VASERETIC- enalapril maleate and hydrochlorothiazide tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

Enalapril Maleate (UNII: 9O25354EPJ) (enalaprilat anhydrous - UNII:Q508Q118JM), Hydrochlorothiazide (UNII: 0J48LPH2TH) (Hydrochlorothiazide - UNII:0J48LPH2TH)

थमां उपलब्ध:

Bausch Health US, LLC

INN (इंटरनेशनल नाम):

Enalapril Maleate

रचना:

Enalapril Maleate 10 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

VASERETIC is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial treatment (see DOSAGE AND ADMINISTRATION ). In using VASERETIC, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril does not have a similar risk (see WARNINGS ). In considering use of VASERETIC, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Head and Neck Angioedema ). VASERETIC is contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. Because of the hydroch

उत्पाद समीक्षा:

VASERETIC Tablets 10-25 mg are rust-colored, oval-shaped tablets with one side imprinted with “VASE 10-25” and both sides scored. Each tablet contains 10 mg of enalapril maleate and 25 mg of hydrochlorothiazide. They are supplied as follows: NDC 0187-0146-01 bottles of 100 (with desiccant). Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture. Dispense in a tight container as per USP, if product package is subdivided.

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

VASERETIC- ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET
BAUSCH HEALTH US LLC
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VASERETIC TABLETS
(ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE)
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
DESCRIPTION
VASERETIC (enalapril maleate and hydrochlorothiazide) combines an
angiotensin converting enzyme
inhibitor, enalapril maleate, and a diuretic, hydrochlorothiazide.
Enalapril maleate is the maleate salt of enalapril, the ethyl ester of
a long-acting angiotensin converting
enzyme inhibitor, enalaprilat. Enalapril maleate is chemically
described as (_S_)-1-[_N_-[1-
(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline,
(_Z_)-2-butenedioate salt (1:1). Its empirical
formula is C
H N O •C H O , and its structural formula is:
Enalapril maleate is a white to off-white crystalline powder with a
molecular weight of 492.53. It is
sparingly soluble in water, soluble in ethanol, and freely soluble in
methanol.
Enalapril is a pro-drug; following oral administration, it is
bioactivated by hydrolysis of the ethyl ester
to enalaprilat, which is the active angiotensin converting enzyme
inhibitor.
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:
It is a white, or practically white, crystalline powder with a
molecular weight of 297.74, which is
slightly soluble in water, but freely soluble in sodium hydroxide
solution.
VASERETIC is available in the tablet combination of enalapril maleate
with hydrochlorothiazide:
VASERETIC 10-25 mg, containing 10 mg enalapril maleate and 25 mg
hydrochlorothiazide. Inactive
ingredients are: iron oxide, lactose, magnesium stearate, sodium
bicarbonate, and starch.
®
WHEN PREGNANCY IS DETECTED, DISCONTINUE VASERETIC 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
®
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CLINICAL PHARMACOLOGY
As a