Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Edenbridge Pharmaceuticals LLC.
ORAL
PRESCRIPTION DRUG
Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension. Bisoprolol fumarate and hydrochlorothiazide tablets are contraindicated in patients in cardiogenic shock, overt cardiac failure (see WARNINGS ), second or third degree AV block, marked sinus bradycardia, anuria, and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.
Bisoprolol fumarate and hydrochlorothiazide tablets, 2.5 mg/6.25 mg: Yellow, round, biconvex, film-coated, unscored tablets, debossed with “920” on one side and plain on the reverse side, supplied as follows: Bisoprolol fumarate and hydrochlorothiazide tablets, 5 mg/6.25 mg: Pink, round, biconvex, film-coated, unscored tablets, debossed with “921” on one side and plain on the reverse side, supplied as follows: Bisoprolol fumarate and hydrochlorothiazide tablets, 10 mg/6.25 mg: White to off-white, round, biconvex, film-coated, unscored tablets, debossed with “922” on one side and plain on the reverse side, supplied as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Edenbridge Pharmaceuticals, LLC Parsippany, New Jersey, 07054 Revised January 2024
Abbreviated New Drug Application
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE - BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED EDENBRIDGE PHARMACEUTICALS LLC. ---------- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS DESCRIPTION BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS, USP RX ONLY REVISED JANUARY 2024 DESCRIPTION Bisoprolol fumarate and hydrochlorothiazide tablets, USP, are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta -selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-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. Its empirical formula is (C H NO ) •C H O and it has a molecular weight of 766.97. Its structural formula is: Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7- sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical 1 18 31 4 2 4 4 4 formula is C H ClN O S and it has a molecular weight of 297.73. Its structural formula is: Each bisoprolol fumarate and hydrochlorothiazide tablet 2.5 mg/6.25 mg for oral administration contains: Bisoprolol fumarate....................................................... 2.5 mg Hydrochlorothiazide…..................................... Przeczytaj cały dokument