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Methylphenidate Hydrochloride

METHYLPHENIDATE HYDROCHLORIDE

Manufacturer: Rhodes Pharmaceuticals

Score: 144.0

Quick Summary

Methylphenidate Hydrochloride is a central nervous system stimulant used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children, adolescents, and adults. It is available in extended-release tablets and should be taken once daily in the morning. The recommended starting dose is 18 mg for children and adolescents, and 18 or 36 mg for adults. Doses may be increased in 18 mg increments at weekly intervals. Important safety information includes the risk of abuse, misuse, and addiction, as well as potential adverse reactions such as insomnia, anxiety, and increased blood pressure. Contraindications include known hypersensitivity to the product and the use of monoamine oxidase inhibitors. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children, adolescents, and adults
  • Central nervous system stimulant
  • Available in extended-release tablets

Important Safety Information

Warning

WARNING: ABUSE, MISUSE, AND ADDICTION. Methylphenidate Hydrochloride has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction.

Contraindications

  • Known hypersensitivity to the product
  • Use of monoamine oxidase inhibitors

Adverse Reactions

  • Insomnia
  • Anxiety
  • Increased blood pressure
  • Abdominal pain
  • Vomiting
  • Dizziness
  • Headache
  • Nausea

Dosing Recommendations

General Guidance

Doses may be increased in 18 mg increments at weekly intervals

ADHD

Adult Dose

18 or 36 mg once daily

Pediatric Dose

18 mg once daily for children and adolescents

Special Population Considerations

Pregnancy

  • Methylphenidate has been shown to have teratogenic effects in rabbits
  • The safety of methylphenidate for use during human pregnancy has not been established

Nursing Mothers

  • It is not known whether methylphenidate is excreted in human milk
  • Caution should be exercised if Methylphenidate Hydrochloride is administered to a nursing woman

Pediatric Use

  • Methylphenidate Hydrochloride should not be used in children under six years
  • Long-term effects of methylphenidate in children have not been well established

Geriatric Use

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