Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
ANI Pharmaceuticals, Inc.
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 - 2.5 mg/6.25 mg Tablets, USP (bisoprolol fumarate 2.5 mg and hydrochlorothiazide 6.25 mg): Yellow, round, uncoated, unscored tablets debossed “N” and “412” on one side and plain on the other side, supplied as follows: Bottle of 30 Tablets NDC 70954-412-10 Bottle of 100 Tablets NDC 70954-412-30 Bottle of 500 Tablets NDC 70954-412-40 Bisoprolol Fumarate and Hydrochlorothiazide - 5 mg/6.25 mg Tablets, USP (bisoprolol fumarate 5 mg and hydrochlorothiazide 6.25 mg): Pink, round, uncoated, unscored tablets debossed “N” and “413” on one side and plain on the other side, supplied as follows: Bottle of 30 Tablets NDC 70954-413-10 Bottle of 100 Tablets NDC 70954-413-30 Bottle of 500 Tablets NDC 70954-413-40 Bisoprolol Fumarate and Hydrochlorothiazide - 10 mg/6.25 mg Tablets, USP (bisoprolol fumarate 10 mg and hydrochlorothiazide 6.25 mg): Blue, round, uncoated, unscored tablets debossed “N” and “414” on one side and plain on the other side, supplied as follows: Bottle of 30 Tablets NDC 70954-414-10 Bottle of 100 Tablets NDC 70954-414-30 Bottle of 500 Tablets NDC 70954-414-40 Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520 Issued: 03/2024 LB4310-02
Abbreviated New Drug Application
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE - BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET ANI PHARMACEUTICALS, INC. ---------- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 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 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 formula is C H ClN O S and it has a molecular weight of 297.73. Its structural formula 1 18 31 4 2 4 4 4 7 8 3 4 2 is: Each bisoprolol fumarate and hydrochlorothiazide - 2.5 mg/6.25 mg tablet, USP for oral administration contains: Bisoprolol fumarate…………………………………………..2.5 mg Hydrochlorothiazide………………………………………..6.25 mg Each bisoprolol fumarate and hydrochlorothiazide - 5 mg/6.25 mg tablet, USP for Läs hela dokumentet