Nifedipine Extended Release
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Questions & Answers
Side Effects & Adverse Reactions
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.
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.
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 Patients recently withdrawn from beta blockers may develop a withdrawal syndrome with increased angina, probably related to increased sensitivity to catecholamines.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 (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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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.
History
There is currently no drug history available for this drug.
Other Information
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, C17H18N2O6, and has the structural formula:
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 90 mg of nifedipine, USP for once-a-day oral administration.
Inert ingredients in the formulation are: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, and povidone. The inert ingredients in the film coating are: hypromellose, polydextrose, polyethylene glycol, titanium dioxide, triacetin, and yellow iron oxide.
Dissolution test is pending.
Sources
Nifedipine Extended Release Manufacturers
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American Health Packaging
![Nifedipine Extended Release (Nifedipine) Tablet, Extended Release [American Health Packaging]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Nifedipine Extended Release | American Health Packaging
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. Nifedipine extended-release is 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 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 to assure that the extended release dosage form has been prescribed.
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American Health Packaging
Nifedipine Extended Release | American Health Packaging
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. 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.
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Par Pharmaceutical, Inc.
Nifedipine Extended Release | Par Pharmaceutical, Inc.
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. Nifedipine extended-release is 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 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 to assure that the extended release dosage form has been prescribed.
-
Par Pharmaceutical, Inc.
Nifedipine Extended Release | Par Pharmaceutical, Inc.
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. 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.
-
Lake Erie Medical Dba Quality Care Products Llc
Nifedipine Extended Release | Lake Erie Medical Dba Quality Care Products Llc
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. 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.
-
Lake Erie Medical Dba Quality Care Products Llc
Nifedipine Extended Release | Lake Erie Medical Dba Quality Care Products Llc
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. Nifedipine extended-release is 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 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 to assure that the extended release dosage form has been prescribed.
-
State Of Florida Doh Central Pharmacy
Nifedipine Extended Release | State Of Florida Doh Central Pharmacy
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. 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.
![Nifedipine Extended Release (Nifedipine) Tablet, Extended Release [American Health Packaging]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=997db376-9f25-4a99-a5b8-52c88f23baf6&name=0297932_0115_Nifedipine30mg_V1-FINAL-print.jpg)
![Nifedipine Extended Release (Nifedipine) Tablet, Extended Release [Par Pharmaceutical, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=912b0ad4-86e3-4993-88d1-006ffca3f4a0&name=0fffb6c5-figure-01.jpg)
![Nifedipine Extended Release (Nifedipine) Tablet, Extended Release [Par Pharmaceutical, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4617417a-08df-4417-a944-dfc30de183db&name=be0ad7fd-figure-01.jpg)
![Nifedipine Extended Release (Nifedipine) Tablet, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8dc63e02-43c6-47ef-9c82-8edccedabcbc&name=NifedipineER60mgPar.jpg)
![Nifedipine Extended Release (Nifedipine) Tablet, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=28a716b5-4bcd-44c1-be8b-546ab3e238cf&name=NifediphineER90mgPar.jpg)
![Nifedipine Extended Release (Nifedipine) Tablet, Extended Release [State Of Florida Doh Central Pharmacy]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6e740c6e-483b-4e7d-833f-2e8bdd36d625&name=30mg100mgpar.jpg)
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