Methylphenidate transdermal

Name: Methylphenidate transdermal

Description

Daytrana is an adhesive-based matrix transdermal system (patch) that is applied to intact skin. The chemical name for methylphenidate is α-phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether. Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is 233.31. Its empirical formula is C14H19NO2. The structural formula of methylphenidate is:

Patch Components

Daytrana contains methylphenidate in a multipolymeric adhesive. The methylphenidate is dispersed in acrylic adhesive that is dispersed in a silicone adhesive. The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the patch size and wear time.

The patch consists of three layers, as seen in the figure below (cross-section of the patch).

Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a polyester/ethylene vinyl acetate laminate film backing, (2) a proprietary adhesive formulation incorporating Noven Pharmaceuticals, Inc.’s DOT Matrix™ transdermal technology consisting of an acrylic adhesive, a silicone adhesive, and methylphenidate, and (3) a fluoropolymer-coated polyester protective liner which is attached to the adhesive surface and must be removed before the patch can be used.

The active component of the patch is methylphenidate. The remaining components are pharmacologically inactive.

Indications

Daytrana (methylphenidate transdermal system) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The efficacy of Daytrana in patients diagnosed with ADHD was established in two 7 -week controlled clinical trials in children (ages 6-12) and one 7 -week, controlled clinical trial in adolescents (ages 13-17).

A diagnosis of ADHD (DSM-IV-TR®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

The specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV-TR® characteristics.

Need For Comprehensive Treatment Program

Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.

What is the most important information i should know about methylphenidate transdermal (daytrana)?

Do not use methylphenidate if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

You should not use this medicine if you are allergic to methylphenidate or if you have glaucoma, tics (muscle twitches) or Tourette's syndrome, or severe anxiety, tension, or agitation (methylphenidate can make these symptoms worse).

Methylphenidate may be habit forming. Never share methylphenidate with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Keep track of the amount of patches used from each new package. Methylphenidate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription. Using methylphenidate improperly can cause death or serious side effects on the heart.

Children using this medication should be warned never to remove the skin patch and place it onto another person. Serious side effects may result.

Side effects

Detailed information on serious and adverse reactions of particular importance is provided in the Boxed Warning and Warnings and Precautions (5) sections:

  • Drug dependence [see BOX WARNING]
  • Hypersensitivity to Methylphenidate [see CONTRAINDICATIONS]
  • Marked anxiety, tension, or agitation [see CONTRAINDICATIONS]
  • Glaucoma [see CONTRAINDICATIONS]
  • Tics or a family history of Tourette’s syndrome [see CONTRAINDICATIONS]
  • Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS and DRUG INTERACTIONS]
  • Serious Cardiovascular Events [see WARNINGS AND PRECAUTIONS]
  • Increase in Blood Pressure [see WARNINGS AND PRECAUTIONS]
  • Psychiatric Adverse Events [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Priapism [see WARNINGS AND PRECAUTIONS]
  • Peripheral Vasculopathy[see WARNINGS AND PRECAUTIONS]
  • Long-Term Suppression of Growth [see WARNINGS AND PRECAUTIONS]
  • Chemical Leukoderma [see WARNINGS AND PRECAUTIONS]
  • Contact Sensitization [see WARNINGS AND PRECAUTIONS]
  • Visual Disturbance [see WARNINGS AND PRECAUTIONS]
  • External Heat [see WARNINGS AND PRECAUTIONS]
  • Hematologic Monitoring [see WARNINGS AND PRECAUTIONS]

The most commonly reported (frequency ≥ 5% and twice the rate of placebo) adverse reactions in a controlled trial in children aged 6-12 included appetite decreased, insomnia, nausea, vomiting, weight decreased, tic, affect lability, and anorexia. The most commonly reported (frequency ≥ 5% and twice the rate of placebo) adverse reactions in a controlled trial in adolescents aged 13-17 were appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia [see Clinical Trials Experience].

