nifedipine
Tablet, Extended Release · Oral
Uses
Nifedipine extended-release tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Dosage and administration
Dosage should be adjusted according to each patient's needs. It is recommended that nifedipine extended-release tablets, USP be administered orally once daily on an empty stomach. The nifedipine extended-release tablet, USP is an extended release dosage form and tablets should be swallowed whole, not bitten or divided. In general, titration should proceed over a 7-14 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 the nifedipine extended-release tablet is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision. Co-administration 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.
Contraindications
Concomitant administration with strong P450 inducers, such as rifampin, are contraindicated since the efficacy of nifedipine tablets could be significantly reduced. (See PRECAUTIONS , Drug Interactions. ) Nifedipine must not be used in cases of cardiogenic shock. Nifedipine extended-release tablets are contraindicated in patients with a known hypersensitivity to any component of the tablet.
Warnings
Excessive Hypotension Although in most 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 using concomitant beta-blockers. Severe hypotension and/or increased fluid volume requirements have been reported in patients who received immediate release capsules together with a beta-blocking agent and who underwent coronary artery bypass surgery using high dose fentanyl anesthesia. The interaction with high dose fentanyl appears to be due to the combination of nifedipine and a beta-blocker, but the possibility that it may occur with nifedipine alone, with low doses of fentanyl, in other surgical procedures, or with other narcotic analgesics cannot be ruled out. In nifedipine-treated patients where surgery using high dose fentanyl anesthesia is contemplated, the physician should be aware of these potential problems and, if the patient's condition permits, sufficient time (at least 36 hours) should be allowed for nifedipine to be washed out of the body prior to surgery. Increased Angina and/or Myocardial Infarction Rarely, patients, particularly those who have severe obstructive coronary artery disease, have developed well-documented increased frequency, duration and/or severity of angina or acute myocardial infarction upon starting nifedipine or at the time of dosage increase. The mechanism of this effect is not established. Beta-Blocker Withdrawal When discontinuing a beta-blocker it is important to taper its dose, if possible, rather than stopping abruptly before beginning nifedipine. Patients recently withdrawn from beta blockers may develop a withdrawal syndrome with increased angina, probably related to increased sensitivity to catecholamines. Initiation of nifedipine treatment will not prevent this occurrence and on occasion has been reported to increase it. Congestive Heart Failure Rarely, patients (usually while receiving a beta-blocker) have developed heart failure after beginning nifedipine. Patients with tight aortic stenosis may be at greater risk for such an event, as the unloading effect of nifedipine would be expected to be of less benefit to these patients, owing to their fixed impedance to flow across the aortic valve.
Precautions
General Hypotension Because nifedipine decreases peripheral vascular resistance, careful monitoring of blood pressure during the initial administration and titration of nifedipine extended-release tablets are suggested. Close observation is especially recommended for patients already taking medications that are known to lower blood pressure (See WARNINGS ). Peripheral Edema Mild to moderate peripheral edema occurs in a dose-dependent manner with nifedipine extended-release tablets. The placebo subtracted rate is approximately 8% at 30 mg, 12% at 60 mg and 19% at 90 mg daily. This edema is a localized phenomenon, thought to be associated with vasodilation of dependent arterioles and small blood vessels and not due to left ventricular dysfunction or generalized fluid retention. With patients whose hypertension is complicated by congestive heart failure, care should be taken to differentiate this peripheral edema from the effects of increasing left ventricular dysfunction. Use in Cirrhotic Patients Clearance of nifedipine is reduced and systemic exposure increased in patients with cirrhosis. It is unknown how systemic exposure may be altered in patients with moderate or severe liver impairment. Careful monitoring and dose reduction may be necessary; consider initiating therapy with