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Tolmetin Pregnancy and Breastfeeding Warnings

Tolmetin is also known as: Tolectin, Tolectin 600, Tolectin DS

Tolmetin Pregnancy Warnings

Tolmetin has been assigned to pregnancy category C by the FDA. Animal studies failed to reveal evidence of teratogenicity and fetal harm. There are no controlled data in human pregnancy. While there are no literature reports linking the use of tolmetin in pregnancy with birth defects, use late in pregnancy may cause premature closure of the ductus arteriosus and prolong labor and delivery. Tolmetin is only recommended for use during pregnancy when benefit outweighs risk. Tolmetin should be avoided near term.

See references

Tolmetin Breastfeeding Warnings

The excretion of tolmetin into breast milk was evaluated in a 33 year-old patient with rheumatoid arthritis. Following oral administration of tolmetin 400 mg one time, tolmetin concentrations in milk ranged from 0.06 to 0.18 mcg/mL, with measured peak levels at approximately one hour post-dose. The milk to plasma ratio ranged from 0.005 to 0.007.

Tolmetin is excreted into human milk in very small amounts. Tolmetin is considered compatible with breast-feeding by the American Academy of Pediatrics.

See references

References for pregnancy information

  1. "Product Information. Tolectin (tolmetin)." McNeil Pharmaceutical, Raritan, NJ.
  2. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37

References for breastfeeding information

  1. "Product Information. Tolectin (tolmetin)." McNeil Pharmaceutical, Raritan, NJ.
  2. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  3. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
  4. Sagraves R, Waller ES, Goehrs HR "Tolmetin in breast milk." Drug Intell Clin Pharm 19 (1985): 55-6

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