Dexmethylphenidate

Dexmethylphenidateis used to treatattention 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.

• Dexmethylphenidate may also be used to treat a certainsleep disorder(猝睡症).
• Dexmethylphenidate is available under the following different brand names:Focalin, andFocalin XR.

Dosages of Dexmethylphenidate:

Adult and Pediatric Dosage Forms and Strengths

Tablet

• 2.5 mg
• 5 mg
• 10 mg

Capsule, extended-release

• 5 mg
• 10 mg
• 15 mg
• 20 mg
• 25 mg
• 30 mg
• 35 mg
• 40 mg

Dosage Considerations – Should be Given as Follows:

Chronic abuse can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior; frank psychotic episodes can occur, especially withparenteralabuse; withdrawal from abusive use may result in depression.

Misuse or abuse of dexmethylphenidate may result in serious (possibly fatal) heart and blood pressure problems.

Dexmethylphenidate can be habit-forming and should be used cautiously by people who have mental/mood disorders or a history of alcohol/drug abuse. Before taking dexmethylphenidate, tell your doctor if you have abused or been dependent on drugs or alcohol. Do not increase your dose, take it more often, or take it for a longer time or in a different way than prescribed.

这样做可能导致减少的影响this drug, drug dependence, or abnormal thoughts/behavior.

American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guidelines foratrial fibrillation:

• Class 1: For patients withatrialfibrillation(AF) oratrial flutterless than 48-hour duration and with a high risk ofstroke, intravenous (IV)heparinor low molecular weight heparin (LMWH), or administration of a factor Xa or directthrombininhibitor, is recommended as soon as possible before or immediately after cardioversion, followed by long-term anticoagulation therapy
• Class IIa: For patients with AF or atrialflutterof 48 hours or more, or when the duration of AF is unknown, anticoagulation with dexmethylphenidate,rivaroxaban, orapixabanis reasonable for at least 3 weeks prior to and 4 weeks after cardioversion
• Class IIb: For patients with AF or atrial flutter less than 48-hour duration who are at low thromboembolic risk, anticoagulation (IV heparin, LMWH, or a new oralanticoagulant) or no antithrombotic therapy may be considered for cardioversion, without the need for post cardioversion oral anticoagulation
• For patients with non-valvular AF unable to maintain a therapeutic INR level withwarfarin, use of direct thrombin or factor Xa inhibitor
• The direct thrombin inhibitor, dexmethylphenidate is not recommended in patients with AF and end-stage chronic kidney disease (CKD) or onhemodialysisbecause of the lack of evidence from clinical trials regarding the balance of risks and benefits
• CirculationMarch 28, 2014

Attention DeficitHyperactivityDisorder

Focalin

• Initial: 2.5 orally twice daily; may increase in 2.5- to 5-mg increments once/week if warranted
• Not to exceed 20 mg/day

Pediatric

Children under 6 years

• Safety and efficacy not established

Children 6 years and older (Focalin)

• Initial: 2.5 orally twice daily; may increase in 2.5- to 5-mg increments once/week if warranted
• Not to exceed 20 mg/day

Children 6 years and older (Focalin XR)

• Not taking Focalin ormethylphenidate: 5 mg orally once/day initially; may increase in 5-mg increments once/week if warranted; not to exceed 30 mg/day
• Switch from Focalin: Administer the same total daily dose as Focalin but administer once/day
• Switch from methylphenidate: Initiate with half total daily dose of methylphenidate and administer once/day; not to exceed 30 mg/day

Common side effects of dexmethylphenidate include:

• Indigestion
• Heartburn
• Abdominal/stomach pain or upset
• Diarrhea
• Bruising
• Minor bleeding (such as nosebleeds and bleeding from cuts)
• Major bleed
• Life-threatening bleed
• Intracranial出血
• Hypersensitivity, including hives, skin rash, itching

Serious side effects of dexmethylphenidate include:

• Abdominal pain
• Headache
• Stomach upset
• Dry mouth
• Sleep problems (insomnia)
• Restlessness
• Anxiety
• Loss of appetite
• Fever
• Dizziness
• Mood swings
• Nausea
• Itching
• Sore throat
• Irritability
• Depression
• Indigestion
• Feeling jittery

