Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

Pregnancy:
The systemic concentration of ibuprofen is lower after topical administration, compared to oral formulations. With reference to experience from treatment with systemically applied NSAIDs, the following is recommended:
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 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.
During the first and second trimester of pregnancy, Nurofen Medicated Plaster 200mg should not be given unless clearly necessary. If Nurofen Medicated Plaster 200mg is used during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

Rarely, taking NSAIDs after the 20th week of pregnancy may cause impaired renal function of the fetus, which may cause low levels of amniotic fluid (oligohydramnios).

The effects were observed after days to weeks of treatment. However, in rare cases, low levels of amniotic fluid were observed already after 48 hours of taking NSAIDs. In most cases, oligohydramnios passed with the treatment discontinuation.

Using NSAIDs after the 20th week of pregnancy should be limited. If it was decided that the benefit outweighs the risk for the fetus and the treatment with the medicine is essential after the 20th week of pregnancy, the lowest effective dose should be used for the shortest possible period.

Referring the patient to ultrasound scan should be considered, in order to estimate the amount of amniotic fluid when the treatment with therapeutic dosage of these medicines exceeding 5 days and stopping the treatment if low levels of amniotic fluid is detected.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
-       cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
-       renal dysfunction, which may progress to renal failure with oligo-hydroamniosis  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 labour.

Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.

Breast-feeding:
After systemic application, only small amounts of ibuprofen and its metabolites pass into the breast milk. As no harmful effects to infants are known to date, it is not usually necessary to interrupt breast-feeding during short-term treatment with this medicated plaster at the recommended dose.
However, as a precautionary measure, this medicated plaster should not be applied directly onto the breast area of women who are breast-feeding.