METHYLDOPA AND HYDROCHLOROTHIAZIDE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

METHYLDOPA (UNII: 56LH93261Y) (METHYLDOPA ANHYDROUS - UNII:M4R0H12F6M), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Inapatikana kutoka:

Mylan Pharmaceuticals Inc.

INN (Jina la Kimataifa):

METHYLDOPA

Tungo:

METHYLDOPA ANHYDROUS 250 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Hypertension - (see box WARNING). Methyldopa and hydrochlorothiazide tablets are contraindicated in patients:

Bidhaa muhtasari:

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

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

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