Bisoprolol Fumarate (Bisoprolol Fumarate)

Trade Name : bisoprolol fumarate

Eon Labs, Inc.

TABLET, COATED

Strength 5 mg/1

BISOPROLOL FUMARATE Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Bisoprolol Fumarate (Bisoprolol Fumarate) which is also known as bisoprolol fumarate and Manufactured by Eon Labs, Inc.. It is available in strength of 5 mg/1 per ml. Read more

Bisoprolol Fumarate (Bisoprolol Fumarate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Bisoprolol fumarate tablets, USP (bisoprolol fumarate) is a synthetic, beta-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate, USP is (u00b1)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol()-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 activity. Its molecular formula is (CHNO)CHO and its structure is:
Bisoprolol fumarate has a molecular weight of 766.96. 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 mg and 10 mg tablets for oral administration.
The tablets contain the following inactive ingredients: colloidal silicon dioxide, corn starch, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate and titanium dioxide. In addition, the 5 mg tablets contain FD&C yellow No. 6 aluminum lake and FD&C red No. 40 aluminum lake.

Bisoprolol fumarate is a beta-selective (cardioselective) adrenoceptor blocking agent without significant membrane stabilizing activity or intrinsic sympathomimetic activity in its therapeutic dosage range. Cardioselectivity is not absolute, however, and at higher doses (greater than or equal to 20 mg) bisoprolol fumarate also inhibits beta-adrenoceptors, chiefly located in the bronchial and vascular musculature; to retain selectivity it is therefore important to use the lowest effective dose.

Bisoprolol fumarate tablets, USP are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.

Bisoprolol fumarate is contraindicated in patients with cardiogenic shock, overt cardiac failure, second or third degree AV block, and marked sinus bradycardia.

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Safety data are available in more than 30,000 patients or volunteers. Frequency estimates and rates of withdrawal of therapy for adverse events were derived from two U.S. placebo-controlled studies.
In Study A, doses of 5 mg, 10 mg, and 20 mg bisoprolol fumarate were administered for 4 weeks. In Study B, doses of 2.5 mg, 10 mg, and 40 mg of bisoprolol fumarate were administered for 12 weeks. A total of 273 patients were treated with 5 mg to 20 mg of bisoprolol fumarate; 132 received placebo.
Withdrawal of therapy for adverse events was 3.3% for patients receiving bisoprolol fumarate and 6.8% for patients on placebo. Withdrawals were less than 1% for either bradycardia or fatigue/lack of energy.
The following table presents adverse experiences, whether or not considered drug related, reported in at least 1% of patients in these studies, for all patients studied in placebo-controlled clinical trials (2.5 mg to 40 mg), as well as for a subgroup that was treated with doses within the recommended dosage range (5 mg to 20 mg). Of the adverse events listed in the table, bradycardia, diarrhea, asthenia, fatigue, and sinusitis appear to be dose related.
The following is a comprehensive list of adverse experiences reported with bisoprolol fumarate in worldwide studies, or in postmarketing experience (in italics):
Arrayn- Central Nervous System
Dizziness, vertigo, headache, paresthesia, hypoesthesia, hyperesthesia, somnolence, anxiety/restlessness, decreased concentration/memory.
Arrayn- Autonomic Nervous System
Dry mouth.
Arrayn- Cardiovascular
Bradycardia, palpitations and other rhythm disturbances, cold extremities, claudication, hypotension, orthostatic hypotension, chest pain, congestive heart failure, dyspnea on exertion.
Arrayn- Psychiatric
Vivid dreams, insomnia, depression.
Arrayn- Gastrointestinal
Gastric/epigastric/abdominal pain, gastritis, dyspepsia, nausea, vomiting, diarrhea, constipation, peptic ulcer.
Arrayn- Musculoskeletal
Muscle/joint pain, back/neck pain, muscle cramps, twitching/tremor.
Arrayn- Skin
Rash, acne, eczema, skin irritation, pruritus, flushing, sweating, alopecia, cutaneous vasculitis.
Arrayn- Special Senses
Visual disturbances, ocular pain/pressure, abnormal lacrimation, tinnitus, earache, taste abnormalities.
Arrayn- Metabolic
Gout.
Arrayn- Respiratory
Asthma/bronchospasm, bronchitis, coughing, dyspnea, pharyngitis, rhinitis, sinusitis, URI.
Arrayn- Genitourinary
Decreased libido/impotence, , cystitis, renal colic, polyuria.
Arrayn- Hematologic
Purpura.
Arrayn- 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:
Arrayn- 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.
Arrayn- Allergic
Fever, combined with aching and sore throat, laryngospasm, respiratory distress.
Arrayn- Hematologic
Agranulocytosis, thrombocytopenia, thrombocytopenic purpura.
Arrayn- Gastrointestinal
Mesenteric arterial thrombosis, ischemic colitis.
Arrayn- 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.
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 to 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 to 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.

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:

The dose of bisoprolol fumarate tablets 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.

Bisoprolol Fumarate Tablets, USP, for oral administration, are available as
Arrayn- 5 mg
Pink, round, biconvex, film-coated, debossed u201cu201d over u201c771u201d and bisected on the other side and supplied as:
NDC 0185-0771-30 bottles of 30
NDC 0185-0771-01 bottles of 100
Arrayn- 10 mg
White, round, biconvex, film-coated, debossed u201cu201d over u201c774u201d and plain on the other side and supplied as:
NDC 0185-0774-30 bottles of 30
NDC 0185-0774-01 bottles of 100
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
Protect from moisture.
Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.
KEEP TIGHTLY CLOSED.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured by
Sandoz Inc.
Princeton, NJ 08540
46192536
Rev. September 2016
MF0771REV09/16

NDC 0185-0771-30
Bisoprolol Fumarate Tablets, USP
5 mg
Rx only
30 Tablets
Sandoz

NDC 0185-0774-30
Bisoprolol Fumarate Tablets, USP
10 mg
Rx only
30 Tablets
Sandoz

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Bisoprolol Fumarate (Bisoprolol Fumarate)

Trade Name : bisoprolol fumarate

TABLET, COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Bisoprolol Fumarate (Bisoprolol Fumarate)

Trade Name : bisoprolol fumarate

TABLET, COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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