ATACAND HCT- 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:

Physicians Total Care, Inc.

INN (Algemene Internationale Benaming):

CANDESARTAN CILEXETIL

Samenstelling:

CANDESARTAN CILEXETIL 16 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, ATACAND HCT should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality. ATACAND HCT is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). ATACAND HCT is contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Product samenvatting:

No. 3825 — Tablets ATACAND HCT 16-12.5, are peach, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACS on one side. They are supplied as follows: No. 3826 — Tablets ATACAND HCT 32-12.5, are yellow, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACJ on one side. They are supplied as follows: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. ATACAND HCT is a trademark of the AstraZeneca group of companies ©AstraZeneca 2008 Manufactured under the license from Takeda Pharmaceutical Company, Ltd. by: AstraZeneca AB, S-151 85 Södertälje, Sweden for: AstraZeneca LP, Wilmington, DE 19850 Made in Sweden Rev. 04/11 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma     74146

Autorisatie-status:

New Drug Application

Productkenmerken

ATACAND HCT - CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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ATACAND HCT® 16-12.5
(_CANDESARTAN CILEXETIL−HYDROCHLOROTHIAZIDE_)
TABLETS
ATACAND HCT® 32-12.5
(_CANDESARTAN CILEXETIL−HYDROCHLOROTHIAZIDE_)
TABLETS
ATACAND HCT® 32–25
CANDESARTAN CILEXETIL-HYDROCHLOROTHIAZIDE
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, DRUGS
THAT ACT DIRECTLY ON THE
RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND EVEN DEATH TO THE
DEVELOPING FETUS. When
pregnancy is detected, ATACAND HCT should be discontinued as soon as
possible. See WARNINGS,
Fetal/Neonatal Morbidity and Mortality.
DESCRIPTION
ATACAND HCT (candesartan cilexetil-hydrochlorothiazide) combines 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
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.
1
33
34
6
6
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.
ATACAND HCT is available for oral administration in three tablet
strengths of candesartan cilexetil
and hydrochlorothiazide.
ATACAND HCT 16-12.5 contains 16 mg of c