bisoprolol fumarate and hydrochlorothiazide 10 mg/1
bisoprolol fumarate and hydrochlorothiazide · TABLET · Unichem Pharmaceuticals (USA), Inc.
Bisoprolol Fumarate and Hydrochlorothiazide is a combination medication used to treat high blood pressure, containing a beta-blocker and a diuretic that work together to help lower blood pressure. This prescription tablet is taken by mouth and comes in a 10 mg/1 strength.
Key Facts
- Brand Name
- bisoprolol fumarate and hydrochlorothiazide
- Generic Name
- bisoprolol fumarate and hydrochlorothiazide
- NDC Code (Product)
29300-189- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA079106
- Drug Class
- Thiazide Diuretic [EPC]
- Marketing Start
- 10/12/2010
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
Glenmark Pharmaceuticals Inc., USA
Failed Impurities/Degradation Specifications
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 & USAGE Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.
Dosage & Administration
DOSAGE & ADMINISTRATION Bisoprolol is an effective treatment of hypertension in once-daily doses of 2.5 to 40 mg, while hydrochlorothiazide is effective in doses of 12.5 to 50 mg. In clinical trials of bisoprolol/hydrochlorothiazide combination therapy using bisoprolol doses of 2.5 to 20 mg and hydrochlorothiazide doses of 6.25 to 25 mg, the antihypertensive effects increased with increasing doses of either component. The adverse effects (see WARNINGS ) of bisoprolol are a mixture of dose-dependent phenomena (primarily bradycardia, diarrhea, asthenia, and fatigue) and dose-independent phenomena (eg, occasional rash); those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (eg, possibly pancreatitis); the dose- dependent phenomena for each being much more common than the dose-independent phenomena. The latter consist of those few that are truly idiosyncratic in nature or those that occur with such low frequency that a dose relationship may be difficult to discern. Therapy with a combination of bisoprolol and hydrochlorothiazide will be associated with both sets of dose- independent adverse effects, and to minimize…
Warnings
WARNINGS Cardiac 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 these agents. In such situations, they must be used cautiously. 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 and hydrochlorothiazide tablets should be considered. In some cases bisoprolol fumarate and hydrochlorothiazide tablet therapy can be continued while heart failure is treated with other drugs. Abrupt Cessation of Therapy Exacerbations 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 cautioned against interruption or discontinuation of therapy without the physician’s advice. Even in patients without overt coronary artery disease, it may be advisable to taper therapy with bisoprolol…
Contraindications
CONTRAINDICATIONS Bisoprolol fumarate and hydrochlorothiazide tablets are contraindicated in patients in cardiogenic shock, overt cardiac failure (see WARNINGS ), second or third degree AV block, marked sinus bradycardia, anuria, and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.
Adverse Reactions
ADVERSE REACTIONS Bisoprolol fumarate and hydrochlorothiazide tablets Bisoprolol fumarate/HCTZ 6.25 mg is well tolerated in most patients. Most adverse effects (AEs) have been mild and transient. In more than 65,000 patients treated worldwide with bisoprolol fumarate, occurrences of bronchospasm have been rare. Discontinuation rates for AEs were similar for bisoprolol fumarate/HCTZ 6.25 mg and placebo-treated patients. In the United States, 252 patients received bisoprolol fumarate (2.5, 5, 10, or 40 mg)/HCTZ 6.25 mg and 144 patients received placebo in two controlled trials. In Study 1, bisoprolol fumarate 5/HCTZ 6.25 mg was administered for 4 weeks. In Study 2, bisoprolol fumarate 2.5, 10, or 40/HCTZ 6.25 mg was administered for 12 weeks. All adverse experiences, whether drug related or not, and drug related adverse experiences in patients treated with bisoprolol fumarate 2.5 10/HCTZ 6.25 mg, reported during comparable, 4 week treatment periods by at least 2% of bisoprolol fumarate/HCTZ 6.25 mg-treated patients (plus additional selected adverse experiences) are presented in the following table: a) Averages adjusted to combine across studies. b) Combined across studies. Other adv…
Frequently Asked Questions
What is bisoprolol fumarate and hydrochlorothiazide used for?
Bisoprolol Fumarate and Hydrochlorothiazide is a combination medication used to treat high blood pressure, containing a beta-blocker and a diuretic that work together to help lower blood pressure. This prescription tablet is taken by mouth and comes in a 10 mg/1 strength.
Is bisoprolol fumarate and hydrochlorothiazide a controlled substance?
bisoprolol fumarate and hydrochlorothiazide is not classified as a controlled substance by the DEA.
What is the generic name for bisoprolol fumarate and hydrochlorothiazide?
The generic name for bisoprolol fumarate and hydrochlorothiazide is bisoprolol fumarate and hydrochlorothiazide. There are 8 other brand versions of bisoprolol fumarate and hydrochlorothiazide.
What is the NDC code for bisoprolol fumarate and hydrochlorothiazide 10 mg/1?
The NDC (National Drug Code) for bisoprolol fumarate and hydrochlorothiazide 10 mg/1 is 29300-189, listed by Unichem Pharmaceuticals (USA), Inc..
Other bisoprolol fumarate and hydrochlorothiazide Dosages
Other Bisoprolol Brands
See all →- Bisoprolol Fumarate and Hydrochlorothiazide5 mg/150090-7357
- Bisoprolol Fumarate and Hydrochlorothiazide2.5 mg/110135-740
- Bisoprolol Fumarate and Hydrochlorothiazide10 mg/110135-742
- Bisoprolol Fumarate and Hydrochlorothiazide5 mg/168462-879
- Bisoprolol Fumarate and Hydrochlorothiazide2.5 mg/10378-0501
- Bisoprolol Fumarate and Hydrochlorothiazide5 mg/170954-413
- Bisoprolol Fumarate and Hydrochlorothiazide2.5 mg/171335-1931
- Bisoprolol Fumarate and Hydrochlorothiazide5 mg/150090-6413
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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