The most common (≥ 2% of subjects) adverse reaction associated with discontinuations in double-blind clinical trials in children or adolescents was application site reactions [see Clinical Trials Experience].

The overall Daytrana development program included exposure to Daytrana in a total of 2,152 participants in clinical trials, including 1,529 children aged 6-12, 223 adolescents aged 13-17, and 400 adults. The 1,752 child and adolescent subjects aged 6-17 years were evaluated in 10 controlled clinical studies, 7 open-label clinical studies, and 5 clinical pharmacology studies. In a combined studies pool of children using Daytrana with a wear time of 9 hours, 212 subjects were exposed for ≥ 6 months and 115 were exposed for ≥ 1 year; 85 adolescents have been exposed for ≥ 6 months. Most patients studied were exposed to Daytrana patch sizes of 12.5 cm2, 18.75 cm2, 25 cm2 or 37.5 cm2, with a wear time of 9 hours.

In the data presented below, the adverse reactions reported during exposure were obtained primarily by general inquiry at each visit, and were recorded by the clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of events into a smaller number of standardized event categories.

Throughout this section adverse reactions reported are events that were considered to be reasonably associated with the use of Daytrana based on comprehensive assessment of the available adverse event information. A causal association for Daytrana often cannot be reliably established in individual cases. Further, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trials Experience

Adverse Reactions Associated With Discontinuation Of Treatment

In a 7-week double-blind, parallel-group, placebo-controlled study in children with ADHD conducted in the outpatient setting, 7.1% (7/98) of patients treated with Daytrana discontinued due to adverse events compared with 1.2% (1/85) receiving placebo. The most commonly reported (≥ 1% and twice the rate of placebo) adverse reactions leading to discontinuation in the Daytrana group were application site reaction (2%), tics (1%), headache (1%), and irritability (1%).

In a 7-week double-blind, parallel-group, placebo-controlled study in adolescents with ADHD conducted in the outpatient setting, 5.5% (8/145) of patients treated with Daytrana discontinued due to adverse reactions compared with 2.8% (2/72) receiving placebo. The most commonly reported adverse reactions leading to discontinuation in the Daytrana group were application site reaction (2%) and decreased appetite/anorexia (1.4%).

Commonly Observed Adverse Reactions In Double-Blind, Placebo-Controlled Trials

Skin Irritation and Application Site Reactions

Daytrana is a dermal irritant. In addition to the most commonly reported adverse reactions presented in Table 2, the majority of subjects in those studies had minimal to definite skin erythema at the patch application site. This erythema generally caused no or minimal discomfort and did not usually interfere with therapy or result in discontinuation from treatment. Erythema is not by itself a manifestation of contact sensitization. However, contact sensitization should be suspected if erythema is accompanied by evidence of a more intense local reaction (edema, papules, vesicles) that does not significantly improve within 48 hours or spreads beyond the patch site [see WARNINGS AND PRECAUTIONS].

Most Commonly Reported Adverse Reactions

Table 2 lists treatment-emergent adverse reactions reported in ≥ 1% Daytrana-treated children or adolescents with ADHD in two 7 week double-blind, parallel-group, placebo-controlled studies conducted in the outpatient setting. Overall, in these studies, 75.5% of children and 78.6% of adolescents experienced at least 1 adverse event.

Table 2 Number (%) of Subjects with Commonly Reported Adverse Reactions (≥ 1% in the Daytrana Group) in 7-Week Placebo-controlled Studies in Either Children or Adolescents -Safety Population

