Medikinet MR

Medikinet MR

methylphenidate

Manufacturer:

Hyphens

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Methylphenidate HCl
Indications/Uses
Part of comprehensive treatment programme for ADHD in adults & childn ≥6 yr.
Dosage/Direction for Use
Adult Initially 10 mg daily, may be increased by 10 mg wkly increments. Max: 80 mg daily. Childn ≥6 yr Initially 5 mg once or bd, may be increased by 5-10 mg wkly increments. Max: 60 mg daily.
Administration
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. Swallow immediately w/o chewing/crushing followed by drinking some fluids (eg, water). Do not store for future use.
Contraindications
Hypersensitivity. Diagnosis or history of severe depression & mood disorders, anorexia nervosa/anorexic & psychopathic/borderline personality disorders, suicidal tendencies, psychotic symptoms, mania, schizophrenia; severe & episodic bipolar disorder. 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. Glaucoma; phaeochromocytoma; hyperthyroidism or thyrotoxicosis. Concomitant use w/ non-selective, irreversible MAOIs or w/in 14 days of discontinuation. Concomitant use w/ H2-blockers or antacid.
Special Precautions
Discontinue use if seizure frequency increases or new-onset seizures occur. Not to be used for prevention or treatment of normal fatigue states. Not recommended in patients w/ known cardiac structural & serious heart rhythm abnormalities, cardiomyopathy or other serious cardiac problems. Patients w/ underlying medical conditions compromised by increased BP or heart rate; development of new neurological symptoms consistent w/ cerebral ischemia; emergent psychiatric symptoms or exacerbation of pre-existing psychiatric disorders; exacerbation of pre-existing psychotic or manic symptoms in psychotic patients; suicidal tendencies; worsening of pre-existing anxiety, agitation or tension. Epilepsy; priapism. Patients w/ known drug or alcohol dependency. Haematologic effects. Screen patients w/ comorbid depressive symptoms at risk for bipolar disorders prior to initiation. Regularly monitor CV status; development or worsening of psychiatric disorders, aggressive behaviour or hostility & tics at initiation, every visit & dose adjustment, then at least every 6 mth. Assess family history & clinical evaluation for tics or Tourette's syndrome. False +ve amphetamine immunoassay test & +ve reaction to anti-doping test. Drug w/drawal & long-term use (>12 mth). Not to be taken in patients w/ fructose intolerance, glucose-galactose malabsorption or sucrose isomaltose insufficiency. Concomitant use w/ BP-elevating medications. May affect ability to drive & use machines. Renal & hepatic insufficiency. Not recommended during pregnancy. Lactation. Not to be used in childn <6 yr. Monitor wt gain & growth retardation during long-term use in childn. Not to be used in elderly >60 yr.
Adverse Reactions
Insomnia, nervousness; headache; palpitations. Nasopharyngitis; anorexia, decreased appetite, moderately reduced wt & height gain in childn; affect lability, aggression, agitation, anxiety, depression, irritability, abnormal behaviour, bruxism; dizziness, dyskinesia, psychomotor hyperactivity, somnolence; arrhythmia, tachycardia; HTN; cough, pharyngolaryngeal pain; abdominal pain, diarrhoea, nausea, stomach discomfort, vomiting, dry mouth; alopecia, pruritus, rash, urticaria, hyperhidrosis; arthralgia; pyrexia, growth retardation in childn; BP & heart rate changes, decreased wt.
Drug Interactions
Inhibited metabolism of coumarin anticoagulants, anticonvulsants (eg, phenobarb, phenytoin, primidone), antidepressants (eg, tricyclics, SSRIs). Decreased effectiveness of anti-hypertensives. Hypertensive crisis w/ non-selective, irreversible MAOIs. Exacerbated adverse CNS effects w/ alcohol. Risk of sudden BP increase during surgery w/ halogenated anesth. Serious adverse events w/ centrally-acting α2-agonists eg, clonidine. Increased extracellular dopamine levels w/ dopaminergic active substances. Not to be taken w/ H2-blockers or antacids. Combination w/ other medicinal products w/ narrow therapeutic index. Concomitant use w/ BP-elevating 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.
Presentation/Packing
Form
Medikinet MR hard cap 10 mg
Packing/Price
30's
Form
Medikinet MR hard cap 20 mg
Packing/Price
30's
Form
Medikinet MR hard cap 5 mg
Packing/Price
30's
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