Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH), BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U)
RedPharm Drug, Inc.
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE 6.25 mg
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 USP are supplied as 2.5 mg/6.25 mg Light yellow coloured, biconvex, round, film coated tablets debossed with UL on one side and | on other side. Bottles of 30: NDC 29300-187-13 Bottles of 100: NDC 29300-187-01 Bottles of 500: NDC 29300-187-05 Bottles of 1000: NDC 29300-187-10 5 mg/6.25 mg Salmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side. Bottles of 30: NDC 29300-188-13 Bottles of 100: NDC 29300-188-01 Bottles of 500: NDC 29300-188-05 Bottles of 1000: NDC 29300-188-10 10 mg/6.25 mg White coloured, biconvex, round, film coated tablets debossed with UL on one side and | | | on other side. Bottles of 30: NDC 29300-189-13 Bottles of 100: NDC 29300-189-01 Bottles of 500: NDC 29300-189-05 Bottles of 1000: NDC 29300-189-10 Store at 200 to 250C (680 to 770F) [See USP Controlled Room Temperature]. Dispense in a tight container. Please address medical inquiries to Unichem's toll free # 1-866-562-4616.
Abbreviated New Drug Application
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET REDPHARM DRUG, INC. ---------- SPL UNCLASSIFIED SECTION Rx only 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 beta1-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 molecular formula is (C18H31NO4)2•C4H4O4 and it has a molecular weight of 766.97. Its structural formula is: [Bisoprolol Fumarate] 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-2H-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 molecular formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is: [Hydrochlorothiazide] Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 2.5 mg/6.25 mg for oral administration contains: Bisoprolol fumarate USP….. 2.5 mg Hydrochlorothiazide USP…. 6.25 mg Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 5 mg/6.25 mg for oral administration contains: Bisoprolol fumarate USP….. 5 mg Hydrochlorothiazide USP…. 6.25 mg Each Bi Прочитајте комплетан документ