# Cotempla XR-ODT ### (methylphenidate XR-ODT)
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=33f70f58-c871-42c8-8adb-345caeafefcd&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=33f70f58-c871-42c8-8adb-345caeafefcd)
--- **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).