Dexmethylphenidate

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Unless your doctor tells you otherwise, continue your normal diet.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Dexmethylphenidate is used to treat attention deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Dexmethylphenidate increases attention and decreases restlessness in patients who are hyperactive, cannot concentrate, or are easily distracted. It is used as part of a total treatment program that also includes social, educational, and psychological therapy.

dexmethylphenidate is available only with a doctor's prescription. Prescriptions cannot be refilled. A new prescription must be obtained from your doctor each time you need dexmethylphenidate.

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for any unwanted effects.

Do not take dexmethylphenidate together with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking dexmethylphenidate during the 2 weeks after you stop a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, headaches, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Dexmethylphenidate may cause serious heart or blood vessel problems. This may be more likely to occur 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 taking dexmethylphenidate.

dexmethylphenidate may cause some people to have vision changes or to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to dexmethylphenidate before you drive, use machines, or do anything else that could be dangerous if you are dizzy, not alert, or not able to see well.

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

If you have been using dexmethylphenidate for a long time and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence may be:

• A strong desire or need to continue taking the medicine.
• A need to increase the dose to receive the same effects.
• Withdrawal effects after stopping the medicine such as mental depression, nausea or vomiting, stomach cramps or pain, trembling, or unusual tiredness or weakness.

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

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

dexmethylphenidate may cause Raynaud phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter (OTC)) medicines, and especially those for appetite control, asthma, colds, cough, hay fever, allergies, or sinus problems.

Pharmacodynamics

Dexmethylphenidate hydrochloride is a central nervous system stimulant. Dexmethylphenidate hydrochloride, the more pharmacologically active enantiomer of the d- and l-enantiomers, is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known.

Effects on QT Interval

The effect of Dexmethylphenidate hydrochloride extended-release capsules on the QT interval was evaluated in a double-blind, placebo- and open label active (moxifloxacin)-controlled study following single doses of Dexmethylphenidate hydrochloride extended-release capsules 40mg in 75 healthy volunteers. ECGs were collected up to 12 hours postdose. Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was <5 ms, and the upper limit of the 90% confidence interval was below 10 ms for all time matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident-exposure response relationship.

Pharmacokinetics

Absorption
Dexmethylphenidate hydrochloride is readily absorbed following oral administration of Dexmethylphenidate hydrochloride tablets. In patients with ADHD, plasma Dexmethylphenidate concentrations increase rapidly, reaching a maximum in the fasted state at about 1 to 1.5 hours postdose. No differences in the pharmacokinetics of Dexmethylphenidate hydrochloride tablets were noted following single and repeated twice daily dosing, thus indicating no significant drug accumulation in children with ADHD.

When given to children as capsules in single doses of 2.5 mg, 5 mg, and 10 mg, Cmax and AUC0-inf of Dexmethylphenidate were proportional to dose. In the same study, plasma Dexmethylphenidate levels were comparable to those achieved following single dl-threo-methylphenidate HCl doses given as capsules in twice the total mg amount (equimolar with respect to Dexmethylphenidate hydrochloride tablets).

Food Effects
In a single dose study conducted in adults, coadministration of 2 x 10 mg Dexmethylphenidate hydrochloride tablets with a high fat breakfast resulted in a Dexmethylphenidate tmax of 2.9 hours postdose as compared to 1.5 hours postdose when given in a fasting state. Cmax and AUC0-inf were comparable in both the fasted and nonfasted states.

Distribution
Plasma Dexmethylphenidate concentrations in children decline exponentially following oral administration of Dexmethylphenidate hydrochloride tablets.

Metabolism and Excretion
In humans, Dexmethylphenidate is metabolized primarily to d-α-phenyl-piperidine acetic acid (also known as d-ritalinic acid) by de-esterification. This metabolite has little or no pharmacological activity. There is little or no in vivo interconversion to the l-threo-enantiomer, based on a finding of minute levels of l-threo-methylphenidate being detectable in a few samples in only 2 of  58 children and adults. After oral dosing of radiolabeled racemic methylphenidate in humans, about 90% of the radioactivity was recovered in urine. The main urinary metabolite was ritalinic acid, accountable for approximately 80% of the dose.

In vitro studies showed that Dexmethylphenidate did not inhibit cytochrome P450 isoenzymes.

The mean plasma elimination half-life of Dexmethylphenidate is approximately 2.2 hours.

Special Populations

Gender
Pharmacokinetic parameters were similar for boys and girls (mean age 10 years).

In a single dose study conducted in adults, the mean Dexmethylphenidate AUC0-inf values (adjusted for body weight) following single 2 x 10 mg doses of Dexmethylphenidate hydrochloride tablets were 25%-35% higher in adult female volunteers (n=6) compared to male volunteers (n=9). Both tmax and t1/2 were comparable for males and females.

