Methylphenidate Hydrochloride Sandoz

Methylphenidate HCl

ADHD, as part of a comprehensive treatment programme, in childn ≥6 yr when remedial measures alone prove insufficient.

Initiate at the lowest possible dose, may be adjusted in 18-mg increments at approx wkly intervals. Max: 54 mg daily. Patient not currently taking methylphenidate Initially 18 mg once daily. Patient previously taking 5 mg methylphenidate tds Recommended dose: 18 mg once daily. Patient previously taking 10 mg methylphenidate tds Recommended dose: 36 mg once daily. Patient previously taking 15 mg methylphenidate tds Recommended dose: 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 discontinuing those drugs; hyperthyroidism or thyrotoxicosis; diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder; diagnosis or history of severe & episodic (type I) bipolar (affective) disorder (that is not well-controlled); pre-existing CV disorders including severe HTN, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, MI, potentially life-threatening arrhythmias & channelopathies; pre-existing cerebrovascular disorders, cerebral aneurysm, vascular abnormalities including vasculitis or stroke.

Not indicated in all childn w/ ADHD. Long-term (>12 mth) use must have careful ongoing monitoring for CV status, growth, appetite, development of de novo or worsening pre-existing psychiatric disorders. Adolescents whose symptoms persist into adulthood & who have shown clear benefit from treatment may continue treatment into adulthood. Initiating treatment in adults is not appropriate. Carefully monitor CV status. Caution in patients whose underlying medical conditions might be compromised by increases in BP or heart rate. Patients w/ additional risk factors (eg, history of CV disease or concomitant medications that elevate BP) should be assessed for neurological signs & symptoms after treatment initiation. Emergent psychiatric symptoms or exacerbation of pre-existing psychiatric disorders; emergence or worsening of psychotic or manic symptoms; emergence or worsening of aggression or hostility; suicidal ideation or behaviour. Associated w/ onset or exacerbation of motor & verbal tics; worsening of pre-existing anxiety, agitation or tension. Reports of worsening of Tourette's syndrome; moderately reduced wt gain & growth retardation in long-term use; priapism. Possible precipitation of a mixed/manic episodes in patients w/ comorbid bipolar disorder. May lower convulsive threshold in patients w/ prior history of seizures, in patients w/ prior EEG abnormalities in absence of seizures, & rarely in patients w/o history of convulsions & no EEG abnormalities. Carefully monitor patients for risk of diversion, misuse & abuse. Careful supervision is required during drug w/drawal. Should not be used for prevention or treatment of normal fatigue states. Consider discontinuation in case of leukopenia, thrombocytopenia, anaemia or other alterations, including those indicative of serious renal or hepatic disorders. Potential for GI obstruction. Reports of serotonin syndrome w/ serotonergic medicinal products. May induce a false +ve lab test for amphetamines, particularly w/ immunoassay screen test. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Moderate influence on the ability to drive & use machines. Patients w/ renal or hepatic insufficiency. Pregnancy & lactation. Should not be used in older people. Should not be used in childn <6 yr.

Insomnia, nervousness; headache. Nasopharyngitis, URTI, sinusitis; anorexia, decreased appetite, moderately reduced wt & height gain during prolonged use in childn; affect lability, aggression, agitation, anxiety, depression, irritability, abnormal behaviour, mood swings, tics, initial insomnia, depressed mood, decreased libido, tension, bruxism, panic attack; dizziness, dyskinesia, psychomotor hyperactivity, somnolence, paresthaesia, tension headache; accommodation disorder; vertigo; arrhythmia, tachycardia, palpitations; HTN; cough, oropharyngeal pain; upper abdominal pain, diarrhoea, nausea, abdominal discomfort, vomiting, dry mouth, dyspepsia; increased ALT; alopecia, pruritus, rash, urticaria; arthralgia, muscle tightness, muscle spasms; erectile dysfunction; pyrexia, growth retardation during prolonged use in childn, fatigue, irritability, feeling jittery, asthenia, thirst; changes in BP & heart rate (usually an increase), decreased wt.

May inhibit metabolism of coumarin anticoagulants, anticonvulsants (eg, phenobarb, phenytoin, primidone), & some antidepressants (TCAs & SSRIs). May decrease effectiveness of antihypertensive drugs. Additive effect on BP w/ drugs that also elevate BP; w/ use of halogenated anaesth during surgery. Possible hypertensive crisis w/ non-selective, irreversible MAOIs. Exacerbated adverse CNS effect w/ alcohol. Reports of serotonin syndrome w/ serotonergic medicinal products. Pharmacodynamic interactions w/ direct & indirect dopamine agonists (including DOPA & TCAs) or w/ dopamine antagonists including antipsychotics. Caution when combining w/ other drugs, especially those w/ narrow therapeutic window; centrally acting α-2 agonists (eg, clonidine).

Other CNS Drugs & Agents for ADHD

N06BA04 - methylphenidate ; Belongs to the class of centrally-acting sympathomimetics. Used as CNS stimulant.

DD, P₁S₁S₃