dexmethylphenidate hydrochloride

(redirected from 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.

Action

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

Availability

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.

Contraindications

• Hypersensitivity to drug

• Glaucoma

• Anxiety, agitation, tension

• Family history or diagnosis of Tourette syndrome

• MAO inhibitor use within past 14 days

Precautions

Use cautiously in:

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

• pregnant or breastfeeding patients

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

Administration

• 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)

Interactions

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 ?
The study contained three treatment arms: (1) Focalin XR, (2) CTX-1301 with radiolabeled second layer, and (3) CTX-1301 with radiolabeled third layer.
M2 EQUITYBITES-July 6, 2017-Impax unveils additional strengths of generic Focalin XR Extended-Release Capsules CII upon US FDA approval
Food and Drug Administration ("FDA") approval on its Abbreviated New Drug Application ("ANDA") for a generic version of Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules CII, 25 and 35 mg.
Instead, Adderall XR, Ritalin LA and Focalin XR need to be opened up and mixed with water or applesauce to stop diversion.
NORDIC BUSINESS REPORT-November 21, 2014-Intellipharmaceutics announces Teva's launch of 5mg Focalin XR generic
Dexmethylphenidate has a 4-6 hour duration of effect (a long-acting formulation, Focalin XR, which spans 12 hours is also available and has been shown to be as effective as racemic d,1-methylphenidate XR (Concerta, Ritalin LA), with flexible dosing and good tolerability.
IPC's lead product candidates include Dexmethylphenidate XR, a generic version of the marketed drug Focalin XR, which is partnered with Par Pharmaceutical and is currently the subject of an Abbreviated New Drug application (ANDA) filing with the United States Food and Drug Administration (FDA), and Carvedilol CR, a generic version of the brand name drug Coreg CR, an internal pipeline product now ready for entry into pivotal bioequivalence studies.
The FDA warned the makers of Adderall XR, Methylin, and Focalin XR for implying these drugs can reduce the negative consequences that are seen with ADHD.
The warnings, contained in letters sent in late September to the makers of Adder-all XR, Concerta, Focalin XR, Methylin, and Strattera, "cite issues we've been seeing across the promotion for this therapeutic area," said FDA spokeswoman Sandra Walsh in an interview.
The warnings, contained in letters sent to the makers of Adderall XR, Concerta, Focalin XR, Methylin, and Strattera, "cite issues we've been seeing across the promotion for this therapeutic area," said FDA spokeswoman Sandra Walsh.
Warning letters were sent to the makers of Adderall XR, Concerta, Focalin XR, Methylin, and Strattera, FDA spokesperson Sandra Walsh said in an interview.