Adderall warnings

Psychosis: Clinical experience suggests that in psychotic children, administration of amphetamine may exacerbate symptoms of behavior disturbance and thought disorder.

Long-Term Suppression of Growth: Data are inadequate to determine whether chronic administration of amphetamine may be associated with growth inhibition; therefore, growth should be monitored during treatment.

Sudden Death and Pre-existing Structural Cardiac Abnormalities: Sudden death has been reported in association with amphetamine treatment at usual doses in children with structural cardiac abnormalities. Adderall generally should not be used in children or adults with structural cardiac abnormalities.

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

General: The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Hypertension: Caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. Blood pressure and pulse should be monitored at appropriate intervals in patients taking Adderall, especially patients with hypertension.

Carcinogenesis/Mutagenesis: Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of amphetamine, have not been performed.

WARNINGS

Psychosis: Clinical experience suggests that in psychotic children, administration of amphetamine may exacerbate symptoms of behavior disturbance and thought disorder.

Long-Term Suppression of Growth: Data are inadequate to determine whether chronic administration of amphetamine may be associated with growth inhibition; therefore, growth should be monitored during treatment.

Sudden Death and Pre-existing Structural Cardiac Abnormalities: Sudden death has been reported in association with amphetamine treatment at usual doses in children with structural cardiac abnormalities. Adderall generally should not be used in children or adults with structural cardiac abnormalities.

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

General: The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Hypertension: Caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. Blood pressure and pulse should be monitored at appropriate intervals in patients taking Adderall, especially patients with hypertension.

Pregnancy - Teratogenic Effects: Pregnancy Category C. Amphetamine has been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose. Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose. While there are no adequate and well-controlled studies in pregnant women, there has been one report of severe congenital bony deformity, tracheoesophageal 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. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.

Pediatric Use: Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended for use in children under 3 years of age with Attention Deficit Disorder with Hyperactivity described under INDICATIONS AND USAGE.

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.

Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe amphetamines should depend on the physician’s assessment of the chronicity and severity of the child’s symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics. When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually not indicated.

Adderall warnings

Psychosis: Clinical experience suggests that in psychotic children, administration of amphetamine may exacerbate symptoms of behavior disturbance and thought disorder.

Long-Term Suppression of Growth: Data are inadequate to determine whether chronic administration of amphetamine may be associated with growth inhibition; therefore, growth should be monitored during treatment.

Sudden Death and Pre-existing Structural Cardiac Abnormalities: Sudden death has been reported in association with amphetamine treatment at usual doses in children with structural cardiac abnormalities. Adderall generally should not be used in children or adults with structural cardiac abnormalities.

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

General: The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Hypertension: Caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. Blood pressure and pulse should be monitored at appropriate intervals in patients taking Adderall, especially patients with hypertension.

Carcinogenesis/Mutagenesis: Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of amphetamine, have not been performed.

WARNINGS

Psychosis: Clinical experience suggests that in psychotic children, administration of amphetamine may exacerbate symptoms of behavior disturbance and thought disorder.

Long-Term Suppression of Growth: Data are inadequate to determine whether chronic administration of amphetamine may be associated with growth inhibition; therefore, growth should be monitored during treatment.

Sudden Death and Pre-existing Structural Cardiac Abnormalities: Sudden death has been reported in association with amphetamine treatment at usual doses in children with structural cardiac abnormalities. Adderall generally should not be used in children or adults with structural cardiac abnormalities.

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

General: The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Hypertension: Caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. Blood pressure and pulse should be monitored at appropriate intervals in patients taking Adderall, especially patients with hypertension.

Pregnancy - Teratogenic Effects: Pregnancy Category C. Amphetamine has been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose. Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose. While there are no adequate and well-controlled studies in pregnant women, there has been one report of severe congenital bony deformity, tracheoesophageal 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. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.

Pediatric Use: Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended for use in children under 3 years of age with Attention Deficit Disorder with Hyperactivity described under INDICATIONS AND USAGE.

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.

Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe amphetamines should depend on the physician’s assessment of the chronicity and severity of the child’s symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics. When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually not indicated.