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Diclofenac topical Pregnancy and Breastfeeding Warnings

Diclofenac topical is also known as: Flector Patch, Pennsaid, Solaraze, Voltaren Gel

Diclofenac topical Pregnancy Warnings

Diclofenac topical has been assigned to pregnancy category C prior to 30 weeks gestation and category D starting at 30 weeks gestation by the FDA. Approximately 10% of a topically applied dose is absorbed systemically and systemic bioavailability is significantly lower than after oral dosing. Animal data have revealed evidence of dystocia, prolonged gestation, reduced fetal weights, growth, and survival associated with maternally toxic levels of orally administered diclofenac. There are no controlled data in human pregnancy. The manufacturer recommends that the use of diclofenac topical be avoided during late pregnancy because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (premature closure of the ductus arteriosus). Diclofenac topical should only be given during pregnancy when benefit outweighs risk, keeping in mind the manufacturer's warning against its use during late pregnancy.

See references

Diclofenac topical Breastfeeding Warnings

There are no data on the excretion of diclofenac topical into human milk. Approximately 10% of a topically applied dose is absorbed systemically. Oral diclofenac is excreted into milk in small amounts. Some experts consider diclofenac suitable for use during lactation. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the nursing woman.

See references

References for pregnancy information

  1. "Product Information. Solaraze (diclofenac topical)" SkyePharma, San Diego, CA.
  2. "Product Information. Solaraze (diclofenac topical)." Doak Dermatologics Division, Fairfield, NJ.

References for breastfeeding information

  1. Needs CJ, Brooks PM "Antirheumatic medication during lactation." Br J Rheumatol 24 (1985): 291-7
  2. "Product Information. Solaraze (diclofenac topical)" SkyePharma, San Diego, CA.
  3. Goldsmith DP "Neonatal rheumatic disorders. View of the pediatrician." Rheum Dis Clin North Am 15 (1989): 287-305
  4. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  5. "Product Information. Arthrotec (diclofenac-misoprostol)." Searle, Skokie, IL.

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