Tolura

Tolura Use In Pregnancy & Lactation

telmisartan

Manufacturer:

KRKA

Distributor:

Uni Drug
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see Precautions). The use of angiotensin II receptor antagonists is contraindicated during the second and third trimesters of pregnancy (see Contraindications and Precautions).
There are no adequate data from the use of Tolura in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Pharmacodynamics under Actions).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs. Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (See Pharmacology: Toxicology: Preclinical safety data under Actions). Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension (see Contraindications and Precautions).
Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see Contraindications and Use in Pregnancy & Lactation).
Lactation: Because no information is available regarding the use of Tolura during breast-feeding, Tolura is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Fertility: In preclinical studies, no effects of Tolura on male and female fertility were observed.
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