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Ritalin/Ritalin LA

Ritalin/Ritalin LA

methylphenidate

Manufacturer:

Novartis

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Methylphenidate HCl
Indications/Uses
Ritalin/Ritalin LA: ADHD. Ritalin: Narcolepsy.
Dosage/Direction for Use
Ritalin ADHD Childn & adolescent ≥6 yr Initially 5 mg once daily or bd w/ gradual 5- or 10-mg wkly increments. Administer total daily dose in divided doses. Narcolepsy Adult Administer in divided doses bd or tds. Ave dose is 20-30 mg daily. Some patients may require 40-60 mg daily, while 10-15 mg daily will be adequate in others. Max daily dose: 60 mg. Ritalin LA ADHD Adult Adjust dose at wkly intervals in 20-mg increments. Max daily dose: 80 mg. New to methylphenidate: Initially 20 mg once daily. Currently using methylphenidate: May continue treatment w/ the same daily dose. Dose should be equal to the total daily dose of previous IR formulation. Childn & adolescent ≥6 yr Adjust dose at wkly intervals in 10-mg increments. Max daily dose: 60 mg. New to methylphenidate: Initially 20 mg once daily. May begin treatment w/ 10 mg when appropriate. Currently using methylphenidate: May continue treatment w/ the same daily dose. Dose should be equal to the total daily dose of previous IR formulation.
Administration
Ritalin: Should be taken with food. Ritalin LA: May be taken with or without food: Do not crush/chew/divide. Swallow as whole cap. Alternatively, open cap & sprinkle contents on a small amount of soft food (eg, applesauce); food should not be warm; immediately swallow unchewed mixt of drug & food.
Contraindications
Hypersensitivity. Treatment w/ MAOIs, & w/in a min of 14 days following discontinuation of MAOI. Patients w/ anxiety & tension states; agitation; family history or diagnosis of Tourette's syndrome; glaucoma; hyperthyroidism; pre-existing CV disorders including uncontrolled HTN, angina pectoris, arterial occlusive disease especially coronary arteries; heart failure, haemodynamically significant congenital heart disease, cardiomyopathies, MI, cardiac arrhythmia & channelopathies; phaeochromocytoma; drug dependence or alcohol abuse; severe depression, anorexia nervosa, psychotic symptoms or suicidal tendency.
Special Precautions
Not indicated in all cases of ADHD. Consider treatment only after detailed history taking & patient evaluation. Not usually indicated when symptoms are associated w/ acute stress reactions. Assess patients w/ pre-existing structural cardiac abnormalities or other serious heart problems before initiating treatment, & maintain on-going cardiological supervision throughout treatment. Do not use in patients w/ serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, CAD, or other serious cardiac problems. Risk of increased heart rate & systolic/diastolic BP. Monitor BP at appropriate intervals during treatment, especially in patients w/ HTN. Evaluate patients who develop symptoms suggestive of cardiac disease during treatment. Misuse may be associated w/ sudden death & other serious CV adverse events. Assess for pre-existing & family history of psychiatric disorders prior to initiating treatment. May exacerbate symptoms of behaviour disturbance & thought disorder in psychotic patients. Do not use in patients w/ pre-existing CNS abnormalities (eg, cerebral aneurysm) &/or other vascular abnormalities (eg, vasculitis or pre-existing stroke); for the treatment of severe depression or for the prevention or treatment of normal fatigue states; in patients w/ acute psychosis, acute mania, or acute suicidality. Do not give to patients w/ emergent psychiatric symptoms or exacerbation of pre-existing psychiatric symptoms unless benefit outweighs potential risk. Risk of psychotic symptoms, including visual & tactile hallucinations or mania. Consider treatment discontinuation if psychotic symptoms occur. Possible induction of mixed/manic episode in patients w/ comorbid bipolar disorder. Risk of emergent aggressive behaviour or exacerbation of baseline aggressive behaviour. Evaluate need for treatment adjustment