Product Description.:
Logo, FX
tablet , yellow , round round
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.
DESCRIPTION
Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat.
Trandolapril is a colorless, crystalline substance 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, povidone, sodium stearyl fumarate.
INDICATIONS
Hypertension
MAVIK is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide.
In considering the use of MAVIK, it should be noted that in controlled trials ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients. (See WARNINGS ? Angioedema.)
When using MAVIK, 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. Available data are insufficient to show that MAVIK does not have a similar risk.
MAVIK is indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of trandolapril to Caucasian patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risk of heart failure-related hospitalization
SIDE EFFECTS
The safety experience in U.S. placebo-controlled trials included 1067 hypertensive patients, of whom 831 received MAVIK. Nearly 200 hypertensive patients received MAVIK for over one year in open-label trials. In controlled trials, withdrawals for adverse events were 2.1% on placebo and 1.4% on MAVIK. Adverse events considered at least possibly related to treatment occurring in 1% of MAVIK-treated patients and more common on MAVIK than placebo, pooled for all doses, are shown below, together with the frequency of discontinuation of treatment because of these events.
