Methylphenidate - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS • Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease. • Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. • Psychiatric Adverse Reactions: Prior to initiating methylphenidate transdermal system, screen patients for risk factors for developing a manic episode.

If new psychotic or manic symptoms occur, consider discontinuing methylphenidate transdermal system. • Seizures: Stimulants may lower the convulsive threshold.

Discontinue in the presence of seizures. • Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention. • Peripheral Vasculopathy, including Raynaud’s phenomenon: Careful observation for digital changes is necessary during methylphenidate transdermal system treatment.

Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy. • Long-Term Suppression of Growth in Pediatric Patients: Closely monitor (height and weight) in pediatric patients.

Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted. • Chemical Leukoderma: Methylphenidate transdermal system use may result in a persistent loss of skin pigmentation at and around the application site.

Loss of pigmentation, in some cases, has been reported at other sites distant from the application site.

Monitor for signs of skin depigmentation.

Discontinue methylphenidate transdermal system if it occurs. • Contact Sensitization: Use of methylphenidate transdermal system may lead to contact sensitization.

Treatment should be discontinued if contact sensitization is suspected.

Erythema is commonly seen with use of methylphenidate transdermal system and is not by itself an indication of sensitization.

However, contact sensitization should be suspected if erythema is accompanied by evidence of a more intense local reaction (edema, papules, vesicles) that does not significantly improve within 48 hours or spreads beyond the transdermal system site. • External Heat: Patients should be advised to avoid exposing the methylphenidate transdermal system application site to direct external heat sources.

When heat is applied to methylphenidate transdermal system after application, both the rate and extent of absorption are significantly increased. • Hematologic monitoring: Periodic CBC, differential, and platelet counts are advised during prolonged therapy. • Acute Angle Closure Glaucoma: Methylphenidate transdermal system-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist. • Increased Intraocular Pressure (IOP) and Glaucoma: Prescribe methylphenidate transdermal system to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.

Closely monitor patients with a history of increased IOP or open angle glaucoma. • Motor and Verbal Tics and Worsening of Tourette’s Syndrome: Before initiating methylphenidate transdermal system, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome.

Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome.

Discontinue treatment if clinically appropriate.

5.1 Abuse, Misuse, and Addiction Methylphenidate transdermal system has a high potential for abuse and misuse.

The use of methylphenidate transdermal system exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction.

Methylphenidate can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence ] .

Misuse and abuse of CNS stimulants, including methylphenidate transdermal system, can result in overdose and death [see Overdosage ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing methylphenidate transdermal system, assess each patient’s risk for abuse, misuse, and addiction.

Educate patients and their caregivers or families about these risks.

Advise patients to store methylphenidate transdermal system in a safe place, preferably locked, and instruct patients to not give methylphenidate transdermal system to anyone else.

Throughout methylphenidate transdermal system treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Methylphenidate transdermal system has special disposal instructions.

Instruct patients to find a take back location to dispose of unused or expired methylphenidate transdermal system.