DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), CII 10 mg
This information is intended for U.S. healthcare professionals only.
INDICATIONS AND USAGE
Mixed Salts of a Single Entity Amphetamine Product are indicated in attention deficit hyperactivity disorder (ADHD) and narcolepsy.
IMPORTANT RISK INFORMATION
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
- Mixed Salts of a Single Entity Amphetamine Product are contraindicated in:
- Patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, and glaucoma.
- Agitated states.
- Patients with a history of drug abuse.
- During or within 14 days following the administration of monoamine oxidase inhibitors.
WARNINGS AND PRECAUTIONS
- Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Adults have a greater risk for these cardiac abnormalities.
- Stimulant medications cause a modest increase in average blood pressure and average heart rate and individuals may have larger increases.
- Use of stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with preexisting psychiatric illness, including bipolar or pre-existing psychosis. Clinical evaluation for bipolar disorder is recommended prior to stimulant use. Monitor for aggressive behavior.
- Consistently medicated children may exhibit a temporary slowing in growth rate.
- Stimulants may lower the convulsive threshold.
- Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
- Amphetamines have been reported to exacerbate motor and phonic tics and Tourette’s syndrome.
- Serious adverse events may sudden death, strokes, myocardial infarction, slowing of growth, seizures, changes in vision, and rhabdomyolysis.
- Common adverse events include headache, stomach ache, insomnia, decreased appetite, nervousness, and dizziness.
USE IN SPECIFIC POPULATIONS
- Pregnancy: 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.
- Breastfeeding: Amphetamines are excreted in human milk.
- Pediatrics: 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.
||White to cream colored/mottled pillow shaped tablet
||DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII
||Debossed with a “10” and a partial quadrisect on one side and a boxed M on the other side.
For additional information on DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), CII 10 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.