CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Solco Healthcare LLC

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

Candesartan cilexetil and hydrochlorothiazide tablets 16 mg/12.5 mg, are white to off-white, oval, biconvex, non-film-coated tablets, scored on both sides and debossed with “588” on one side and “P” on the other side. They are supplied as follows: NDC 43547-459-09      bottles of 90 NDC 43547-459-50      bottles of 500 Candesartan cilexetil and hydrochlorothiazide tablets 32 mg/12.5 mg, are yellow, oval, biconvex, non-film-coated tablets, scored on both sides and debossed with “589” on one side and “P” on the other side. They are supplied as follows: NDC 43547-460-09      bottles of 90 NDC 43547-460-50      bottles of 500 Candesartan cilexetil and hydrochlorothiazide tablets 32 mg/25 mg, are white to off-white, oval, biconvex, non-film-coated tablets, scored on both sides and debossed with “590” on one side and “P” on the other side. They are supplied as follows: NDC 43547-461-09      bottles of 90 NDC 43547-461-50      bottles of 500 Storage: Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088. Distributed by:     Solco Healthcare US, LLC                              Somerset, NJ 08873, USA Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd.                               Xunqiao, Linhai, Zhejiang, 317024, China                                                                                                                                              Revised: 05/2021                                                                                                                                                         200561-02

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE- CANDESARTAN CILEXETIL
AND HYDROCHLOROTHIAZIDE TABLET
SOLCO HEALTHCARE LLC
----------
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS, 16 MG/12.5 MG,
FOR
ORAL USE/CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLETS, 32
MG/12.5
MG, FOR ORAL USE/CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
TABLETS, 32
MG/25 MG, FOR ORAL USE
WARNING: FETAL TOXICITY
•
•
DESCRIPTION
Candesartan cilexetil and hydrochlorothiazide tablets combine an
angiotensin II receptor
(type AT ) antagonist and a diuretic, hydrochlorothiazide.
Candesartan cilexetil, a nonpeptide, is chemically described as
(±)-1-Hydroxyethyl 2-
ethoxy-1-[_p_-(_o_-1_H_-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate,
cyclohexyl
carbonate (ester).
Its empirical formula is C
H
N O and its structural formula is:
Candesartan cilexetil is a white to off-white powder with a molecular
weight of 610.67. 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
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
ester group. Following oral administration, candesartan cilexetil
undergoes hydrolysis at
the ester link to form the active drug, candesartan, which is achiral.
Hydrochlorothiazide is
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide. Its empirical formula is C H ClN O S and its structural
formula is:
Hydrochlorothiazide is a white, or practically white, crystalline
powder with a molecular
weight of 297.72, which is slightly soluble in water, but freely
soluble in sodium
hydroxide solution.
Candesartan cilexetil and hydrochlorothiazide tablets, USP, are
available for oral
administration in three tablet strengths of candesartan cilexetil,
USP, and
hy