Medikinet CR

Medikinet CR

methylphenidate

Manufacturer:

Hua Tai

Distributor:

Zuellig
Concise Prescribing Info
Contents
Methylphenidate HCl
Indications/Uses
ADHD in adults & childn ≥6 yr as part of a comprehensive treatment program, when remedial measures alone prove insufficient.
Dosage/Direction for Use
Adult Recommended starting dose: 10 mg daily, may be increased if necessary by wkly increments of 10 mg in the daily dose. Total daily dose should be given in 2 divided doses in the morning & at midday. Max daily dose: 80 mg. Childn Recommended starting dose: 5 mg once daily or bd, increasing if necessary by wkly increments of 5-10 mg in the daily dose. Max daily dose: 60 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Glaucoma; phaeochromocytoma; 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; history of pronounced anacidity of the stomach w/ a pH value >5.5, in therapy w/ H2 receptor blockers or in antacid therapy; during treatment w/ non-selective, irreversible MAOIs, or w/in a min of 14 days of discontinuing those medicinal products.
Special Precautions
Not indicated in all patients w/ ADHD; treatment must be based on a very thorough assessment of severity & chronicity of patient's symptoms. Treatment w/ methylphenidate should not & need not be indefinite. Careful monitoring of patients on long-term therapy (>12 mth) & periodically re-evaluate usefulness of treatment. Risk of changes in diastolic & systolic BP. Carefully monitor CV status of patients. Reports of sudden death in childn w/ cardiac structural abnormalities or other serious heart problems. Misuse may be associated w/ sudden death & other serious CV adverse events. Patients w/ risk factors for cerebrovascular disorders should be assessed at every visit for neurological signs & symptoms after treatment initiation. Not contraindicated in patients w/ hemiplegic cerebral palsy. Risk of prolonged & painful erections mainly associated w/ change in treatment regimen; emergent psychiatric symptoms or exacerbation of pre-existing psychiatric disorders; exacerbation of pre-existing psychotic or manic symptoms; emergence of new psychotic or manic symptoms; emergence or worsening of aggression or hostility; emergence of suicidal ideation or behaviour; onset or exacerbation of motor & verbal tics; worsening of Tourette's syndrome; worsening of pre-existing anxiety, agitation or tension; precipitation of a mixed/manic episode in patients w/ bipolar disorder; moderately reduced wt gain & growth retardation w/ long-term use in childn; lowered convulsive threshold in patients w/ history of seizures, w/ prior EEG abnormalities in absence of seizures & rarely, in patients w/o history of convulsion & no EEG abnormalities. Potential for abuse misuse or diversion; caution in patients w/ known drug or alcohol dependency. Careful supervision during drug w/drawal; may unmask depression or chronic overactivity. Should not be used for prevention or treatment of normal fatigue states. May induce false positive laboratory test for amphetamines, particularly w/ immunoassay screen test. May cause positive reaction to anti-doping tests. Should not be used on the day of surgery in case of planned surgery. Discontinue treatment in case of leukopenia, thrombocytopenia, anaemia or other alterations, including those indicative of serious renal or hepatic disorders. Patients w/ rare hereditary problem of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Moderate influence on the ability to drive & use machines. Pregnancy & lactation. Should not be used in the elderly. Should not be used in childn <6 yr.
Adverse Reactions
Insomnia, nervousness; headache; palpitations. Nasopharyngitis; anorexia, decreased appetite, moderately reduced wt & ht gain during prolonged use in childn; affect lability, aggression, agitation, anxiety, depression, irritability, abnormal behaviour; dizziness, dyskinesia, psychomotor hyperactivity, somnolence; arrhythmia, tachycardia; HTN; cough, pharyngolaryngeal pain; abdominal pain, diarrhoea, nausea, stomach discomfort, vomiting, dry mouth; alopecia, pruritus, rash, urticaria; arthralgia; pyrexia, growth retardation during prolonged use in childn; changes in BP & heart rate; wt decreased.
Drug Interactions
Caution when combined w/ other medicinal products, especially those w/ narrow therapeutic window. May inhibit metabolism of coumarin anticoagulants, anticonvulsants (eg, phenobarb, phenytoin, primidone) & some antidepressants (eg, TCAs, SSRIs). May decrease effectiveness of antihypertensives. Caution when co-administered w/ drugs that can also elevate BP. Possible hypertensive crisis w/ non-selective, irreversible MAOIs. Exacerbated adverse CNS effects w/ alcohol. Risk of serious adverse events, including sudden death, w/ clonidine (centrally acting α2 agonist). Pharmacodynamic interaction w/ direct & indirect dopamine agonists or dopamine antagonists including antipsychotics. Must not be taken together w/ H2 receptor blockers or antacids; may lead to faster release of the total amount of active substance.
ATC Classification
N06BA04 - methylphenidate ; Belongs to the class of centrally-acting sympathomimetics. Used as CNS stimulant.
Presentation/Packing
Form
Medikinet CR modified-release cap 20 mg
Packing/Price
30's
Form
Medikinet CR modified-release cap 40 mg
Packing/Price
30's
Form
Medikinet CR modified-release cap 30 mg
Packing/Price
30's
Form
Medikinet CR modified-release cap 10 mg
Packing/Price
30's
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