System Organ Class Preferred term Adolescents Children
Placebo
N = 72
Daytrana
N = 145
Placebo
N = 85
Daytrana
N = 98
Cardiac Disorders
  Tachycardia 0 (0) 1 (0.7) 0 (0) 1 (1.0)
Gastrointestinal disorders
  Abdominal pain 0 (0) 7 (4.8) 5 (5.9) 7 (7.1)
  Nausea 2 (2.8) 14 (9.7) 2 (2.4) 12 (12.2)
  Vomiting 1 (1.4) 5 (3.4) 4 (4.7) 10 (10.2)
Investigations
  Weight decreased 1 (1.4) 8 (5.5) 0 (0) 9 (9.2)
Metabolism and nutrition disorders
  Anorexia 1 (1.4) 7 (4.8) 1 (1.2) 5 (5.1)
  Decreased appetite 1 (1.4) 37 (25.5) 4 (4.7) 25 (25.5)
Nervous system disorders
  Dizziness 1 (1.4) 8 (5.5) 1 (1.2) 0 (0)
  Headache 9 (12.5) 18 (12.4) 10 (11.8) 15 (15.3)
Psychiatric disorders
  Affect lability 1 (1.4) 0 (0) 0 (0) 6 (6.1)*
  Insomnia 2 (2.8) 9 (6.2) 4 (4.7) 13 (13.3)
  Irritability 5 (6.9) 16 (11) 4 (4.7) 7 (7.1)
  Tic 0 (0) 0 (0) 0 (0) 7 (7.1)
* Six subjects had affect lability, all judged as mild and described as increased emotionally sensitive, emotionality, emotional instability, emotional lability, and intermittent emotional

Adverse Reactions With The Long-Term Use Of Daytrana

In a long-term open-label study of up to 12 months duration in 326 children wearing Daytrana 9 hours daily, the most common (≥ 10%) adverse reactions were decreased appetite, headache, and weight decreased. A total of 30 subjects (9.2%) were withdrawn from the study due to adverse events and 22 additional subjects (6.7%) discontinued treatment as the result of an application site reaction. Other than application site reactions, affect lability (5 subjects, 1.5%) was the only additional adverse reaction leading to discontinuation reported with a frequency of greater than 1%.

In a long-term open-label study of up to 6 months duration in 162 adolescents wearing Daytrana 9 hours daily, the most common (≥ 10%) adverse reactions were decreased appetite and headache. A total of 9 subjects (5.5%) were withdrawn from the study due to adverse events and 3 additional subjects (1.9%) discontinued treatment as the result of an application site reaction. Other adverse reactions leading to discontinuation that occurred with a frequency of greater than 1% included affect lability and irritability (2 subjects each, 1.2%).

Postmarketing Experience

In addition, the following adverse reactions have been identified during the postapproval use of Daytrana. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to Daytrana exposure.

Cardiac Disorders: palpitations

Eye Disorders: visual disturbances, blurred vision, mydriasis, accommodation disorder

General Disorders and Administration Site Disorders: fatigue, application site reactions such as bleeding, bruising, burn, burning, dermatitis, discharge, discoloration, discomfort, dryness, eczema, edema, erosion, erythema, excoriation, exfoliation, fissure, hyperpigmentation, hypopigmentation, induration, infection, inflammation, irritation, pain, papules, paresthesia, pruritus, rash, scab, swelling, ulcer, urticaria, vesicles, and warmth

Immune System Disorders: hypersensitivity reactions including generalized erythematous and urticarial rashes, allergic contact dermatitis, angioedema, and anaphylaxis

Investigations: blood pressure increased

Nervous System Disorders: convulsion, dyskinesia, lethargy, somnolence, serotonin syndrome in combination with serotonergic drugs

Psychiatric Disorders: transient depressed mood, hallucination, nervousness, libido changes

Skin and Subcutaneous Tissue Disorders: alopecia

Adverse Reactions With Oral Methylphenidate Products

Nervousness and insomnia are the most common adverse reactions reported with other methylphenidate products. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed below may also occur.

Other Reactions Include

Cardiac: angina, arrhythmia, pulse increased or decreased

Immune: hypersensitivity reactions including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura

Metabolism/Nutrition: anorexia, weight loss during prolonged therapy

Nervous System: drowsiness, rare reports of Tourette’s syndrome, toxic psychosis

Vascular: blood pressure increased or decreased, cerebral arteritis and/or occlusion

Although a definite causal relationship has not been established, the following have been reported in patients taking methylphenidate:

Blood/lymphatic: leukopenia and/or anemia

Hepatobiliary: abnormal liver function, ranging from transaminase elevation to severe hepatic injury

Psychiatric: transient depressed mood

Skin/Subcutaneous: scalp hair loss

Neuroleptic Malignant Syndrome: Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten-year-old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.

