Bisoprolol Fumarate Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
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 should be considered. In some cases, beta-blocker therapy can be continued while heart failure is treated with other drugs.
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 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 FUMARATE over approximately one week with the patient under careful observation. If withdrawal symptoms occur, BISOPROLOL FUMARATE therapy should be reinstituted, at least temporarily.
Beta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in such individuals.
PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS. Because of its relative beta1-selectivity, however, BISOPROLOL FUMARATE may be used with caution in patients with bronchospastic disease who do not respond to, or who cannot tolerate other antihypertensive treatment. Since beta1-selectivity is not absolute, the lowest possible dose of BISOPROLOL FUMARATE should be used, with therapy starting at 2.5 mg. A beta2 agonist (bronchodilator) should be made available.
If BISOPROLOL FUMARATE treatment is to be continued perioperatively, particular care should be taken when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. See OVERDOSAGE for information on treatment of bradycardia and hypotension.
Beta-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective beta-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. Because of its beta1-selectivity, this is less likely with BISOPROLOL FUMARATE. However, patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be cautioned about these possibilities and bisoprolol fumarate should be used with caution.
Beta-adrenergic blockade may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of beta-blockade may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate thyroid storm.
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FDA Safety Alerts
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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.
BISOPROLOL FUMARATE is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.
There is currently no drug history available for this drug.
BISOPROLOL FUMARATE USP is a synthetic, beta1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol ( E )-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2•C4H4O4 and its structure is:
Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform.
BISOPROLOL FUMARATE TABLETS USP are available as 5 and 10 mg tablets for oral administration.
Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch (Pregelatinized), Crospovidone, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80 and Titanium Dioxide. The 5 mg tablets also contain Red and Yellow Iron Oxide.
Bisoprolol Fumarate Manufacturers
- Rebel Distributors Corp
- Physicians Total Care, Inc.
- Unichem Pharmaceuticals (Usa), Inc.
- Aurobindo Pharma Limited
- Mylan Pharmaceuticals Inc.
- Eon Labs, Inc.
- American Health Packaging
- Greenstone Llc
- Bryant Ranch Prepack
- Teva Pharmaceuticals Usa Inc
- Carilion Materials Management
- Citron Pharma Llc
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