Focalin (dexmethylphenidate HCl)

Dosage of dexmethylphenidate hydrochloride generally is expressed in terms of the salt; however, dosage of the fixed combination containing serdexmethylphenidate chloride and dexmethylphenidate hydrochloride is expressed in terms of serdexmethylphenidate and dexmethylphenidate. Each 26.1, 39.2, or 52.3 mg of serdexmethylphenidate is equivalent to 28, 42, or 56 mg, respectively, of serdexmethylphenidate chloride, and each 5.2, 7.8, or 10.4 mg of dexmethylphenidate is equivalent to 6, 9, or 12 mg, respectively, of dexmethylphenidate hydrochloride. The combined molar dose of serdexmethylphenidate and dexmethylphenidate in each dosage strength of the fixed combination (i.e., 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, or 52.3 mg/10.4 mg of serdexmethylphenidate/dexmethylphenidate, respectively) is equivalent to 20, 30, or 40 mg, respectively, of dexmethylphenidate hydrochloride.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

Methylphenidate is not metabolized by cytochrome P-450 (CYP) isoenzymes to a clinically relevant extent. Inducers or inhibitors of CYP isoenzymes are not expected to substantially impact the pharmacokinetics of methylphenidate. The possibility that drug interactions reported with racemic methylphenidate could also occur with dexmethylphenidate should be considered.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to methylphenidate, serdexmethylphenidate, or any ingredient in the formulation. Bronchospasm, rash, and pruritus have been reported in patients receiving serdexmethylphenidate and dexmethylphenidate in fixed combination (Azstarys(R)).

*Concomitant or recent (within 14 days) administration of monoamine oxidase (MAO) inhibitors, since hypertensive crisis could result.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Dexmethylphenidate hydrochloride conventional tablets: Abdominal pain, fever, nausea, and anorexia each occurred in 5% or more of pediatric patients 6-17 years of age receiving dexmethylphenidate hydrochloride conventional tablets in clinical trials and were at least twice as frequent in patients receiving the drug as in those receiving placebo. Twitching (motor or vocal tics), anorexia, insomnia, and tachycardia each resulted in discontinuance of dexmethylphenidate hydrochloride conventional tablets in approximately 1% of patients.

Dexmethylphenidate hydrochloride extended-release capsules: Dyspepsia, decreased appetite, headache, and anxiety each occurred in 5% or more of pediatric patients 6-17 years of age receiving dexmethylphenidate hydrochloride extended-release capsules in clinical trials and were at least twice as frequent in patients receiving the drug as in those receiving placebo. Dry mouth, dyspepsia, headache, pharyngolaryngeal pain, and anxiety each occurred in 5% or more of adult patients receiving dexmethylphenidate hydrochloride extended-release capsules in clinical trials. Twitching (motor or vocal tics), anorexia, insomnia, and tachycardia each resulted in discontinuance of dexmethylphenidate hydrochloride extended-release capsules in approximately 1% of pediatric patients. In adult patients, insomnia, jittery feeling, anorexia, and anxiety each resulted in discontinuance of therapy in about 1-2% of patients.

Serdexmethylphenidate/dexmethylphenidate capsules: Based on accumulated data from other methylphenidate products, the most common adverse effects (reported in 5% or more of patients and at least twice the rate of placebo) are decreased appetite, insomnia, nausea, vomiting, dyspepsia, abdominal pain, decreased weight, anxiety, dizziness, irritability, affect lability, tachycardia, and increased blood pressure.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Safety and efficacy of dexmethylphenidate for the treatment of ADHD have been established in pediatric patients 6-17 years of age in controlled clinical studies. Safety and efficacy of dexmethylphenidate have not been established in pediatric patients <6 years of age.

Long-term efficacy of dexmethylphenidate in pediatric patients has not been established.

Long-term administration of CNS stimulants has been associated with at least a temporary suppression of normal weight and height patterns in pediatric patients. Therefore, the manufacturers state that patients requiring long-term therapy with dexmethylphenidate should be carefully monitored, and children who are not growing or gaining height or weight as expected may require temporary discontinuance of therapy.

In juvenile animal toxicity studies, rats receiving racemic methylphenidate beginning early in the postnatal period and continuing through sexual maturation at a dosage of 4 or more times the maximum recommended pediatric dosage of 60 mg daily exhibited decreased spontaneous locomotor activity in adulthood; in addition, female rats exhibited a deficit in acquisition of a specific learning task at a dosage of 8 times the maximum recommended pediatric dosage. The no-effect level for juvenile neurobehavioral development in rats was approximately 0.5 times the maximum recommended pediatric dosage. The clinical relevance of these long-term behavioral effects observed in rats is unknown.

Pharmacokinetics of dexmethylphenidate hydrochloride administered as conventional or extended-release preparations have not been established in pediatric patients younger than 6 or 18 years of age, respectively. Following single-dose oral administration of conventional dexmethylphenidate hydrochloride in children 6-12 years of age, peak plasma concentrations were similar to those achieved in adults, although total systemic exposure (area under the concentration-time curve (AUC)) was somewhat less in children; pharmacokinetics of the drug were similar in boys and girls (mean age of 10 years). Following oral administration of equivalent doses of the fixed combination of serdexmethylphenidate chloride and dexmethylphenidate hydrochloride in adults and pediatric patients, dexmethylphenidate exposure in children 6-12 years of age was approximately twice that in adults and adolescents 13-17 years of age.

The National Pregnancy Registry for ADHD Medications monitors pregnancy outcomes in women exposed to ADHD medications during pregnancy. Clinicians are encouraged to register women who become pregnant while receiving dexmethylphenidate products by calling 866-961-2388 or visiting https://womensmentalhealth.org/adhdmedications/.

Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, spontaneous abortion, or adverse maternal or fetal outcomes; however, there may be fetal risks associated with use of CNS stimulants during pregnancy. CNS stimulants can cause vasoconstriction and thereby decrease placental perfusion. While no fetal or neonatal adverse reactions have been reported with the use of therapeutic dosages of methylphenidate during pregnancy, premature delivery and low birthweight infants have been reported in women dependent on amphetamines.

In animal embryofetal development studies, delayed fetal skeletal ossification was observed in rats at dexmethylphenidate dosages equivalent to up to 5 times an adult dosage of 20 mg daily. In a pre- and post-natal development study, decreased pup weight was observed in male rats at a dexmethylphenidate dosage equivalent to 5 times a human dosage of 20 mg daily.

Limited data indicate that methylphenidate is distributed into milk, resulting in infant doses of 0.16-0.7% of the maternal weight-adjusted dosage and a milk-to-plasma ratio of 1.1-2.7. There are no reports of adverse effects of methylphenidate on breast-fed infants and no reported effects on milk production. Long-term neurodevelopmental effects resulting from infant exposure to CNS stimulants are unknown.

The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for dexmethylphenidate and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition. Infants exposed to dexmethylphenidate through breast milk should be monitored for adverse effects such as agitation, insomnia, anorexia, and reduced weight gain.

The manufacturers do not provide specific dosage recommendations in geriatric patients.

Dexmethylphenidate hydrochloride and the fixed combination of serdexmethylphenidate chloride and dexmethylphenidate hydrochloride have not been studied in geriatric patients.