Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation e. Serotonin Syndrome Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors MAOIs , selective serotonin reuptake inhibitors SSRIs , serotonin norepinephrine reuptake inhibitors SNRIs , triptans, tricyclic antidepressants , fentanyl, lithium , tramadol, tryptophan , buspirone, and St.
Serotonin syndrome symptoms may include mental status changes e. Visual Disturbance Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. Tics Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in children and their families should precede use of stimulant medications. Information For Patients Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with amphetamine or dextroamphetamine and should counsel them in its appropriate use. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents.
Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. These doses are approximately 2.
These doses are approximately 1. Administration of these doses was also associated with severe maternal toxicity. 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 amphetamines have an increased risk of premature delivery and low birth weight.
FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. It could cause premature birth, low birth weight, or withdrawal symptoms in a newborn if the mother takes amphetamine and dextroamphetamine during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Amphetamine and dextroamphetamine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using this medication.
Long-term use of amphetamine and dextroamphetamine can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly. Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.
Do not take amphetamine and dextroamphetamine in the evening because it may cause sleep problems insomnia. Do not crush, chew, break, or open an extended-release capsule. Breaking or opening the pill may cause too much of the drug to be released at one time.
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