WARNING: ABUSE, MISUSE, AND ADDICTION
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RELEXXII has a high potential for abuse and misuse, which can lead to the development of a
substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including
RELEXXII, can result in overdose and death.
- Before prescribing RELEXXII, assess each patient's risk for abuse, misuse, and
- Educate patients and their families about these risks, proper storage of the drug, and
proper disposal of any unused drug.
- Throughout treatment, reassess each patient's risk and frequently monitor for signs and
symptoms of abuse, misuse, and addiction.
- RELEXXII is contraindicated in patients with known hypersensitivity to methylphenidate or
other components of RELEXXII.
- RELEXXII is contraindicated in patients with concurrent treatment of monoamine oxidase
inhibitor (MAOI) or using MAOI within the preceding 14 days.
- Risks to Patients with Serious
Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities,
cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or serious cardiac
- Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. Monitor all
RELEXXII-treated patients for hypertension and tachycardia.
- Psychiatric Adverse Reactions: Prior to initiating RELEXXII, screen patients for risk
factors for developing a manic episode. If new psychotic or manic symptoms occur, consider
- 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 RELEXXII treatment. Further clinical evaluation (e.g,
rheumatology referral) may be appropriate for patients who develop signs or symptoms of
- Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and
weight) in pediatric patients. Pediatric patients not growing or gaining weight as expected
may need to have their treatment interrupted.
- Gastrointestinal Obstruction: Avoid use with preexisting GI narrowing.
- Acute Angle Closure Glaucoma: RELEXXII treated patients considered at risk for acute angle
closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an
- Increased Intraocular Pressure (IOP) and Glaucoma: Prescribe RELEXXII 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 RELEXXII,
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.
- Concomitant use of Monoamine oxidase Inhibitors (MAOIs) and CNS stimulants can cause
hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic
dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Do not administer RELEXXII concomitantly with MAOIs or within 14 days after discontinuing
- RELEXXII may decrease the effectiveness of drugs used to treat hypertension. Monitor blood
pressure and adjust the dosage of the antihypertensive drug as needed.
- Concomitant use of halogenated anesthetics and RELEXXII may increase the risk of sudden
blood pressure and heart rate increase during surgery. Avoid use of RELEXXII in patients
being treated with anesthetics on the day of surgery.
- Combined use of methylphenidate with risperidone when there is a change in dosage of either
or both medications, may increase the risk of extrapyramidal symptoms (EPS). Monitor
patients on RELEXXII for signs of EPS with concomitant use of risperidone with associated
changes in dosage.
RELEXXIl is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric
patients 6 years of age and older.
You may report side effects to Vertical Pharmaceuticals, LLC at 1-800-444-5164 or to the
FDA at 1-800-FDA-1088.
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