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  • Adderall XR
    (Amphetamine Salt Combo) - Shire

    BOXED WARNING

    High potential for abuse; prolonged use may lead to drug dependence. Misuse may cause sudden death and serious cardiovascular (CV) adverse reactions.

    THERAPEUTIC CLASS

    Sympathomimetic amine

    DEA CLASS

    CII

    INDICATIONS

    Treatment of attention-deficit hyperactivity disorder.

    ADULT DOSAGE

    Adults: Individualize dose. Amphetamine-Naive/Switching from Another Medication: 20mg qam. Switching from Amphetamine Immediate-Release (IR): Give the same total daily dose, qd. Titrate at weekly intervals as indicated.

    PEDIATRIC DOSAGE

    Pediatrics: Individualize dose. Switching from Amphetamine IR: Give the same total daily dose, qd. Titrate at weekly intervals as indicated. Amphetamine-Naive/Switching from Another Medication: 13-17 Yrs: Initial: 10mg qam. Titrate: May increase to 20mg/day after 1 week if symptoms are not controlled. 6-12 Yrs: Initial: 10mg qam or 5mg qam when lower initial dose is appropriate. Titrate: Adjust daily dosage in increments of 5mg or 10mg at weekly intervals. Max: 30mg/day.

    HOW SUPPLIED

    Cap, Extended-Release: 5mg, 10mg, 15mg, 20mg, 25mg, 30mg

    CONTRAINDICATIONS

    Advanced arteriosclerosis, symptomatic CV disease, moderate to severe HTN, hyperthyroidism, glaucoma, agitated states, history of drug abuse, during or within 14 days following MAOI use.

    WARNINGS/PRECAUTIONS

    Sudden death, stroke, and myocardial infarction (MI) reported in adults. Sudden death reported in children and adolescents with structural cardiac abnormalities or other serious heart problems. Avoid use in patients with known serious structural cardiac and heart rhythm abnormalities, cardiomyopathy, coronary artery disease (CAD), or other serious cardiac problems. May cause modest increase in BP and HR; caution with conditions that could be compromised by BP or HR elevation (eg, preexisting HTN, heart failure, recent MI, or ventricular arrhythmia). Perform prompt cardiac evaluation when symptoms suggestive of cardiac disease develop. May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder. Caution in patients with comorbid bipolar disorder; may cause induction of mixed/manic episode. May cause treatment-emergent psychotic/manic symptoms (eg, hallucination, delusional thinking, mania) in children and adolescents without a prior history of psychotic illness or mania; may be appropriate to d/c if symptoms occur. Aggressive behavior or hostility reported; monitor for appearance or worsening. May slow growth rate in children; may need to d/c if patients are not growing or gaining weight as expected. May lower convulsive threshold; d/c if seizure develops. Associated with peripheral vasculopathy, including Raynaud's phenomenon, which generally improves after dose reduction or discontinuation; observe carefully for digital changes during treatment. Difficulties with accommodation and blurring of vision reported. Exacerbation of motor and phonic tics, and Tourette's syndrome reported. Prescribe or dispense the least amount feasible at one time to minimize possibility of overdosage. May significantly elevate plasma corticosteroid levels or interfere with urinary steroid determinations. Where possible, interrupt occasionally to determine the need for continued therapy.

    ADVERSE REACTIONS

    Dry mouth, loss of appetite, insomnia, headache, abdominal pain, weight loss, agitation, anxiety, N/V, dizziness, tachycardia, nervousness, asthenia, diarrhea.