Race
There is insufficient experience with the use of Dexmethylphenidate hydrochloride tablets to detect ethnic variations in pharmacokinetics.

Age
The pharmacokinetics of Dexmethylphenidate after Dexmethylphenidate hydrochloride tablets administration have not been studied in children less than 6 years of age. When single doses of Dexmethylphenidate hydrochloride tablets were given to children between the ages of 6 to 12 years and healthy adult volunteers, Cmax of Dexmethylphenidate was similar, however, children showed somewhat lower AUCs compared to the adults.

Renal Insufficiency
There is no experience with the use of Dexmethylphenidate hydrochloride tablets in patients with renal insufficiency. After oral administration of radiolabeled racemic methylphenidate in humans, methylphenidate was extensively metabolized and approximately 80% of the radioactivity was excreted in the urine in the form of ritalinic acid. Since very little unchanged drug is excreted in the urine, renal insufficiency is expected to have little effect on the pharmacokinetics of Dexmethylphenidate hydrochloride tablets.

Hepatic Insufficiency
There is no experience with the use of Dexmethylphenidate hydrochloride tablets in patients with hepatic insufficiency (see PRECAUTIONS, Drug Interactions).

Clinical Studies

Dexmethylphenidate hydrochloride tablets were evaluated in 2 double-blind, parallel-group, placebo-controlled trials in untreated or previously treated patients aged 6 to 17 years old with a DSM-IV diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). Both studies included all 3 subtypes of ADHD, i.e., Combined Type, Predominantly Inattentive Type, or Predominantly Hyperactive-Impulsive Type. While both children and adolescents were included, the sample was predominantly children, thus, the findings are most pertinent to this age group. In both studies, the primary comparison of interest was Dexmethylphenidate hydrochloride tablet versus placebo.

Dexmethylphenidate hydrochloride tablets (5, 10, or 20 mg/day total dose), dl-threo-methylphenidate HCl (10, 20, or 40 mg/day total dose), and placebo were compared in a multicenter, 4-week, parallel group study in n=132 patients. Patients took the study medication twice daily, 3.5 to 5.5 hours between doses. Treatment was initiated with the lowest dose, and doses could be doubled at weekly intervals, depending on clinical response and tolerability, up to the maximum dose. The change from baseline to week 4 of the averaged score (an average of 2

ratings during the week) of the teacher’s version of the SNAP-ADHD Rating Scale, a scale for assessing ADHD symptoms, was the primary outcome. Patients treated with Dexmethylphenidate hydrochloride tablets showed a statistically significant improvement in symptom scores from baseline over patients who received placebo. 

Figure 1

Mean Change from Baseline in Teacher SNAP-ADHD Scores in a 4-week Double-Blind Placebo-Controlled Study of Dexmethylphenidate Hydrochloride Tablets*

*Figure 1: Error bars represent the standard error of the mean.

 The other study, involving n=75 patients, was a multicenter, placebo-controlled, double-blind, 2-week treatment withdrawal study in children who were responders during a 6-week, open label initial treatment period. Children took study medication twice a day separated by a 3.5 to 5.5 hour interval. The primary outcome was proportion of treatment failures at the end of the 2-week withdrawal phase, where treatment failure was defined as a rating of 6 (much worse) or 7 (very much worse) on the Investigator Clinical Global Impression - Improvement (CGI-I). Patients continued on Dexmethylphenidate hydrochloride tablets showed a statistically significant lower rate of failure over patients who received placebo.

Figure 2

Percent of Treatment Failures Following a 2-week Double-Blind Placebo-Controlled Withdrawal of Dexmethylphenidate Hydrochloride Tablets

Agitation

Dexmethylphenidate hydrochloride tablets are contraindicated in patients with marked anxiety, tension, and agitation, since the drug may aggravate these symptoms.

Hypersensitivity to Methylphenidate

Dexmethylphenidate hydrochloride tablets are contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product. Hypersensitivity reactions, including angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate (see ADVERSE REACTIONS).

Glaucoma

Dexmethylphenidate hydrochloride tablets are contraindicated in patients with glaucoma.

Tics

Dexmethylphenidate hydrochloride tablets are contraindicated in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome (see ADVERSE REACTIONS).

Monoamine Oxidase Inhibitors

Dexmethylphenidate hydrochloride tablets are contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).

Hematologic Monitoring

Periodic CBC, differential, and platelet counts are advised during prolonged therapy.

Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Dexmethylphenidate and should counsel them in its appropriate use. A patient Medication Guide is available for Dexmethylphenidate hydrochloride tablets. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Priapism
Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism.

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:

Drug Interactions

Methylphenidate may decrease the effectiveness of drugs used to treat hypertension. Because of possible effects on blood pressure, Dexmethylphenidate hydrochloride tablets should be used cautiously with pressor agents.

