Methylphenidate Teva

Methylphenidate HCl

Part of a comprehensive treatment programme for ADHD in childn ≥6 yr when remedial measures alone prove insufficient.

Start dose titration at the lowest possible dose. Dose may be adjusted in 18-mg increments at approx wkly intervals. Take once daily in the morning. Max daily dose: 54 mg. Patient not currently taking methylphenidate or patient on stimulants other than methylphenidate Recommended starting dose: 18 mg once daily. Patient previously taking methylphenidate 5 mg tds Recommended dose: 18 mg once daily, previously taking methylphenidate 10 mg tds Recommended dose: 36 mg once daily, previously taking methylphenidate 15 mg tds Recommended dose: 54 mg once daily.

May be taken with or without food: 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 their discontinuation. 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; severe & episodic (type 1) bipolar (affective) disorder that is not well controlled. Pre-existing CV disorders; cerebrovascular disorders, cerebral aneurysm, vascular abnormalities.

Not indicated in all childn w/ ADHD; decision to use must be based on very thorough assessment of severity & chronicity of child's symptoms in relation to age. Continuously monitor growth, psychiatric & CV status, especially in patients on long-term therapy. Caution in patients whose underlying medical conditions might be compromised by increases in BP or heart rate. Patients w/ additional risk factors for cerebrovascular disorders (eg, history of CV disease or concomitant medications that elevate BP) should be assessed for neurological signs & symptoms after treatment initiation. Risk of exacerbation of pre-existing psychotic or manic symptoms; emergence of new psychotic or manic symptoms; aggression or hostility; tics; anxiety, agitation or tension. Possible precipitation of mixed/manic episode in patients w/ comorbid bipolar disorder. Reports of moderately reduced wt gain & growth retardation w/ long-term use in childn. Caution in patients w/ epilepsy. Discontinue treatment if seizure frequency increases or new-onset seizures occur. Risk of priapism. Monitor for signs of suicide-related behaviour during treatment, including at dose initiation/optimization & drug discontinuation. Potential for abuse, misuse or diversion. Careful supervision is required during w/drawal since this may unmask depression & chronic overactivity. Do not use for prevention or treatment of normal fatigue states. Consider treatment discontinuation in case of leukopenia, thrombocytopenia, anaemia or other alterations, including those indicative of serious renal or hepatic disorders. Potential for GI obstruction. Concomitant use w/ serotonergic medicinal products. May induce false +ve lab test for amphetamines. Moderate influence on the ability to drive & use machines. No experience in patients w/ renal or hepatic impairment. Not recommended during pregnancy unless necessary. Discontinue breast-feeding or discontinue/abstain from methylphenidate therapy. Safety & efficacy have not been established for treatment initiation in adults or routine continuation of treatment beyond 18 yr of age. Do not use in childn <6 yr or the elderly.

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, paraesthesia, 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/spasms; erectile dysfunction; pyrexia, growth retardation (during prolonged use in childn), fatigue, irritability, feeling jittery, asthenia, thirst; changes in BP & heart rate (usually increased), decreased wt.

May inhibit metabolism of coumarin anticoagulants, anticonvulsants (eg, phenobarb, phenytoin, primidone), & some antidepressants (TCAs & SSRIs). May decrease effectiveness of antihypertensive drugs. Risk of hypertensive crisis w/ non-selective irreversible MAOIs. Alcohol may exacerbate adverse CNS effects of psychoactive medicinal products, including methylphenidate. Risk of serotonin syndrome w/ serotonergic medicinal products. Additive effect on BP w/ use of halogenated anaesth in surgery. Long-term safety has not been systematically evaluated in combination w/ clonidine or other centrally-acting α₂ agonists. May be associated w/ pharmacodynamic interactions w/ direct & indirect dopamine agonists (including DOPA & TCAs) or w/ dopamine antagonists (including antipsychotics). Caution in combining w/ drugs w/ narrow therapeutic index; drugs that elevate BP.

Other CNS Drugs & Agents for ADHD

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

DD, P₁S₁S₃