the lowest dose available. Information for Patients Nifedipine extended-release tablets are an extended release tablet and should be swallowed whole and taken on an empty stomach. It should not be administered with food. Do not chew, divide or crush tablets. Laboratory Tests Rare, usually transient, but occasionally significant elevations of enzymes such as alkaline phosphatase, CPK, LDH, SGOT, and SGPT have been noted. The relationship to nifedipine therapy is uncertain in most cases, but probable in some. These laboratory abnormalities have rarely been associated with clinical symptoms; however, cholestasis with or without jaundice has been reported. A small increase (<5%) in mean alkaline phosphatase was noted in patients treated with nifedipine extended-release tablets. This was an isolated finding and it rarely resulted in values which fell outside the normal range. Rare instances of allergic hepatitis have been reported with nifedipine treatment. In controlled studies, nifedipine extended-release tablets did not adversely affect serum uric acid, glucose, cholesterol or potassium. Nifedipine, like other calcium channel blockers, decreases platelet aggregation in vitro . Limited clinical studies have demonstrated a moderate but statistically significant decrease in platelet aggregation and increase in bleeding time in some nifedipine patients. This is thought to be a function of inhibition of calcium transport across the platelet membrane. No clinical significance for these findings has been demonstrated. Positive direct Coombs' test with or without hemolytic anemia has been reported but a causal relationship between nifedipine administration and positivity of this laboratory test, including hemolysis, could not be determined. Although nifedipine has been used safely in patients with renal dysfunction and has been reported to exert a beneficial effect in certain cases, rare reversible elevations in BUN and serum creatinine have been reported in patients with pre-existing chronic renal insufficiency. The relationship to nifedipine therapy is uncertain in most cases but probable in some. Drug Interactions Nifedipine is mainly eliminated by metabolism and is a substrate of CYP3A. Inhibitors and inducers of CYP3A can impact the exposure to nifedipine and consequently its desirable and undesirable effects. In vitro and in vivo data indicate that nifedipine can inhibit the metabolism of drugs that are substrates of CYP3A, thereby increasing the exposure to other drugs. Nifedipine is a vasodilator, and co-administration of other drugs affecting blood pressure may result in pharmacodynamic interactions. CYP3A inhibitors CYP3A inhibitors such as ketoconazole, fluconazole, itraconazole, clarithromycin, erythromycin (Azithromycin, although structurally related to the class of macrolide antibiotic is void of clinically relevant CYP3A4 inhibition), grapefruit, nefazodone, fluoxetine, saquinavir, indinavir, nelfinavir, and ritonavir may result in increased exposure to nifedipine when co-administered. Careful monitoring and dose adjustment may be necessary; consider initiating nifedipine at the lowest dose available if given concomitantly with these medications. Strong CYP3A inducers Strong CYP3A inducers, such as rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, and St. John's Wort reduce the bioavailability and efficacy of nifedipine; therefore nifedipine should not be used in combination with strong CYP3A inducers such as rifampin (See CONTRAINDICATIONS ). Cardiovascular Drugs Antiarrhythmics Quinidine: Quinidine is a substrate of CYP3A and has been shown to inhibit CYP3A in vitro . Co-administration of multiple doses of quinidine sulfate, 200 mg t.i.d., and nifedipine, 20 mg t.i.d., increased C max and AUC of nifedipine in healthy volunteers by factors of 2.30 and 1.37, respectively. The heart rate in the initial interval after drug administration was increased by up to 17.9 beats/minute. The exposure to quinidine was not importantly changed in the presence of nifedipine. Monitoring of heart rate and adjustment of the nifedipine dose, if necessary, are recommended when quinidine is added to a treatment with nifedipine. Flecainide: There has been too little experience with the co-administration of Tambocor with nifedipine to recommend concomitant use. Calcium Channel Blockers Diltiazem: Pre-treatment of healthy volunteers with 30 mg or 90 mg t.i.d. diltiazem p.o. increased the AUC of nifedipine after a single dose of 20 mg nifedipine by factors of 2.2 and 3.1, respectively. The corresponding C max values of nifedipine increased by factors of 2.0 and 1.7, respectively.
