Home About

Methylphenidate

METHYLPHENIDATE

Manufacturer: Mylan Pharmaceuticals Inc.

Score: 144.0

Quick Summary

Daytrana is a central nervous system stimulant used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. The recommended starting dose is 10 mg, and it should be applied to the hip area 2 hours before an effect is needed and removed 9 hours after application. Important safety information includes the risk of abuse, misuse, and addiction, as well as contraindications such as hypersensitivity to methylphenidate and use with monoamine oxidase inhibitors. Adverse reactions may include decreased appetite, insomnia, nausea, vomiting, weight loss, and tic. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age
  • Central nervous system stimulant
  • Recommended starting dose is 10 mg

Important Safety Information

Warning

High potential for abuse, misuse, and addiction

Contraindications

  • Hypersensitivity to methylphenidate
  • Use with monoamine oxidase inhibitors

Adverse Reactions

  • Decreased appetite
  • Insomnia
  • Nausea
  • Vomiting
  • Weight loss
  • Tic

Dosing Recommendations

General Guidance

Dosage should be titrated to effect, and dose adjustments should be made based on individual patient response

ADHD

Adult Dose

Not established

Pediatric Dose

10 mg, applied to the hip area 2 hours before an effect is needed and removed 9 hours after application

Special Population Considerations

Pregnancy

  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Daytrana
  • Published studies and post-marketing reports on methylphenidate use during pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

Nursing Mothers

  • Not established

Pediatric Use

  • The safety and effectiveness of Daytrana in pediatric patients less than 6 years have not been established
  • Long-term effects of methylphenidate in children have not been well established

Geriatric Use

  • Daytrana has not been studied in patients greater than 65 years of age