’s ingredients when an excipient allergy is suspected.

The reviewed single-ingredient Norvasc label has no boxed warning. Its warnings about hypotension, coronary symptoms, and hepatic impairment still apply.

Peripheral edema is dose related. Dizziness, flushing, and palpitations can also occur; fatigue, nausea, abdominal pain, and somnolence were reported in trials. Rare postmarketing reports include jaundice or elevated liver enzymes; report jaundice promptly. Trial rates and voluntary reports do not establish an individual patient’s risk.

Overdose may produce severe, prolonged hypotension and requires immediate medical assessment. Call U.S. Poison Control at 1-800-222-1222; call 911 for collapse, seizure, difficulty breathing, or inability to awaken.

• Moderate or strong CYP3A inhibitors can increase exposure: monitor hypotension and edema; a lower amlodipine dose may be needed.
• CYP3A inducers: monitor blood pressure closely because the quantitative interaction is uncertain.
• Simvastatin: limit to 20 mg daily with amlodipine.
• Cyclosporine or tacrolimus: check trough levels frequently and adjust the immunosuppressant as needed.
• Sildenafil: monitor for additive hypotension.

Human pregnancy data are insufficient to define risks of birth defects or miscarriage. Poorly controlled maternal hypertension also carries risk. Review treatment with the obstetric clinician rather than changing therapy without a plan.

Amlodipine enters milk. The label reports limited infant observations without adverse effects and no information on milk production. Current LactMed considers milk levels usually low and says required maternal treatment is not a reason to stop breastfeeding. Evidence remains limited; individualize care for the infant.

Pediatric hypertension dosing is established for ages 6–17, with a studied limit of 5 mg daily. Elderly patients may clear amlodipine more slowly; start cautiously at the lower end and reassess blood pressure, symptoms, and edema.

Hepatic insufficiency increases exposure and may require 2.5 mg initially for hypertension with slow titration. Renal failure alone does not require the same adjustment. Other clinical factors can still justify a lower dose.

Amlodipine inhibits calcium entry, predominantly in vascular smooth muscle. Reduced peripheral resistance lowers blood pressure; reduced afterload and inhibition of coronary spasm contribute to antianginal effects. Chronic oral dosing generally does not substantially change heart rate.

Absorption

Peak plasma levels about 6–12 hours after an oral dose; food does not alter bioavailability.

Metabolism

Extensive hepatic conversion to inactive metabolites.

Elimination

Terminal half-life about 30–50 hours; steady state after 7–8 days. Renal impairment has little effect, whereas hepatic impairment prolongs elimination.

• Assess blood pressure and symptoms after initiation and dose changes; monitor edema, dizziness, and palpitations.
• Reassess new or worsening angina immediately.
• When interacting medicines are started or stopped, reassess blood pressure; obtain transplant-drug trough levels when relevant.

• Take once daily at a consistent time, with or without food, and continue as prescribed even when feeling well.
• For a missed dose, take it when remembered unless the next dose is less than 12 hours away; then skip it. Do not double doses.
• Shake suspension before use; measure either liquid with a suitable dosing device. Confirm refrigeration versus room-temperature storage with the pharmacist.
• Amlodipine is preventive treatment for angina. Keep the prescribed rescue plan; seek urgent care for new or worsening chest pain.

Generic tablets can have different imprints and appearance. A photograph alone does not safely establish identity.

Dosage form / strength

Oral tablet · 5 mg amlodipine as the besylate salt

Label distributor

Viatris Specialty LLC

Appearance

White elongated octagon; flat-faced, beveled edge

Imprint

NORVASC and 5 on one face; other face plain

Example package NDC

58151-354-77 · bottle of 90

Norvasc tablets

2.5, 5, and 10 mg

Katerzia suspension

1 mg/mL; amlodipine benzoate; white to off-white aqueous suspension

Norliqva solution

1 mg/mL; clear pale straw-colored mixed berry solution

Norvasc bottles: 15–30°C (59–86°F); dispense in tight, light-resistant containers. Katerzia: refrigerate at 2–8°C (36–46°F), protect from light, and avoid freezing or excessive heat. Norliqva: 20–25°C (68–77°F), permitted excursions 15–30°C; use a tight, light-resistant container. Follow the dispensed product’s exact label.