Halaven

Halaven Manufacturers

• Eisai Inc.
  

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  Halaven | Actavis Pharma, Inc.

  

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  Dexmethylphenidate hydrochloride extended-release is for oral administration once daily in the morning.

  Dexmethylphenidate hydrochloride extended-release 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 Patients New to Methylphenidate

  The recommended starting dose of dexmethylphenidate hydrochloride extended-release for patients who are not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg/day for pediatric patients and 10 mg/day for adult patients.

  Dosage may be adjusted in 5 mg increments for pediatric patients and in 10 mg increments for adult patients. In general, dosage adjustments may proceed at approximately weekly intervals. The patient should be observed for a sufficient duration at a given dose to ensure that a maximal benefit has been achieved before a dose increase is considered. In dose-response (fixed-dose) studies (pediatric from 10 to 30 mg/day and adult from 20 to 40 mg/day), all doses were effective vs. placebo. There was no clear finding, however, of greater average benefits for the higher doses compared to the lower doses. Adverse events and discontinuations, however, were dose-related. Doses above 30 mg/day in pediatrics and 40 mg/day in adults have not been studied and are not recommended.

  2.2 Patients Currently Using Methylphenidate

  For patients currently using methylphenidate, the recommended starting dose of dexmethylphenidate hydrochloride extended-release is half the total daily dose of racemic methylphenidate. Patients currently using dexmethylphenidate hydrochloride may be switched to the same daily dose of dexmethylphenidate hydrochloride extended-release.

  2.3 Maintenance/Extended Treatment

  There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with dexmethylphenidate hydrochloride extended-release. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use dexmethylphenidate hydrochloride extended-release for extended periods in patients with ADHD should periodically reevaluate the long-term usefulness of the drug for the individual patient with periods off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

  2.4 Dose Reduction and Discontinuation

  If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.

  If improvement is not observed after appropriate dosage adjustment over a 1-month period, the drug should be discontinued.

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