Afeditab Cr
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Questions & Answers
Side Effects & Adverse Reactions
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 Patients recently withdrawn from beta-blockers may develop a withdrawal syndrome with increased angina, probably related to increased sensitivity to catecholamines.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.
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
Afeditab® CR is 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
Afeditab® CR is 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.
Afeditab® CR tablets contain either 30 mg or 60 mg of nifedipine for once-a-day oral administration.
Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate (60 mg), magnesium stearate, and microcrystalline cellulose (30 mg). The inert ingredients in the film coating are: hypromellose, iron oxide, polyethylene glycol, and titanium dioxide. The ingredients of the printing ink are: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac.
Does not meet USP Drug Release Test
Sources
Afeditab Cr Manufacturers
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Bryant Ranch Prepack
![Afeditab Cr (Nifedipine) Tablet, Film Coated, Extended Release [Bryant Ranch Prepack]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Afeditab Cr | Bryant Ranch Prepack
Dosage should be adjusted according to each patient’s needs. It is recommended that nifedipine extended-release tablets be administered orally once daily on an empty stomach. Afeditab® CR 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 Afeditab® CR 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 (SeeCLINICAL PHARMACOLOGY andPRECAUTIONS).
Care should be taken when dispensing Afeditab® CR to assure that the extended-release dosage form has been prescribed.
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Watson Laboratories, Inc.
Afeditab Cr | Actavis Pharma, Inc.
Dosage should be adjusted according to each patient’s needs. It is recommended that nifedipine extended-release tablets be administered orally once daily on an empty stomach. Afeditab® CR 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 Afeditab® CR 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 Afeditab® CR to assure that the extended-release dosage form has been prescribed.
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Aphena Pharma Solutions – Tennessee, Llc
Afeditab Cr | Aphena Pharma Solutions - Tennessee, Llc
Dosage should be adjusted according to each patient’s needs. It is recommended that nifedipine extended-release tablets be administered orally once daily on an empty stomach. Afeditab® CR 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 Afeditab® CR 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 (SeeCLINICAL PHARMACOLOGY andPRECAUTIONS).
Care should be taken when dispensing Afeditab® CR to assure that the extended-release dosage form has been prescribed.
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Carilion Materials Management
Afeditab Cr | Carilion Materials Management
Dosage should be adjusted according to each patient’s needs. It is recommended that nifedipine extended-release tablets be administered orally once daily on an empty stomach. Afeditab CR 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 Afeditab CR 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 and ). ®CLINICAL PHARMACOLOGYPRECAUTIONS
Care should be taken when dispensing Afeditab CR to assure that the extended-release dosage form has been prescribed. ®
![Afeditab Cr (Nifedipine) Tablet, Film Coated, Extended Release [Watson Laboratories, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ad65c43d-91c7-4c7c-b16f-5025c764cad6&name=nifedipine-extended-release-tablets---afeditab-cr-2.jpg)
![Afeditab Cr (Nifedipine) Tablet, Film Coated, Extended Release [Aphena Pharma Solutions – Tennessee, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=323351d8-de18-4cd6-9497-c2d5e8666414&name=43353-782.jpg)
![Afeditab Cr (Nifedipine) Tablet, Film Coated, Extended Release [Carilion Materials Management]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8343a631-be3a-43a6-9f43-03fdf7458f24&name=68151-4223.jpg)
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