Bisoprolol Fumarate 10 mg/1
Bisoprolol Fumarate · TABLET, FILM COATED · Aurobindo Pharma Limited
Bisoprolol Fumarate is a tablet, film coated containing bisoprolol fumarate at 10 mg/1, taken oral. Manufactured by Aurobindo Pharma Limited.
Key Facts
- Brand Name
- Bisoprolol Fumarate
- Generic Name
- Bisoprolol Fumarate
- NDC Code (Product)
65862-087- Manufacturer
- Aurobindo Pharma Limited
- Strength
- 10 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077910
- Marketing Start
- 12/27/2006
Recall History
Unichem Pharmaceuticals USA Inc.
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Glenmark Pharmaceuticals Inc., USA
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Unichem Pharmaceuticals Usa Inc
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Glenmark Pharmaceuticals Inc., USA
Failed Impurities/Degradation Specifications
Teva Pharmaceuticals USA
Failed Dissolution Specifications: OOS result during stability testing
Aidapak Services, LLC
Labeling: Label Mixup; BISOPROLOL FUMARATE Tablet, 5 mg may be potentially mislabeled as: ESTROPIPATE, Tablet, 0.75 mg, NDC 00591041401, Pedigree: AD34934_4, EXP: 5/10/2014.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.
Dosage & Administration
DOSAGE AND ADMINISTRATION The dose of bisoprolol fumarate tablets must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily. In some patients, 2.5 mg may be an appropriate starting dose (see Bronchospastic Disease in WARNINGS ). If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily. Patients with Renal or Hepatic Impairment In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 mL/min), the initial daily dose should be 2.5 mg and caution should be used in dose-titration. Since limited data suggest that bisoprolol fumarate is not dialyzable, drug replacement is not necessary in patients undergoing dialysis. Geriatric Patients It is not necessary to adjust the dose in the elderly, unless there is also significant renal or hepatic dysfunction (see above and Geriatric Use in PRECAUTIONS ). Pediatric Patients There is no pediatric experience with bisoprolol fumarate tablets.
Warnings
WARNINGS Click here to enter Warnings Cardiac Failure Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and beta-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In general, beta-blocking agents should be avoided in patients with overt congestive failure. However, in some patients with compensated cardiac failure it may be necessary to utilize them. In such a situation, they must be used cautiously. In Patients Without a History of Cardiac Failure Continued depression of the myocardium with beta-blockers can, in some patients, precipitate cardiac failure. At the first signs or symptoms of heart failure, discontinuation of bisoprolol fumarate tablets should be considered. In some cases, beta-blocker therapy can be continued while heart failure is treated with other drugs. Abrupt Cessation of Therapy Exacerbation of angina pectoris, and, in some instances, myocardial infarction or ventricular arrhythmia, have been observed in patients with coronary artery disease following abrupt cessation of therapy with beta-blockers. Such patients should, therefore, be c…
Contraindications
CONTRAINDICATIONS Bisoprolol fumarate tablets are contraindicated in patients with cardiogenic shock, overt cardiac failure, second or third degree AV block, and marked sinus bradycardia.
Adverse Reactions
ADVERSE REACTIONS Safety data are available in more than 30,000 patients or volunteers. Frequency estimates and rates of withdrawal of therapy for adverse events were derived from two U.S. placebo-controlled studies. In Study A, doses of 5, 10, and 20 mg bisoprolol fumarate were administered for 4 weeks. In Study B, doses of 2.5, 10, and 40 mg of bisoprolol fumarate were administered for 12 weeks. A total of 273 patients were treated with 5-20 mg of bisoprolol fumarate; 132 received placebo. Withdrawal of therapy for adverse events was 3.3% for patients receiving bisoprolol fumarate and 6.8% for patients on placebo. Withdrawals were less than 1% for either bradycardia or fatigue/lack of energy. The following table presents adverse experiences, whether or not considered drug related, reported in at least 1% of patients in these studies, for all patients studied in placebo-controlled clinical trials (2.5-40 mg), as well as for a subgroup that was treated with doses within the recommended dosage range (5-20 mg). Of the adverse events listed in the table, bradycardia, diarrhea, asthenia, fatigue, and sinusitis appear to be dose related. Body System/Adverse Experience All Adverse Experi…
Frequently Asked Questions
What is Bisoprolol Fumarate used for?
Bisoprolol Fumarate contains Bisoprolol Fumarate. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Bisoprolol Fumarate a controlled substance?
Bisoprolol Fumarate is not classified as a controlled substance by the DEA.
What is the generic name for Bisoprolol Fumarate?
The generic name for Bisoprolol Fumarate is Bisoprolol Fumarate. There are 7 other brand versions of Bisoprolol Fumarate.
What is the NDC code for Bisoprolol Fumarate 10 mg/1?
The NDC (National Drug Code) for Bisoprolol Fumarate 10 mg/1 is 65862-087, listed by Aurobindo Pharma Limited.
Other Bisoprolol Brands
See all →- Bisoprolol Fumarate and Hydrochlorothiazide5 mg/150090-7357
- BISOPROLOL FUMARATE5 mg/170095-020
- bisoprolol fumarate and hydrochlorothiazide5 mg/171335-0595
- Bisoprolol5 mg/171335-1678
- Bisoprolol Fumarate and Hydrochlorothiazide2.5 mg/110135-740
- bisoprolol fumarate and hydrochlorothiazide10 mg/129300-189
- Bisoprolol10 mg/163629-6907
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)