Side effects
The incidence of adverse events during treatment with nifedipine extendedrelease tablets in doses up to 90 mg daily were derived from multi-center placebo-controlled clinical trials in 370 hypertensive patients. Atenolol 50 mg once daily was used concomitantly in 187 of the 370 patients on nifedipine extendedrelease tablets and in 64 of the 126 patients on placebo. All adverse events reported during nifedipine extendedrelease tablets therapy were tabulated independently of their causal relationship to medication. The most common adverse event reported with nifedipine extendedrelease tablets was peripheral edema. This was dose related and the frequency was 18% on nifedipine extendedrelease tablets 30 mg daily, 22% on nifedipine extendedrelease tablets 60 mg daily and 29% on nifedipine extendedrelease tablets 90 mg daily versus 10% on placebo. Other common adverse events reported in the above placebo-controlled trials include: Where the frequency of adverse events with nifedipine extended-release tablets and placebo is similar, causal relationship cannot be established. The following adverse events were reported with an incidence of 3% or less in daily doses up to 90 mg: Body as a Whole/Systemic: chest pain, leg pain Central Nervous System: paresthesia, vertigo Dermatologic: rash Gastrointestinal: constipation Musculoskeletal: leg cramps Respiratory: epistaxis, rhinitis Urogenital: impotence, urinary frequency Other adverse events reported with an incidence of less than 1.0% were: Body as a Whole/Systemic: allergic reaction, asthenia, cellulitis, substernal chest pain, chills, facial edema, lab test abnormal, malaise, neck pain, pelvic pain, pain, photosensitivity reaction Cardiovascular: atrial fibrillation, bradycardia, cardiac arrest, extrasystole, hypotension, migraine, palpitations, phlebitis, postural hypotension, tachycardia, cutaneous angiectases Central Nervous System: anxiety, confusion, decreased libido, depression, hypertonia, hypesthesia, insomnia, somnolence Dermatologic: angioedema, petechial rash, pruritus, sweating Gastrointestinal: abdominal pain, diarrhea, dry mouth, dysphagia, dyspepsia, eructation, esophagitis, flatulence, gastrointestinal disorder, gastrointestinal hemorrhage, GGT increased, gum disorder, gum hemorrhage, vomiting Hematologic: eosinophilia, lymphadenopathy Metabolic: gout, weight loss Musculoskeletal: arthralgia, arthritis, joint disorder, myalgia, myasthenia Respiratory: dyspnea, increased cough, rales, pharyngitis, stridor Special Senses: abnormal vision, amblyopia, conjunctivitis, diplopia, eye disorder, eye hemorrhage, tinnitus Urogenital/Reproductive: dysuria, kidney calculus, nocturia, breast engorgement, polyuria, urogenital disorder, erectile dysfunction (ED) The following adverse events have been reported rarely in patients given nifedipine in coat core or other formulations: allergenic hepatitis, alopecia, anaphylactic reaction, anemia, arthritis with ANA (+), depression, erythromelalgia, exfoliative dermatitis, fever, gingival hyperplasia, gynecomastia, hyperglycemia, jaundice, leukopenia, mood changes, muscle cramps, nervousness, paranoid syndrome, purpura, shakiness, sleep disturbances, Stevens-Johnson syndrome, syncope, taste perversion, thrombocytopenia, toxic epidermal necrolysis, transient blindness at the peak of plasma level, tremor and urticaria. To report SUSPECTED ADVERSE REACTIONS, please call Ingenus Pharmaceuticals, LLC toll-free at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. image-03
Drug interactions
Drug Interactions Nifedipine is mainly eliminated by metabolism and is a substrate of CYP3A. Inhibitors and inducers of CYP3A can impact the exposure to nifedipine and consequently its desirable and undesirable effects. In vitro and in vivo data indicate that nifedipine can inhibit the metabolism of drugs that are substrates of CYP3A, thereby increasing the exposure to other drugs. Nifedipine is a vasodilator, and co-administration of other drugs affecting blood pressure may result in pharmacodynamic interactions. CYP3A inhibitors CYP3A inhibitors such as ketoconazole, fluconazole, itraconazole, clarithromycin, erythromycin (Azithromycin, although structurally related to the class of macrolide antibiotic is void of clinically relevant CYP3A4 inhibition), grapefruit, nefazodone, fluoxetine, saquinavir, indinavir, nelfinavir, and ritonavir may result in increased exposure to nifedipine when co-administered. Careful monitoring and dose adjustment may be necessary; consider initiating nifedipine at the lowest dose available if given concomitantly with these medications. Strong CYP3A inducers Strong CYP3A inducers, such as rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, and