PEMOLINE

Drugs in Pregnancy and Lactation.

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Name: PEMOLINE
Class: Central Stimulant
Risk Factor:    BM

Fetal Risk Summary

Pemoline, used for the treatment of attention deficit disorder, is a central nervous system stimulant that is chemically unrelated to amphetamines and methylphenidate. Reproduction studies in mice, rats, and rabbits showed no evidence of impaired fertility or adverse effects in the fetus (1,2). Doses used in the studies with pregnant rats and rabbits were 18.75 and 37.5 mg/kg/day, respectively (1). In rats, however, a dose of 37.5 mg/kg/day, equal to the recommended starting dose in humans, was associated with an increased incidence of stillbirths and cannibalization. Moreover, in rats dosed with 18.75 and 37.5 mg/kg/day, decreased postnatal survival of offspring was observed (1).

No published reports describing the use of pemoline during human pregnancy have been located. Because of its relatively low molecular weight (about 176), placental transfer of the drug should be expected. A 1984 source stated that no harmful effects had been reported in the human fetus and that the agent was not contraindicated in pregnancy (3).

Breast Feeding Summary

It is not known whether pemoline is excreted into human breast milk. No reports describing the use of this drug during lactation have been located. The molecular weight of pemoline, approximately 176, is low enough that passage into milk should be anticipated. The effects of exposure on a nursing infant, if any, are unknown.

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References

  1. Product information. Cylert. Abbott Laboratories, 1997.
  2. Schardein JL. Chemically Induced Birth Defects. 2nd ed. New York, NY: Marcel Dekker, 1993:223.
  3. Onnis A, Grella P. The Biochemical Effects of Drugs in Pregnancy. Volume 1: Drugs Active on The Nervous, Cardiovascular and Haemopoietic Systems. West Sussex, England: Ellis Horwood Limited, 1984:161.

Index

Q&A about Pemoline

Cynthia J
is there a subsitute prescription for the drug Cylert (pemoline) it was taken off the market in 2006?
Cylert was the only medication I was on that worked, I have been subscribed meds from concerta,straterram ritalin, to paxil,any amphetamine to every anti-depressent, but nothing has worked. my symptoms range from complete swelling, lack of concentration to memory loss. I was diagnosed with PTSD due to abuse as a child I have also been told I have a small brain anurysim along with brain damage. I have been going crazy ever since Cylert was removed from the market. I really could use someones help. I took 37.5mg times two a day along with 200mg of Topamax. I had no side effects and lived life clear and wonderfully for years along with the help of a wonderful councelor. So Could someone out there please, please help me out with some information!!!!!! Thank YOU so very much. this is my last hope
Dr Frank
Cylert was withdrawn as I am sure you are aware as a result of being linked with 21 cases of liver failure, of which 13 resulted in liver replacement or death. I am afraid it was unique chemically and there is thus no direct replacement.