|Manufacturer:||Boehringer Ingelheim Pharmaceuticals, Inc.|
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Tablets should not be removed from blisters until immediately before administration.Distributed by:Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USALicensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany©Copyright 2008, Boehringer Ingelheim International GmbH, ALL RIGHTS RESERVEDMICARDIS tablets are covered by U.S.Patent 5,591,762Rev: September 2008OT1200DI1008340194/4IT12004A10005385/01
Micardis® (telmisartan) tablets are indicated for the treatment of hypertension.It may be used alone or in combination with other antihypertensive agents.
Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women.
Several dozen cases have been reported in the world literature in patients who were taking angiotensin converting enzyme inhibitors.
When pregnancy is detected, MICARDIS tablets should be discontinued as soon as possible.The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death.
Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development.
Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug.These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester.
Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist only during the first trimester should be so informed.
Nonetheless, when patients become pregnant, physicians should have the patient discontinue the use of MICARDIS tablets as soon as possible.Rarely (probably less often than once in every thousand pregnancies), no alternative to an angiotensin II receptor antagonist will be found.
In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intra-amniotic environment.If oligohydramnios is observed, MICARDIS tablets should be discontinued unless they are considered life-saving for the mother.
Contraction stress testing (CST), a non-stress test (NST), or biophysical profiling (BPP) may be appropriate, depending upon the week of pregnancy.
Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.Infants with histories of in utero exposure to an angiotensin II receptor antagonist should be closely observed for hypotension, oliguria, and hyperkalemia.
If oliguria occurs, attention should be directed toward support of blood pressure and renal perfusion.
Exchange transfusion or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.There is no clinical experience with the use of MICARDIS tablets in pregnant women.
No teratogenic effects were observed when telmisartan was administered to pregnant rats at oral doses of up to 50 mg/kg/day and to pregnant rabbits at oral doses up to 45 mg/kg/day.
In rabbits, embryolethality associated with maternal toxicity (reduced body weight gain and food consumption) was observed at 45 mg/kg/day [about 12 times the maximum recommended human dose (MRHD) of 80 mg on a mg/m2 basis].
In rats, maternally toxic (reduction in body weight gain and food consumption) telmisartan doses of 15 mg/kg/day (about 1.9 times the MRHD on a mg/m2 basis), administered during late gestation and lactation, were observed to produce adverse effects in neonates, including reduced viability, low birth weight, delayed maturation, and decreased weight gain.
Telmisartan has been shown to be present in rat fetuses during late gestation and in rat milk.The no observed effect doses for developmental toxicity in rats and rabbits, 5 and 15 mg/kg/day, respectively, are about 0.64 and 3.7 times, on a mg/m2 basis, the maximum recommended human dose of telmisartan (80 mg/day).