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Nifediac CC

Generic Name: Nifedipine
Drug Category: Calcium Channel Blocker
Litigation Alert Level: Medium
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 5 years.

Approved Uses

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

Nifedipine must not be used in cases of cardiogenic shock.

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. 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.

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 Patients recently withdrawn from beta-blockers may develop a withdrawal syndrome with increased angina, probably related to increased sensitivity to catecholamines.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

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.

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.

Mild to moderate peripheral edema occurs in a dose-dependent manner with nifedipine extended-release tablets.

Cholestasis with or without jaundice has been reported.

Clearance of nifedipine is reduced and systemic exposure increased in patients with cirrhosis.

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.

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.

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.

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.

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.

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

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. 

Hypotension is more likely to occur if dihydropyridine calcium antagonists such as nifedipine are coadministered with timolol.

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. Since there have been isolated reports of patients with elevated digoxin levels, and there is a possible interaction between digoxin and nifedipine extended-release, it is recommended that digoxin levels be monitored when initiating, adjusting and discontinuing nifedipine extended-release to avoid possible over- or under- digitalization.

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.

Nifedipine tends to produce hyperglycemia and may lead to loss of glucose control when used with acarbose. If nifedipine is co-administered with acarbose, blood glucose levels should be monitored carefully and a dose adjustment of nifedipine considered.

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

Off-label Uses

• Use in patients under the age of 18. GoToSource

• Systemic sclerosis. GoToSource

• Prevention and treatment of cognitive decline and dementia. GoToSource

• Management of preterm labor. GoToSource

• Alcohol withdrawal syndrome. GoToSource

• Intractable hiccups. GoToSource

• Use with atenolol for treatment of angina. GoToSource

• Migraine prophylaxis. GoToSource

• Diabetic nephropathy. GoToSource

• Raynaud’s syndrome. GoToSource

• Acute mountain sickness. GoToSource

• Chronic urticaria. GoToSource

• Neuroleptic-induced tardive dyskinesia. GoToSource

Adverse Events

Gingival hyperplasia (increased size of gums). GoToSource

Gynecomastia (swelling of male breast tissue). GoToSource

Lip cancer. GoToSource 

Angioedema and cough. GoToSource

Sjögren syndrome (autoimmune disease). GoToSource 

Worsening heart failure. GoToSource

Increased rate of death after acute myocardial infarction. GoToSource

Increased angina. GoToSource  

Peripheral edema (swelling from fluid accumulation in body tissues). GoToSource

Hepatitis with jaundice (inflammation of the liver and yellowish pigmentation of the skin, tissues, and body fluids caused by bile pigments). GoToSource

Tachycardia (rapid heart rate) rash, pruritus (severe itching of the skin), shortness of breath and constipation. GoToSource

Hemolytic anemia (red blood cells are destroyed faster than they can be made). GoToSource

Hypotension (low blood pressure), asthenia (abnormal weakness or lack of energy), impotence and polyuria (excessive passage of urine). GoToSource

Increased risk for periodontal destruction in patients with type 2 diabetes mellitus. GoToSource

Litigation

Lawsuits filed for lip cancer. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024