Label Changes for:

Ritalin LA 10mg, 20mg, 30mg, and 40mg Capsules

May 2013

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

  

May 2013

PRECAUTIONS

Information for Patients
  • Patients should be advised to avoid alcohol while taking RITALIN LA. Consumption of alcohol while taking RITALIN LA may result in a more rapid release of the dose of methylphenidate.

MEDICATION GUIDE

How should RITALIN LA be taken?

  • Ritalin LA should not be taken with alcohol. This may result in a more rapid release of the dose of Ritalin LA

 

April 2010

 

PRECAUTIONS

Information for Patients
  • Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with methylphenidate and should counsel them in its appropriate use. A patient Medication Guide is available for Ritalin LA. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.
Drug Interactions
  • Methylphenidate may decrease the effectiveness of drugs used to treat hypertension.
  • As an inhibitor of dopamine reuptake, methylphenidate may be associated with pharmacodynamic interactions when coadministered with direct and indirect dopamine agonists (including DOPA and tricyclic antidepressants) as well as dopamine antagonists (antipsychotics, e.g., haloperidol).
  • Case reports suggest a potential interaction of methylphenidate with coumarin anticoagulants,..but pharmacokinetic interactions were not confirmed when explored at higher sample sizes.
  • Methylphenidate is not metabolized by cytochrome P450 to a clinically relevant extent. Inducers or inhibitors of cytochrome P450 are not expected to have any relevant impact on methylphenidate pharmacokinetics. Conversely, the d- and l- enantiomers of methylphenidate did not relevantly inhibit cytochrome P450 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A.
  • Methylphenidate coadministration did not increase plasma concentrations of the CYP2D6 substrate desipramine.
  • An interaction with the anticoagulant ethylbiscoumacetate in 4 subjects was not confirmed in a subsequent study with a higher sample size (n=12). Other specific drug-drug interaction studies with methylphenidate have not been performed in vivo.

ADVERSE EVENTS

Adverse Events with Other Methylphenidate HCl Dosage Forms
  • Vascular: cerebrovascular vasculitis, cerebral hemorrhages, cerebrovascular accidents

 

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