Musculoskeletal: rhabdomyolysis

Read the entire FDA prescribing information for Daytrana (Methylphenidate Transdermal)

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  • ADHD Medication for Children
  • ADHD Medications for Adults

What is the most important information I should know about methylphenidate transdermal?

You should not use methylphenidate if you have glaucoma, tics or Tourette's syndrome, or severe anxiety, tension, or agitation. Do not use methylphenidate if you have taken an MAO inhibitor in the past 14 days, including isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Methylphenidate may be habit forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction.

Using this medicine improperly can cause death or serious side effects on the heart.

How should I use methylphenidate transdermal?

Follow all directions on your prescription label. Using this medicine improperly can cause death or serious side effects on the heart. Read all patient information, medication guides, and instruction sheets provided to you. The medicine comes with a dosing schedule that shows when to apply and remove a skin patch based on 9- hour time frames. Ask your doctor or pharmacist if you have any questions.

Methylphenidate may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Selling or giving away this medicine is against the law.

Apply the patch to a clean and dry area on your hip. Press firmly onto the skin with the palm of your hand for about 30 seconds. The patch should stay on while swimming or bathing. The effects of this medicine may not be noticeable until 2 hours after applying the skin patch.

Wash your hands after applying a skin patch.

Remove the patch 9 hours after it was applied. Peel off slowly and fold the patch in half so it sticks together. Flush the folded patch down the toilet or place it into a waste can with a lid. If you discontinue using methylphenidate transdermal, fold together and flush any unused patches at that time.

Apply a new patch to the opposite hip. Do not wear a patch on the same side of the body two days in a row.

If a patch falls off, replace it with a new one. Then remove the new patch after it has been 9 hours since you applied the first patch. Do not wear a patch longer than 9 hours per day, even if you apply a new patch to replace one that has fallen off. Use the dosing schedule provided to track your patch wearing time.

Over time, methylphenidate transdermal can cause your skin to lighten around areas where the patches are worn. This effect may be permanent. Check your skin often. Tell your doctor if you see new areas of lighter color under or around a skin patch. Do not change your doses or medication schedule without your doctor's advice.

If you have trouble sleeping or loss of appetite in the evenings, try removing the skin patch earlier in the day. Never cut the skin patch to try and reduce the amount of medicine you receive while wearing it.

Children using this medicine should be warned never to remove the skin patch and place it onto another person. Serious side effects may result.

While using methylphenidate, your doctor will need to check your progress at regular visits. Your heart rate, blood pressure, height and weight may also need to be checked often.

Keep each patch in its sealed pouch until you are ready to use it. Store at room temperature away from heat and moisture. Do not refrigerate or freeze. Throw away any unused patches if it has been more than 2 months since you opened the original package.

Keep track of the amount of medicine used from each new package. Methylphenidate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Methylphenidate dosing information

Usual Adult Dose for Attention Deficit Disorder:

IMMEDIATE-RELEASE (IR) SOLUTION [Methylin(R)]; IR TABLET [Ritalin(R)]:
10 to 60 mg orally in 2 or 3 divided doses per day, preferably 30 to 45 minutes before meals.
Comments:
-Average dosage is 20 to 30 mg/day.
-Advise patients to take the last dose before 6 pm if they are unable to sleep when medication is taken late in the day.

EXTENDED-RELEASE CAPSULE:
ALL:
-Maximum Dose: 60 mg/day
-Duration of Therapy: Discontinue treatment if improvement is not observed after appropriate dosage adjustment over a 1-month period.

