ATACAND HCT- candesartan cilexetil and hydrochlorothiazide tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

AstraZeneca Pharmaceuticals LP

INN (International Adı):

CANDESARTAN CILEXETIL

Kompozisyon:

CANDESARTAN CILEXETIL 16 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

ATACAND HCT is 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 ATACAND HCT. 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 Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blo

Ürün özeti:

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: NDC 0186-0162-54 unit of use bottles of 90. 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: NDC 0186-0322-54 unit of use bottles of 90. No. 3899 — Tablets ATACAND HCT 32–25, are pink, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACD on one side. They are supplied as follows: NDC 0186-0324-54 unit of use bottles of 90. 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 registered trademark of the AstraZeneca group of companies. ©AstraZeneca 2016 Manufactured under the license from: Takeda Pharmaceutical Company, Ltd. by: AstraZeneca AB, SE-151 85 Södertälje, Sweden for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 Rev. 07/2016

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

ATACAND HCT- CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET
ASTRAZENECA PHARMACEUTICALS LP
----------
ATACAND HCT 16-12.5
(_CANDESARTAN CILEXETIL−HYDROCHLOROTHIAZIDE_)
TABLETS, FOR ORAL USE
ATACAND HCT 32-12.5
(_CANDESARTAN CILEXETIL−HYDROCHLOROTHIAZIDE_)
TABLETS, FOR ORAL USE
ATACAND HCT 32–25
_(CANDESARTAN CILEXETIL-HYDROCHLOROTHIAZIDE)_
TABLETS, FOR ORAL USE
WARNING: FETAL TOXICITY
•
•
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.
®
®
®
WHEN PREGNANCY IS DETECTED, DISCONTINUE ATACAND HCT 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
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.
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 candesartan cilexetil and 12.5