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COTEMPLA XR-ODT contains methylphenidate, a central nervous system (CNS) stimulant. COTEMPLA XR-ODT is an extended-release orally disintegrating tablet intended for once daily administration. COTEMPLA XR-ODT contains approximately 25% immediate-release and 75% extended-release methylphenidate. Methylphenidate is ionically-bound to the sulfonate of polystyrenesulfonate particles.
CONTEMPLA XR-ODT contains 8.6 mg, 17.3 mg or 25.9 mg of methylphenidate which is the same as the amount of methylphenidate (base equivalent) found, respectively, in 10 mg, 20 mg and 30 mg strength methylphenidate hydrochloride products.
The chemical name of methylphenidate is methyl α-phenyl-2-piperidineacetate, and its structural formula is shown in Figure 1.
COTEMPLA XR-ODT (methylphenidate) Structural Formula Illustration
COTEMPLA XR-ODT also contains the following inactive ingredients: Mannitol, Fructose, Microcrystalline Cellulose, Crospovidone, Methacrylic Acid, Polystyrene Sulfonate, Citric Acid, Colloidal Silicon Dioxide, Grape Flavor, Natural Masking Type Powder, Triethyl Citrate, Magnesium Stearate, Ethylcellulose, Sucralose, Lake Blend Purple, and Polyethylene Glycol.
Before starting or refilling a Cotempla XR-ODT prescription, read the medication guide included with your child’s pills, as it may be updated with new information.
This guide should not replace a conversation with your child’s doctor, who has a holistic view of your or your child’s medical history, other diagnoses, and other prescriptions. If you have questions, ask your doctor or pharmacist before your child begins taking the medication.
Tell your doctor about the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
Monoamine oxidase inhibitors such as
selegiline (Emsam, Eldepryl, Zelapar)
This is not a complete list of Cotempla XR-ODT drug interactions. Ask your doctor or pharmacist for more information.
As with all medications, follow your Cotempla XR-ODT prescription instructions exactly. Cotempla XR-ODT is taken orally, once daily in the morning with or without food and water.
Tablets are available in 8.6mg, 17.3mg, and 25.9mg tablets. The time-release formulation is designed to maintain a steady level of medication in your child’s body throughout the day.
The optimal dosage varies patient by patient. Your doctor may adjust your child’s daily dosage until your child experiences the best response — that is, the lowest dosage at which your child experiences the greatest improvement in symptoms without side effects.
Cotempla XR-ODT is a grape-flavored quick-dissolving tablet. To keep it from dissolving before your child places the tablet in the mouth, leave it contained in its blister package until your child is ready to take it. When opening the medication, make sure your hands are clean and dry so as not to accidentally trigger dissolution. Peel back the blister package backing to take out the tablet instead of pushing it through the foil. Place the tablet on your child’s tongue to dissolve. Do not crush or chew the tablet.
Your teen should not drink alcohol while taking this medication.
During treatment, your doctor may periodically ask your child to stop taking Cotempla XR-ODT so that he or she can monitor ADHD symptoms; check vital statistics including blood, heart, and blood pressure; or evaluate height and weight. If any problems are found, your doctor may recommend discontinuing treatment.
Some patients report developing a tolerance to Cotempla XR-ODT after long-term use. If you notice that your child’s dosage is no longer controlling symptoms, talk to your child’s doctor to plan a course of action.
WARNINGS AND PRECAUTIONS
5.1Potential for Abuse and Dependence
Reference ID: 41134084 CNS stimulants, including COTEMPLA XR-ODT, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy
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
structural cardiac abnormalities and other serious cardiac problems 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. 5.3
Blood Pressure and Heart Rate Increases
CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg)
and heart rate (mean increase approximately 3 to 6 bpm). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia. 5.4
Psychiatric Adverse Reactions Exacerbation of Pre-
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 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 recommended doses, 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 COTEMPLA XR-ODT. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0 in placebo-treated patients.5.5
Prolonged and painful erections, sometimes requiring surgical intervention, have been reported
with methylphenidate products in both pediatric and adult patients. Priapism was not reported
with drug initiation but developed after some time on the drug, often subsequent to an increase in
dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
Reference ID: 41134085 5.6Peripheral Vasculopathy, including Raynaud’s Phenomenon
CNS stimulants, including COTEMPLA XR-ODT, used to treat ADHD 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.
Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups
throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients. 5.7 Long-Term Suppression of Growth CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.
Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or nonmedication-treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and nonmedication-treated pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e. treatment for 7 days per week throughout the year) have a temporary
slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.
Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including COTEMPLA XR-ODT. Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted
The most common side effects of Cotempla XR-ODT are as follows: decreased appetite, difficulty sleeping, nausea, vomiting, stomach ache, abdominal pain, weight loss, anxiety, dizziness, mood swings, increased blood pressure, and irritability.
Other serious side effects include slowing of growth in children, blurred vision, and priapism.
If side effects are bothersome, or do not go away, talk to your child’s doctor. Most people taking this medication do not experience any of these side effects.
Report to your doctor any heart-related problems or a family history of heart and blood pressure problems. Patients with structural cardiac abnormalities and other serious heart problems have experienced sudden death, stroke, heart attack, and increased blood pressure while taking Cotempla XR-ODT. Stimulants can increase blood pressure and heart rate. Physicians should monitor these vital signs closely during treatment. Call your doctor immediately if your child experiences warning signs such as chest pain, shortness of breath, or fainting while taking Cotempla XR-ODT.
Also disclose to your physician all mental health issues including any family history of suicide, BPD, or depression. Cotempla XR-ODT may create new or exacerbate existing behavior problems or BPD. The manufacturer recommends evaluating patients for risk factors for developing a manic episode prior to treatment. Call your doctor immediately if your child experiences new or worsening mental health symptoms including hallucinations or sudden suspicions.
Discuss circulation problems with your doctor before taking Cotempla XR-ODT, which has been known to cause numbness, coolness, or pain in fingers or toes, including Raynaud’s phenomenon. Report to your child’s doctor any new blood-flow problems, pain, skin color changes, or sensitivities to temperature while taking Cotempla XR-ODT.
Stimulants like Cotempla XR-ODT have a high potential for abuse and addiction, especially among people who do not have ADHD. It is a “Schedule II Stimulant,” a designation that the Drug Enforcement Agency uses for drugs with a high potential for abuse. Other Schedule II drugs include Dexedrine, Ritalin, and cocaine. People with a history of drug abuse should use caution when trying this medication. Taking the medication exactly as prescribed can reduce the potential for abuse.
The above is not a complete list of potential side effects. If you notice any health changes not listed above, discuss them with your doctor or pharmacist.
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