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ADDERALL-XR (AMPHETAMINE, DEXTROAMPHETAMINE): USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C.

Teratogenic Effects

Amphetamine, in the enantiomer ratio present in Adderall-XR (Amphetamine, Dextroamphetamine) capsules XR (D- to L- ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively.

These doses are approximately 2 and 12 times, respectively, the maximum recommended human dose (MRHD) for adolescents of 20 mg/day, on a mg/m2 body surface area basis. Fetal malformations and death have been reported in mice following parenteral administration of D-Amphetamine doses of 50 mg/kg/day (approximately 10 times the MRHD for adolescents on a mg/m2 basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity. A study was conducted in which pregnant rats received daily oral doses of amphetamine (D- to L-enantiomer ratio of 3:1, the same as in Adderall-XR) of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20. These doses are approximately 0.8, 2, and 4 times the MRHD for adolescents of 20 mg/day, on a mg/m2 basis. All doses caused hyperactivity and decreased weight gain in the dams. A decrease in pup survival was seen at all doses. A decrease in pup bodyweight was seen at 6 and 10 mg/kg which correlated with delays in developmental landmarks. Increased pup locomotor activity was seen at 10 mg/kg on day 22 postpartum but not at 5 weeks postweaning. When pups were tested for reproductive performance at maturation, gestational weight gain, number of implantations, and number of delivered pups were decreased in the group whose mothers had been given 10 mg/kg.

A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (D- or D, L-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function.

There are no adequate and well-controlled studies in pregnant women. There has been one report of severe congenital bony deformity, tracheo-esophageal fistula, and anal atresia (vater association) in a baby born to a woman who took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Infants born to mothers dependent on Adderall-XR (Amphetamine, Dextroamphetamine) have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.

Labor and Delivery

The effects of Adderall-XR (Amphetamine, Dextroamphetamine mixed salts) on labor and delivery in humans is unknown.

Nursing Mothers

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

Pediatric Use

Adderall-XR (Amphetamines) is indicated for use in children 6 years of age and older.

The safety and efficacy of Adderall-XR (Amphetamines) capsules in children under 6 years of age have not been studied. Longterm effects of amphetamines in children have not been well established.

In a juvenile developmental study, rats received daily oral doses of amphetamine (D- to L-enantiomer ratio of 3:1, the same as in Adderall-XR) of 2, 6, or 20 mg/kg on days 7-13 of age; from day 14 to approximately day 60 of age these doses were given b.i.d. for total daily doses of 4, 12, or 40 mg/kg. The latter doses are approximately 0.6, 2, and 6 times the maximum recommended human dose for children of 30 mg/day, on a mg/m2 basis. Post dosing hyperactivity was seen at all doses; motor activity measured prior to the daily dose was decreased during the dosing period but the decreased motor activity was largely absent after an 18 day drug-free recovery period. Performance in the Morris water maze test for learning and memory was impaired at the 40 mg/kg dose, and sporadically at the lower doses, when measured prior to the daily dose during the treatment period; no recovery was seen after a 19 day drugfree period. A delay in the developmental milestones of vaginal opening and preputial separation was seen at 40 mg/kg but there was no effect on fertility.

Geriatric Use

Amphetamines (Adderall-XR) has not been studied in the geriatric population.



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