    DRUG INTERACTIONS

    See Contraindications. Avoid with GI alkalinizing agents (eg, sodium bicarbonate, antacids). Urinary alkalinizing agents (eg, acetazolamide, some thiazides) may increase blood levels and potentiate effects. GI acidifying agents (eg, guanethidine, reserpine, glutamic acid HCl, ascorbic acid) and urinary acidifying agents (eg, ammonium chloride, sodium acid phosphate, methenamine salts) may lower blood levels and efficacy. May reduce CV effects of adrenergic blockers. May counteract sedative effects of antihistamines. May antagonize effects of antihypertensives. May inhibit hypotensive effect of veratrum alkaloids. May delay intestinal absorption of phenobarbital, phenytoin, and ethosuximide. May enhance activity of TCAs or sympathomimetic agents; caution with other sympathomimetic drugs. Increased d-amphetamine levels in the brain with desipramine or protriptyline and possibly other tricyclics. May potentiate analgesic effect of meperidine. May enhance the adrenergic effect of norepinephrine. Chlorpromazine and haloperidol may inhibit the central stimulant effects. Lithium carbonate may inhibit anorectic and stimulatory effects. Norepinephrine may enhance the adrenergic effect. Use in cases of propoxyphene overdose may potentiate CNS stimulation and cause fatal convulsions. Monitor for changes in clinical effect when coadministered with proton pump inhibitors.

    PREGNANCY

    Category C, not for use in nursing.

    MECHANISM OF ACTION

    Sympathomimetic amine; has not been established. Thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

    PHARMACOKINETICS

    Absorption: Tmax=7 hrs. Distribution: Found in breast milk. Metabolism: CYP2D6 (oxidation); 4-hydroxy-amphetamine and norephedrine (active metabolites). Elimination: Urine (normal pH) (30-40%, unchanged; 50%, α-hydroxy-amphetamine derivatives). (20mg single dose) d-amphetamine: T1/2=10 hrs (adults), 11 hrs (13-17 yrs), 9 hrs (6-12 yrs). l-amphetamine: T1/2=13 hrs (adults), 13-14 hrs (13-17 yrs), 11 hrs (6-12 yrs).

    ASSESSMENT

    Assess for advanced arteriosclerosis, symptomatic CV disease (structural/rhythm abnormalities, CAD, recent MI), moderate to severe HTN, hyperthyroidism, hypersensitivity or idiosyncrasy to sympathomimetic amines, glaucoma, agitation, history of drug abuse, psychiatric history (eg, family history of suicide, bipolar disorder, depression), history of seizure, tics or Tourette's syndrome, hepatic/renal dysfunction, pregnancy/nursing status, and possible drug interactions.

    MONITORING

    Monitor for CV abnormalities, exacerbations of behavior disturbances and thought disorder, psychotic or manic symptoms, aggressive behavior, hostility, seizures, visual disturbances, exacerbation of motor and phonic tics and Tourette's syndrome, and other adverse reactions. Monitor BP and HR. Monitor height and weight in children. Observe carefully for signs and symptoms of peripheral vasculopathy (eg, digital changes); further clinical evaluation (eg, rheumatology referral) may be appropriate for certain patients.

    PATIENT COUNSELING

    Inform about benefits and risks of treatment, appropriate use, and about the potential for abuse/dependence. Advise about serious CV risks. Inform that treatment-emergent psychotic or manic symptoms may occur. Inform about the risk of peripheral vasculopathy, including Raynaud's phenomenon; instruct to report to physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes, and to call physician immediately if any signs of unexplained wounds appear on fingers or toes while on therapy. Instruct parents or guardians of pediatric patients to monitor growth and weight during treatment. Advise to notify physician if pregnant or planning to become pregnant. Advise to avoid breastfeeding. Advise to use caution when engaging in potentially hazardous activities (eg, operating machinery or vehicles).

    ADMINISTRATION/STORAGE

    Administration: PO route. Give upon awakening; avoid pm doses due to potential for insomnia. Take with or without food. Take caps whole or sprinkle entire contents on applesauce. Consume sprinkled applesauce immediately without chewing the sprinkled beads. Do not divide the dose of a single cap or take anything <1 cap/day. Storage: 25°C (77°F); excursions permitted to 15-30°C (59-86°F).