Bisoprolol Fumarate (Page 4 of 4)
Central Nervous System
Dizziness, , vertigo, , headache, paresthesia, hypoesthesia, hyperesthesia, somnolence, , anxiety/restlessness, decreased concentration/memory. unsteadiness syncope sleep disturbances
Autonomic Nervous System
Cardiovascular
Bradycardia, palpitations and other rhythm disturbances, cold extremities, claudication, hypotension, orthostatic hypotension, chest pain, congestive heart failure, dyspnea on exertion
Psychiatric
Vivid dreams, insomnia, depression.
Gastrointestinal
Gastric/epigastric/abdominal pain, gastritis, dyspepsia, nausea, vomiting, diarrhea, constipation, peptic ulcer
Musculoskeletal
Muscle/joint pain, , back/neck pain, muscle cramps, twitching/tremor. arthralgia
Skin
Rash, acne, eczema, , skin irritation, pruritus, flushing, sweating, alopecia, , , , cutaneous vasculitis psoriasis dermatitis angioedema exfoliative dermatitis
Special Senses
Visual disturbances, ocular pain/pressure, abnormal lacrimation, tinnitus, , earache, taste abnormalities. decreased hearing
Metabolic
Respiratory
Asthma/bronchospasm, bronchitis, coughing, dyspnea, pharyngitis, rhinitis, sinusitis, URI.
Genitourinary
Decreased libido/impotence, , cystitis, renal colic, polyuria. Peyronie’s disease
Hematologic
General
Fatigue, asthenia, chest pain, malaise, edema, weight gain, angioedema.
In addition, a variety of adverse effects have been reported with other beta-adrenergic blocking agents and should be considered potential adverse effects of BISOPROLOL FUMARATE:
Central Nervous System
Reversible mental depression progressing to catatonia, hallucinations, an acute reversible syndrome characterized by disorientation to time and place, emotional lability, slightly clouded sensorium.
Allergic
Fever, combined with aching and sore throat, laryngospasm, respiratory distress.
Hematologic
Agranulocytosis, thrombocytopenia, thrombocytopenic purpura.
Gastrointestinal
Mesenteric arterial thrombosis, ischemic colitis.
Miscellaneous
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with BISOPROLOL FUMARATE during investigational use or extensive foreign marketing experience.
Laboratory Abnormalities
In clinical trials, the most frequently reported laboratory change was an increase in serum triglycerides, but this was not a consistent finding.
Sporadic liver test abnormalities have been reported. In the U.S. controlled trials experience with bisoprolol fumarate treatment for 4-12 weeks, the incidence of concomitant elevations in SGOT and SGPT from 1 to 2 times normal was 3.9%, compared to 2.5% for placebo. No patient had concomitant elevations greater than twice normal.
In the long-term, uncontrolled experience with bisoprolol fumarate treatment for 6-18 months, the incidence of one or more concomitant elevations in SGOT and SGPT from 1 to 2 times normal was 6.2%. The incidence of multiple occurrences was 1.9%. For concomitant elevations in SGOT and SGPT of greater than twice normal, the incidence was 1.5%. The incidence of multiple occurrences was 0.3%. In many cases these elevations were attributed to underlying disorders, or resolved during continued treatment with bisoprolol fumarate.
Other laboratory changes included small increases in uric acid, creatinine, BUN, serum potassium, glucose, and phosphorus and decreases in WBC and platelets. These were generally not of clinical importance and rarely resulted in discontinuation of bisoprolol fumarate.
As with other beta-blockers, ANA conversions have also been reported on bisoprolol fumarate. About 15% of patients in long-term studies converted to a positive titer, although about one-third of these patients subsequently reconverted to a negative titer while on continued therapy.
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 AND 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 ). 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. Bronchospastic Disease in WARNINGS
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:68151-4504-0 in a PACKAGE of 1 TABLETS
Manufactured by:
UNICHEM LABORATORIES LTD.
Pilerne Ind.Estate, Pilerne, Bardez,
Goa 403511 India.
Marketed by:

13004178
R-01-07/2011
Bisoprolol Fumarate 5 MG TAB

PRINCIPAL DISPLAY PANEL – 5 MG
NDC 29300-126-01
Bisoprolol Fumarate Tablets USP
5 mg
Rx Only
100 Tablets
Each tablet contains:
Bisoprolol Fumarate USP………..5 mg
Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch (Pregelatinized), Crospovidone, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide, Red and Yellow Iron Oxide.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Protect from moisture. Dispense in a tight, light-resistant container.
For complete directions for use, see accompanying circular. Dosage:
13004178
R-01-07/2011
Manufactured by:
UNICHEM LABORATORIES LTD.
Pilerne Ind. Estate, Pilerne, Bardez,
Goa 403 511, India
Marketed by:

PRINCIPAL DISPLAY PANEL – 10 MG
NDC 29300-127-13
Bisoprolol Fumarate Tablets USP
10 mg
Rx Only
30 Tablets
Each tablet contains:
Bisoprolol Fumarate USP………..10 mg
Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch (Pregelatinized), Crospovidone, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Protect from moisture. Dispense in a tight, light-resistant container.
For complete directions for use, see accompanying circular. Dosage:
13004178
R-01-07/2011
Manufactured by:
UNICHEM LABORATORIES LTD.
Pilerne Ind. Estate, Pilerne, Bardez,
Goa 403 511, India
Marketed by:

PRINCIPAL DISPLAY PANEL – 10 MG
NDC 29300-127-01
Bisoprolol Fumarate Tablets USP
10 mg
Rx Only
100 Tablets
Each tablet contains:
Bisoprolol Fumarate USP……….10 mg
Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch (Pregelatinized), Crospovidone, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Protect from moisture. Dispense in a tight, light-resistant container.
For complete directions for use, see accompanying circular. Dosage:
13004178
R-01-07/2011
Manufactured by:
UNICHEM LABORATORIES LTD.
Pilerne Ind. Estate, Pilerne, Bardez,
Goa 403 511, India
Marketed by:

BISOPROLOL FUMARATE bisoprolol fumarate tablet | ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
|
Labeler — Carilion Materials Management (079239644) |
Registrant — Carilion Materials Management (079239644) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Carilion Materials Management | 079239644 | REPACK (68151-4504) |
Revised: 09/2011 Carilion Materials Management
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/bisoprolol-fumarate-3/page/4/