Clinical Pharmacology Details


METHYLPHENIDATE HCL.


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Indications & Dose:

Attention deficit hyperactivity disorder (initiated under specialist supervision)



Child 6–17 years: Initially 5 mg 1–2 times a day, increased in steps of 5–10 mg daily if required, at weekly intervals, increased if necessary up to 60 mg daily in 2–3 divided doses, increased if necessary up to 2.1 mg/kg daily in 2–3 divided doses, the licensed maximum dose is 60mg daily in 2–3 doses, higher dose (up to a maximum of 90 mg daily) under the direction of a specialist, discontinue if no response after 1 month, if effect wears off in evening (with rebound hyperactivity) a dose at bedtime may be appropriate (establish need with trial bedtime dose). Treatment may be started using a modified-release preparation


Adult: Initially 5 mg 2–3 times a day, dose is increased if necessary at weekly intervals according to response, increased if necessary up to 100 mg daily in 2–3 divided doses, if effect wears off in evening (with rebound hyperactivity) a dose at bedtime may be appropriate (establish need with trial bedtime dose).


Treatment may be started using a modifiedrelease preparation Narcolepsy



Adult: 10–60 mg daily in divided doses; usual dose 20–30 mg daily in divided doses, dose to be taken before meals


Attention deficit hyperactivity disorder



Child 6–17 years: Initially 18 mg once daily, dose to be taken in the morning, increased in steps of 18 mg every week, adjusted according to response; increased if necessary up to 2.1 mg/kg daily, licensed max. dose is 54 mg once daily, to be increased to higher dose only under direction of specialist; discontinue if no response after 1 month; maximum 108 mg per day


Adult: Initially 18 mg once daily, dose to be taken in the morning; adjusted at weekly intervals according to response; maximum 108 mg per day


Attention deficit hyperactivity disorder



Child 6–17 years: Initially 10 mg once daily, dose to be taken in the morning before breakfast; increased gradually at weekly intervals if necessary; increased if necessary up to 2.1 mg/ kg daily, licensed max. dose is 60 mg daily, to be increased to higher dose only under direction of specialist; discontinue if no response after 1 month; maximum 90 mg per day


Adult: Initially 10 mg once daily, dose to be taken in the morning before breakfast; increased gradually at weekly intervals if necessary; maximum 100 mg per day


CNS stimulant.



Usually 20-30mg daily in two or three doses.


Children: Above 6 years, initially 5mg once or twice daily with gradual increments of 5-10mg weekly. Max 60mg/day. Below 6 years, not recommended.

Contraindications:

Anxiety and tension states, agitation, tics, tics in siblings, a family history or diagnosis of Tourette’s syndrome, glaucoma, hyperthyroidism, cardiac arrhythmia, severe angina pectoris, hypersensitivity to methylphenidate. Treatment of severe depression. 

Side Effects:

Cautions:

Precautions:

In psychotic patients Ritalin may exacerbate symptoms of behavioural disturbances and thought disorders. Prolonged administration can lead to marked tolerance and psychic dependance. 

Interaction:

DRUGS


anticholinergics: Possibly increased antichoHnergic effects of both drugs anticonvulsants, oral anticoagulants, phenyl-butazone, tricyclic antidepressants: Inhibited metabolism and increased blood levels of these drugs


dopamine agonists and antagonists: Possibly altered effectiveness of these drugs diuretics, antihypertensives: Decreased therapeutic effects of these drugs halogenated anesthetics: Possibly sudden decrease in blood pressure during surgery


MAO inhibitors: Possibly increased adverse effects of methylphenidate, possibly severe hypertension dermatitis.


 

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

CNS: Agitation, aggressiveness, anxiety, confusion, depression, dizziness, dyskinesia, emotional lability, fever, hallucinations, headache, hyperactivity insomnia, irritability, ischemic neurologic defects (reversible), mania, migraine, motor tics, nervousness, obsessive-compulsive disorder, paresthesia, psychosis, sedation, seizures, stroke, suicidal ideation, transient mood depression, tension, tremor, Tourette’s syndrome, vertigo


CV: Angina, arrhythmias, bradycardia, cardiac arrest, chest pain, extrasystoles, hypertension, hypotension, MI, palpitations, Raynaud’s phenomenon, sudden death, tachycardia


EENT: Accommodation abnormality, blurred vision, diplopia, dry mouth or throat, mydriasis, pharyngitis, rhinitis, sinusitis, vision changes


ENDO: Dysmenorrhea, growth suppression in children with long-term use


GI: Abdominal pain, anorexia, constipation, diarrhea, dyspepsia, hepatotoxicity, nausea, vomiting


GU: Decreased libido HEME: Anemia, decreased platelet count, leukopenia, pancytopenia, thrombocytopenia, thrombocytopenic purpura


MS: Arthralgia, myalgia, muscle tightness or twitching


RESP: Increased cough, upper respiratory tract infection


SKIN: Allergic contact dermatitis, alopecia, application-site reactions (transdermal patch), diaphoresis, erythema multiforme, exfoliative dermatitis, pruritus, rash, urticaria


Other: Anaphylaxis, angioedema, physical and psychological dependence, weight loss 

Patient And Carer Advice: