Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
REMEDYREPACK 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.
The 10 mg/6.25 mg tablets are white, film-coated, round, unscored tablets debossed with 505 on one side of the tablet and M on the other side. They are available as follows: NDC: 70518-3207-00 PACKAGING: 90 in 1 BOTTLE PLASTIC Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED REMEDYREPACK INC. ---------- 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-[[α-(2-Isopropoxyethoxy)-4-toly]oxy]- 3-(isopropylamino)-2-propanol fumarate (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 (C H NO ) •C H O and it has a molecular weight of 766.97. Its structural formula is: Bisoprolol fumarate, USP 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 molecular 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, for oral administration, 1 18 31 4 2 4 4 4 7 8 3 4 2 Each bisoprolol fumarate and hydrochlorothiazide tablet, for oral administration, contains one of the following combinations of bisoprolol fumarate/hydrochlorothiazide: 2.5 mg/6.25 mg, 5 mg/6.25 mg or 10 mg/6.25 mg. Each tablet also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, h Belgenin tamamını okuyun