Nifedipine (Page 5 of 6)

OVERDOSAGE

Experience with nifedipine overdosage is limited. Generally, overdosage with nifedipine leading to pronounced hypotension calls for active cardiovascular support, including monitoring of cardiovascular and respiratory function, elevation of extremities, judicious use of calcium infusion, pressor agents, and fluids. Clearance of nifedipine would be expected to be prolonged in patients with impaired liver function. Since nifedipine is highly protein-bound, dialysis is not likely to be of any benefit.

There has been one reported case of massive overdosage with Nifedipine Extended-release Tablets. The main effects of ingestion of approximately 4800 mg of Nifedipine Extended-release Tablets in a young man attempting suicide as a result of cocaine-induced depression was initial dizziness, palpitations, flushing, and nervousness. Within several hours of ingestion, nausea, vomiting, and generalized edema developed. No significant hypotension was apparent at presentation, 18 hours post-ingestion. Electrolyte abnormalities consisted of a mild, transient elevation of serum creatinine, and modest elevations of LDH and CPK, but normal SGOT. Vital signs remained stable, no electrocardiographic abnormalities were noted, and renal function returned to normal within 24 to 48 hours with routine supportive measures alone. No prolonged sequelae were observed.

The effect of a single 900 mg ingestion of nifedipine capsules in a depressed anginal patient also on tricyclic antidepressants was loss of consciousness within 30 minutes of ingestion, and profound hypotension, which responded to calcium infusion, pressor agents, and fluid replacement. A variety of ECG abnormalities were seen in this patient with a history of bundle branch block, including sinus bradycardia and varying degrees of AV block. These dictated the prophylactic placement of a temporary ventricular pacemaker, but otherwise resolved spontaneously. Significant hyperglycemia was seen initially in this patient, but plasma glucose levels rapidly normalized without further treatment.

A young hypertensive patient with advanced renal failure ingested 280 mg of nifedipine capsules at one time, with resulting marked hypotension responding to calcium infusion and fluids. No AV conduction abnormalities, arrhythmias, or pronounced changes in heart rate were noted, nor was there any further deterioration in renal function.

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. Titration to doses above 120 mg are not recommended.

Angina patients controlled on nifedipine capsules alone or in combination with other antianginal medications may be safely switched to Nifedipine Extended-release Tablets at the nearest equivalent total daily dose (e.g., 30 mg t.i.d. of nifedipine capsules may be changed to 90 mg once daily of Nifedipine Extended-release Tablets). Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. Experience with doses greater than 90 mg in patients with angina is limited. Therefore, doses greater than 90 mg should be used with caution and only when clinically warranted.

Avoid co-administration of nifedipine with grapefruit juice (see CLINICAL PHARMACOLOGY and PRECAUTIONS: Other Interactions).

No “rebound effect” has been observed upon discontinuation of Nifedipine Extended-release Tablets. However, if discontinuation of nifedipine is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.

Care should be taken when dispensing Nifedipine Extended-release Tablets to assure that the extended release dosage form has been prescribed.

Co-Administration with Other Antianginal Drugs

Sublingual nitroglycerin may be taken as required for the control of acute manifestations of angina, particularly during nifedipine titration. See PRECAUTIONS, Drug Interactions, for information on co-administration of nifedipine with beta blockers or long-acting nitrates.

HOW SUPPLIED

Nifedipine Extended-release Tablets 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 62175-260-46
Bottles of 100 Tablets	NDC 62175-260-37
Bottles of 300 Tablets	NDC 62175-260-55

Nifedipine Extended-release Tablets 60 mg are round, biconvex, pink coated tablets imprinted with “KU 261” in black ink. They are supplied as follows:

Bottles of 90 Tablets	NDC 62175-261-46
Bottles of 100 Tablets	NDC 62175-261-37
Bottles of 300 Tablets	NDC 62175-261-55

Nifedipine Extended-release Tablets 90 mg are round, biconvex, pink coated tablets imprinted with “KU 262” in black ink. They are supplied as follows:

Bottles of 30 Tablets	NDC 62175-262-32
Bottles of 90 Tablets	NDC 62175-262-46
Bottles of 100 Tablets	NDC 62175-262-37

Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature).

Protect from moisture, humidity, and light.

For Medical Information
Contact: Medical Affairs Department
Phone: 1-844-834-0530

Distributed by:

Lannett Company, Inc.

Philadelphia, PA 19136

CIA70797L
Rev. 05/2023

PRINCIPAL DISPLAY PANEL — 30MG 90CT

90 Tablets NDC 62175-260-46
Nifedipine
Extended ReleaseTablets, USP

PRINCIPAL DISPLAY PANEL-30MG 100CT

100 Tablets NDC 62175-260-37
Nifedipine
Extended ReleaseTablets, USP

PRINCIPAL DISPLAY PANEL-30MG 300CT

300 Tablets NDC 62175-260-55
Nifedipine
Extended ReleaseTablets, USP

PRINCIPAL DISPLAY PANEL — 60MG 90CT

90 Tablets NDC 62175-261-46
Nifedipine
Extended ReleaseTablets, USP