St. John's Wort reduce the bioavailability and efficacy of nifedipine; therefore nifedipine should not be used in combination with strong CYP3A inducers such as rifampin (See CONTRAINDICATIONS ). Cardiovascular Drugs Antiarrhythmics Quinidine: Quinidine is a substrate of CYP3A and has been shown to inhibit CYP3A in vitro . Co-administration of multiple doses of quinidine sulfate, 200 mg t.i.d., and nifedipine, 20 mg t.i.d., increased C max and AUC of nifedipine in healthy volunteers by factors of 2.30 and 1.37, respectively. The heart rate in the initial interval after drug administration was increased by up to 17.9 beats/minute. The exposure to quinidine was not importantly changed in the presence of nifedipine. Monitoring of heart rate and adjustment of the nifedipine dose, if necessary, are recommended when quinidine is added to a treatment with nifedipine. Flecainide: There has been too little experience with the co-administration of Tambocor with nifedipine to recommend concomitant use. Calcium Channel Blockers Diltiazem: Pre-treatment of healthy volunteers with 30 mg or 90 mg t.i.d. diltiazem p.o. increased the AUC of nifedipine after a single dose of 20 mg nifedipine by factors of 2.2 and 3.1, respectively. The corresponding C max values of nifedipine increased by factors of 2.0 and 1.7, respectively. Caution should be exercised when co-administering diltiazem and nifedipine and a reduction of the dose of nifedipine should be considered. Verapamil: Verapamil, a CYP3A inhibitor, can inhibit the metabolism of nifedipine and increase the exposure to nifedipine during concomitant therapy. Blood pressure should be monitored and reduction of the dose of nifedipine considered. ACE Inhibitors Benazepril: In healthy volunteers receiving single dose of 20 mg nifedipine ER and benazepril 10 mg, the plasma concentrations of benazeprilat and nifedipine in the presence and absence of each other were not statistically significantly different. A hypotensive effect was only seen after co-administration of the two drugs. The tachycardic effect of nifedipine was attenuated in the presence of benazepril. Angiotensin-II Blockers Irbesartan: In vitro studies show significant inhibition of the formation of oxidized irbesartan metabolites by nifedipine. However, in clinical studies, concomitant nifedipine had no effect on irbesartan pharmacokinetics. Candesartan: No significant drug interaction has been reported in studies with candesartan cilexitil given together with nifedipine. Because candesartan is not significantly metabolized by the cytochrome P450 system and at therapeutic concentrations has no effect on cytochrome P450 enzymes, interactions with drugs that inhibit or are metabolized by those enzymes would not be expected. Beta-blockers Nifedipine extended-release tablets were well tolerated when administered in combination with beta-blockers in 187 hypertensive patients in a placebo-controlled clinical trial. However, there have been occasional literature reports suggesting that the combination nifedipine and beta-adrenergic blocking drugs may increase the likelihood of congestive heart failure, severe hypotension or exacerbation of angina in patients with cardiovascular disease. Clinical monitoring is recommended and a dose adjustment of nifedipine should be considered. Timolol: Hypotension is more likely to occur if dihydropryridine calcium antagonists such as nifedipine are co-administered with timolol. Central Alpha1-Blockers Doxazosin: Healthy volunteers participating in a multiple dose doxazosin-nifedipine interaction study received 2 mg doxazosin q.d. alone or combined with 20 mg nifedipine ER b.i.d. Co-administration of nifedipine resulted in a decrease in AUC and C max of doxazosin to 83% and 86% of the values in the absence of nifedipine, respectively. In the presence of doxazosin, AUC and C max of nifedipine were increased by factors of 1.13 and 1.23, respectively. Compared to nifedipine monotherapy, blood pressure was lower in the presence of doxazosin. Blood pressure should be monitored when doxazosin is co-administered with nifedipine, and dose reduction of nifedipine considered. Digitalis Digoxin: The simultaneous administration of nifedipine and digoxin may lead to reduced clearance resulting in an increase in plasma concentrations of digoxin. Since there have been isolated reports of patients with elevated digoxin levels, and there is a possible interaction between digoxin and nifedipine extended-release tablets, it is recommended that digoxin levels be monitored when initiating, adjusting and discontinuing nifedipine extended-release tablets, to avoid possible over- or under- digitalization.
