Ketesse Use In Pregnancy & Lactation

Use in Pregnancy: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies raise concern about 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-foetal lethality. In addition, increased incidences of various malformations including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. Nevertheless, animal studies with dexketoprofen trometamol haven't shown reproductive toxicity. During the first and second trimester of pregnancy, Dexketoprofen trometamol should not be given unless clearly necessary. If Dexketoprofen trometamol is used by a women 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 oligo-hydroamniosis.
At the end of pregnancy, all prostaglandin synthesis inhibitors may expose the mother and the neonate 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 labour. It is not known whether dexketoprofen is excreted in human milk.
Ketesse Solution for Injection or Concentrate for Solution for Infusion (I.V./I.M.): Dexketoprofen (KETESSE) Solution for Injection or concentrate for solution for infusion is contraindicated during third trimester of pregnancy and lactation.