Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
Enalapril Maleate (UNII: 9O25354EPJ) (enalaprilat anhydrous - UNII:Q508Q118JM), Hydrochlorothiazide (UNII: 0J48LPH2TH) (Hydrochlorothiazide - UNII:0J48LPH2TH)
Bausch Health US, LLC
Enalapril Maleate
Enalapril Maleate 10 mg
ORAL
PRESCRIPTION DRUG
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
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.
New Drug Application
VASERETIC- ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET BAUSCH HEALTH US LLC ---------- 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 ® 20 28 2 5 4 4 4 7 8 3 4 2 CLINICAL PHARMACOLOGY As a Perskaitykite visą dokumentą