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Methylphenidate Pregnancy and Breastfeeding Warnings

Methylphenidate is also known as: Aptensio XR, Concerta, Cotempla XR-ODT, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, QuilliChew ER, Quillivant XR, Ritalin, Ritalin LA, Ritalin-SR

Methylphenidate Pregnancy Warnings

Methylphenidate has been assigned to pregnancy category C by the FDA. Adequate animal reproductive studies to establish the safe use of methylphenidate during pregnancy have not been conducted. There are no controlled data in human pregnancy. However, in the Michigan Medicaid Birth Defects Study involving 229,101 pregnancies from 1985 to 1992, there was one major cardiovascular birth defect reported out of 13 newborns who were exposed to methylphenidate during the first trimester. (One was expected.) (Written communication, Franz Rosa, MD, Food and Drug Administration, 1994) Methylphenidate is only recommended for use during pregnancy when benefit outweighs risk.

See references

Methylphenidate Breastfeeding Warnings

In another case report, following a maternal dose of 5 mg in the morning and 10 mg at noon (immediate-release formulation), the mean milk/serum concentration ratio was 1.1 (range 0.8 to 1.6). The relative infant dose was 0.16% of the weight- adjusted maternal dose and the estimated absolute infant dose was 0.38 mcg/kg/day. Adverse effects were not observed in the infant.

Methylphenidate is excreted into human milk. Adverse effects in the nursing infant are unlikely given a relatively low exposure. In one case, following a maternal daily dose of 40 mg twice daily, the milk-to-plasma ratio was 2.7. The relative infant dose was 0.2% of the weight- adjusted maternal dose and the absolute infant dose was 2.3 mcg/kg/day. Adverse effects were not detected in the infant. Caution is recommended if the drug is to be administered to a nursing woman.

See references

References for pregnancy information

  1. "Product Information. Metadate ER (methylphenidate)." Celltech Pharmacueticals Inc, Appleton, WI.
  2. "Product Information. Quillivant XR (methylphenidate)." NextWave Pharmaceuticals , Vernon Hills, IL.
  3. "Product Information. Ritalin (methylphenidate)." Novartis Pharmaceuticals, East Hanover, NJ.
  4. "Product Information. Metadate CD Capsules (methylphenidate)" Celltech Pharmaceuticals, Inc, Applegate, WI.
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. "Product Information. Concerta (methylphenidate)." Alza, Palo Alto, CA.
  7. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  8. "Clinical practice guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder." Pediatrics 108 (2001): 1033-44

References for breastfeeding information

  1. Spigset O, Brede WR, Zahlsen K "Excretion of methylphenidate in breast milk." Am J Psychiatry 164 (2007): 348
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  3. Hackett LP, Kristensen JH, Hale TW, Paterson R, Ilett KF "Methylphenidate and breast-feeding." Ann Pharmacother 40 (2006): 1890-1

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