Concerta

Concerta

methylphenidate

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Methylphenidate HCl
Dosage/Direction for Use
Individualized dosage, to be taken once daily in the morning. Patient new to methylphenidate Adult 18 or 36 mg once daily. Childn & adolescent 18 mg once daily. Patient currently using methylphenidate 18-72 mg once daily depending on previous methylphenidate daily dose. May be adjusted in 18-mg increments at wkly intervals to max: 54 mg daily (childn), 72 mg daily (adolescent) & 108 mg daily (adult).
Administration
May be taken with or without food: Swallow whole, do not divide/chew/crush.
Contraindications
Hypersentivity. Glaucoma. Concomitant or w/in 14 days following discontinuation of MAOI therapy.
Special Precautions
Discontinue use if cerebrovascular disorder is suspected. Not to be used for depression &/or for prevention or treatment of normal fatigue states. Not to be administered to preexisting severe GI narrowing (pathologic or iatrogenic), dysphagia. Not recommended in patients w/ pre-existing cerebrovascular disorders. Structural cardiac abnormalities; occurrence of psychotic or manic symptoms in patients w/o prior history; priapism; patients whose underlying conditions may be compromised by BP or heart rate increases; history of drug dependence/alcoholism & seizures. May exacerbate symptoms of behavior disturbance & thought disorder in psychotic patients. Regular monitoring for onset or exacerbation of motor & verbal tics, emergence or worsening of tics or Tourette's syndrome during treatment. Carefully monitor growth suppression w/ long-term therapy. Monitor for appearance or worsening of aggressive behavior, marked anxiety or agitation. Perform periodic hematologic monitoring during prolonged therapy. May impair ability to drive or operate machinery. Pregnancy & lactation. Not to be used in childn <6 yr.
Adverse Reactions
Decreased appetite, anorexia; insomnia, anxiety, initial insomnia, depressed mood, restlessness, agitation, nervousness, bruxism, depression, affect lability, decreased libido, panic attack, tension, aggression, confusional state; headache, dizziness, tremor, paresthesia, tension headache; accommodation disorder, blurred vision; vertigo; tachycardia, palpitations; HTN, hot flush; oropharyngeal pain, cough, dyspnea; dry mouth, nausea, dyspepsia, vomiting, constipation; hyperhidrosis; muscle tightness & spasms; erectile dysfunction; irritability, fatigue, thirst, asthenia; decreased wt, increased heart rate, BP & ALT; tic, mood swings; somnolence; diarrhea, abdominal discomfort & pain; rash; feeling jittery.
Drug Interactions
Not to be used w/ MAOIs. Possible increased BP w/ vasopressor agents. Decreased effectiveness of antihypertensives. Increased risk of sudden BP & heart rate increase w/ halogenated anesth. Serotonin syndrome w/ serotonergic drugs. Pharmacodynamic interactions w/ antipsychotics. Inhibited metabolism of coumarin anticoagulants, anticonvulsants (eg, phenobarb, phenytoin, primidone), some antidepressants (TCAs, SSRIs).
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
Concerta XR tab 18 mg
Packing/Price
30's
Form
Concerta XR tab 27 mg
Packing/Price
30's
Form
Concerta XR tab 36 mg
Packing/Price
30's
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