Đăng xuất
Pregnancy: Inhibition of prostaglandin synthesis by NSAIDs may affect the course of pregnancy and/or the development of the embryo or foetus.
Risks associated with use during the 1st trimester: Data from epidemiological studies suggest an increased risk of miscarriage, heart defects and gastroschisis after treatment with a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformation has increased from less than 1% in the general population to approximately 1.5% in people exposed to NSAIDs. The risk appears to increase with dose and duration of treatment. In animals, administration of a prostaglandin synthesis inhibitor has been shown to cause increased pre- and post-implantation loss and increased embryo-foetal lethality. In addition, a higher incidence of certain malformations, including cardiovascular, has been reported in animals given a prostaglandin synthesis inhibitor during the organogenesis phase of gestation.
Risks associated with use from the 12th week of amenorrhea until birth: From the 12th week of amenorrhea and until birth, all NSAIDs, by inhibiting the synthesis of prostaglandins, can expose the fetus to renal functional impairment: In utero which can be observed from 12 weeks of amenorrhea (initiation of fetal diuresis): Oligohydramnios (most often reversible when treatment is stopped), or even anamnios in particular during prolonged exposure.
At birth, renal failure (reversible or not) may persist, particularly in the event of late and prolonged exposure (with a risk of severe delayed hyperkalaemia).
Risks associated with use beyond the 24th week of amenorrhea and until birth: Beyond the 24th week of amenorrhea, NSAIDs can expose the fetus to cardiopulmonary toxicity (premature closure of the arterial duct and pulmonary arterial hypertension). Constriction of the arterial duct can occur from the beginning of the 6th month (beyond the 24th week of amenorrhea) and can lead to fetal or neonatal right heart failure or even fetal death in utero. This risk is all the more important as the catch is close to the end (less reversibility). This effect exists even for a onetime shot.
At the end of pregnancy, the mother and the newborn may present: A prolongation of the bleeding time due to an anti-aggregating action which may occur even after administration of very low doses of medicinal product; inhibition of uterine contractions leading to delayed delivery or prolonged labour.
Consequently: Unless absolutely necessary, this medicine should not be prescribed to a woman planning a pregnancy or during the first 5 months of pregnancy (first 24 weeks of amenorrhea). If this medicine is administered to a woman wishing to become pregnant or less than 6 months pregnant, the dose should be as low as possible and the duration of treatment as short as possible. Prolonged intake is strongly discouraged.
From the beginning of the 6th month (beyond 24 weeks of amenorrhea): any intake of this medicine, even occasionally, is contraindicated. Inadvertent use from this date justifies cardiac and renal, fetal and/or neonatal monitoring depending on the term of exposure. The duration of this monitoring will be adapted to the elimination half-life of the molecule.
Breastfeeding: As NSAIDs pass into breast milk, this medication is not recommended for breastfeeding women.
