increases effects of venlafaxine by decreasing metabolism. Minor/Significance Unknown.xylometazolineMonitor Closely (2)dexmethylphenidate and xylometazoline both decrease sedation. Use Caution/Monitor. dexmethylphenidate and xylometazoline both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.yerba mateMinor (1)yerba mate increases effects of dexmethylphenidate by pharmacodynamic synergism. Minor/Significance Unknown.yohimbeSerious - Use Alternative (1)yohimbe, dexmethylphenidate. Mechanism: pharmacodynamic synergism. Contraindicated. Risk of acute hypertensive episode.yohimbineMonitor Closely (2)dexmethylphenidate and yohimbine both decrease sedation. Use Caution/Monitor. dexmethylphenidate and yohimbine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.ziconotideMonitor Closely (1)ziconotide increases and dexmethylphenidate decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.ziprasidoneMonitor Closely (1)ziprasidone increases and dexmethylphenidate decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.zonisamideMinor (1)dexmethylphenidate increases effects of zonisamide by decreasing metabolism. Minor/Significance Unknown. >10% Abdominal pain (15%) Headache (25-39%) Insomnia (5-17%) Restlessness (12%) Anxiety (5-11%) 1-10% Anorexia (5-7%) Fever (5%) Dizziness (6%) Mood swings (<3%) Nausea (9%) Pruritus (<3%) Pharyngolaryngeal pain (4-7%) Irritability (5%) Depression (<3%) Dyspepsia (5-9%) Postmarketing Reports Anaphylaxis Hypersensitivity reactions Rhabdomyolysis Drowsiness Dyskinesia Tourette’s syndrome (rare) Toxic psychosis Serotonin syndrome in combination with serotonergic drugs Abnormal liver function, ranging from transaminase elevation to severe hepatic injury Black Box Warnings Chronic abuse can lead to a marked tolerance and psychological dependence with varying degrees of abnormal behavior; frank psychotic episodes can occur, especially with parenteral abuse; withdrawal from abusive use may result in depression. Assess risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy; give cautiously to patients with a history of drug dependence or alcoholism Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-upContraindications Hypersensitivity to methylphenidate; reactions may include angioedema and anaphylaxis Notable tension and agitation, glaucoma, Tourette syndrome, motor tics, anxiety MAOIs: Risk of severe hypertensive reaction; do not use within 14 days of taking MAOI Cautions Should be used as part of a comprehensive treatment program of attention deficit disorder Caution in patients with history of drug dependence or alcoholism, HTN, preexisting structural cardiac abnormalities Discontinue if no improvement after 1 month Reevaluate need for treatment q6Week Associated with peripheral vasculopathy, including Raynaud phenomenon; monitor for digital changes during therapy and seek further evaluation (eg, rheumatology) if necessary Difficulties with visual accommodation and blurring of vision have been reported with stimulant treatment Do not use for depression, fatigue Sudden deaths, stroke, and myocardial infarction reported in adults taking stimulants at usual doses Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported Monitor growth of children ages 7 to 10 years during treatment with stimulants; may need to interrupt therapy in patients not growing or gaining weight as expected Stimulants may lower convulsive threshold in patients with prior history of seizure, patients with prior EEG abnormalities in absence of seizures, and very rarely, patients without a history of seizures and no prior EEG evidence of seizures; discontinue therapy in the presence of seizures Use with caution in patients who use other sympathomimetic drugs Amphetamines may exacerbate motor and phonic tics and Tourette’s syndrome; perform clinical evaluation for tics and Tourette’s syndrome in children and their families prior to treating with stimulant medications Rare instances of prolonged and sometimes painful erections (priapism), sometimes requiring surgical intervention, reported with methylphenidate products; typically not reported during initiation, but often subsequent to an increase in dose; seek immediate medical attention for abnormally sustained or frequent and painful erections Use with caution in patients with hypertension and other vascular conditions, including heart failure, ventricular arrhythmia; recent myocardial infarction; CNS stimulants may increase heart rate and blood pressure Hypersensitivity reactions, including anaphylactic reactions and angioedema reported in patients treated with methylphenidate Use caution in patients with preexisting psychosis; stimulants may exacerbate symptoms of behavior and though disorder; use with caution in patients with bipolar disorder; stimulants may induce mixed/manic episodes; new onset of psychosis or mania may occur in children or adolescents with stimulant use; patients presenting with depressive symptoms should be screened for bipolar disorder, including family history of suicide, bipolar disorder, and depression; consider discontinuation of therapy if symptoms of psychosis develop Appetite suppression may occur in children; stimulant use is associated with weight loss and slowing growth rate; monitor growth rate and weight during treatment; consider interrupting therapy in patients who are not increasing in height or gaining weight as expected Abrupt discontinuation following high doses or prolonged periods may result in symptoms of wighdrawal including severe depression Avoid use in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that could increase risk of sudden death; evaluate promptly patients who develop exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease Hypersensitivity reactions, including angioedema and anaphylactic reactions reported in patients treated with methylphenidate Drug interaction overview Therapy may decrease effectiveness of drugs used to treat hypertension; monitor blood pressure and adjust dosage of the antihypertensive drug as needed Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase risk of extrapyramidal symptoms (EPS); monitor for signs of EPS Pregnancy There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy registry for ADHD medications at 1-866-961-2388 or visit, https://womensmentalhealth.org/adhd­medications Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate; published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; there may be risks to fetus associated with use of CNS stimulants use during pregnancy CNS stimulants can cause vasoconstriction and thereby decrease placental perfusion; no fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers Animal data Embryo-fetal development studies in rats showed delayed fetal skeletal ossification at doses up to 5 times maximum recommended human dose (MRHD) of 20 mg/day given to adults based on plasma levels A decrease in pup weight in males was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 5 times the MRHD of 20 mg/day given to adults based on plasma levels; plasma levels in adults were comparatively similar to plasma levels in adolescents Lactation Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate; Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7 There are no reports of adverse effects on breastfed infant and no effects on milk production; long-term neurodevelopmental effects on infants from stimulant exposure are unknown; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weightPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action The more pharmacologically active CNS stimulant of the d-threo-enantiomers; blocks reuptake of norepinephrine and dopamine, causing an increase of their release into the extraneuronal space Absorption Bioavailability: 22-25% Onset of action: 12hr (extended release) Peak plasma time: 1-1.5 hr (Focalin XR: 2nd peak at 6.5 hr) Distribution Protein bound: 12-25% Vd: 1.54-3.76 L/kg Metabolism Metabolized by deesterification Metabolites: Inactive Elimination Half-life: 2-4.5 hr (adults); 2-3 hr (children) Excretion: Urine (90%) Extended Release Administer once daily; do not crush, chew, or divide Capsules may be opened and contents sprinkled over a spoonful of applesause; do not store for future use; consume immediately Immediate Release Administer twice daily, not sooner than 4 hours apart; may administer with or without food BRAND FORM. UNIT PRICE PILL IMAGE Focalin oral- 10 mg tabletFocalin oral- 5 mg tabletFocalin oral- 2.5 mg tabletdexmethylphenidate oral- 15 mg capsuledexmethylphenidate oral- 30 mg capsuledexmethylphenidate oral- 25 mg capsuledexmethylphenidate oral- 5 mg tabletdexmethylphenidate oral- 2.5 mg tabletdexmethylphenidate oral- 5 mg tabletdexmethylphenidate oral- 15 mg capsuledexmethylphenidate oral- 10 mg tabletdexmethylphenidate oral- 10 mg capsuledexmethylphenidate oral- 35 mg capsuledexmethylphenidate oral- 25 mg capsuledexmethylphenidate oral- 20 mg capsuledexmethylphenidate oral- 35 mg capsuledexmethylphenidate oral- 25 mg capsuledexmethylphenidate oral- 35 mg capsuledexmethylphenidate oral- 10 mg tabletdexmethylphenidate oral- 5 mg tabletdexmethylphenidate oral- 40 mg capsuledexmethylphenidate oral- 10 mg capsuledexmethylphenidate oral- 5 mg tabletdexmethylphenidate oral- 2.5 mg tabletdexmethylphenidate oral- 30 mg capsuledexmethylphenidate oral- 2.5 mg tabletdexmethylphenidate oral- 40 mg capsuledexmethylphenidate oral- 35 mg capsuledexmethylphenidate oral- 30 mg capsuledexmethylphenidate oral- 25 mg capsuledexmethylphenidate oral- 20 mg capsuledexmethylphenidate oral- 15 mg capsuledexmethylphenidate oral- 10 mg capsuledexmethylphenidate oral- 5 mg capsuledexmethylphenidate oral- 10 mg tabletdexmethylphenidate oral- 5 mg tabletdexmethylphenidate oral- 2.5 mg tabletdexmethylphenidate oral- 20 mg capsuledexmethylphenidate oral- 10 mg capsuledexmethylphenidate oral- 20 mg capsuledexmethylphenidate oral- 15 mg capsuledexmethylphenidate oral- 5 mg capsuledexmethylphenidate oral- 40 mg capsuledexmethylphenidate oral- 15 mg capsuledexmethylphenidate oral- 10 mg capsuledexmethylphenidate oral- 5 mg capsuledexmethylphenidate oral- 25 mg capsuledexmethylphenidate oral- 30 mg capsuledexmethylphenidate oral- 40 mg capsuledexmethylphenidate oral- 40 mg capsuledexmethylphenidate oral- 35 mg capsuledexmethylphenidate oral- 30 mg capsuledexmethylphenidate oral- 25 mg capsuledexmethylphenidate oral- 20 mg capsuledexmethylphenidate oral- 15 mg capsuledexmethylphenidate oral- 10 mg capsuledexmethylphenidate oral- 5 mg capsuledexmethylphenidate oral- 5 mg capsuledexmethylphenidate oral- 30 mg capsuleFocalin XR oral- 35 mg capsuleFocalin XR oral- 25 mg capsuleFocalin XR oral- 15 mg capsuleFocalin XR oral- 40 mg capsuleFocalin XR oral- 30 mg capsuleFocalin XR oral- 20 mg capsuleFocalin XR oral- 10 mg capsuleFocalin XR oral- 5 mg capsuleCopyright © 2010 First DataBank, Inc.Print Patient Educationdexmethylphenidate oral DEXMETHYLPHENIDATE EXTENDED-RELEASE CAPSULE - ORAL (dex-METH-il-FEN-i-date) COMMON BRAND NAME(S): Focalin XR WARNING: Misuse or abuse of dexmethylphenidate may result in serious (possibly fatal) heart and blood pressure problems.This medication can be habit-forming and should be used cautiously by people who have mental/mood disorders or a substance use disorder (such as overuse of or addiction to drugs/alcohol). Before using this medication, tell your doctor if you have a personal or family history of a substance use disorder. Do not increase your dose, use it more often, or use it for a longer time or in a different way than prescribed. Doing so may result in a decrease in the effect of this drug, drug dependence, or abnormal thoughts/behavior.Your doctor may monitor you for a while after the medication is stopped, especially if you have taken this drug for a long time or in high doses. (See also How to Use section.) USES: This medication is used to treat attention deficit hyperactivity disorder - ADHD. It works by changing the amounts of certain natural substances in the brain. Dexmethylphenidate belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills. HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking dexmethylphenidate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually once daily in the