Methylphenidate Sandoz

Methylphenidate Sandoz





Zuellig Pharma
Concise Prescribing Info
Methylphenidate HCl
Attention deficit hyperactivity disorder (ADHD) in childn & adolescents 6-17 yr & adults 18-65 yr when remedial measures alone prove insufficient.
Dosage/Direction for Use
Dose may be adjusted in 18 mg increments; may proceed at approx wkly intervals. Max daily dose: 54 mg. Patients new to methylphenidate Recommended starting dose: 18 mg once daily. Patients currently using methylphenidate Previous methylphenidate daily dose: 5 mg tid 18 mg once daily, 10 mg tid 36 mg once daily, 15 mg tid 54 mg once daily.
May be taken with or without food: Take in the morning. Swallow whole, do not chew/divide/crush.
Hypersensitivity. Glaucoma; phaeochromocytoma. During treatment w/ non-selective, irreversible MAOIs, or w/in a min of 14 days of discontinuation of a MAOI. Hyperthyroidism or thyrotoxicosis. Preexisting or history of severe depression, anorexia nervosa/anorexic disorder, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder; severe & episodic (type 1) bipolar (affective) disorder. Preexisting CV disorders including severe HTN, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, MI, potentially life-threatening arrhythmias & channelopathies. Preexisting cerebrovascular disorders, cerebral aneurysm, vascular abnormalities including vasculitis or stroke.
Special Precautions
Carefully monitor patients on long-term therapy (ie, over 12 mth) for CV status, growth, appetite, development of de novo or worsening of preexisting psychiatric disorders. Patients whose underlying medical conditions might be compromised by increases in BP or heart rate; w/ emergent suicidal ideation or behavior during treatment; w/ known drug or alcohol dependency; emotionally unstable. Record BP & pulse on a centile chart at each adjustment of dose, & then at least every 6 mth. Sudden death & preexisting structural cardiac abnormalities or other serious cardiac disorders. Assess patients w/ additional risk factors for cerebrovascular conditions eg, history of CV disease, concomitant drugs that elevate BP at every visit for neurological signs & symptoms after initiating treatment. Psychiatric symptoms or exacerbation of preexisting psychiatric disorders. Monitor for development or worsening of psychiatric disorders at every dose adjustment, then at least every 6 mth, & at every visit. Exacerbation of preexisting manic or psychotic symptoms. Discontinue use if manic or psychotic symptoms, seizure frequency increases or new-onset seizures, & leukopenia, thrombocytopenia, anemia or other alterations including indicative of serious renal or hepatic disorders occur. Closely monitor for the emergence or worsening of aggressive bahaviour or hostility at treatment initiation, at every dose adjustment & then at least every 6 mth & every visit. Regularly monitor for the emergence or worsening of tics during treatment. Concomitant use w/ serotonergic drugs. Priapsim may develop. Regularly monitor for emergence or worsening of anxiety, agitation or tension during treatment, at every adjustment of dose, & then at least every 6 mth or every visit. Adequately screen patients w/ patients w/ comorbid depressive symptoms prior to initiation of treatment. Monitor growth in childn during treatment especially in prolonged use; record height, wt & appetite at least 6 mthly w/ maintenance of growth chart. Epilepsy. Severe depression may occur during w/drawal. Should not be used for the prevention or treatment of normal fatigue states. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. False positive lab test for amphetamines particularly w/ immunoassay screen test. Renal or hepatic insufficiency. Severe GI narrowing or dysphagia. Avoid potentially hazardous activities eg, driving or operating machinery. Pregnancy & lactation. Childn <6 yr. Elderly >65 yr.
Adverse Reactions
Insomnia, nervousness; headache. Nasopharyngitis; anorexia, decreased appetite, moderately reduced wt & height gain during prolonged use in childn; anorexia, affect lability, aggression, agitation, anxiety, depression, irritability, abnormal behaviour, mood swings, tics; dizziness, dyskinesia, psychomotor hyperactivity, somnolence; arrhythmia, tachycardia, palpitations; HTN; cough, oropharyngeal pain; upper abdominal pain, diarrhoea, nausea, stomach discomfort, vomiting, dry mouth; alopecia, pruritus, rash, urticaria; arthralgia; pyrexia, growth retardation during prolonged use, fatigue; changes in BP & heart rate, decreased wt.
Drug Interactions
May inhibit the metabolism of coumarin anticoagulants, phenobarb, phenytoin, primidone, TCAs & SSRIs. May decrease effectiveness of antihypertensive drugs. Nonselective, irreversible MAOIs. CNS effects may be exacerbated w/ alcohol. Risk of sudden increase in BP w/ halogenated anaesth. Concomitant use w/ clonidine or other centrally acting α-2 agonists. Pharmacodynamic interactions w/ direct & indirect dopamine agonists or w/ dopamine antagonists including antipsychotics. Increased extracellular serotonin & norepinephrine levels w/ serotonergic drugs.
MIMS Class
Other CNS Drugs & Agents for ADHD
ATC Classification
N06BA04 - methylphenidate ; Belongs to the class of centrally-acting sympathomimetics. Used as CNS stimulant.
Methylphenidate Sandoz PR tab 18 mg
Methylphenidate Sandoz PR tab 36 mg
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