Ritalin/Ritalin LA

Ritalin/Ritalin LA

methylphenidate

Manufacturer:

Novartis Healthcare

Distributor:

Zuellig
Concise Prescribing Info
Contents
Methylphenidate HCl
Indications/Uses
ADHD in adults & childn ≥6 yr. Ritalin Narcolepsy.
Dosage/Direction for Use
Ritalin ADHD Childn & adolescent ≥6 yr Initially 5 mg once daily or bid w/ 5-10 mg wkly increments. Max: 60 mg daily. Narcolepsy Adult 20-30 mg in 2-3 divided doses. Max: 60 mg daily. Ritalin LA ADHD Adult Initially 20 mg once daily. Max: 80 mg daily. Childn & adolescent ≥6 yr Initially 20 mg once daily. Max: 60 mg daily. Patient new to methylphenidate Initially 20 mg once daily. Patient currently using methylphenidate Continued w/ the same daily dose. Max: 80 mg daily.
Administration
May be taken with or without food: LA MR Cap: Swallow whole, do not crush/chew/divide. Alternatively, carefully open cap & sprinkle entire contents over room temp soft food (eg, applesauce). Take mixt immediately. Do not store for future use.
Contraindications
Hypersensitivity. Anxiety, tension; agitation; hyperthyroidism; preexisting CV disorders including severe HTN, angina, arterial occlusive disease, heart failure, hemodynamically significant congenital heart disease, cardiomyopathies, MI, potentially life-threatening arrhythmias & channelopathies; glaucoma; phaeochromocytoma; diagnosis or family history of Tourette's syndrome. Concomitant use w/ MAOIs or w/in a min of 2 wk after discontinuation.
Special Precautions
Not indicated in all cases of ADHD. Should not be used in patients w/ known structural cardiac abnormalities or other serious cardiac disorders that may increase the risk of sudden death; w/ preexisting CNS abnormalities eg, cerebral aneurysm &/or other vascular abnormalities eg, vasculitis or preexisting stroke. Assess patients for preexisting CV disorders & family history of sudden death & ventricular arrhythmia before initiating treatment; regularly for neurological/psychiatric signs & symptoms after initiating treatment; for preexisting psychiatric disorders & family history of psychiatric disorders. Patients whose underlying medical conditions might be compromised by increases in BP or heart rate eg, those w/ preexisting HTN; prompt cardiac evaluation in patients who develop symptoms of cardiac disease during treatment. Misuse may be associated w/ sudden death & other serious CV adverse events. Should not be initiated in patients w/ acute psychosis, mania or suicidality. Patients w/ emergent of psychiatric symptoms of exacerbation of preexisting psychiatric symptoms. Consider treatment discontinuation in patients w/ psychotic symptoms including visual & tactile hallucinations or mania. Emergent of aggressive behavior or exacerbation of baseline aggressive behavior during therapy; evaluate the need for adjustment of treatment regimen. Monitor patients for clinical worsening, suicidal behavior/thoughts, or unusual changes in behavior. Regularly monitor for the emergence or worsening of tics during treatment. Priapism. Growth retardation in childn. Epileptic patients; discontinue if seizure frequency increases. Emotionally unstable patients eg, w/ history of drug dependence or alcoholism. May unmask depression & effects of chronic overactivity during drug w/drawal. Periodically perform complete & differential blood & platelet counts in patients requiring long-term therapy. Not recommended in concomitant use w/ serotonergic drugs eg, SSRIs & SNRIs. May impair ability to drive or operate machinery. Pregnancy & lactation. Not to be used in childn <6 yr.
Adverse Reactions
Nasopharyngitis; decreased appetite; nervousness, insomnia; nausea, dry mouth. Anxiety, restlessness, sleep disorder, agitation, depression, aggression, bruxism; dyskinesia, tremor, headache, drowsiness, dizziness; tachycardia, palpitation, arrhythmias, changes in BP & heart rate (usually increase); cough; abdominal pain, vomiting, dyspepsia, toothache; rash, pruritus, urticaria, fever, scalp hair loss, hyperhidrosis; arthralgia, feeling jittery; decreased wt; Raynaud's phenomenon, peripheral coldness.
Drug Interactions
May decrease effectiveness of drugs used to treat HTN. Hypertensive crisis w/ MAOIs. May exacerbate CNS effects w/ alcohol. Risk of sudden BP & heart rate increase w/ anesth during surgery. Serious adverse events including sudden death w/ centrally acting α2-agonists (eg, clonidine). Development of serotonin syndrome w/ serotonergic drugs. Counteracts mechanism of action w/ antipsychotics. May induce false +ve laboratory tests for amphetamines particularly w/ immunoassays screen test. Drugs elevating BP; direct & indirect dopamine agonists (including DOPA & TCAs), dopamine antagonists (antipsychotics eg, haloperidol); coumarin anticoagulants, anticonvulsants (eg, phenobarb, phenytoin, primidone), phenylbutazone & TCAs.
ATC Classification
N06BA04 - methylphenidate ; Belongs to the class of centrally-acting sympathomimetics. Used as CNS stimulant.
Presentation/Packing
Form
Ritalin tab 10 mg
Packing/Price
30's
Form
Ritalin LA MR cap 20 mg
Packing/Price
30's
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