CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Disponible des:

Mylan Pharmaceuticals Inc.

Designació comuna internacional (DCI):

CANDESARTAN CILEXETIL

Composición:

CANDESARTAN CILEXETIL 16 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexetil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joi

Resumen del producto:

Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP are available containing 16 mg or 32 mg of candesartan cilexetil, USP and 12.5 mg or 25 mg of hydrochlorothiazide, USP providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg. The 16 mg/12.5 mg tablets are peach, mottled, round, scored tablets debossed with M on the left side of the score and X on the right side of the score on one side of the tablet and C1 on the other side of the tablet. They are available as follows: NDC 0378-3001-77 bottles of 90 tablets NDC 0378-3001-05 bottles of 500 tablets The 32 mg/12.5 mg tablets are yellow, mottled, round, scored tablets debossed with M on the left side of the score and X on the right side of the score on one side of the tablet and C2 on the other side of the tablet. They are available as follows: NDC 0378-3002-77 bottles of 90 tablets NDC 0378-3002-05 bottles of 500 tablets The 32 mg/25 mg tablets are peach, mottled, round, scored tablets debossed with M on the left of the score and X on the right of the score on one side of the tablet and C3 on the other side of the tablet. They are available as follows: NDC 0378-3003-77 bottles of 90 tablets NDC 0378-3003-05 bottles of 500 tablets 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. Keep container tightly closed. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India 75076992 Revised: 8/2020 MX:CNDHTZ:R10

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE- CANDESARTAN CILEXETIL
AND
HYDROCHLOROTHIAZIDE TABLET
MYLAN PHARMACEUTICALS INC.
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WARNING: FETAL TOXICITY
•
•
DESCRIPTION
Candesartan cilexetil and hydrochlorothiazide tablets, USP combine an
angiotensin II receptor (type
AT ) antagonist and a diuretic, hydrochlorothiazide.
Candesartan cilexetil, a nonpeptide, is chemically described as
(±)2-Ethoxy-1-[[2’-(1_H_-tetrazol-5-
yl)[1,1’-biphenyl]-4-yl]methyl]-1_H_-benzimidazole-7-carboxylic
acid-1-
[[(cyclohexyloxy)carbonyl]oxy]ethyl ester.
Its molecular formula is C
H N O , and its structural formula is:
Candesartan cilexetil, USP is a white to off-white powder with a
molecular weight of 610.66. It is
practically insoluble in water and sparingly soluble in methanol.
Candesartan cilexetil is a racemic
mixture containing one chiral center at the cyclohexyloxycarbonyloxy
ethyl ester group. Following oral
administration, candesartan cilexetil undergoes hydrolysis at the
ester link to form the active drug,
candesartan, which is achiral.
Hydrochlorothiazide is 2H-1,2,4-Benzothiadiazine-7-sulfonamide,
6-chloro-3,4-dihydro-,1,1-dioxide.
Its molecular formula is C H ClN O S and its structural formula is:
WHEN PREGNANCY IS DETECTED, DISCONTINUE CANDESARTAN CILEXETIL AND
HYDROCHLOROTHIAZIDE TABLETS AS SOON AS POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO
THE DEVELOPING FETUS. SEE WARNINGS: FETAL TOXICITY.
1
33
34
6
6
7
8
3
4
2
Hydrochlorothiazide, USP is a white, or practically white, practically
odorless crystalline powder with
a molecular weight of 297.7, which is slightly soluble in water, but
freely soluble in sodium hydroxide
solution.
Candesartan cilexetil and hydrochlorothiazide tablets are available
for oral administration in three tablet
strengths of candesartan cilexetil and hydrochlorothiazide.
Candesartan cilexetil and hydrochlorothiazide tablets contain 16 mg or
32 mg of candesartan cilexetil
and 12.5 mg or 25 mg of hydrochlorothiazide providing for th