Pregnancy
Pregnancy Pregnancy Category C. In rodents, rabbits and monkeys, nifedipine has been shown to have a variety of embryotoxic, placentotoxic, teratogenic and fetotoxic effects, including stunted fetuses (rats, mice and rabbits), digital anomalies (rats and rabbits), rib deformities (mice), cleft palate (mice), small placentas and underdeveloped chorionic villi (monkeys), embryonic and fetal deaths (rats, mice and rabbits), prolonged pregnancy (rats; not evaluated in other species), and decreased neonatal survival (rats; not evaluated in other species). On a mg/kg or mg/m 2 basis, some of the doses associated with these various effects are higher than the maximum recommended human dose and some are lower, but all are within an order of magnitude of it. The digital anomalies seen in nifedipine-exposed rabbit pups are strikingly similar to those seen in pups exposed to phenytoin, and these are in turn similar to the phalangeal deformities that are the most common malformation seen in human children with in utero exposure to phenytoin. From the clinical evidence available, a specific prenatal risk has not been identified. However, an increase in perinatal asphyxia, caesarean delivery, prematurity and intrauterine growth retardation have been reported. Careful monitoring of blood pressure must be exercised in pregnant women, when administering nifedipine in combination with IV magnesium sulfate due to the possibility of an excessive fall in blood pressure which could harm the mother and fetus. There are no adequate and well-controlled studies in pregnant women.
Pediatric use
Pediatric Use The safety and effectiveness of nifedipine extended-release tablets in pediatric patients have not been established.
Geriatric use
Geriatric Use Although small pharmacokinetic studies have identified an increased half-life and increased C max and AUC (See CLINICAL PHARMACOLOGY : Pharmacokinetics and Metabolism ), clinical studies of nifedipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Overdosage
Experience with nifedipine overdosage is limited. Symptoms associated with severe nifedipine overdosage include loss of consciousness, drop in blood pressure, heart rhythm disturbances, metabolic acidosis, hypoxia, cardiogenic shock with pulmonary edema. 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. After oral ingestion, thorough gastric lavage is indicated, if necessary in combination with irrigation of the small intestine. In cases involving overdosage of a slow-release product like nifedipine, elimination must be as complete as possible, including from the small intestine, to prevent the subsequent absorption of the active substance.Additional liquid or volume must be administered with caution because of the risk of fluid overload. 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; however, plasmapheresis may be beneficial. There has been one reported case of massive overdosage with tablets of another extended release formulation of nifedipine. The main effects of ingestion of approximately 4800 mg of nifedipine 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. 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. Bradycardiac heart rhythm disturbances may be treated symptomatically with ß-sympathomimetics, and in life-threatening bradycardiac disturbances of heart rhythm temporary pacemaker therapy can be advisable.
Description
Nifedipine extended-release tablets, USP are an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-dimethyl ester, C 17 H 18 N 2 O 6 , and has the structural formula: Product meets USP dissolution test 10. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended release tablets contain either: 30, 60, or 90 mg of nifedipine for once-a-day oral administration. Inert ingredients in the 30mg nifedipine extended-release tablet formulation are lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide, macrogol/polyethylene glycol 3350, lecithin (soy), iron oxide yellow and iron oxide black. Inert ingredients in the 60mg nifedipine extended-release tablet formulation are lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350, lecithin (soy), iron oxide red, iron oxide black and iron oxide yellow. Inert ingredients in the 90mg nifedipine extended-release tablet formulation are: lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate, polyvinyl alcohol, iron oxide red, talc, macrogol/polyethylene glycol 3350, iron oxide yellow, titanium dioxide, lecithin (soy) and iron oxide black. image-01
Mechanism of action
Mechanism of Action The mechanism by which nifedipine reduces arterial blood pressure involves peripheral arterial vasodilatation and, consequently, a reduction in peripheral vascular resistance. The increased peripheral vascular resistance, an underlying cause of hypertension, results from an increase in active tension in the vascular smooth muscle. Studies have demonstrated that the increase in active tension reflects an increase in cytosolic free calcium. Nifedipine is a peripheral arterial vasodilator which acts directly on vascular smooth muscle. The binding of nifedipine to voltage-dependent and possibly receptor-operated channels in vascular smooth muscle results in an inhibition of calcium influx through these channels. Stores of intracellular calcium in vascular smooth muscle are limited and thus dependent upon the influx of extracellular calcium for contraction to occur. The reduction in calcium influx by nifedipine causes arterial vasodilation and decreased peripheral vascular resistance which results in reduced arterial blood pressure.
