Methylphenidate

DRUG INFORMATION

  ADULT
    - ( 2.2 ) Patients new to methylphenidate: Start at 20 mg daily, titrating the dose
      weekly in 10-mg increments.
      Source: US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)),
      section 'dosage and administration', retrieved 2026-08-29
    - Doses above 60 mg daily are not recommended.
      Source: US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)),
      section 'dosage and administration', retrieved 2026-08-29
    - Maintain careful prescription records, educate patients about abuse, monitor for
      signs of abuse and overdose, and periodically reevaluate the need for
      methylphenidate hydrochloride extended-release capsules use [see Boxed Warning,
      Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9 )]. 2.2 General
      Dosing Information The recommended starting dose for methylphenidate hydrochloride
      extended-release capsules is 20 mg once daily.
      Source: US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)),
      section 'dosage and administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of methylphenidate hydrochloride extended-release
      capsules for the treatment of ADHD have been established in pediatric patients 6
      to 12 years. The safety and effectiveness of methylphenidate hydrochloride
      extended-release capsules in pediatric patients less than 6 years have not been
      established. The long- term efficacy of methylphenidate in pediatric patients has
      not been established.
      Source: US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)),
      section 'pediatric use', retrieved 2026-08-29
    - The doses at which these findings were observed are at least 4 times the MRHD of
      60 mg/day given to children on a mg/m 2 basis.
      Source: US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)),
      section 'pediatric use', retrieved 2026-08-29
    - In a study conducted in young rats, methylphenidate was administered orally at
      doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period
      (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10).
      Source: US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)),
      section 'pediatric use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for methylphenidate
      (Methylphenidate Hydrochloride (LA)), retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for methylphenidate
      (Methylphenidate Hydrochloride (LA)), retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Published studies and postmarketing reports on methylphenidate use
      during pregnancy have not identified a drug-associated risk of major birth
      defects, miscarriage or adverse maternal or fetal outcomes.
      Source: US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)),
      section 'pregnancy', retrieved 2026-08-29
    - There may be risks to the fetus associated with the use of CNS stimulants use
      during pregnancy (see Clinical Considerations) .
      Source: US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)),
      section 'pregnancy', retrieved 2026-08-29
    - No effects on morphological development were observed in embryo-fetal development
      studies with oral administration of methylphenidate to pregnant rats and rabbits
      during organogenesis at doses up to 10 and 15 times, respectively, the maximum
      recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis.
      Source: US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)),
      section 'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - Risk Summary Limited published literature, based on milk sampling from seven
      mothers reports that methylphenidate is present in human milk, which resulted in
      infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a
      milk/plasma ratio ranging between 1.1 and 2.7.
      Source: US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)),
      section 'nursing mothers', retrieved 2026-08-29
    - There are no reports of adverse effects on the breastfed infant and no effects on
      milk production.
      Source: US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)),
      section 'nursing mothers', retrieved 2026-08-29
    - Long-term neurodevelopmental effects on infants from stimulant exposure are
      unknown.
      Source: US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)),
      section 'nursing mothers', retrieved 2026-08-29