Mesalamine Pregnancy and Breast Feeding Warnings
Mesalamine is also known as: Apriso, Asacol, Canasa, Canasa Pac, FIV-ASA, Lialda, Mesasal Enteric Coated, Pentasa, Rowasa, Salofalk
Overview
If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mesalamine Controlled-Release Capsules while you are pregnant. Mesalamine Controlled-Release Capsules is found in breast milk. If you are or will be breast-feeding while you use Mesalamine Controlled-Release Capsules, check with your doctor. Discuss any possible risks to your baby.
Mesalamine Pregnancy Warnings
Mesalamine oral tablets and rectal products have been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of teratogenicity. In a controlled study, mesalamine did not represent a major teratogenic risk in humans when administered at recommended doses. In a retrospective study, exposure to mesalamine during human pregnancy increased preterm deliveries (but not birth defects) and decreased birth weight. Mesalamine is only recommended for use during pregnancy when benefit outweighs risk.
Mesalamine or 5-acetylsalicylic acid (5-ASA) is known to cross the placenta. In six women, plasma concentrations of 5-ASA ranged from 0 to 3 mmol/L at delivery. Plasma concentrations in the newborn were 0.5 mmol/L or less. Plasma concentrations of N-acetyl-5-ASA were similar in the mothers and the newborns. Renal hyperchogenicity has occurred in one infant whose mother received oral mesalamine from the second through the fifth month of pregnancy. At six months of age, the infant demonstrated a creatinine clearance of 52 mL/min. A renal biopsy showed focal tubulointerstitial lesions characterized by the association of interstitial fibrosis and tubular atrophy in the absence of cell infiltration.
Mesalamine Lactation Warnings
Mesalamine is excreted into human milk in small amounts. Watery diarrhea has been reported in a breastfed infant beginning 12 hours after the first dose of rectal mesalamine and persisting for 10 hours after the last dose. Several rechallenges reproduced the diarrhea in the infant. The manufacturer recommends that caution be used when administering mesalamine to nursing women.
Following oral administration of mesalamine, the milk to plasma ratio ranges from 0.1 to 0.3. The milk to plasma ratio of N-acetyl-5-aminosalicylic acid ranges from 5.1 to 16.5.
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