How supplied
Nifedipine extended-release tablets, USP are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows: Nifedipine extended-release tablets, USP are supplied in the following bottle configurations: The tablets should be protected from light and moisture and stored at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. image4 image5 image6
Patient information
Information for Patients Nifedipine extended-release tablets are an extended release tablet and should be swallowed whole and taken on an empty stomach. It should not be administered with food. Do not chew, divide or crush tablets.
Label text from the FDA structured product label by Ingenus Pharmaceuticals, LLC (revised Apr 15, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Nifedipine in 128 products
nifedipine NDC products (128)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-6767 | Nifedipine 60 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-6732 | Nifedipine 30 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-6450 | Nifedipine 90 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-6203 | Nifedipine 30 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-6201 | Nifedipine 60 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-5284 | Nifedipine 30 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-4158 | Nifedipine 90 mg/1 Tablet, Film Coated, Extended Release | A-S Medication Solutions | ANDA |
| 62332-734 | Nifedipine 90 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-733 | Nifedipine 60 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-732 | Nifedipine 30 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-732 | Nifedipine 30 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Limited | ANDA |
| 46708-733 | Nifedipine 60 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Limited | ANDA |
| 46708-734 | Nifedipine 90 mg/1 Tablet, Extended Release | Alembic Pharmaceuticals Limited | ANDA |
| 68084-597 | Nifedipine 30 mg/1 Tablet, Film Coated, Extended Release | American Health Packaging | ANDA |
| 68084-603 | Nifedipine 90 mg/1 Tablet, Film Coated, Extended Release | American Health Packaging | ANDA |
| 68084-598 | Nifedipine 60 mg/1 Tablet, Film Coated, Extended Release | American Health Packaging | ANDA |
| 71610-290 | Nifedipine 30 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-144 | Nifedipine 30 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-012 | Nifedipine 60 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-055 | Nifedipine 90 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-689 | Nifedipine 30 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-841 | Nifedipine 30 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 67877-758 | Nifedipine 60 mg/1 Tablet, Extended Release | Ascend Laboratories, LLC | ANDA |
| 67877-757 | Nifedipine 30 mg/1 Tablet, Extended Release | Ascend Laboratories, LLC | ANDA |
| 67877-756 | Nifedipine 90 mg/1 Tablet, Extended Release | Ascend Laboratories, LLC | ANDA |
| 59651-295 | Nifedipine 30 mg/1 Tablet, Extended Release | Aurobindo Pharma Limited | ANDA |
| 59651-296 | Nifedipine 60 mg/1 Tablet, Extended Release | Aurobindo Pharma Limited | ANDA |
| 59651-297 | Nifedipine 90 mg/1 Tablet, Extended Release | Aurobindo Pharma Limited | ANDA |
| 50268-597 | Nifedipine 30 mg/1 Tablet, Film Coated, Extended Release | AvPAK | ANDA |
| 50268-599 | Nifedipine 90 mg/1 Tablet, Film Coated, Extended Release | AvPAK | ANDA |
| 50268-598 | Nifedipine 60 mg/1 Tablet, Film Coated, Extended Release | AvPAK | ANDA |
| 63629-9109 | Nifedipine 30 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-1721 | Nifedipine 60 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-1277 | Nifedipine 30 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-1887 | Nifedipine 30 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-0744 | Nifedipine 60 mg/1 Tablet, Film Coated, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-2260 | Nifedipine 60 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-9651 | Nifedipine 90 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-2261 | Nifedipine 90 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-1550 | Nifedipine 30 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-2534 | Nifedipine 30 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-2535 | Nifedipine 60 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2132 | Nifedipine 90 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 72162-2536 | Nifedipine 90 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 55154-0196 | Nifedipine 10 mg/1 Capsule | Cardinal Health 107, LLC | ANDA |
