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Pregnancy: Etoricoxib Teva Tablet must not be taken during pregnancy. If patient is pregnant or thinks she could be pregnant, or if planning to become pregnant, do not take the tablets. If patient becomes pregnant, stop taking the tablets and consult the doctor. Consult the doctor if unsure or need more advice.
Breast-feeding: It is not known if etoricoxib is excreted in human milk. If patient is breast-feeding, or planning to breast-feed, consult the doctor before taking Etoricoxib Teva Tablet. If patient is using Etoricoxib Teva Tablet, she must not breast-feed.
Fertility: Etoricoxib Teva Tablet is not recommended in women attempting to become pregnant.
Extra information for healthcare professionals: Special Populations: Pregnant Women: Etoricoxib Teva Tablet are contraindicated for use during the third trimester of pregnancy because of risks of premature closure of the ductus arteriosus and the potential to prolong parturition. Caution is recommended in prescribing Etoricoxib Teva Tablet during the first and second trimesters of pregnancy, particularly from the middle to end of the second trimester of pregnancy (onset at approximately 20 weeks) due to possible fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment or failure.
Etoricoxib Teva Tablet should not be used during the first two trimesters of pregnancy unless the expected benefits to the mother outweigh the risks to the fetus.
Published studies and post-marketing reports describe maternal Non-Steroidal Anti-Inflammatory Drug (NSAID) use at approximately 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment or failure. NSAIDs were shown to cause significant reduction in fetal urine production prior to reduction of amniotic fluid volume. There have also been a limited number of case reports of maternal NSAID use and neonatal renal dysfunction and renal impairment without oligohydramnios, some of which were irreversible, even after treatment discontinuation.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
Complications of prolonged oligohydramnios may for example, include limb contractures and delayed lung maturation. In some post-marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If after careful consideration of the benefit-risk, NSAID treatment is considered necessary to be administered anywhere from the middle (onset at approximately 20 weeks) to the end of the second trimester of pregnancy, the use should be limited to the lowest effective dose and shortest duration possible. It is also recommended that ultrasound monitoring of amniotic fluid be considered if Etoricoxib Teva Tablet treatment extends beyond 48 hours and that NSAIDs treatment be discontinued if oligohydramnios occurs, followed by appropriate medical follow-up.
Contraindications: The third trimester of pregnancy, because of risks of premature closure of the ductus arteriosus, and prolonged parturition.