Aptensio XR(TM):
-Initial Dose: 10 mg orally once a day in the morning with or without food.
-Maintenance Dose: May increase dose with increments of 10 mg weekly.
-Comments: Advise patients to establish a routine pattern with regard to meals.

Metadate CD(R):
-Initial Dose: 20 mg orally once a day in the morning before breakfast.
-Maintenance Dose: May increase dose with increments of 10 to 20 mg weekly.

Ritalin LA(R):
Patients New to Methylphenidate:
-Initial Dose: 20 mg orally once a day in the morning; may start at 10 mg/day when a lower dose is appropriate based on clinician judgement.
-Maintenance Dose: May increase dose with increments of 10 mg weekly.

Patients Switching From IR or SR Formulations:
-If Current Using IR 5 mg 2 times/day: 10 mg/day of Ritalin LA(R)
-If Current Using IR 10 mg 2 times/day or SR 20 mg/day: 20 mg/day of Ritalin LA(R)
-If Current Using IR 15 mg 2 times/day: 30 mg/day of Ritalin LA(R)
-If Current Using IR 20 mg 2 times/day day or SR 40 mg/day: 40 mg/day of Ritalin LA(R)
-If Current Using IR 30 mg 2 times/day day or SR 60 mg/day: 60 mg/day of Ritalin LA(R)

EXTENDED-RELEASE SUSPENSION [Quillivant XR(R)]:
-Initial Dose: 20 mg orally once a day in the morning with or without food.
-Maintenance Dose: May increase dose with gradual increments of 10 to 20 mg weekly.
-Maximum Dose: 60 mg/day

EXTENDED-RELEASE or SUSTAINED-RELEASE TABLET:
Concerta(R):
Adults Up to the Age of 65 Years:
Patients New to Methylphenidate:
-Initial Dose: 18 or 36 mg orally once a day in the morning with or without food.

Patients Switching From IR Formulation:
-If Currently Using IR 5 mg 2 or 3 times/day: 18 mg of Concerta(R)
-If Currently Using IR 10 mg 2 or 3 times/day: 36 mg of Concerta(R)
-If Currently Using IR 15 mg 2 or 3 times/day: 54 mg of Concerta(R)
-If Currently Using IR 20 mg 2 or 3 times/day: 72 mg of Concerta(R)

All Concerta(R) Patients:
-Maintenance Dose: May increase dose in 18 mg/day increments at weekly intervals if an optimal response at a lower dose has not been achieved.
-Maximum Dose: 72 mg/day
-Duration of Therapy: Discontinue treatment if improvement is not observed after appropriate dosage adjustment over a 1-month period.
-Comments: A 27 mg dosage strength is available for physicians who wish to prescribe between the 18 and 36 mg dosages.

Metadate ER(R); Ritalin-SR(R):
-May be used in place of IR tablets when the 8-hour dosage of the ER or SR Tablets corresponds to the titrated 8-hour dosage of the IR tablets.

EXTENDED-RELEASE CHEWABLE TABLET [Quillichew ER(TM)]:
-Initial Dose: 20 mg orally once a day in the morning with or without food.
-Maintenance Dose: May be titrated up or down weekly in increments of 10, 15, or 20 mg.
-Maximum Dose: 60 mg/day
-Duration of Therapy: Discontinue treatment if improvement is not observed after appropriate dosage adjustment over a 1-month period.
Comments:
-If Switching From Other Methylphenidate Products: Discontinue that treatment and use the usual titration schedule for the ER chewable tablet.
-Do not substitute for other methylphenidate products on a milligram-per-milligram basis because of different methylphenidate base compositions and differing pharmacokinetic profiles.

Use: Part of a total treatment program for Attention Deficit Hyperactivity Disorder (ADHD), that may include other measures (psychological, educational, social) for patients with this syndrome.

