Diclotroy Use In Pregnancy & Lactation

Pregnancy: No data is available for use of DICLOTROY in pregnant women. 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, cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation increased from less than 1% to approximately 1.5%. The risk increases with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been found to increase pre- and post-implantation loss and embryo/foetal lethality. In addition, increased incidence of various malformations including cardiovascular have been reported in animals administered with prostaglandin synthesis inhibitor during organogenesis.
During the first and second trimester of pregnancy, DICLOTROY should not be given unless the benefit outweighs the risk. If DICLOTROY is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept low and duration of treatment as short as possible.
DICLOTROY is contraindicated during the third trimester of pregnancy.
Lactation: Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of DICLOTROY no effects on the suckling child are anticipated. Because of a lack of controlled studies in lactating women, the product should only be used during lactation under advice from a healthcare professional. Under this circumstance, DICLOTROY should not be applied on the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time.