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MAVIK®
(trandolapril) Tablets
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, MAVIK should be discontinued as soon as possible. See WARNINGS - Fetal/Neonatal Morbidity and Mortality.
Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat. Trandolapril is chemically described as (2S, 3aR, 7aS)-1-[(S)-N-[(S)-1-Carboxy-3phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl ester. Its empirical formula is C24H34N2O5 and its structural formula is
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M.W. = 430.54
Melting Point =
125°C
Trandolapril is a white or almost white powder that is soluble ( > 100 mg/mL) in chloroform, dichloromethane, and methanol. MAVIK tablets contain 1 mg, 2 mg, or 4 mg of trandolapril for oral administration. Each tablet also contains corn starch, croscarmellose sodium, hypromellose, iron oxide, lactose monohydrate, povidone, sodium stearyl fumarate.
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 any of these serious side effects:
Read All Potential Side Effects and See Pictures of Mavik »
Before taking trandolapril, tell your doctor or pharmacist if you are allergic to it; or to other ACE inhibitors (e.g., benazepril, captopril); or if you have any other allergies (including exposure to certain membranes used for blood filtering). 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: history of an allergic reaction which included swelling of the face/lips/tongue/throat (angioedema).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, high blood...
Last reviewed on RxList: 2/2/2012
This monograph has been modified to include the generic and brand name in many instances.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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