Human pharmacologic studies have shown that racemic methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and some antidepressants (tricyclics and selective serotonin reuptake inhibitors). Downward dose adjustments of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentration (or, in the case of coumarin, coagulation times), when initiating or discontinuing concomitant methylphenidate.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Lifetime carcinogenicity studies have not been carried out with Dexmethylphenidate. In a lifetime carcinogenicity study carried out in B6C3F1 mice, racemic methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas at a daily dose of approximately 60 mg/kg/day. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown.

Racemic methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day.

In a 24-week study of racemic methylphenidate in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Mice were fed diets containing the same concentrations as in the lifetime carcinogenicity study; the high-dose group was exposed to 60-74 mg/kg/day of racemic methylphenidate.

Dexmethylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, the in vitro mouse lymphoma cell forward mutation assay, or the in vivo mouse bone marrow micronucleus test.

Racemic methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or the in vitro mouse lymphoma cell forward mutation assay, and was negative in vivo in the mouse bone marrow micronucleus assay. However, sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay of racemic methylphenidate in cultured Chinese Hamster Ovary (CHO) cells.

Racemic methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week Continuous Breeding study. The study was conducted at doses of up to 160 mg/kg/day.

Pregnancy

Pregnancy Category C
In studies conducted in rats and rabbits, Dexmethylphenidate was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. No evidence of teratogenic activity was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. When Dexmethylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, postweaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed. At the highest doses tested, plasma levels (AUCs) of Dexmethylphenidate in pregnant rats and rabbits were approximately 5 and 1 times, respectively, those in adults dosed with the maximum recommended human dose of 20 mg/day.

Racemic methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day throughout organogenesis.

Adequate and well-controlled studies in pregnant women have not been conducted. Dexmethylphenidate hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether Dexmethylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Dexmethylphenidate hydrochloride tablets are administered to a nursing woman.

Pediatric Use

The safety and efficacy of Dexmethylphenidate hydrochloride tablets in children under 6 years old have not been established.  Long-term effects of Dexmethylphenidate hydrochloride tablets in children have not been well established (see WARNINGS).

In a study conducted in young rats, racemic methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (Postnatal Day 7) and continuing through sexual maturity (Postnatal Week 10). When these animals were tested as adults (Postnatal Weeks 13-14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] of racemic methylphenidate on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (12 times the racemic MRHD on a mg/m2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (half the racemic MRHD on a mg/m2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.

American Psychiatric Association. Diagnosis and Statistical Manual of Mental Disorders. 4th ed. Washington DC: American Psychiatric Association 1994.

Dexmethylphenidate Hydrochloride Tablets CII
’deks meth" l-fen 'i-dat - 'hī-(׀)drō'klō(ə)r-׀īd

Read the Medication Guide that comes with Dexmethylphenidate hydrochloride tablets before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with Dexmethylphenidate hydrochloride tablets.

What are Dexmethylphenidate hydrochloride tablets?

Dexmethylphenidate hydrochloride tablets are a central nervous system stimulant prescription medicine. They are used for the treatment of attention deficit and hyperactivity disorder (ADHD).

Dexmethylphenidate hydrochloride tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Dexmethylphenidate hydrochloride tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Dexmethylphenidate hydrochloride tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Who should not take Dexmethylphenidate hydrochloride tablets?

Dexmethylphenidate hydrochloride tablets should not be taken if you or your child:

• are very anxious, tense, or agitated

• have an eye problem called glaucoma

• have tics or Tourette’s syndrome, or a family history of Tourette’s syndrome. Tics are hard to control repeated movements or sounds.

• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase

inhibitor or MAOI.

• are allergic to anything in Dexmethylphenidate hydrochloride tablets. See the end of this Medication

Guide for a complete list of ingredients.

Dexmethylphenidate hydrochloride tablets should not be used in children less than 6 years old because it has not been studied in this age group.

Dexmethylphenidate hydrochloride tablets may not be right for you or your child. Before starting

Dexmethylphenidate hydrochloride tablets tell your or your child’s doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, high blood pressure

• mental problems including psychosis, mania, bipolar illness, or depression

• tics or Tourette’s syndrome

• seizures or have had an abnormal brain wave test (EEG)

• circulation problems in fingers or toes

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breast-feeding.

Can Dexmethylphenidate hydrochloride tablets be taken with other medicines?

Tell your doctor about all of the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. Dexmethylphenidate hydrochloride tablets and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Dexmethylphenidate hydrochloride tablets.

Your doctor will decide whether Dexmethylphenidate hydrochloride tablets can be taken with other medicines.

Especially tell your doctor if you or your child takes:

• anti-depression medicines including MAOIs

• seizure medicines

• blood thinner medicines

• blood pressure medicines

• cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Dexmethylphenidate hydrochloride tablets without talking to your doctor first.

How should Dexmethylphenidate hydrochloride tablets be taken?

