Dexmethylphenidate Hydrochloride Extended-Release

DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE- dexmethylphenidate hydrochloride capsule, extended release
Par Pharmaceuticals, Inc.

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Dexmethylphenidate Hydrochloride Extended-release Capsules, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Warning and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)].

1 INDICATIONS AND USAGE

Dexmethylphenidate Hydrochloride Extended-release Capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

Dexmethylphenidate Hydrochloride Extended-release Capsules is for oral administration once daily in the morning.
Dexmethylphenidate Hydrochloride Extended-release Capsules may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Dexmethylphenidate Hydrochloride Extended-release Capsules and/or their contents should not be crushed, chewed, or divided.
The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.

Dosage should be individualized according to the needs and responses of the patient.

2.1 Pretreatment Screening

Prior to treating pediatric patients and adults with central nervous system (CNS) stimulants including Dexmethylphenidate Hydrochloride Extended-release Capsules, assess for the presence of cardiac disease (i.e., perform a careful history including family history of sudden death or ventricular arrhythmia, and physical examination) [see Warnings and Precautions (5.2)].
Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain
careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically
re-evaluate the need for Dexmethylphenidate Hydrochloride Extended-release Capsules use [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9)].

2.2 Treatment of ADHD

Patients New to Methylphenidate
The recommended starting dosage of Dexmethylphenidate Hydrochloride Extended-release Capsules for patients who are not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate are:

  • Pediatric patients: Start with 5 mg orally once daily in the morning with or without food.
  • Adult patients: Start with 10 mg orally once daily in the morning with or without food.

Patients Currently on Methylphenidate
The recommended starting dose of Dexmethylphenidate Hydrochloride Extended-release Capsules for patients currently using methylphenidate is half the total daily dose of racemic methylphenidate.
Patients currently using dexmethylphenidate immediate-release tablets may be given the same daily dose of Dexmethylphenidate Hydrochloride Extended-release Capsules.
Titration Schedule
The dose may be titrated weekly in increments of 5 mg in pediatric patients and 10 mg in adult patients. The dose should be individualized according to the needs and response of the patient. Daily doses above 30 mg in pediatrics and 40 mg in adults have not been studied and are not recommended.
Maintenance/Extended Treatment
Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of Dexmethylphenidate Hydrochloride Extended-release Capsules and adjust dosage as needed.

2.3 Administration Instructions

Dexmethylphenidate Hydrochloride Extended-release Capsules is administered orally and may be taken whole or the capsule may be opened and the entire contents sprinkled onto applesauce. If the patient is using the sprinkled administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.

2.4 Dose Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse reactions occur, reduce the dosage, or if necessary, discontinue Dexmethylphenidate Hydrochloride Extended-release Capsules. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

3 DOSAGE FORMS AND STRENGTHS

15 mg extended-release capsules – white opaque cap and body, imprinted in black ink “par” on cap and “428” on body.
30 mg extended-release capsules – white opaque cap and body, imprinted in green ink “par” on cap and “430” on body.

4 CONTRAINDICATIONS

  • Hypersensitivity to methylphenidate or other components of Dexmethylphenidate Hydrochloride Extended-release Capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions (6.1)].
  • Concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions (7.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Potential for Abuse and Dependence

CNS stimulants, including Dexmethylphenidate Hydrochloride Extended-release Capsules, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Boxed Warning, Drug Abuse and Dependence(9.2, 9.3)].

5.2 Serious Cardiovascular Reactions

Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Dexmethylphenidate Hydrochloride Extended-release Capsules treatment.

5.3 Blood Pressure and Heart Rate Increases

CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia.

5.4 Psychiatric Adverse Reactions

Exacerbation of Preexisting Psychosis
CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder.
Induction of a Manic Episode in Patients with Bipolar Disorder
CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating treatment, screen patients for risk factors for developing manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).
New Psychotic or Manic Symptoms
CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Dexmethylphenidate Hydrochloride Extended-release Capsules. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0 in placebo-treated patients.

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