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(enalapril maleate-hydrochlorothiazide) Tablets
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.
- 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
VASERETIC® (enalapril maleate-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 C20H28N2O5•C4H4O4, 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-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1dioxide. Its empirical formula is C7H8ClN3O4S2 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, containing 10 mg enalapril maleate and 25 mg hydrochlorothiazide. Inactive ingredients are: iron oxide, lactose, magnesium stearate, sodium bicarbonate, and starch.
What are the possible side effects of hydrochlorothiazide and enalapril (Vaseretic 10-25, Vaseretic 5-12.5)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- eye pain, vision problems;
- high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
- low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
- dry mouth,...
What are the precautions when taking enalapril maleate-hydrochlorothiazide tablets (Vaseretic)?
Before taking this product, tell your doctor or pharmacist if you are allergic to either enalapril or hydrochlorothiazide; or to other ACE inhibitors (such as captopril, lisinopril); or to other thiazides (such as chlorothiazide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a history of an allergic reaction that included swelling of the face/lips/tongue/throat (angioedema), an inability to make urine (anuria).
Before using this medication, tell your doctor or pharmacist your medical history,...
Last reviewed on RxList: 9/24/2012
This monograph has been modified to include the generic and brand name in many instances.
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