Generic Thorazine

CHLORPROMAZINE
(Thorazine, Thor-Prom)
Chlorpromazine is a widely used phenothiazine. It is employed as a tranquilizer and sedative in the treatment of psychoses and as a premedication for operations and diagnostic procedures. Chlorpromazine is also used as an antiemetic. The drug is given orally, parenterally, or rectally in doses of 20-2000 mg/d.

Teratogenic Risk
Magnitude of teratogenic risk to child born after exposure during gestation: Unlikely.
Quality and quantity of data on which risk estimate is based: Fair to good.
Therapeutic doses of chlorpromazine are unlikely to pose a substantial teratogenic risk, but the data are insufficient to state that there is no risk.
Transient neurological dysfunction may occur among newborn infants of women who were treated with chlorpromazine late in pregnancy.

The frequency of congenital anomalies was no greater than expected among the children of 142 women treated with chlorpromazine during the first four lunar months of pregnancy or the children of 284 women treated with this drug anytime during pregnancy in one epidemiological study. Similarly, the frequency of congenital anomalies was not increased among the infants of 264 women treated with a low dose of chlorpromazine in the first trimester of pregnancy in another study.
In most investigations, the frequency of malformations was no greater than expected among the offspring of rats treated with chlorpromazine during pregnancy in doses 1-6 times those used in humans. Increased fetal loss, decreased fetal weight gain, and maternal toxicity were often observed, especially at the higher doses. Increased frequencies of skeletal, central nervous system, and other anomalies have also been reported among the offspring of pregnant rats treated with chlorpromazine in doses 2-10 times those used in humans. In mice, increased frequencies of eye, palate, skeletal, and other anomalies as well as of fetal death have been observed among the offspring of animals treated with chlorpromazine in doses Many behavioral studies in the offspring of mice and rats treated with chlorpromazine during pregnancy have been published. A variety of long-lasting alterations of behavior and neurological function have been observed in the offspring with maternal treatment using Neurological dysfunction with extrapyramidal signs has been reported in several infants born to women treated with chlorpromazine during pregnancy. The muscle rigidity, hypertonia, and tremor seen in these children are quite unusual among newborns. Although the abnormalities appear to be transient, they may last for months. It seems likely that the neurological dysfunction in these infants is related to their mothers' drag therapy because similar signs of extrapyramidal dysfunction may occur as a side effect of chlorpromazine administration in adults. The frequency of this complication among infants born to women treated with chlorpromazine during pregnancy appears to be low. More commonly, the infants of women treated with chlorpromazine late in pregnancy exhibit hypertonia, tremulousness, and poor motor maturity suggestive of a neonatal withdrawal syndrome.

Risk Related to Breast-feeding
Chlorpromazine is excreted in breast milk in low concentrations. The amount of chlorpromazine that the nursing infant would be expected to ingest is between 0.03-1.3% of the lowest pediatric dose, based on data obtained from five lactating women. No adverse effects were observed in two of the infants that were breast-fed, although one infant was said to be drowsy and lethargic after nursing.
The American Academy of Pediatrics lists chlorpromazine as a drug whose effect on the nursing infant may be of concern because of its potential to alter central nervous system functioning.
MENTAL DISORDERS

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