Usual Adult Dose for Narcolepsy:

IMMEDIATE-RELEASE (IR) SOLUTION [Methylin(R)]; IR TABLET [Ritalin(R)]:
10 to 60 mg orally a day in 2 or 3 divided doses, preferably 30 to 45 minutes before meals.
Comments:
-Average dosage is 20 to 30 mg/day.
-Advise patients to take the last dose before 6 pm if they are unable to sleep when medication is taken late in the day.

EXTENDED-RELEASE [Metadate ER(R)]; SUSTAINED-RELEASE TABLET [Ritalin-SR(R)]:
-May be used in place of IR tablets when the 8-hour dosage of the ER or SR Tablets corresponds to the titrated 8-hour dosage of the IR tablets.

Use: Treatment of Narcolepsy

Usual Pediatric Dose for Attention Deficit Disorder:

UNDER AGE 6 YEARS (All Formulations): Not recommended.

AGE 6 YEARS AND OLDER:
ALL:
-Maximum Dose: 60 mg/day (for all formulations EXCEPT Concerta(R) extended-release tablet)
-Concerta(R) Maximum Dose: Age 6 to 12 Years: 54 mg/day; Age 13 to 17 Years: 72 mg/day, not to exceed 2 mg/kg/day
-Duration of Therapy: Discontinue treatment if improvement is not observed after appropriate dosage adjustment over a 1-month period.

IMMEDIATE RELEASE (IR) SOLUTION [Methylin(R)]; IR TABLET [Ritalin(R)]:
-Initial Dose: 5 mg orally twice a day before breakfast and lunch.
-Maintenance Dose: May increase dose with gradual increments of 5 to 10 mg weekly.

EXTENDED-RELEASE CAPSULE:
Aptensio XR(TM):
-Initial Dose: 10 mg orally once a day in the morning with or without food.
-Maintenance Dose: May increase dose with increments of 10 mg weekly.

Metadate CD(R):
-Initial Dose: 20 mg orally once a day in the morning before breakfast.
-Maintenance Dose: May increase dose with gradual increments of 10 to 20 mg weekly.

Ritalin LA(R):
Patients New to Methylphenidate:
-Initial Dose: 20 mg orally once a day in the morning; may start at 10 mg/day when a lower dose is appropriate based on clinician judgement.
-Maintenance Dose: May increase dose with increments of 10 mg weekly.

Patients Switching From IR or SR Formulations:
-If Current Using IR 5 mg 2 times/day: 10 mg/day of Ritalin LA(R)
-If Current Using IR 10 mg 2 times/day or SR 20 mg/day: 20 mg/day of Ritalin LA(R)
-If Current Using IR 15 mg 2 times/day: 30 mg/day of Ritalin LA(R)
-If Current Using IR 20 mg 2 times/day day or SR 40 mg/day: 40 mg/day of Ritalin LA(R)
-If Current Using IR 30 mg 2 times/day day or SR 60 mg/day: 60 mg/day of Ritalin LA(R)

EXTENDED-RELEASE SUSPENSION [Quillivant XR(R)]:
-Initial Dose: 20 mg orally once a day in the morning with or without food.
-Maintenance Dose: May increase dose with gradual increments of 10 to 20 mg weekly.

EXTENDED-RELEASE or SUSTAINED-RELEASE TABLET:
Concerta(R):
Patients New to Methylphenidate:
-Initial Dose: 18 mg orally once a day in the morning with or without food.

Patients Switching From IR Formulation:
-If Currently Using IR 5 mg 2 or 3 times/day: 18 mg of Concerta(R)
-If Currently Using IR 10 mg 2 or 3 times/day: 36 mg of Concerta(R)
-If Currently Using IR 15 mg 2 or 3 times/day: 54 mg of Concerta(R)
-If Currently Using IR 20 mg 2 or 3 times/day: 72 mg of Concerta(R)

All Concerta(R) Patients:
-Maintenance Dose: May increase dose in 18 mg/day increments at weekly intervals if an optimal response at a lower dose has not been achieved.
-Comments: A 27 mg dosage strength is available for physicians who wish to prescribe between the 18 and 36 mg dosages.

