Dextroamphetamine

Dextroamphetamine is an amphetamine for the treatment of narcolepsy. Zenzedi is also indicated as a treatment for attention deficit hyperactivity disorder (ADHD) in pediatric patients ages 3 to 16 years as an integral part of a total treatment program for ADHD that may include counseling or other therapies.

• Dextroamphetamine is available under the following different brand names: Dexedrine, ProCentra, and Zenzedi.

Adult and Pediatric Dosage Forms and Strengths

Capsule, extended-release (Dexedrine): Schedule II

• 5mg
• 10mg
• 15mg

Tablet, immediate-release (Zenzedi): Schedule II

• 2.5mg
• 5mg
• 7.5mg
• 10mg
• 15mg
• 20mg
• 30mg

Oral solution (ProCentra): Schedule II

• 5mg/5mL

• Adult: 10 mg/day orally; may titrate every week until side effects appear
• Not to exceed 60 mg/day
• Children over 12 years: 10 mg orally once/day initially; may increase by 10 mg once/week to optimal response
• Geriatric: 5 mg/day orally; may increase the dose by 5 mg/day every week until side effects appear
• Not to exceed 60 mg/day
• Start at the lowest dose

• Adult: 5 mg orally once or twice daily (4-6 hours apart); may increase 5 mg/day once/week until optimal response
• Rarely necessary to exceed 40 mg/day

Pediatric:

• Children under 3 years: Safety and efficacy not established
• Children 3-5 years
  • Initial: 2.5 mg orally once/day; may increase by 2.5 mg/day once/week
• Children 6 years and older
  • Initial: 5 mg orally once or twice daily (4-6 hours apart); may increase by 5 mg/day once/week until optimal response
  • Maintenance: 5-15 mg orally every 12 hours OR 5-10 mg orally every 8 hours
  • May substitute with once/day dosing of extended-release capsules
  • Rarely necessary to exceed 40 mg/day

Common side effects of Dextroamphetamine include:

• Appetite loss
• Trouble sleeping (insomnia)
• Abdominal pain
• Anxiety
• Blurred vision
• Changes in sex drive
• Diarrhea
• Dizziness
• Euphoria
• Fatigue
• Fever
• Hives
• Impotence
• Indigestion/heartburn
• Infection
• Involuntary movements
• Mood swings
• Nausea
• Nervousness
• Overstimulation
• Restlessness
• Seizures
• Stomach upset
• Unpleasant taste in the mouth
• Vomiting
• Weight loss

Other side effects of dextroamphetamine include:

• Hyperactivity
• Hypomania
• Heart palpitations
• Fast heart rate
• High blood pressure (hypertension)
• Dry mouth
• Constipation
• Tremors
• Headache

Postmarketing side effects of dextroamphetamine reported include:

• Musculoskeletal: Muscle wasting (rhabdomyolysis)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Severe interactions of dextroamphetamine include:
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • phenelzine
  • procarbazine
  • rasagiline
  • safinamide
  • selegiline
  • selegiline transdermal
  • tranylcypromine
• Dextroamphetamine has serious interactions with at least 39 different drugs.
• Dextroamphetamine has moderate interactions with at least 225 different drugs.
• Dextroamphetamine has mild interactions with at least 58different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• Dextroamphetamine has a high potential for abuse; particular attention should be paid to the possibility of patients obtaining dextroamphetamine for nontherapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.
• Administration of dextroamphetamine for prolonged periods of time may lead to drug dependence and must be avoided.
• Misuse of dextroamphetamine may cause sudden death and serious cardiovascular adverse events.
• This medication contains dextroamphetamine. Do not take Dexedrine, ProCentra, or Zenzedi if you are allergic to dextroamphetamine or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to drug or components
• Hyperthyroidism
• Glaucoma
• High blood pressure (hypertension), advanced arteriosclerosis, symptomatic cardiovascular disease
• Agitated states, history of drug abuse
• Within 14 days of administering monoamine oxidase inhibitors (MAOIs)

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Dextroamphetamine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Dextroamphetamine?"

Cautions

• Risk of sudden death in children and adolescents with structural cardiac abnormalities; generally avoid.
• Risk of adverse psychiatric events; e.g., hallucinations and mania.
• Caution in mild high blood pressure (hypertension).
• Associated with peripheral vasculopathy, including Raynaud's phenomenon.
• Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
• Sudden deaths, stroke, and myocardial infarction were reported in adults taking stimulants at usual doses.
• Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.
• Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episodes in such patients.
• Aggressive behavior or hostility is often observed in children and adolescents with ADHD; monitor for the appearance of or worsening of aggressive behavior or hostility.
• Monitor growth of children ages 7 to 10 years during treatment with stimulants; may need to interrupt therapy in patients not growing or gaining weight as expected.
• Stimulants may lower the convulsive threshold in patients with prior history of seizures, patients with prior EEG abnormalities in absence of seizures, and very rarely, patients without a history of seizures and no prior EEG evidence of seizures; discontinue therapy in the presence of seizures.
• Use caution in patients who use other sympathomimetic drugs.
• Amphetamines may exacerbate motor and phonic tics and Tourette's syndrome; perform a clinical evaluation for tics and Tourette's syndrome in children and their families prior to treating with stimulant medications.
• Rare instances of prolonged and sometimes painful erections (priapism), sometimes requiring surgical intervention, reported with methylphenidate products; typically not reported during initiation, but often subsequent to an increase in dose; seek immediate medical attention for abnormally sustained or frequent and painful erections.

Drug interaction overview

• 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. John's wort
• Amphetamines are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism; potential for a pharmacokinetic interaction exists with coadministration of CYP2D6 inhibitors which may increase risk with increased exposure to amphetamines; in these situations, consider alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6
• If concomitant use with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate therapy with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of increased risk for serotonin syndrome

Pregnancy and Lactation

• Use dextroamphetamine with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• Dextroamphetamine enters breast milk; it is not recommended for use while breastfeeding.