Nifedipine 90 mg/1
nifedipine · TABLET, EXTENDED RELEASE · Ingenus Pharmaceuticals, LLC
Nifedipine is a tablet, extended release containing nifedipine at 90 mg/1, taken oral. Manufactured by Ingenus Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Nifedipine
- Generic Name
- nifedipine
- NDC Code (Product)
50742-622- Manufacturer
- Ingenus Pharmaceuticals, LLC
- Strength
- 90 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202987
- Drug Class
- Dihydropyridine Calcium Channel Blocker [EPC]
- Marketing Start
- 02/15/2017
Recall History
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Aidapak Services, LLC
Labeling: Label Mixup; NIFEDIPINE Capsule, 10 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F), NDC 64376081501, Pedigree: AD22609_7, EXP: 5/2/2014; NIFEDIPINE, Capsule, 10 mg, NDC 43386044024, Pedigree: AD23082_7, EXP: 9/23/2013.
Alvogen, Inc
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Greenstone Llc
Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months.
Alvogen, Inc
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Amerisource Health Services
Presence of Foreign Tablets/Capsules
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Aidapak Services, LLC
Labeling:Label Mixup; NIFEdipine, Capsule, 10 mg may be potentially mislabeled as NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg, NDC 47781030301, Pedigree: AD52778_58, EXP: 5/20/2014.
Aidapak Services, LLC
Labeling: Label Mixup: NIFEdipine ER, Tablet, 60 mg may have potentially been mislabeled as the following drug: NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001, Pedigree: W003749, EXP: 6/26/2014.
Alvogen, Inc
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS & USAGE I. Vasospastic Angina Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers. II. Chronic Stable Angina (Classical Effort-Associated Angina) Nifedipine extended-release tablets are indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospa…
Dosage & Administration
DOSAGE & ADMINISTRATION Dosage must be adjusted according to each patient’s needs. Therapy for either hypertension or angina should be initiated with 30 or 60 mg once daily. Nifedipine Extended-Release Tablets USP should be swallowed whole and should not be bitten or divided. In general, titration should proceed over a 7 to 14 day period so that the physician can fully assess the response to each dose level and monitor blood pressure before proceeding to higher doses. Since steady-state plasma levels are achieved on the second day of dosing, titration may proceed more rapidly, if symptoms so warrant, provided the patient is assessed frequently. Titration to doses above 120 mg are not recommended. Angina patients controlled on nifedipine capsules alone or in combination with other antianginal medications may be safely switched to nifedipine extended-release tablets at the nearest equivalent total daily dose (e.g., 30 mg t.i.d. of nifedipine capsules may be changed to 90 mg once daily of nifedipine extended-release tablets). Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. Experience with doses greater than 90 mg in patie…
Warnings
WARNINGS Excessive Hypotension Although in most angina 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 on concomitant beta blockers. Severe hypotension and/or increased fluid volume requirements have been reported in patients receiving nifedipine together with a beta-blocking agent 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 p…
Contraindications
CONTRAINDICATIONS Known hypersensitivity reaction to nifedipine.
Adverse Reactions
ADVERSE EXPERIENCES Over 1000 patients from both controlled and open trials with nifedipine extended-release tablets in hypertension and angina were included in the evaluation of adverse experiences. All side effects reported during nifedipine extended-release tablets therapy were tabulated independent of their causal relation to medication. The most common side effect reported with nifedipine extended-release tablets was edema which was dose related and ranged in frequency from approximately 10% to about 30% at the highest dose studied (180 mg). Other common adverse experiences reported in placebo-controlled trials include: Nifedipine Extended-Release Tablets (%) (N=707) Placebo (%) (N=266) Adverse Effect Headache 15.8 9.8 Fatigue 5.9 4.1 Dizziness 4.1 4.5 Constipation 3.3 2.3 Nausea 3.3 1.9 Of these, only edema and headache were more common in nifedipine extended-release tablets patients than placebo patients. The following adverse reactions occurred with an incidence of less than 3.0%. With the exception of leg cramps, the incidence of these side effects was similar to that of placebo alone. Body as a Whole/Systemic: asthenia, flushing, pain Cardiovascular: palpitations Central …
Frequently Asked Questions
What is Nifedipine used for?
Nifedipine contains nifedipine. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Nifedipine a controlled substance?
Nifedipine is not classified as a controlled substance by the DEA.
What is the generic name for Nifedipine?
The generic name for Nifedipine is nifedipine. There are 2 other brand versions of nifedipine.
What is the NDC code for Nifedipine 90 mg/1?
The NDC (National Drug Code) for Nifedipine 90 mg/1 is 50742-622, listed by Ingenus Pharmaceuticals, LLC.