Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
METHYLDOPA (UNII: 56LH93261Y) (METHYLDOPA ANHYDROUS - UNII:M4R0H12F6M), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Mylan Pharmaceuticals Inc.
METHYLDOPA
METHYLDOPA ANHYDROUS 250 mg
ORAL
PRESCRIPTION DRUG
Hypertension - (see box WARNING). Methyldopa and hydrochlorothiazide tablets are contraindicated in patients:
Methyldopa and Hydrochlorothiazide Tablets, USP are available containing 250 mg of methyldopa, USP (calculated as anhydrous) with 15 mg or 25 mg of hydrochlorothiazide, USP providing the following combinations: 250 mg/15 mg or 250 mg/25 mg. The 250 mg/15 mg tablets are green, film-coated, round, unscored tablets debossed with MYLAN on one side and 507 on the other side. They are available as follows: NDC 0378-0507-01 bottles of 100 tablets The 250 mg/25 mg tablets are green, film-coated, capsule-shaped, unscored tablets debossed with MYLAN on one side and 711 on the other side. They are available as follows: NDC 0378-0711-01 bottles of 100 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 4/2020 MDHZ:R6AQ
Abbreviated New Drug Application
METHYLDOPA AND HYDROCHLOROTHIAZIDE- METHYLDOPA AND HYDROCHLOROTHIAZIDE TABLET MYLAN PHARMACEUTICALS INC. ---------- WARNING This fixed combination drug is not indicated for initial therapy of hypertension. Hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension is not static, but must be re-evaluated as conditions in each patient warrant. DESCRIPTION This fixed combination product combines two antihypertensives: methyldopa and hydrochlorothiazide. METHYLDOPA Methyldopa is an antihypertensive and is the _L_-isomer of alpha-methyldopa. It is levo-3-(3,4- Dihydroxy-phenyl)-2-methylalanine sesquihydrate. Its molecular formula is C H NO •1 ⁄ H O with a molecular weight of 238.24, and its structural formula is: Methyldopa is a white to yellowish white, odorless fine powder and is sparingly soluble in water. HYDROCHLOROTHIAZIDE Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-Chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C H CIN O S and its structural formula is: Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.75 which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Each tablet for oral administration contains: 250 mg methyldopa and 15 mg 10 13 4 1 2 2 7 8 3 4 2 hydrochlorothiazide, or 250 mg methyldopa and 25 mg hydrochlorothiazide. Potency for methyldopa is calculated on anhydrous basis. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide and triacetin. C Lue koko asiakirja