Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
A-S Medication Solutions
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.
Product: 50090-5905 NDC: 50090-5905-0 30 TABLET, FILM COATED in a BOTTLE
Abbreviated New Drug Application
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE - BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED A-S MEDICATION SOLUTIONS ---------- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS DESCRIPTION BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS, USP RX ONLY REVISED MARCH 2021 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…................................................ Les hele dokumentet