Cotempla XR-ODT

METHYLPHENIDATE

Manufacturer: Neos Therapeutics Brands, LLC

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