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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

This drug should not be used during pregnancy unless the potential benefits outweigh the possible risks. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: -There have been spontaneous case reports of neonatal cardio-respiratory toxicity, specifically fetal tachycardia and respiratory distress. -Premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. -Central nervous system stimulant medications can cause vasoconstriction, decreasing placental perfusion.

Animal studies have revealed evidence of teratogenicity (e.g., increased incidence of fetal spina bifida) and adverse effects including decreased offspring weights and survival at maternally toxic doses. Findings in animals showed no fertility impairment at doses approximately 7- to 16-fold the maximum recommended human dose on a mg/m2 basis. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Methylphenidate Breastfeeding Warnings

Published reports reveal an estimated dose of 0.16% to 0.7% of the maternal weight-adjusted dosage was received by breastfed infants of mothers taking 15 to 80 mg/day of this drug. Additionally, this drug was undetectable (less than 1 mcg/L) in the blood of 2 breastfed infants whose mothers took an average of 52 mg/day of this drug. Another study showed no drug-related adverse reactions and normal development in 7 infants (average age 4.4 months) whose mothers took this drug (average dose 52 mg/day) or dextroamphetamine (average dose 25 mg/day).

This drug should not be used during breastfeeding unless the potential benefits outweigh the possible risks. Excreted into human milk: Yes Excreted into animal milk: Yes Comments: -Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. -Limited evidence indicates the levels of this drug in breastmilk are very low and might not affect nursing infants adversely; however, the effects of this drug on the neurological development of the infant have not been well studied. -This drug reduces serum prolactin, but its effect on milk production is unknown. Large dosages might interfere with milk production, especially in women whose lactation is not well established.

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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  7. "Product Information. Concerta (methylphenidate)." Alza, Palo Alto, CA.

References for breastfeeding information

  1. "Product Information. Metadate CD Capsules (methylphenidate)" Celltech Pharmaceuticals, Inc, Applegate, WI.
  2. "Product Information. Quillivant XR (methylphenidate)." NextWave Pharmaceuticals , Vernon Hills, IL.
  3. "Product Information. Metadate ER (methylphenidate)." Celltech Pharmacueticals Inc, Appleton, WI.
  4. "Product Information. Ritalin (methylphenidate)." Novartis Pharmaceuticals, East Hanover, NJ.
  5. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  7. "Product Information. Concerta (methylphenidate)." Alza, Palo Alto, CA.
  8. Cerner Multum, Inc. "Australian Product Information." O 0

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