Metadate ER(R); Ritalin-SR(R):
-May be used in place of IR tablets when the 8-hour dosage of the ER or SR Tablets corresponds to the titrated 8-hour dosage of the IR tablets.

EXTENDED-RELEASE CHEWABLE TABLET [Quillichew ER(TM)]:
-Initial Dose: 20 mg orally once a day in the morning with or without food.
-Maintenance Dose: May be titrated up or down weekly in increments of 10, 15, or 20 mg.
-Comments: If switching from other methylphenidate products to this extended-release chewable tablet, discontinue that methylphenidate product then use the usual titration schedule for Quillichew ER(TM).

TRANSDERMAL PATCH [Daytrana(R)]:
Week 1: 10 mg/9 hour patch per day
Week 2: 15 mg/9 hour patch per day
Week 3: 20 mg/9 hour patch per day
Week 4: 30 mg/9 hour patch per day
Comments:
-Instruct parents/caregivers to apply one patch to a clean, dry area of the child's hip 2 hours before an effect is needed; application sites other than the hip can have different absorption characteristics and have not been adequately studied.
-Direct parents/caregivers to remove the patch 9 hours after application; may remove earlier than 9 hours if a shorter duration of effect is desired or late day side effects appear.
-Consult the manufacturer product information for additional information about patch application/removal/disposal.

Use: Part of a total treatment program for Attention Deficit Hyperactivity Disorder (ADHD), which typically includes remedial measures for a stabilizing effect in children with this behavioral syndrome.

Usual Pediatric Dose for Narcolepsy:

UNDER AGE 6 YEARS (All Formulations): Not recommended.

AGE 6 YEARS AND OLDER:
IMMEDIATE-RELEASE (IR) SOLUTION [Methylin(R)]; IR TABLET [Ritalin(R)]:
-Initial Dose: 5 mg orally twice a day before breakfast and lunch.
-Maintenance Dose: May increase dose with gradual increments of 5 to 10 mg weekly.
-Maximum Dose: 60 mg/day
-Duration of Therapy: Drug treatment should not be indefinite and usually may be discontinued after puberty; discontinue treatment if improvement is not observed after appropriate dosage adjustment over a 1-month period.

EXTENDED-RELEASE [Metadate ER(R)]; SUSTAINED-RELEASE TABLET [Ritalin-SR(R)]:
-May be used in place of IR tablets when the 8-hour dosage of the ER or SR Tablets corresponds to the titrated 8-hour dosage of the IR tablets.

Use: Treatment of Narcolepsy

Precautions While Using methylphenidate

Your doctor should check your progress at regular visits to make sure methylphenidate is working properly and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

You will need to have your blood pressure measured before starting methylphenidate and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away.

You should not use methylphenidate if you used a medicine for depression called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, within the past 14 days.

Methylphenidate may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, trouble breathing, or fainting while using methylphenidate.

If you have any redness, itching, swelling, or blistering where the patch has been, call your doctor right away.

Tell your doctor right away if you notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Check with your doctor if you have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

methylphenidate may cause a condition called Raynaud phenomenon. Check with your doctor right away if you have tingling or pain in the fingers or toes when exposed to cold, paleness or a cold feeling in the fingertips and toes, or a skin color change of your fingers while using methylphenidate.

methylphenidate may cause slow growth. If your child is using methylphenidate, the doctor will need to keep track of your child's height and weight.

If you have a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.

Using methylphenidate may cause loss of skin color where the patch is applied or on other areas of the skin. This usually occurs more often if you have a personal or family history of vitiligo. Call your doctor right away if you notice changes in skin color while using methylphenidate.

Methylphenidate may cause dizziness, drowsiness, or changes in vision. Do not drive a car, ride a bicycle, operate machinery, or do other things that might be dangerous until you know how methylphenidate affects you.

Avoid putting methylphenidate near external sources of direct heat, such as hair dyers, heating pads, electric blankets, heated water beds, or hot tubs.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.

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