Important Safety Information
Indication
METADATE CD is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.
Limitation of Use
The use of METADATE CD is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage.
WARNING: ABUSE, MISUSE, AND ADDICTION
METADATE CD 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 METADATE CD, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing METADATE CD, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout METADATE CD treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Contraindications
- Known hypersensitivity to methylphenidate or other components of METADATE CD.
- Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days.
- Use in patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency.
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 all METADATE CD treated patients for hypertension and tachycardia.
- Psychiatric Adverse Reactions
- 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 Disorder: CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating METADATE CD treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).
- New Psychotic or Manic Symptoms: CNS stimulants, at the recommended dosages, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing METADATE CD.
- Priapism: METADATE CD-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
- Peripheral Vasculopathy, including Raynaud’s Phenomenon: Careful observation for digital changes is necessary during METADATE CD 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: METADATE CD is not approved for use and is not recommended in pediatric patients below 6 years of age. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in METADATE-CD-treated pediatric patients. Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
- Acute Angle Closure Glaucoma: METADATE CD-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 METADATE CD 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 METADATE CD, 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.
Adverse Reactions
The most common adverse reactions (≥ 5% and twice the rate of placebo) were anorexia and insomnia. To report SUSPECTED ADVERSE REACTIONS, contact Aytu BioPharma at 1-855-298-8246 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Pregnancy
- Fetal/Neonatal Adverse Reactions: CNS stimulants, such as METADATE CD, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.
Lactation
Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
Geriatric Use
METADATE CD has not been studied in patients over the age of 65 years.
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