#特殊劑型：不建議磨粉、管灌藥品 #最小單位貼紙

Attention-deficit/hyperactivity disorder, narcolepsy

Central Nervous System Stimulant

Onset of action: Children: 20 to 60 minutes
Duration of action: 6 to 8 hours
Absorption:A high-fat meal delayed absorption and peak times, but not the amount absorbed nor initial peak concentration (second peak lowered by ~25%). At an alcohol concentration of 40%, there was a 98% release of methylphenidate in the first hour.
Half-life elimination: Children: 1.5 to 4 hours; Adults: 3 to 4.2 hours
Time to peak: Children: Initial: 1 to 3 hours; Second peak: 5 to 11 hour
Adults: Initial: 1.3 to 4 hours; Second peak: 4.3 to 6.5 hours
Additional Considerations
Pediatric:
Time until the between peak minimum and the time until the second peak were delayed and more variable in children 10 to 12 years of age compared to adults. After a 20 mg dose, concentrations in children were approximately twice the concentrations observed in adults 18 to 35 years of age.

US labeling: Hypersensitivity (eg, angioedema, anaphylaxis) to methylphenidate or any component of the formulation; use during or within 14 days following MAOI therapy.
Canadian labeling: Hypersensitivity to methylphenidate or any component of the formulation; marked anxiety, tension, and agitation; glaucoma; use during or within 14 days following MAO inhibitor therapy; family history or diagnosis of Tourette syndrome or tics (excluding Concerta), thyrotoxicosis, advanced arteriosclerosis, symptomatic cardiovascular disease, or moderate to severe hypertension.

Information related to the use of methylphenidate in pregnant women with attention-deficit/hyperactivity disorder or narcolepsy is limited and outcome data is conflicting.
If treatment of ADHD in pregnancy is needed, methylphenidate may be considered.

1.Methylphenidate is present in breast milk.
2.The relative infant dose (RID) of methylphenidate is 0.7% when calculated using the highest breast milk concentration located and compared to a weight-adjusted maternal dose of 52 mg/day.
In general, breastfeeding is considered acceptable when the RID of a medication is <10%. However, some sources note breastfeeding should only be considered if the RID is <5% for psychotropic agents.

>10%:
Central nervous system: Insomnia (including initial insomnia; oral: 2% to 33%; transdermal: 6% to 13%), headache (2% to 22%), irritability (6% to 11%)
Endocrine & metabolic: Weight loss (2% to 13%)
Gastrointestinal: Decreased appetite (2% to 28%), xerostomia (oral: 4% to 14%), nausea (2% to 13%)
1% to 10%:
Cardiovascular: Tachycardia (oral: 5%; transdermal: ?1%), palpitations (oral: 3%; transdermal: <1%), increased blood pressure (?2%), increased heart rate (oral: ?2%)
Central nervous system: Emotional lability (1% to 9%), anxiety (oral: 8%), jitteriness (oral: 3% to 8%), increased diastolic blood pressure (oral: 7%), tic disorder (transdermal: 7%; oral: 2%), dizziness (2% to 7%), psychomotor agitation (oral: 5%), depressed mood (oral: 4%), nervousness (oral: 3%; transdermal: <1%), restlessness (oral: 3%), aggressive behavior (oral: 2%), agitation (oral: 2%), depression (?2%), hypertonia (oral: 2%), lack of emotion (oral: 2%), vertigo (oral: 2%), confusion (oral: 1%), sedated state (oral: 1%), tension (oral: 1%), tension headache (oral: 1%), paresthesia (?1%)
Dermatologic: Hyperhidrosis (oral: 5%), excoriation of skin (oral: 4%), skin rash (oral: 2%)
Endocrine & metabolic: Decreased libido (oral: 2%)
Gastrointestinal: Vomiting (1% to 10%), abdominal pain (transdermal: 5% to 7%), diarrhea (oral: 3% to 7%), upper abdominal pain (oral: 4% to 6%), anorexia (2% to 5%), bruxism (oral: 2%), dyspepsia (oral: 2%), motion sickness (oral: 2%), constipation (oral: 1%)
Hematologic & oncologic: Bruise (oral: 3%)
Neuromuscular & skeletal: Back pain (oral: 3%), tremor (oral: 3%)
Ophthalmic: Blurred vision (?2%), eye pain (oral: 2%)
Respiratory: Upper respiratory tract infection (oral: 2% to 4%), nasopharyngitis (oral: 3%), streptococcal pharyngitis (oral: 3%), cough (oral: 2%), oropharyngeal pain (oral: 1% to 2%)
Miscellaneous: Fever (oral: 2%)

Initial: 10 to 20 mg once daily in the morning; may increase dose based on response and tolerability in 10 mg increments at weekly or greater intervals up to a maximum dose of 60 mg/day. Some experts suggest a further increase up to 100 mg/day may be necessary in some patients for optimal response.
Conversion from IR or intermediate-acting ER methylphenidate (eg, Metadate ER, Ritalin SR [Canadian product]) to Ritalin LA: Use equivalent TDD administered once daily.
Adult:
Administer Ritalin LA in the morning and Jornay PM in the evening between 6:30 PM to 9:30 PM. Administer with or without food; capsules may be opened, and the contents sprinkled onto a small amount (equal to 1 tablespoon) of cold applesauce. Swallow applesauce mixture immediately without chewing. Do not crush, chew, or divide capsule contents.
Pediatric:
Administer dose once daily in the morning; may be administered with or without food (but some food consumed at breakfast may delay absorption); capsule may be swallowed whole; do not crush, chew, or divide capsule or its contents; may be opened and contents sprinkled on a small amount (one spoonful) of applesauce.

Children ?6 years and Adolescents:
Methylphenidate-naive patients: Initial: 20 mg once daily; may increase by 10 mg/day increments at weekly intervals; usual maximum daily dose: 60 mg/day; however, some patients weighing >50 kg may require and tolerate daily doses up to 100 mg/day with frequent monitoring (AACAP [Pliszka 2007]). Note: If a lower initial dose is desired, patients may begin with Ritalin LA 10 mg once daily. Alternatively, patients may begin therapy with an immediate-release product, and switch to Ritalin LA once immediate-release dosage is titrated to 5 mg twice daily (see below).
Patients currently receiving immediate-release methylphenidate: The same total daily dose of Ritalin LA should be used.
Patients currently receiving methylphenidate sustained release (SR): The same total daily dose of Ritalin LA should be used.

There are no dosage adjustments provided in manufacturer's labeling (has not been studied); undergoes extensive metabolism to a renally eliminated metabolite with little or no pharmacologic activity.

There are no dosage adjustments provided in manufacturer's labeling (has not been studied).

Store at 20°C to 25°C , excursions permitted 15°C to 30°C.