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  • Ritalin
    (Methylphenidate HCl) - Novartis

    BOXED WARNING

    Caution with history of drug dependence or alcoholism. Chronic abuse may lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes may occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic use may unmask symptoms of underlying disorder that may require follow-up.

    OTHER BRAND NAMES

    Ritalin-SR (Novartis)

    THERAPEUTIC CLASS

    Sympathomimetic amine

    DEA CLASS

    CII

    INDICATIONS

    Treatment of attention deficit disorders and narcolepsy.

    ADULT DOSAGE

    Adults: Individualize dose. (Tab) 10-60mg/day given in divided doses bid-tid 30-45 min ac. Take last dose before 6 pm if unable to sleep. (Tab, SR) May be used in place of methylphenidate tabs when the 8-hr dosage corresponds to the titrated 8-hr dosage of methylphenidate tabs.

    PEDIATRIC DOSAGE

    Pediatrics: ≥6 Yrs: Individualize dose. Initiate in small doses, with gradual weekly increments. Max: 60mg/day. D/C if no improvement seen after appropriate dose adjustment over 1 month. (Tab) Initial: 5mg bid before breakfast and lunch. Titrate: Increase gradually by 5-10mg weekly. (Tab, SR) May be used in place of methylphenidate tabs when the 8-hr dosage corresponds to the titrated 8-hr dosage of methylphenidate tabs. Reduce dose or d/c if paradoxical aggravation of symptoms or other adverse effects occur. Periodically d/c to assess child's condition. Drug treatment should not be indefinite and usually may be discontinued after puberty.

    HOW SUPPLIED

    Tab: (Ritalin) 5mg, 10mg*, 20mg*; Tab, Sustained-Release (SR): (Generic) 10mg, (Ritalin-SR) 20mg *scored

    CONTRAINDICATIONS

    Marked anxiety, tension, agitation, glaucoma, motor tics, or family history or diagnosis of Tourette's syndrome. Treatment with MAOIs or within a minimum of 14 days following discontinuation of an MAOI.

    WARNINGS/PRECAUTIONS

    Avoid with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Sudden death reported in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction reported in adults. May increase BP and HR. Prior to treatment, obtain medical history (including assessment for family history of sudden death or ventricular arrhythmia) and perform physical exam to assess for presence of cardiac disease. Promptly perform cardiac evaluation if symptoms 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 induce mixed/manic episode. May cause treatment-emergent psychotic or manic symptoms (eg, hallucinations, delusional thinking, mania) in children and adolescents without prior history of psychotic illness or mania; consider discontinuation if such symptoms occur. Aggressive behavior or hostility reported in children and adolescents. May cause long-term suppression of growth in children; monitor growth, and may need to interrupt treatment in patients not growing or gaining height or weight as expected. May lower convulsive threshold; d/c if seizures occur. Priapism, sometimes requiring surgical intervention, reported. Associated with peripheral vasculopathy, including Raynaud's phenomenon. Difficulties with accommodation and blurring of vision reported. Patients with an element of agitation may react adversely; d/c if necessary.

    ADVERSE REACTIONS

    Nervousness, insomnia, hypersensitivity reactions, anorexia, nausea, dizziness, palpitations, headache, dyskinesia, drowsiness, BP and pulse changes, tachycardia, angina, cardiac arrhythmia, abdominal pain.

    DRUG INTERACTIONS

    See Contraindications. Caution with pressor agents. May decrease effectiveness of drugs used to treat HTN. May inhibit metabolism of coumarin anticoagulants, anticonvulsants, and TCAs; downward dose adjustment and monitoring of plasma drug concentration (or coagulation times for coumarin) of these drugs may be necessary when initiating or discontinuing methylphenidate.

    PREGNANCY

    Category C, caution in nursing.

    MECHANISM OF ACTION

    Sympathomimetic amine; mild CNS stimulant. Has not been established; thought to activate the brain stem arousal system and cortex to produce its stimulant effect.

    PHARMACOKINETICS

    Absorption: (Children) Tmax=4.7 hrs (Tab, SR), 1.9 hrs (Tab). Metabolism: Deesterification to α-phenyl-2-piperidine acetic acid (ritalinic acid) (major metabolite). Elimination: Urine (Tab, SR) (86%; 67% [Children])

    ASSESSMENT

    Assess for hypersensitivity to the drug, marked anxiety, tension, agitation, glaucoma, motor tics, family history or diagnosis of Tourette's syndrome, cardiovascular conditions, history of drug dependence or alcoholism, psychotic disorder, comorbid bipolar disorder, any other conditions where treatment is contraindicated or cautioned, pregnancy/nursing status, and possible drug interactions.

    MONITORING

    Monitor for changes in HR and BP, signs/symptoms of cardiac disease, exacerbation of behavior disturbance and thought disorder, psychosis, mania, appearance of or worsening of aggressive behavior or hostility, seizures, priapism, digital changes, visual disturbances, and other adverse reactions. In pediatric patients, monitor growth. Perform periodic monitoring of CBC, differential, and platelet counts during prolonged therapy.

    PATIENT COUNSELING

    Inform about the benefits and risks of therapy and counsel about appropriate use. Instruct to seek immediate medical attention in the event of priapism. Instruct to report to physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes, and to contact physician immediately if any signs of unexplained wounds appear on fingers or toes while taking the drug.

    ADMINISTRATION/STORAGE

    Administration: Oral route. (Tab, SR) Swallow tabs whole; do not crush or chew. Storage: (Ritalin/Ritalin-SR) 25°C (77°F); excursions permitted to 15-30°C (59-86°F). (Generic) 20-25°C (68-77°F). (Ritalin) Protect from light. (Tab, SR) Protect from moisture.