Indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

No studies have been performed with Adalat CC in patients with renal failure. Since the absorption of nifedipine from nifedipine extended-release tablets could be modified by renal disease, caution should be exercised in treating such patients.

Because nifedipine is metabolized via the cytochrome P450 3A4 system, its pharmacokinetics may be altered in patients with chronic liver disease. Nifedipine extended-release tablets have not been studied in patients with hepatic disease; however, in patients with hepatic impairment (liver cirrhosis) nifedipine has a longer elimination half-life and higher bioavailability than in healthy volunteers.

Nifedipine must not be used in cases of cardiogenic shock.

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.

Rare, usually transient, but occasionally significant elevations of enzymes such as alkaline phosphatase, CPK, LDH, SGOT, and SGPT have been noted.

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 Patients recently withdrawn from beta blockers may develop a withdrawal syndrome with increased angina, probably related to increased sensitivity to catecholamines.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.

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.

St. John’s Wort is an inducer of CYP3A and may decrease exposure to nifedipine. Alternative antihypertensive therapy should be considered in patients in whom St. John’s Wort therapy is necessary.

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.

Co-administration of nifedipine with grapefruit juice is to be avoided.

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.

There has been too little experience with the co-administration of TAMBOCOR with nifedipine to recommend concomitant use.

Caution should be exercised when co-administering diltiazem and nifedipine and a reduction of the dose of nifedipine should be considered.

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.

The tachycardic effect of nifedipine was attenuated in the presence of benazepril.

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.

The simultaneous administration of nifedipine and digoxin may lead to reduced clearance resulting in an increase in plasma concentrations of digoxin.

There have been rare reports of increased prothrombin time in patients taking coumarin anticoagulants to whom nifedipine was administered.

The interaction between cimetidine and nifedipine is of clinical relevance and blood pressure should be monitored and a reduction of the dose of nifedipine considered.

Valproic acid may increase the exposure to nifedipine during concomitant therapy. Blood pressure should be monitored and a dose reduction of nifedipine considered.

Nifedipine can increase the exposure to tacrolimus. When nifedipine is co administered with tacrolimus the blood concentrations of tacrolimus should be monitored and a reduction of the dose of tacrolimus considered.

Nifedipine appears to enhance the absorption of metformin.

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.

Nifedipine is excreted in human milk. Nursing mothers are advised not to breastfeed their babies when taking the drug.

GoToSource

• Adult dosage greater than 90 mg daily. GoToSource

• Use in patients under the age of 18. GoToSource

• Bronchial asthma. GoToSource

• Systemic sclerosis. GoToSource

• Facilitate ureteral stone expulsion. GoToSource

• Post-defecation pain syndrome. GoToSource

• Affective disorders and pathological drive for alcohol in patients with chronic alcoholism in the remission period. GoToSource

• Preterm labor. GoToSource

• Hiccups. GoToSource 

Increased risk of coronary events in case of unstable angina or recent myocardial infarction. GoToSource

Hypotension. GoToSource 

Gingival hyperplasia (gum enlargement). GoToSource

Dizziness, flushing, headache, pedal edema and palpitations. GoToSource

Shortness of breath, constipation and tachycardia. GoToSource

Lip cancer. GoToSource

Lawsuits filed for lip cancer.