in patients experiencing behavioural changes. Risk of suicidal tendency. Monitor for clinical worsening, suicidal behaviour or thoughts or unusual changes in behaviour. Risk of onset or exacerbation of motor & verbal tics, & worsening of Tourette's syndrome. Assess family history & evaluate for tics or Tourette's syndrome before treatment. Regularly monitor for emergence or worsening of tics during treatment. Risk of moderately reduced wt gain & slight growth retardation w/ long-term use in childn. Monitor growth as clinically necessary during treatment, & interrupt treatment in patients who are not growing or gaining height or wt as expected. Risk of lowered convulsion threshold in patients w/ history of seizures, w/ prior EEG abnormalities in the absence of seizures &, rarely, in the absence of history of seizures & no prior EEG evidence of seizures. Discontinue treatment in the presence of seizures. Risk of IOP elevation & glaucoma (including open angle glaucoma & angle closure glaucoma). Closely monitor patients w/ history of abnormally increased IOP or glaucoma. Risk of priapism. Patients who develop abnormally sustained or frequent & painful erections should seek immediate medical attention. Risk of peripheral vasculopathy, including Raynaud's phenomenon. Carefully observe for digital changes during treatment. Risk of drug abuse & dependence. Caution in emotionally unstable patients eg, those w/ history of drug or alcohol dependence. Careful supervision is required during drug w/drawal. Risk of haematological effects. Periodic CBC, differential & platelet counts are advisable during prolonged therapy. Concomitant use w/ serotonergic drugs is not recommended. Safe concomitant use w/ anticonvulsants has not been established. Abstain from alcohol during treatment. May induce false +ve lab tests, particularly w/ immunoassays screen test. Patients experiencing dizziness, drowsiness, blurred vision, hallucinations or other CNS side effects should refrain from driving, operating machinery, or engaging in other potentially hazardous activities. Do not prescribe for women of childbearing age & pregnant women unless potential benefits outweigh possible risks. Refrain from breastfeeding during treatment. Do not use in childn <6 yr. Ritalin: Not effective for loss of voluntary muscle tone in the treatment of narcolepsy. Ritalin LA: Use in elderly >60 yr has not been studied.
Adverse Reactions
Nasopharyngitis; decreased appetite; nervousness, insomnia, irritability; 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 an increase); cough; abdominal pain, vomiting (which may be alleviated by concomitant food intake), dyspepsia, toothache; rash, pruritus, urticaria, fever, scalp hair loss, hyperhidrosis; arthralgia; feeling jittery; decreased wt; Raynaud's phenomenon, peripheral coldness.
Drug Interactions
Decreased effectiveness of antihypertensive drugs. Risk of severe HTN w/ drugs that elevate BP. Possible hypertensive crisis w/ non-selective, irreversible MAOIs. Risk of sudden increase in BP & heart rate w/ anaesth during surgery. Risk of serious adverse events including sudden death w/ centrally acting α-2 agonists (eg, clonidine). Pharmacodynamic interactions w/ direct & indirect dopamine agonists (including DOPA & TCAs) & dopamine antagonists (antipsychotics eg, haloperidol). Increased risk of extrapyramidal symptoms w/ antipsychotics. Risk of serotonin syndrome w/ serotonergic drugs eg, SSRIs & SNRIs. Inhibited metabolism of coumarin anticoagulants, anticonvulsants (phenobarb, primidone, phenytoin), phenylbutazone & TCAs (imipramine, desipramine). Exacerbated CNS adverse reactions w/ alcohol.
MIMS Class
Other CNS Drugs & Agents for ADHD
ATC Classification
N06BA04 - methylphenidate ; Belongs to the class of centrally-acting sympathomimetics. Used as CNS stimulant.
Presentation/Packing
Form
Ritalin LA hard cap 10 mg
Packing/Price
30's
Form
Ritalin LA hard cap 20 mg
Packing/Price
30's
Form
Ritalin LA hard cap 30 mg
Packing/Price
30's
Form
Ritalin tab 10 mg
Packing/Price
200's
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