Nifedipine

What it is and how it works

Mechanism class: Calcium Channel Antagonists

Indications

INDICATIONS AND USAGE I. Vasospastic Angina Nifedipine Extended-release Tablet is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine Extended-release Tablet may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta-blockers. II.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Dosage must be adjusted according to each patient's needs. Therapy for either hypertension or angina should be initiated with 30 or 60 mg once daily. Nifedipine Extended-release Tablets should be swallowed whole and should not be bitten or divided. In general, titration should proceed over a 7-14 day period so that the physician can fully assess the response to each dose level and monitor blood pressure before proceeding to higher doses. Since steady-state plasma levels are achieved on the second day of dosing, titration may proceed more rapidly, if symptoms so warrant, provided the patient is assessed frequently.

Contraindications

CONTRAINDICATIONS Known hypersensitivity reaction to nifedipine.

Warnings and precautions

WARNINGS Excessive Hypotension Although in most angina patients the hypotensive effect of nifedipine is modest and well tolerated, occasional patients have had excessive and poorly tolerated hypotension. These responses have usually occurred during initial titration or at the time of subsequent upward dosage adjustment, and may be more likely in patients on concomitant beta-blockers.

Storage and supply

HOW SUPPLIED Nifedipine Extended-release Tablets, USP 30 mg are round, biconvex, pink coated tablets imprinted with "KU 260" in black ink. They are supplied as follows: Bottles of 90 Tablets NDC 62135-521-90 Nifedipine Extended-release Tablets, USP 60 mg are round, biconvex, pink coated tablets imprinted with "KU 261" in black ink.

Source: Nifedipine (Nifedipine) — US FDA prescribing information, 2025-12-17, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.