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Basic Drug Info
Drug Name:Nifedipine
Manufacturer:Actavis South Atlantic LLC
Other Info:

Debrisoquine: In healthy volunteers, pretreatment with nifedipine 20 mg t.i.d.

for 5 days did not change the metabolic ratio of hydroxydebrisoquine to debrisoquine measured in urine after a single dose of 10 mg debrisoquine.

Thus, it is improbable that nifedipine inhibits in vivo the metabolism of other drugs that are substrates of CYP2D6.



Clinical Trials:


Indications and Usage

Nifedipine extended-release tablets is indicated for the treatment of hypertension.

It may be used alone or in combination with other antihypertensive agents.
Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

Contraindications
Known hypersensitivity to nifedipine.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

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.
Branded Drugs
The following US Branded drugs contain Nifedipine


ADALAT -- BAYER PHARMACEUTICALS CORP

PROCARDIA -- PFIZER INC

ADALAT CC -- BAYER PHARMACEUTICALS CORP

AFEDITAB CR -- WATSON LABORATORIES INC

PROCARDIA XL -- PFIZER LABORATORIES DIV PFIZER INC


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