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Dextroamphetamine Sulfate Extended-Release Capsules, USP CII 5 mg

INDICATIONS AND USAGE

Dextroamphetamine Sulfate Extended-Release Capsules (CII) are indicated in narcolepsy and attention deficit disorder with hyperactivity.

IMPORTANT RISK INFORMATION

WARNING

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 NONTHERAPEUTIC 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.

CONTRAINDICATIONS

  • Dextroamphetamine sulfate extended-release capsules are contraindicated:
    • In patients with advanced arteriosclerosis, symptomatic cardiovascular disease, glaucoma or moderate to severe hypertension.
    • In patients with hyperthyroidism or agitated states.
    • In patients with known hypersensitivity or idiosyncrasy to sympathomimetic amines.
    • In patients with a history of drug abuse.
    • During or within 14 days following the administration of monoamine oxidase inhibitors.

WARNINGS AND PRECAUTIONS

  • Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. 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.
  • Stimulant medications cause a modest increase in average blood pressure and average heart rate, and individuals may have larger increases.
  • Administration of stimulants may exacerbate symptoms of behavior disturbances, thought disorders and bipolar disorder. At usual doses, treatment-emergent psychotic or manic symptoms can be caused by stimulants.
  • Consistently medicated children may exhibit a temporarily slowed growth rate.
  • Stimulants may lower the convulsive threshold.
  • Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

ADVERSE REACTIONS

  • Serious adverse reactions may include sudden death, stroke, myocardial infarction, slowing of growth, seizures, and changes in vision.
  • Common adverse reactions include palpitations, tremors, insomnia, stomach upset, dry mouth, decreased appetite, headache, dizziness, and anorexia.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Infants born to mothers dependent on amphetamines have an increased risk of premature delivery, low birth weight, and symptoms of amphetamine withdrawal.
  • Breast feeding: Amphetamines are excreted in human milk.
  • Pediatrics: Long-term effects of amphetamines in pediatric patients have not been well established. Dextroamphetamine sulfate extended-release capsules are not recommended for use in pediatric patients younger than 6 years of age.

Description Capsule with white opaque cap and white opaque body
Compares To Dexedrine® Spansule® Sustained Release Capsules
Rating AB
Dosage Strength 5 mg
Identification Code Imprinted with M® within a box on the cap and 8960 5 mg on the body in black

Ordering Information

NDC # Package Size Case Quantity
0406-8960-01 100 12

For additional information on Dextroamphetamine Sulfate Extended-Release Capsules, USP CII 5 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.

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