Nextwave Pharmaceuticals, Inc.

Nextwave Pharmaceuticals, Inc. Drugs

• Quillichew Er
  

  ×

  Quillichew Er

  

  ---

  2.1 Pretreatment Screening

  Prior to treating pediatric patients and adults with CNS stimulants including QuilliChew ER, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [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 QuilliChew ER use [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9)].

  2.2 General Dosing Information

  The recommended starting dose of QuilliChew ER for patients 6 years and above is 20 mg once daily orally in the morning. The dose may be titrated up or down weekly in increments of 10 mg, 15 mg or 20 mg. The 10 mg and 15 mg doses can each be achieved by breaking in half the functionally scored 20 mg and 30 mg tablets, respectively. The dose should be individualized according to the treatment needs and responses of the patient. Daily doses above 60 mg have not been studied and are not recommended.

  Pharmacological treatment of ADHD may be needed for extended periods. Healthcare providers should periodically re-evaluate the long-term use of QuilliChew ER, and adjust dosage as needed.

  2.3 Administration Instructions

  QuilliChew ER should be administered orally once daily in the morning with or without food [see Clinical Pharmacology (12.3)].

  2.4 Switching from other Methylphenidate Products

  If switching from other methylphenidate products, discontinue that treatment, and titrate with QuilliChew ER using the above titration schedule.

  Do not substitute for other methylphenidate products on a milligram-per-milligram basis, because of different methylphenidate base compositions and differing pharmacokinetic profiles [see Description (11) and Clinical Pharmacology (12.3)].

  2.5 Dose Reduction and Discontinuation

  If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug. QuilliChew ER should be periodically discontinued to assess the child's condition. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

  Close
  More Info