Medikinet

Part of a comprehensive treatment programme for ADHD when remedial measures alone prove insufficient.

Individualized dosing. Adult Starting dose: 10 mg daily, divide total daily dose into 2 equal doses. May be increased by 10 mg wkly increments. Max daily dose: 1 mg/kg; must not exceed 80 mg, independent of the patient's body wt. Adolescent & childn Starting dose: 5 mg once daily or bd. May be increased by 5-10 mg wkly increments. Max daily dose: 60 mg.

Should be taken with food: Cap may be swallowed whole w/ liqd. Alternatively, cap may be opened & contents sprinkled onto a tbsp of applesauce/yoghurt. Do not store for future use. Do not crush or chew.

Hypersensitivity. Anxiety, tension. Agitation. Glaucoma. Phaeochromocytoma. During treatment w/ non-selective, irreversible MAOIs or w/in a min of 14 days of discontinuation due to risk of hypertensive crisis. 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 I bipolar (affective) disorder that is not well-controlled. Pre-existing CV disorders including severe HTN, heart failure, arterial occlusive disease, angina pectoris, haemodynamically significant congenital heart disease, cardiomyopathies, MI, potentially life-threatening arrhythmias & channelopathies. Pre-existing cerebrovascular disorders, cerebral aneurysm, vascular abnormalities including vasculitis or stroke. Diagnosis of pronounced stomach anacidity w/ pH >5.5; in therapy w/ H₂ receptor blockers, antacid or PPIs. Diagnosis or family history of Tourette's syndrome.

Avoid conditions leading to increased gastric pH. Periodically re-evaluate long-term usefulness of methylphenidate for extended periods (>12 mth); de-challenging methylphenidate is recommended at least once yrly to assess patient's condition. Discontinue use if paradoxical aggravation of symptoms or other serious adverse events occur. Not indicated in all cases of ADHD; consider only after detailed history-taking & evaluation; not indicated where symptoms are associated w/ acute stress reactions. Do not use in patients w/ known structural cardiac abnormalities or other serious cardiac disorders that may increase risk of sudden death. Assess for pre-existing CV disorders & family history of sudden death & ventricular arrhythmia before treatment initiation. Monitor BP at appropriate intervals especially those w/ HTN; patients who develop symptoms suggestive of cardiac disease during treatment should undergo prompt cardiac evaluation. Misuse may be associated w/ sudden death & other serious CV adverse events. Regularly assess patients w/ additional risk factors (eg, history of CV disease, concomitant BP-elevating medications) for neurological/psychiatric signs & symptoms after treatment initiation. Assess patients for pre-existing & family history of psychiatric disorders prior to treatment initiation. Not to be initiated in patients w/ acute psychosis, mania or suicidality. Consider treatment discontinuation if psychotic symptoms including visual & tactile hallucinations or mania occur. Possible induction of mixed/manic episode in patients w/ comorbid bipolar disorder. Evaluate the need for treatment regimen adjustment in patients experiencing behavioural changes (eg, aggression); may consider treatment interruption. Evaluate for emergent suicidal ideation & behaviour during treatment; initiate appropriate treatment of the underlying psychiatric condition. Regularly monitor for the emergence or worsening of tics during treatment. Monitor growth as clinically necessary during treatment; interrupt treatment in patients who are not growing or gaining height or wt as expected. May lower the convulsion threshold in patients w/ history of seizures, prior EEG abnormalities in the absence of seizures; rarely, in the absence of history of seizures & no prior EEG evidence. Discontinue use in the presence of seizure or if seizure frequency increases. Possible prolonged & painful erections. Consider possibility of habituation or abuse; chronic abuse can lead to marked tolerance & psychological dependence w/ varying degrees of abnormal behaviour. History of drug dependence or alcoholism. Careful supervision is required during drug w/drawal; may unmask depression & chronic overactivity effects. Interchangeably using long-acting methylphenidate formulations. Carefully monitor complete & differential blood counts & periodically perform platelet count in patients requiring long-term therapy. Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose isomaltose insufficiency. Hepatic & renal impairment. May cause dizziness, drowsiness & visual disturbances including difficulties w/ accommodation, diplopia, blurred vision, hallucinations & other CNS effects; avoid potentially hazardous activities eg, driving or operating machinery. Pregnancy. Advise mothers taking methylphenidate to refrain from breast-feeding their infants. Consider discontinuation if treatment emergent psychotic or manic symptoms (eg, hallucinations, delusional thinking or mania) occur in childn & adolescents w/o prior history of psychotic illness or mania. Not to be used in childn <6 yr & elderly.

Decreased appetite; insomnia, nervousness; headache; nausea, dry mouth. Nasopharyngitis; anorexia, moderately reduced wt & height gain during prolonged use in childn; abnormal behaviour, aggression, affect lability, agitation, anorexia, anxiety, depression, irritability, restlessness, sleep disorder, decreased libido, panic attack, stress, bruxism; tremor, somnolence, dizziness, dyskinesia, psychomotor hyperactivity; tachycardia, palpitations, arrhythmias; HTN, peripheral coldness; cough, pharyngolaryngeal pain, dyspnoea; abdominal pain, diarrhoea, stomach discomfort, vomiting, dyspepsia & toothache; hyperhidrosis, alopecia, pruritus, rash, urticaria; arthralgia; pyrexia, growth retardation during prolonged use in childn, feeling of inner restlessness, fatigue, thirst; BP & heart rate changes, decreased wt.

In combination w/ other drugs especially those w/ narrow therapeutic window. May inhibit metabolism of coumarin anticoagulants, anticonvulsants (eg, phenobarb, phenytoin, primidone), phenylbutazone, antidepressants (eg, tricyclics, SSRIs). May decrease effectiveness of antihypertensives. Possible hypertensive crisis w/ non-selective, irreversible MAOIs. May exacerbate adverse CNS effects w/ alcohol. Risk of sudden BP & heart rate increase during surgery w/ halogenated anaesth. Possible serious adverse events w/ centrally-acting α₂-agonists (eg, clonidine). Increased extracellular dopamine levels w/ dopaminergics. Not recommended to co-administer w/ antipsychotics. Not to be administered w/ H₂ receptor blockers or antacids. May induce false +ve lab tests for amphetamines particularly w/ immunoassays screen test.

Other CNS Drugs & Agents for ADHD

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

POM