Bisoprolol Fumarate (Page 4 of 4)
OVERDOSAGE
The most common signs expected with overdosage of a beta-blocker are bradycardia, hypotension, congestive heart failure, bronchospasm, and hypoglycemia. To date, a few cases of overdose (maximum: 2000 mg) with bisoprolol fumarate have been reported. Bradycardia and/or hypotension were noted. Sympathomimetic agents were given in some cases, and all patients recovered.
In general, if overdose occurs, BISOPROLOL FUMARATE therapy should be stopped and supportive and symptomatic treatment should be provided. Limited data suggest that bisoprolol fumarate is not dialyzable. Based on the expected pharmacologic actions and recommendations for other beta-blockers, the following general measures should be considered when clinically warranted:
Bradycardia
Administer IV atropine. If the response is inadequate, isoproterenol or another agent with positive chronotropic properties may be given cautiously. Under some circumstances, transvenous pacemaker insertion may be necessary.
Hypotension
IV fluids and vasopressors should be administered. Intravenous glucagon may be useful.
Heart Block (second or third degree)
Patients should be carefully monitored and treated with isoproterenol infusion or transvenous cardiac pacemaker insertion, as appropriate.
Congestive Heart Failure
Initiate conventional therapy (i.e., digitalis, diuretics, inotropic agents, vasodilating agents).
Bronchospasm
Administer bronchodilator therapy such as isoproterenol and/or aminophylline.
Hypoglycemia
Administer IV glucose.
DOSAGE & ADMINISTRATION
The dose of BISOPROLOL FUMARATE 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.
HOW SUPPLIED
NDC: 71335-2178-1: 30 Tablets in a BOTTLE
NDC: 71335-2178-2: 100 Tablets in a BOTTLE
NDC: 71335-2178-3: 90 Tablets in a BOTTLE
NDC: 71335-2178-4: 28 Tablets in a BOTTLE
NDC: 71335-2178-5: 120 Tablets in a BOTTLE
Bisoprolol Fumarate 5mg Tablet
| BISOPROLOL FUMARATE bisoprolol fumarate tablet | |||||||||||||||||||||||||||||
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| Labeler — Bryant Ranch Prepack (171714327) |
| Registrant — Bryant Ranch Prepack (171714327) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bryant Ranch Prepack | 171714327 | REPACK (71335-2178), RELABEL (71335-2178) | |
Revised: 10/2022 Bryant Ranch Prepack
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