| 55154-8177 | Nifedipine 60 mg/1 Tablet, Film Coated, Extended Release | Cardinal Health 107, LLC | ANDA |
| 55154-4690 | Nifedipine 30 mg/1 Tablet, Film Coated, Extended Release | Cardinal Health 107, LLC | ANDA |
| 55154-4157 | Nifedipine 60 mg/1 Tablet, Film Coated, Extended Release | Cardinal Health 107, LLC | ANDA |
| 62135-740 | Nifedipine 20 mg/1 Capsule | Chartwell RX, LLC | ANDA |
| 62135-521 | Nifedipine 30 mg/1 Tablet, Film Coated, Extended Release | Chartwell RX, LLC | ANDA |
| 62135-522 | Nifedipine 60 mg/1 Tablet, Film Coated, Extended Release | Chartwell RX, LLC | ANDA |
| 62135-523 | Nifedipine 90 mg/1 Tablet, Film Coated, Extended Release | Chartwell RX, LLC | ANDA |
| 62135-739 | Nifedipine 10 mg/1 Capsule | Chartwell RX, LLC | ANDA |
| 67046-0260 | Nifedipine 30 mg/1 Tablet, Film Coated, Extended Release | Coupler LLC | ANDA |
| 70807-503 | Nifedipine 90 mg/1 Tablet, Film Coated, Extended Release | Elite Pharmaceutical Solution, Inc. | ANDA |
| 60429-047 | Nifedipine 30 mg/1 Tablet, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 60429-049 | Nifedipine 90 mg/1 Tablet, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 60429-048 | Nifedipine 60 mg/1 Tablet, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-624 | Nifedipine 90 mg/1 Tablet, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-623 | Nifedipine 60 mg/1 Tablet, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-622 | Nifedipine 30 mg/1 Tablet, Extended Release | Golden State Medical Supply, Inc. | ANDA |
| 23155-195 | Nifedipine 20 mg/1 Capsule | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-194 | Nifedipine 10 mg/1 Capsule | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 50742-260 | Nifedipine 30 mg/1 Tablet, Film Coated, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-261 | Nifedipine 60 mg/1 Tablet, Film Coated, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-262 | Nifedipine 90 mg/1 Tablet, Film Coated, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-620 | Nifedipine 30 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-621 | Nifedipine 60 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 50742-622 | Nifedipine 90 mg/1 Tablet, Extended Release | Ingenus Pharmaceuticals, LLC | ANDA |
| 62175-262 | Nifedipine 90 mg/1 Tablet, Film Coated, Extended Release | Lannett Company, Inc. | ANDA |
| 62175-261 | Nifedipine 60 mg/1 Tablet, Film Coated, Extended Release | Lannett Company, Inc. | ANDA |
| 62175-260 | Nifedipine 30 mg/1 Tablet, Film Coated, Extended Release | Lannett Company, Inc. | ANDA |
| 0904-7081 | Nifedipine 60 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA |
| 0904-7082 | Nifedipine 90 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA |
| 0904-7208 | Nifedipine 30 mg/1 Tablet, Film Coated, Extended Release | Major Pharmaceuticals | ANDA |
| 0904-7229 | Nifedipine 10 mg/1 Capsule | Major Pharmaceuticals | ANDA |
| 0615-8549 | Nifedipine 60 mg/1 Tablet, Extended Release | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 51655-386 | Nifedipine 60 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-407 | Nifedipine 90 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-593 | Nifedipine 30 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-738 | Nifedipine 90 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-780 | Nifedipine 60 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-798 | Nifedipine 30 mg/1 Tablet, Extended Release | Northwind Health Company, LLC | ANDA |
| 51655-990 | Nifedipine 30 mg/1 Tablet, Film Coated, Extended Release | Northwind Health Company, LLC | ANDA |
| 68071-4097 | Nifedipine 90 mg/1 Tablet, Extended Release | NuCare Pharmaceuticals,Inc. | ANDA |
| 66267-831 | Nifedipine 10 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2838 | Nifedipine 30 mg/1 Tablet, Extended Release | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2619 | Nifedipine 30 mg/1 Tablet, Extended Release | NuCare Pharmaceuticals,Inc. | ANDA |
| 68682-108 | Nifedipine 30 mg/1 Tablet, Film Coated, Extended Release | Oceanside Pharmaceuticals | ANDA |
| 68682-109 | Nifedipine 60 mg/1 Tablet, Film Coated, Extended Release | Oceanside Pharmaceuticals | ANDA |
| 68682-107 | Nifedipine 90 mg/1 Tablet, Extended Release | Oceanside Pharmaceuticals | ANDA |
| 68682-105 | Nifedipine 30 mg/1 Tablet, Extended Release | Oceanside Pharmaceuticals | ANDA |
