Spedifen Use In Pregnancy & Lactation

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo-fetal development. Data from epidemiological studies indicates an increased risk of miscarriage, as well as cardiac malformations and gastroschisis following the use of prostaglandin synthesis inhibitors in early pregnancy. It is believed that the risk is in directly proportional with the dose and duration of therapy.
In animal studies, it has been shown that administration of prostaglandin synthesis inhibitors leads to increased pre- and post-implanted loss and to embryo fetal lethality. Furthermore, increased incidences of various malformations, including cardiovascular malformations, have been reported in animals receiving prostaglandin synthesis inhibitors during the organogenesis phase.
During the first and second trimesters of pregnancy, Spedifen should only be given if absolutely necessary. If Spedifen is used by women trying to get pregnant or if it is used during the first or second trimester of pregnancy, the dose should be kept as low and the duration of treatment as short as possible.
Spedifen is contraindicated during the third trimester of pregnancy. All prostaglandin synthesis inhibitors can: Expose the fetus to the following risks: Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); Kidney dysfunction, which may progress to renal failure with oligohydramniosis.
Expose mother and child to the following risks: 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.
Lactation: NSAIDs pass into breast milk. As a precaution, Spedifen should therefore not be taken by breast-feeding women. If treatment is essential, the baby should be switched over to bottle feeding.
Fertility: The use of ibuprofen may affect female fertility and is therefore not recommended in women who wish to become pregnant. In women who have difficulty getting pregnant or who are being tested for infertility, discontinuation of ibuprofen should be considered.