an 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. Blood chemistry 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 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 should be adjusted according to each patient’s needs. It is recommended that nifedipine extended-release tablets be administered orally once daily on an empty stomach. Nifedipine extended-release tablets are an extended release dosage form and tablets should be swallowed whole, not bitten or divided. In general, titration should proceed over a 7 to 14 day period starting with 30 mg once daily. Upward titration should be based on therapeutic efficacy and safety. The usual maintenance dose is 30 mg to 60 mg once daily. Titration to doses above 90 mg daily is not recommended.
If discontinuation of nifedipine extended-release tablets is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.
Coadministration of nifedipine with grapefruit juice is to be avoided (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Care should be taken when dispensing nifedipine extended-release tablets to assure that the extended release dosage form has been prescribed.
HOW SUPPLIED
Nifedipine Extended-release Tablets, USP are available containing 30 mg, 60 mg or 90 mg of nifedipine, USP.
The 30 mg tablets are supplied as white, film-coated, round, unscored tablets debossed with M on one side of the tablet and NE over 30 on the other side. They are available as follows:
NDC 0378-0353-93
bottles of 30 tablets
NDC 0378-0353-01
bottles of 100 tablets
NDC 0378-0353-10
bottles of 1000 tablets
The 60 mg tablets are supplied as orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and NE over 60 on the other side. They are available as follows:
NDC 0378-0360-93
bottles of 30 tablets
NDC 0378-0360-01
bottles of 100 tablets |
