Prescription Drugs-B - Bisoprolol Fumarate - Bisoprolol Fumerate 5mg Tablets 1X30 each Mfg.by: Greenstone Limited USA

Bisoprolol Fumerate 5mg Tablets 1X30 each Mfg.by: Greenstone Limited USA

This item requires a valid order from a physician licensed in the USA. Item No.: RXD4223111 NDC No.: 59762-1258-01 Compare to: UPC No.: 359762125811 Mfg.Item No.:125801

$ 39.39
Please Provide Us The Name, Address, Phone #, Fax #, State Lic.#, Name Of State, Dea#, And Npi# Of Ordering Physician. Please Provide All Information Available And Ask Your Physician To Fax Us The Prescription At 760-344-6321 For The Quantity.
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Compare To: Zebeta®

DESCRIPTION

ZEBETA (bisoprolol fumarate) 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.

ZEBETA is available as 5 and 10 mg tablets for oral administration.

Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, 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.

INDICATIONS

ZEBETA is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.
DOSAGE AND ADMINISTRATION

The dose of ZEBETA 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.

SIDE EFFECTS

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, 10, and 20 mg bisoprolol fumarate were administered for 4 weeks. In Study B, doses of 2.5, 10, and 40 mg of bisoprolol fumarate were administered for 12 weeks. A total of 273 patients were treated with 5-20 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 (2.5-40 mg), as well as for a subgroup that was treated with doses within the recommended dosage range (5-20 mg). Of the adverse events listed in the table, bradycardia, diarrhea, asthenia, fatigue, and sinusitis appear to be dose related.

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