| 68682-106 | Nifedipine 60 mg/1 Tablet, Extended Release | Oceanside Pharmaceuticals | ANDA |
| 72789-494 | Nifedipine 60 mg/1 Tablet, Film Coated, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-486 | Nifedipine 90 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-485 | Nifedipine 60 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-484 | Nifedipine 30 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-219 | Nifedipine 10 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 55289-798 | Nifedipine 30 mg/1 Tablet, Film Coated, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-8164 | Nifedipine 60 mg/1 Tablet, Film Coated, Extended Release | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7642 | Nifedipine 30 mg/1 Tablet, Film Coated, Extended Release | Preferred Pharmaceuticals, Inc. | ANDA |
| 71205-412 | Nifedipine 60 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 71205-963 | Nifedipine 30 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 71205-964 | Nifedipine 60 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 71205-965 | Nifedipine 90 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 63187-875 | Nifedipine 30 mg/1 Tablet, Film Coated, Extended Release | Proficient Rx LP | ANDA |
| 67296-2157 | Nifedipine 30 mg/1 Tablet, Extended Release | Redpharm Drug | ANDA |
| 67296-2170 | Nifedipine 30 mg/1 Tablet, Extended Release | Redpharm Drug | ANDA |
| 70518-2679 | Nifedipine 30 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 70518-4625 | Nifedipine 10 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-3520 | Nifedipine 60 mg/1 Tablet, Extended Release | REMEDYREPACK INC. | ANDA |
| 60760-859 | Nifedipine 60 mg/1 Tablet, Film Coated, Extended Release | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-862 | Nifedipine 90 mg/1 Tablet, Film Coated, Extended Release | St. Mary's Medical Park Pharmacy | ANDA |
| 24979-011 | Nifedipine 30 mg/1 Tablet, Film Coated, Extended Release | Upsher-Smith Laboratories, LLC | ANDA |
| 24979-010 | Nifedipine 60 mg/1 Tablet, Extended Release | Upsher-Smith Laboratories, LLC | ANDA |
| 24979-009 | Nifedipine 90 mg/1 Tablet, Extended Release | Upsher-Smith Laboratories, LLC | ANDA |
| 70771-1366 | Nifedipine 60 mg/1 Tablet, Extended Release | Zydus Lifesciences Limited | ANDA |
| 70771-1190 | Nifedipine 30 mg/1 Tablet, Extended Release | Zydus Lifesciences Limited | ANDA |
| 70771-1191 | Nifedipine 60 mg/1 Tablet, Extended Release | Zydus Lifesciences Limited | ANDA |
| 70771-1192 | Nifedipine 90 mg/1 Tablet, Extended Release | Zydus Lifesciences Limited | ANDA |
| 70771-1365 | Nifedipine 30 mg/1 Tablet, Extended Release | Zydus Lifesciences Limited | ANDA |
| 70771-1367 | Nifedipine 90 mg/1 Tablet, Extended Release | Zydus Lifesciences Limited | ANDA |
| 68382-685 | Nifedipine 30 mg/1 Tablet, Extended Release | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 68382-686 | Nifedipine 60 mg/1 Tablet, Extended Release | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 68382-687 | Nifedipine 90 mg/1 Tablet, Extended Release | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 68382-688 | Nifedipine 30 mg/1 Tablet, Extended Release | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 68382-689 | Nifedipine 60 mg/1 Tablet, Extended Release | Zydus Pharmaceuticals (USA) Inc. | ANDA |
| 68382-690 | Nifedipine 90 mg/1 Tablet, Extended Release | Zydus Pharmaceuticals (USA) Inc. | ANDA |
nifedipine recalls
- D-0652-2021 Jul 21, 2021 · Class II · Terminated
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Frequently asked questions
What is nifedipine used for?
Nifedipine extended-release tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
What are the side effects of nifedipine?
The incidence of adverse events during treatment with nifedipine extendedrelease tablets in doses up to 90 mg daily were derived from multi-center placebo-controlled clinical trials in 370 hypertensive patients. Atenolol 50 mg once daily was used concomitantly in 187 of the 370 patients on nifedipine extendedrelease tablets and in 64 of the 126 patients on placebo. All adverse events reported… See the full label for the complete list.
Who makes nifedipine?
nifedipine is listed by 32 labelers in the FDA NDC directory, including A-S Medication Solutions, Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited, American Health Packaging.
Has nifedipine been recalled?
The FDA enforcement database lists 1 recall for nifedipine, most recently D-0652-2021 (class ii): Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.