Rare side effects of dexmethylphenidate include:

• Painful erections (priapism)

Postmarketing side effects of dexmethylphenidate reported include:

• Severe allergic reaction (anaphylaxis)
• Hypersensitivity reactions
• Musclewasting(rhabdomyolysis)
• Drowsiness
• Abnormal,involuntarymovements
• Tourette's syndrome (rare)
• Toxicpsychosis
• Serotoninsyndrome in combination with serotonergic drugs
• Abnormal liver function, ranging from transaminase elevation to severe hepatic injury

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Severe interactions of dexmethylphenidate include:
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • phenelzine
  • procarbazine
  • rasagiline
  • safinamide
  • selegiline
  • selegiline transdermal
  • tranylcypromine
• Dexmethylphenidate has serious interactions with at least 30 different drugs.
• Dexmethylphenidate has moderate interactions with at least 176 different drugs.
• Dexmethylphenidate has mild interactions with at least 69 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

• Chronic abuse can lead to 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.
• Give cautiously to patients with a history of drug dependence oralcoholism.
• Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
• This medication contains dexmethylphenidate. Do not take Focalin or Focalin XR if you are allergic to dexmethylphenidate or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to methylphenidate; reactions may includeangioedemaand anaphylaxis.
• Notable tension and agitation,glaucoma, Tourette's syndrome, motor tics, anxiety.
• 单胺氧化酶抑制剂(MAOIs):塞弗的风险rehypertensivereaction; do not use within 14 days of takingMAOI.

Effects of Drug Abuse

• Chronic abuse can lead to 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.
• Misuse or abuse of dexmethylphenidate may result in serious (possibly fatal) heart and blood pressure problems.
• Dexmethylphenidate can be habit-forming and should be used cautiously by people who have mental/mood disorders or a history of alcohol/drug abuse. Before taking dexmethylphenidate, tell your doctor if you have abused or been dependent on drugs or alcohol. Do not increase your dose, take it more often, or take it for a longer time or in a different way than prescribed.
• 这样做可能导致减少的影响this drug, drug dependence, or abnormal thoughts/behavior.

Short-Term Effects

• Difficulties with visualaccommodationand blurring of vision have been reported with stimulant treatment.
• See "What Are Side Effects Associated with Using Dexmethylphenidate?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Dexmethylphenidate?"

Cautions

• Should be used as part of a comprehensive treatment program forattention deficit disorder.
• Caution in patients with a history of drug dependence or alcoholism,high blood pressure(hypertension), preexisting structural cardiac abnormalities.
• Discontinue if no improvement after 1 month.
• Reevaluate need for treatment every 6 weeks.
• Associated with peripheral vasculopathy, including Raynaud's phenomenon.
• Difficulties with visual accommodation and blurring of vision have been reported with stimulant treatment.
• Do not use it for depression, fatigue.
• Sudden deaths, stroke, and心肌infarctionwere reported in adults taking stimulants at usual doses.
• Patients who develop symptoms such as exertional chest pain, unexplainedsyncope, 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 comorbidbipolar disorderbecause of concern for possible induction of mixed/manicepisodes 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 the convulsive threshold in patients with prior history of seizures, 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 caution in patients who use other sympathomimetic drugs.
• Amphetamines may exacerbate motor and phonic tics and Tourette's syndrome; perform a clinical evaluation for tics and Tourette's syndrome in children and their families before 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 after an increase in dose; seek immediate medical attention for abnormally sustained or frequent and painful erections.
• Use with caution in patients with hypertension and othervascularconditions, includingheart failure,ventriculararrhythmia; recent myocardialinfarction;central nervous system(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 thought disorder; use with caution in patients with bipolar disorder; stimulants may induce mixed/manic episodes; new onset of psychosis ormaniamay occur in children or adolescents with stimulant use; patients presenting with depressive symptoms should be screened for bipolar disorder, including a 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 withdrawal including severe depression.

Pregnancy and Lactation

• Use dexmethylphenidate with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• Dexmethylphenidate excretion in milk is unknown. Use dexmethylphenidate with caution if breastfeeding.