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Diclofenac / lidocaine topical Pregnancy and Breastfeeding Warnings

Brand names: Diclona, Trixylitral

Medically reviewed by Drugs.com. Last updated on Dec 21, 2023.

Diclofenac / lidocaine topical Pregnancy Warnings

-Teratogenic effects have been reported with the use of this product.
-Animal studies in pregnant rats revealed significant maternal toxicity after oral administration of 2 or 4 mg/kg diclofenac (1 and 2 times the Maximum Recommended Human Dose).
-There are no controlled data in human pregnancy.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This product should be used during pregnancy only if the benefit to the mother outweighs the risk to the fetus.

US FDA pregnancy category: B

Comments:
-Diclofenac sodium may delay or prevent rupture of ovarian follicles, causing reversible infertility in some women.
-Small studies in women treated with nonsteroidal anti-inflammatory drugs (NSAIDs) have also shown a reversible delay in ovulation.
-Consider withdrawing NSAIDs from women who have difficulties conceiving or are being investigated for infertility.
-Use of NSAIDs at about 20 weeks of gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
-Avoid using NSAIDs in pregnant women at about 30 weeks gestation and later, as this increases the risk of premature closure of the fetal ductus arteriosus.
-If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit the use of this product to the lowest effective dose and for the shortest duration possible.

See references

Diclofenac / lidocaine topical Breastfeeding Warnings

This product should be used during lactation only if the benefit to the mother outweighs the risk to the infant.

Excreted into human milk: Yes (diclofenac, lidocaine)

Comments:
-Exercise caution when administering to a nursing women.

-One woman treated orally with diclofenac 150 mg/day had a milk diclofenac level of 100 mcg/L, equivalent to an infant dose of about 0.03 mg/kg/day.
-Diclofenac was not detected in the breast milk of 12 women who received a dose of 100 mg/day orally for seven days or a single 50 mg intramuscular dose administered in the immediate postpartum period.
-According to clinical studies, the amount of lidocaine excreted in human milk is reported to be low and is not expected to cause any adverse effects in breastfed infants.

See references

References for pregnancy information

  1. Product Information. Diclona (diclofenac-lidocaine topical). Terrain Pharmaceuticals. 2022;1.

References for breastfeeding information

  1. National Library of Medicine (US). Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2019.
  2. Product Information. Diclona (diclofenac-lidocaine topical). Terrain Pharmaceuticals. 2022;1.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.