DOSAGE AND ADMINISTRATION

Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of possible insomnia.

Attention Deficit Disorder With Hyperactivity: Not recommended for pediatric patients under 3 years of age.

In pediatric patients from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.

Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Reference: 1. Agency for Healthcare Research and Quality. Attention Deficit Hyperactivity Disorder: Effectiveness of Treatment in At-Risk Preschoolers; Long-Term Effectiveness in All Ages; and Variability in Prevalence, Diagnosis, and Treatment. AHRQ Publication No. 12-EHC003-EF. 2011.

Multiple short-term studies document that psychostimulant medications as part of a total treatment program, either MPH, dextroamphetamine (DEX), or mixed amphetamine salts (MAS) effectively stabilize the indicated symptoms of ADHD.

The following have been reported with use of ProCentra and other stimulant medicines: (1) Heart-related problems including sudden death in patients who have heart problems or heart defects, stroke and heart attacks in adults, or increased blood pressure and heart rate. (2) Psychiatric problems including new or worse behavior and thought problems , new or worse bipolar illness, or new or worse aggressive behavior or hostility; in children and teenagers: new psychotic symptoms. (3) Circulation problems where fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.

Hypothetical patient portrayal

Common side effects include: tachycardia, tremors, trouble sleeping, dry mouth, decreased appetite, headache, dizziness, and weight loss.

INDICATION AND USAGE

ProCentra® (dextroamphetamine sulfate) Oral Solution CII is indicated for Attention Deficit Disorder with Hyperactivity (ADHD) as an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: Moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity.

The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

IMPORTANT SAFETY 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.

  • ProCentra is contraindicated:
    • – Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.
    • – Agitated states.
    • – Patients with a history of drug abuse.
    • – During or within 14 days following the administration of monoamine oxidase inhibitors (MAOIs). Hypertensive crisis may result.
  • Sudden Death in Patients with Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems. Prior to treatment assess for the presence of cardiac disease. Sudden death has been reported in association with CNS stimulant treatment at usual doses in children, adolescents with serious structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment. Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD.
  • Stimulants cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
  • Prior to treatment assess for the presence of bipolar disorder. Use of stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with preexisting psychosis.
  • Children and adolescents with ADHD beginning and during treatment for ADHD should be monitored for the appearance of, or worsening of, aggressive behavior or hostility.
  • Stimulants have been associated with slowing of growth rate in pediatric patients without evidence of growth rebound. Monitor height and weight in children during treatment with ProCentra. Treatment may need to be interrupted in children not growing as expected.
  • Stimulants used to treat ADHD may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.
  • Stimulants, including ProCentra, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Observe patients for new numbness, pain, skin color change, or sensitivity to temperature in fingers and toes. Further evaluation may be required, including referral.
  • 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. If concomitant use of ProCentra with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate ProCentra with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.
  • Clinical evaluation for tics and Tourette’s syndrome in children and their families should precede use of stimulants.
  • Difficulties with accommodation and blurring of vision have been reported with stimulants used to treat ADHD.
  • Drug Interactions: In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur. See Full Prescribing Information for a list of drug interactions. The concomitant use of ProCentra and CYP2D6 inhibitors increase the risk of serotonin syndrome. See Full Prescribing Information for a list of drug interactions.
  • Use in Specific Populations: Amphetamines have been reported to exacerbate motor and phonic tics and Tourette’s syndrome in children. See full prescribing information for other reported drug interactions.
  • Adverse reactions reported and not mentioned in prior warnings include: overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances, urticaria, impotence, changes in libido, and rhabdomyolysis.
  • Drug Abuse and Dependence: Amphetamines have been extensively abused. Tolerance, extreme psychological dependence and severe social disability have occurred. Educate patients about abuse and periodically re-evaluate the need for ProCentra.