5. 1 Abuse, Misuse, and Addiction Methylphenidate hydrochloride oral solution has a high potential for abuse and misuse. The use of methylphenidate hydrochloride oral solution exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction.
2)]. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride oral solution, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing methylphenidate hydrochloride oral solution, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store methylphenidate hydrochloride oral solution in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride oral solution to anyone else.
Throughout methylphenidate hydrochloride oral solution treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. 2 Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage.
Avoid methylphenidate hydrochloride oral solution use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrythmia, coronary artery disease, or other serious cardiac disease. 3 Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm).
Some patients may have larger increases. Monitor all methylphenidate hydrochloride oral solution-treated patients for hypertension and tachycardia. 4 Psychiatric Adverse Reactions Exacerbation of Pre-Existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
Induction of a Manic Episode in Patients with Bipolar Illness CNS stimulants may induce a manic or mixed mood episode in patients. , comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).
, hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. 1% of CNS stimulant-treated patients, compared with 0% of placebo-treated patients. If such symptoms occur, consider discontinuing methylphenidate hydrochloride oral solution.
5 Priapism Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in both adult and pediatric male patients. Although priapism was not reported with methylphenidate initiation, it developed after some time on methylphenidate, often subsequent to an increase in dosage.
Priapism also occurred during methylphenidate withdrawal (drug holidays or during discontinuation). Methylphenidate hydrochloride oral solution-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
6 Peripheral Vasculopathy, Including Raynaud’s Phenomenon CNS stimulants, including methylphenidate hydrochloride oral solution, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown.
Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in postmarketing reports and at the therapeutic dosages of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant.
Careful observation for digital changes is necessary during methylphenidate hydrochloride oral solution treatment. , rheumatology referral) may be appropriate for methylphenidate hydrochloride oral solution-treated patients who develop signs or symptoms of peripheral vasculopathy.
7 Long-Term Suppression of Growth in Pediatric Patients CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. 7 kg less growth in weight over 3 years), without evidence of growth rebound during this development period.
Closely monitor growth (weight and height) in methylphenidate hydrochloride oral solution-treated pediatric patients. Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
The safety and effectiveness of methylphenidate hydrochloride oral solution have not been established in pediatric patient less than 6 years of age. 8 Acute Angle Closure Glaucoma There have been reports of angle closure glaucoma associated with methylphenidate treatment.
, patients with significant hyperopia) should be evaluated by an ophthalmologist. 2)]. Prescribe methylphenidate hydrochloride oral solution to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.
Closely monitor methylphenidate hydrochloride oral solution-treated patients with a history of abnormally increased IOP or open-angle glaucoma. 10 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics.
2)]. Before initiating methylphenidate hydrochloride oral solution, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor methylphenidate hydrochloride oral solution-treated patients for the emergence or worsening of tics or Tourette’s syndrome and discontinue treatment if clinically appropriate.
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. 2) Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse.
3) Psychiatric Adverse Reactions: Prior to initiating methylphenidate hydrochloride oral solution, screen patients for risk factors for developing a manic episode. 4) Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention.
5) Peripheral Vasculopathy, Including Raynaud’s Phenomenon: Careful observation for digital changes is necessary during methylphenidate hydrochloride oral solution treatment. , rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy.
6) 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.
, patients with significant hyperopia) should be evaluated by an ophthalmologist. 8) Increased Intraocular Pressure (IOP) and Glaucoma: Prescribe methylphenidate hydrochloride oral solution 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. 9) Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating methylphenidate hydrochloride oral solution, 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. 10)