What Patients and caregivers Should Know
Patients, their families, and caregivers should be informed about the benefits and risks associated with treatment with Cotempla XR-ODT. They should be instructed to read the patient Medication Guide available for Cotempla XR-ODT that will be dispensed along with their prescription.
Patients and Caregivers Should be Advised that Cotempla XR-ODT:
- Is a federally controlled substance because it can be abused or lead to dependence.
- Should be stored in a safe place, preferably locked, to prevent abuse.
- Should be disposed of in compliance with laws and regulations on drug disposal. Should be disposed of, including remaining, unused, or expired prescriptions, by a medicine take-back program if available.
Please see additional Important Safety Information below.
Next: Adverse Reactions >
- Known hypersensitivity to methylphenidate or other ingredients in Cotempla XR-ODT. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products.
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within a minimum of 14 days following discontinuation of treatment with a MAOI. Hypertensive crisis can occur.
- Serious Cardiovascular Reactions: Sudden death, stroke and myocardial infarction have occurred in adults treated with CNS stimulants at recommended doses. Sudden death has occurred in pediatric patients with structural cardiac abnormalities and other serious cardiac problems, and in adults taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems. Perform further evaluation on patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Cotempla XR-ODT treatment.
- Blood Pressure and Heart Rate Increases: CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase approximately 3 to 6 bpm). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia.
- Psychiatric Adverse Reactions: CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder, and may induce a manic or mixed episode in patients with bipolar disorder. Prior to initiating treatment, screen patients for risk factors for developing a manic episode. CNS stimulants may cause psychotic or manic symptoms in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Cotempla XR-ODT.
- Priapism: Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
- Peripheral Vasculopathy, including Raynaud’s Phenomenon: CNS stimulants are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary.
- Long-Term Suppression of Growth: CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor weight and height in pediatric patients treated with Cotempla XR-ODT. Treatment may need to be interrupted.
Pregnancy and Lactation
CNS stimulants, such as Cotempla XR-ODT, 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.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Cotempla XR-ODT and any potential adverse effects on the breastfed child from Cotempla XR-ODT or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
Cotempla XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.
- Childress AC, Kollins SH, Cutler AJ, Marraffino A, Sikes CR. Efficacy, safety, and tolerability of an extended‑release orally disintegrating methylphenidate tablet in children 6‑12 years of age with attention‑deficit/hyperactivity disorder in the laboratory classroom setting. J Child Adolesc Psychopharmacol. 2017;27(1):66-74.
- Data on file. Neos Therapeutics, Inc..