dexmethylphenidate hydrochloride

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Related to dexmethylphenidate hydrochloride: Focalin XR

dexmethylphenidate hydrochloride

Focalin, Focalin XR

Pharmacologic class: Methylphenidate derivative

Therapeutic class: CNS stimulant

Controlled substance schedule II

Pregnancy risk category C

FDA Box Warning

• Give cautiously to patient with history of drug dependence or alcoholism. Chronic abuse can cause marked tolerance and psychological dependence with abnormal behavior. Frank psychotic episodes may occur, especially with parenteral abuse. During withdrawal from abusive use, provide careful supervision, as severe depression may occur.

• Withdrawal after prolonged therapeutic use may unmask symptoms of underlying disorder that may require follow-up.


Thought to block norepinephrine and dopamine reuptake, increasing the concentration of these neurotransmitters in extraneuronal space


Capsules (extended-release): 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg

Tablets: 2.5 mg, 5 mg, 10 mg

Indications and dosages

Attention deficit hyperactivity disorder

Adults and children older than age 6: Tablets-In patients not receiving methylphenidate concurrently, 2.5 mg P.O. b.i.d. at least 4 hours apart; increase as needed in 2.5- to 5-mg increments to a maximum of 10 mg b.i.d. (Individualize dosage according to patient needs and response.) In patients receiving methylphenidate concurrently, start with half of methylphenidate dosage; maximum dosage is 10 mg P.O. b.i.d.

Capsules-In adults not receiving methylphenidate concurrently, 10 mg P.O. daily in morning; increase as needed in 10-mg increments approximately weekly to maximum of 20 mg daily. In children not receiving methylphenidate concurrently, 5 mg daily in morning; increase as needed in 5-mg increments approximately weekly to maximum of 20 mg daily. In adults and children receiving methylphenidate concurrently, start with half of methylphenidate total daily dosage.


• Hypersensitivity to drug

• Glaucoma

• Anxiety, agitation, tension

• Family history or diagnosis of Tourette syndrome

• MAO inhibitor use within past 14 days


Use cautiously in:

• hypertension, depression, seizures, cardiovascular disorders, psychosis, drug abuse

• pregnant or breastfeeding patients

• children under age 6 (safety and efficacy not established).


• Administer at same time each day without regard to meals.

• Give last dose at least 8 hours before bedtime to prevent insomnia.

• Know that regular-release tablets may be switched to same daily dosage as extended-release capsules.

• If necessary, open capsules, sprinkle contents over spoonful of applesauce, and administer immediately.

• Don't give within 14 days of MAO inhibitor use.

Adverse reactions

CNS: nervousness, insomnia, dizziness, drowsiness, headache, dyskinesia, chorea, Tourette syndrome, toxic psychosis

CV: increased or decreased heart rate and blood pressure, tachycardia, angina, palpitations, arrhythmias

EENT: blurred vision, visual accommodation problems

GI: nausea, abdominal pain

Hematologic: anemia, leukopenia, thrombocytopenia

Hepatic: hepatic dysfunction, hepatic coma

Skin: rash, alopecia

Other: fever, decreased appetite, weight loss, psychological drug dependence, drug tolerance, growth suppression in children (with long-term use)


Drug-drug. Anticoagulants, phenobarbital, phenytoin, primidone, selective serotonin reuptake inhibitors, tricyclic antidepressants: inhibited metabolism and additive effects of these drugs

Antihypertensives, pressor agents (dopamine, epinephrine): decreased efficacy of these drugs

MAO inhibitors: severe hypertensive crisis

Patient monitoring

Monitor blood pressure closely, especially in patients receiving antihypertensives concurrently.

• Evaluate cardiac status. Report palpitations and other signs and symptoms of arrhythmias.

• During prolonged therapy, regularly monitor CBC with white cell differential and platelet count.

Patient teaching

• Advise patient or parents that drug should be taken at same time each day.

• Instruct patient not to crush or chew capsule. If patient is unable to swallow capsules whole, advise him to open capsules, sprinkle contents over spoonful of applesauce, and take immediately.

• Tell patient or parents that drug usually is discontinued if symptoms don't improve within 1 month.

• Instruct parents to monitor child's height and weight, because CNS stimulants have been associated with growth suppression.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.

References in periodicals archive ?
According to the company, Dexmethylphenidate Hydrochloride Tablets are used for the treatment of attention deficit and hyperactivity disorder (ADHD).
The company stated that total US sales of Dexmethylphenidate Hydrochloride Tablets, 2.
Mylan, which launched its dexmethylphenidate hydrochloride capsules a few days before Par and Teva, is offering 30 mg versions of the drug.
Executives at Teva say products like dexmethylphenidate hydrochloride extended-release capsules are critical to helping control spiraling health care costs.
NYSE: LCI) has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Dexmethylphenidate Hydrochloride Tablets, 2.
For the 12 months ended July 2017, total US sales of Dexmethylphenidate Hydrochloride Tablets, 2.
The approval for Dexmethylphenidate Hydrochloride Tablets is our eighth thus far in 2017 and comes less than 24 months after our filing of the related ANDA," said Arthur Bedrosian, chief executive officer of Lannett.
Pharmaceutical company Mylan Inc (NasdaqGS:MYL) revealed on Monday the launch of its Dexmethylphenidate Hydrochloride Extended-release (ER) Capsules, 30 mg, in the market.
Dexmethylphenidate Hydrochloride Extended-release (ER) Capsules, 30 mg, is reportedly the first generic version of Novartis' Focalin XR, a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients age six years and older.