• Take Dexmethylphenidate hydrochloride tablets exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.

• Take Dexmethylphenidate hydrochloride tablets twice a day, at least 4 hours apart.

• Dexmethylphenidate hydrochloride tablets can be taken with or without food.

• From time to time, your doctor may stop Dexmethylphenidate hydrochloride tablets treatment for a while to check ADHD symptoms.

• Your doctor may do regular checks of the blood, heart, and blood pressure while taking Dexmethylphenidate hydrochloride tablets. Children should have their height and weight checked often while taking Dexmethylphenidate hydrochloride tablets. Dexmethylphenidate hydrochloride tablets treatment may be stopped if a problem is found during these check-ups.

• If you or your child takes too many Dexmethylphenidate hydrochloride tablets or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Dexmethylphenidate hydrochloride tablets?

See “What is the most important information I should know about Dexmethylphenidate hydrochloride tablets?” for information on reported heart and mental problems.

Other serious side effects include:

• serious allergic reactions (symptoms can be difficulty breathing, swelling of the face, neck and throat, rashes and hives, fever)

• slowing of growth (height and weight) in children

• seizures, mainly in patients with a history of seizures

• eyesight changes or blurred vision

• painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.

Common side effects include:

Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

How should I store Dexmethylphenidate hydrochloride tablets?

• Store Dexmethylphenidate hydrochloride tablets in a safe place at room temperature, 20° to 25°C (68° to 77°F).

• Keep Dexmethylphenidate hydrochloride tablets and all medicines out of the reach of children.

General information about Dexmethylphenidate hydrochloride tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Dexmethylphenidate hydrochloride tablets for a condition for which it was not prescribed. Do not give Dexmethylphenidate hydrochloride tablets to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Dexmethylphenidate hydrochloride tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Dexmethylphenidate hydrochloride tablets that was written for healthcare professionals. For more information about Dexmethylphenidate hydrochloride tablets, please contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984.

What are the ingredients in Dexmethylphenidate hydrochloride tablets?

Active Ingredient: Dexmethylphenidate hydrochloride

Inactive Ingredients: lactose monohydrate, sodium starch glycolate, talc, magnesium stearate, and FD&C Blue No.1 aluminum lake (2.5 mg tablet), D&C Yellow No. 10 aluminum lake (5 mg tablet); the 10 mg tablet contains no dye.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured and Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

6487T02

Rev. 01/2017

(dex meth il FEN i date)

In adults, the AUC of dexmethylphenidate immediate release was 25% to 35% higher in women compared with men. After administration of dexmethylphenidate ER, the first peak (Cmax) was 45% higher in women. Parameters for dexmethylphenidate immediate release were similar for boys and girls.

ADHD: Children ≥6 years and Adolescents: Patients not currently taking methylphenidate or who are on other stimulants: Oral:

Immediate release: Initial: 2.5 mg twice daily; dosage may be adjusted in increments of 2.5 to 5 mg at weekly intervals (maximum dose: 20 mg/day)

Extended release: Initial: 5 mg once daily; dosage may be adjusted in increments of 5 mg at weekly intervals (maximum dose: 30 mg/day)

Conversion to dexmethylphenidate from methylphenidate: Immediate release and extended release: Initial: Refer to adult dosing.

Conversion from dexmethylphenidate immediate release to dexmethylphenidate extended release: Refer to adult dosing.

Dose reductions and discontinuation: Refer to adult dosing.

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

Extended release: Should be administered once daily in the morning; do not crush, chew, or divide. Capsules may be opened and contents sprinkled over a spoonful of applesauce; consume immediately; do not store for future use.

Immediate release: Should be administered twice daily at least 4 hours apart; may be taken with or without food.

Blood pressure and heart rate (especially in hypertensive patients), CBC with differential, platelet count; signs of peripheral vasculopathy (eg, digital changes); height and weight in children; signs of misuse, abuse, or addiction. Patients should be re-evaluated at appropriate intervals to assess continued need of the medication.

When used for the treatment of ADHD, thoroughly evaluate for cardiovascular risk. Monitor heart rate, blood pressure, and consider obtaining ECG prior to initiation (Vetter 2008).

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue, anxiety, abdominal pain, headache, weight loss, lack of appetite, insomnia, or dry mouth. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), angina, shortness of breath, severe dizziness, passing out, joint pain, purple patches on skin or mouth, bradycardia, tachycardia, abnormal heartbeat, severe headache, severe nausea, vomiting, blurred vision, vision changes, seizures, dark urine, jaundice, chills, pharyngitis, tremors, abnormal movements, sweating a lot, loss of strength and energy, burning or numbness feeling, change in color of hands or feet from pale to blue or red, temperature sensitivity, wounds on fingers or toes, priapism, urinary retention, change in amount of urine passed, muscle pain, signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), hallucinations, or behavioral changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.