Important Safety Information, Including Boxed Warning & Indication
WARNING: ABUSE, MISUSE, AND ADDICTION
See full prescribing information for complete boxed
warning.
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.
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Before prescribing RELEXXII, assess each patient's risk for
abuse, misuse, and addiction.
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Educate patients and their families about these risks, proper
storage of the drug, and proper disposal of any unused drug.
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Throughout treatment, reassess each patient's risk and
frequently monitor for signs and symptoms of abuse, misuse,
and addiction.
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RELEXXII is contraindicated in patients with known
hypersensitivity to methylphenidate or other components of
RELEXXII.
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RELEXXII is contraindicated in patients with concurrent
treatment of monoamine oxidase inhibitor (MAOI) or using MAOI
within the preceding 14 days.
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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 disease.
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Increased Blood Pressure and Heart Rate: Monitor blood pressure
and pulse. Monitor all RELEXXII-treated patients for
hypertension and tachycardia.
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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 discontinuing
RELEXXII.
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Priapism: If abnormally sustained or frequent and painful
erections occur, patients should seek immediate medical
attention.
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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 peripheral vasculopathy.
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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.
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Gastrointestinal Obstruction: Avoid use with preexisting GI
narrowing.
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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
ophthalmologist.
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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.
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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.
DRUG INTERACTIONS
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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 MAOI treatment.
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RELEXXII may decrease the effectiveness of drugs used to treat
hypertension. Monitor blood pressure and adjust the dosage of
the antihypertensive drug as needed.
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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.
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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.
INDICATION
RELEXXII 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. RELEXXII is not recommended for use in children under 6 years of age as higher plasma exposure may lead to a higher incidence of adverse reactions.
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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for full Prescribing Information, including BOXED WARNING.
