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General principles: Pregnancy Category is C/D (3 trimester).
Women of childbearing potential/Contraception: There is no data regarding the effects of Tenoxicam on birth control (contraception). The use of tenoxicam, as with any agent known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. If it is used by a woman attempting to conceive, the dose should be kept as low and duration of treatment as short as possible.
Pregnancy: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-fetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, Tenoxicam Symgens should not be given unless clearly necessary. If Tenoxicam Symgens is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligohydramnios.
And the mother and the neonate, at the end of pregnancy, to: possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor.
Consequently, Tenoxicam Symgens is contraindicated during the third trimester of pregnancy.
Breastfeeding: Based on findings from single dose administration, a very small amount (mean value less than 0.3% of the dose) of tenoxicam passes into breast milk (see Pharmacology: Pharmacokinetics under Actions).
There is no evidence of adverse reactions in breast-fed infants of mothers taking tenoxicam. Nevertheless, infants should be weaned or the medicine discontinued.
Fertility: The use of tenoxicam, as with any agent known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive.
In women who have difficulty conceiving or are undergoing investigation of infertility, withdrawal of tenoxicam treatment should be considered. (See Pharmacology: Toxicology: Preclinical safety data under Actions.)
