Cotempla XR-ODT

(methylphenidate XR-ODT) 

 

 

 

 Full Prescribing Information 

 DailyMed Drug Information 

 

 

 

 

 Forms/Strengths 

 

 ODT:  8.6 mg, 17.3 mg, 25.9 mg 

 

 

 Dosing 

 

 Age: 6-17 y/o 

 Onset: ~ 30-60 min 

 Duration: ~ 8 hours 

 Release Profile: 25% IR, 75% ER 

 Considerations: Grape-flavored, allow to dissolve in saliva. Advise to take consistently either with food or without food. 

 Initial Dose: 17.3 mg 

 Titration: 8.6 mg - 17.3 mg weekly 

 Max Dose: 51.8 mg 

 

 

 Quick Facts 

 

 Increases synaptic norepinephrine and dopamine through amphetamine action 

 Enhances focus, attention, and impulse control 

 Extended-release ODT with dual-phase release: immediate onset and sustained effect 

 Unique orally disintegrating tablet—dissolves on the tongue without water 

 Common side effects: decreased appetite, insomnia, headache, dry mouth   

 

 

 Indications 

 

   ADHD age 6-17 (ICD-10: F90.0) 

 

 

 Off-Label Uses 

 

   ADHD after age 17 (ICD-10: F90.0) 

 

 

 How to Take 

 

 Take once daily in the morning to minimize the risk of insomnia. 

 Orally disintegrating tablet (ODT) should be placed on the tongue and allowed to dissolve completely—do not chew or crush. 

 Can be taken with or without food . 

 Ensure hands are dry before handling the tablet. 

 

 

 Side Effects 

 

 

 Common : 

 

 Decreased appetite, weight loss 

 Insomnia 

 Stomach pain, nausea 

 Headache 

 Irritability 

 

 

 

 Serious : 

 

 Cardiovascular events: Sudden death in patients with structural cardiac abnormalities or arrhythmias. 

 Psychiatric symptoms: New or worsening anxiety, psychosis, or manic symptoms. 

 Growth suppression in children (monitor height and weight). 

 Peripheral vasculopathy, including Raynaud’s phenomenon. 

 

 

 

 

 Monitoring / Labs 

 

 Cardiovascular : Baseline and routine monitoring of heart rate and blood pressure. 

 Growth in Pediatrics : Regular monitoring of height and weight to detect growth suppression. 

 Psychiatric Symptoms : Observe for mood changes, anxiety, or psychosis. 

 Abuse Potential : Monitor for misuse or diversion. 

 

 

 Education 

 

 

 When to Call the Doctor: 

 

 Severe mood changes, aggression, or suicidal thoughts . 

 Chest pain, rapid heartbeat, shortness of breath ( cardiovascular concerns ). 

 Uncontrolled movements, tics, or worsening anxiety. 

 Numbness, coldness, or color changes in fingers or toes ( circulatory issues ). 

 Unexplained weight loss or delayed growth in pediatric patients . 

 

 

 

 Safety Tips: 

 

 Monitor blood pressure and heart rate , especially in patients with cardiovascular risk. 

 Use caution in patients with anxiety, bipolar disorder, or psychosis , as symptoms may worsen. 

 Avoid caffeine and other stimulants , which may amplify side effects. 

 Ensure adequate hydration and nutrition , as appetite suppression is common. 

 Tapering may be required if discontinuing after long-term use. 

 

 

 

 Parent Tips for Pediatric Patients: 

 

 Encourage a nutrient-dense diet to counteract appetite suppression. 

 Administer in the morning before school for optimal effect. 

 Monitor school performance and behavioral changes . 

 Observe for sleep disturbances ; adjust timing if necessary. 

 Communicate regularly with teachers and caregivers about medication effects. 

 

 

 

 

 Additional Information 

 

 

 Contraindications: 

 

 Hypersensitivity to methylphenidate or formulation components. 

 Use within 14 days of MAOI therapy (risk of hypertensive crisis). 

 Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma . 

 History of substance use disorder , unless benefits outweigh risks. 

 

 

 

 Pregnancy: 

 

 Category C ; use only if benefits outweigh risks. 

 May cause neonatal withdrawal symptoms or low birth weight . 

 

 

 

 Lactation: 

 

 Excreted in breast milk ; not recommended due to potential infant exposure. 

 

 

 

 Drug Interactions: 

 

 Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk . 

 Acidifying agents (e.g., ascorbic acid) may reduce drug absorption. 

 Alkalinizing agents (e.g., sodium bicarbonate) may increase methylphenidate levels. 

 May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).