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

Dry mouth

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

Gout

Respiratory

Asthma/bronchospasm, bronchitis, coughing, dyspnea, pharyngitis, rhinitis, sinusitis, URI.

Genitourinary

Decreased libido/impotence, , cystitis, renal colic, polyuria. Peyronie’s disease

Hematologic

Purpura.

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:

Company Logo

Rochelle Park, NJ 07662

13004178

R-01-07/2011

Bisoprolol Fumarate 5 MG TAB

Label ImageLabel Image

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:

Company Logo

Rochelle Park, NJ 07662.

5 mg 100 tablets
(click image for full-size original)

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:

Company Logo

Rochelle Park, NJ 07662.

10 mg 30 tablets
(click image for full-size original)

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:

Company Logo

Rochelle Park, NJ 07662.

10 mg 100 tablets
(click image for full-size original)
BISOPROLOL FUMARATE bisoprolol fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-4504(NDC:29300-126)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISOPROLOL FUMARATE (BISOPROLOL) BISOPROLOL FUMARATE 5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
CROSPOVIDONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POLYSORBATE 80
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code UL;5;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-4504-0 1 TABLET (1 TABLET) in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078635 09/21/2009
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

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