Loading…
Cotempla XR-ODT is a brand name for Methylphenidate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE COTEMPLA XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see Clinical Studies (14) ]. Limitations of Use The use of COTEMPLA XR-ODT is not recommended in pediatric patients younger than 6 years of age because…
Verbatim from this product's FDA label. Tap a section to expand.
3 mg given orally once daily in the morning. 3 mg per day. 8 mg is not recommended. 2 ) Patients are advised to take COTEMPLA XR-ODT consistently either with food or without food. e. 2) ] . 10) ]. 2 General Dosing Information COTEMPLA XR-ODT is given orally once daily in the morning.
3) ] . 3 mg once daily in the morning. 3 mg. 8 mg have not been studied and are not recommended. The dose should be individualized according to the needs and responses of the patient. 3 Dosage Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage, or, if necessary, discontinue COTEMPLA XR-ODT.
If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue COTEMPLA XR-ODT. 4 COTEMPLA XR-ODT Administration Instruct the patient or caregiver on the following administration instructions: Do not remove the tablet from the blister pack until just prior to dosing.
Take the tablet immediately after opening the blister pack. Do not store the tablet for future use. Use dry hands when opening the blister pack. Remove the tablet by peeling back the foil on the blister pack. Do not push the tablet through the foil.
As soon as the blister is opened, remove the tablet and place on the patient's tongue. Place the whole tablet on the tongue and allow it to disintegrate without chewing or crushing. The tablet will disintegrate in saliva so that it can be swallowed.
No liquid is needed to take the tablet.
10)] Based on accumulated data from other methylphenidate products, the most common (>5% and twice the rate of placebo) adverse reactions are appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, and blood pressure increased.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Neos Therapeutics, Inc. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Adverse Reactions in Studies with Other Methylphenidate Products in Children, Adolescents, and Adults with ADHD Commonly reported (≥2% of the methylphenidate group and at least twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include: appetite decreased, weight decreased, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, insomnia, anxiety, nervousness, restlessness, affect lability, agitation, irritability, dizziness, vertigo, tremor, blurred vision, blood pressure increased, heart rate increased, tachycardia, palpitations, hyperhidrosis, and pyrexia.
Adverse Reactions in Studies with COTEMPLA XR-ODT in Children with ADHD There is limited experience with COTEMPLA XR-ODT in controlled trials. Based on this limited experience, the adverse reaction profile of COTEMPLA XR-ODT appears similar to other methylphenidate extended release-products.
2 Postmarketing Experience The following adverse reactions have been identified during post approval use of methylphenidate products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
5 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. 2 ) Increased Blood Pressure and Heart Rate : Monitor blood pressure and pulse.
Consider the benefits and risks in patients for whom an increase in blood pressure or heart rate would be problematic. 3 ) Psychiatric Adverse Reactions : Prior to initiating COTEMPLA XR-ODT, screen patients for risk factors for developing a manic episode.
If new psychotic or manic symptoms occur, consider discontinuing COTEMPLA XR-ODT. 4 ) Priapism : If abnormally sustained or frequent and painful erection occur, patients should seek immediate medical attention. 5 ) Peripheral Vasculopathy, including Raynaud's Phenomenon : Careful observation for digital changes is necessary during COTEMPLA XR-ODT treatment.
, rheumatology referral) may be appropriate for patients who develop signs or symptoms of perifphral vasculophathy. 6 ) Long-term Suppression of Growth in Pediactric Patients : Closely monitor growth (height and weight) in pediatric patients.
Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted. , patients with significant hyperopia) should be evaluated by an ophthalmologist. 8) Increased Intraocular Pressure (IOP) and Glaucoma : Prescribe COTEMPLA XR-ODT 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. 9) Motor and Verbal Tics and Worsening of Tourette’s Syndrome : Before initiating COTEMPLA XR-ODT, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome.
4 CONTRAINDICATIONS COTEMPLA XR-ODT is contraindicated in patients with: Known hypersensitivity to methylphenidate or other components of COTEMPLA XR-ODT. 2) ] . 1) ] . Known hypersensitivity to methylphenidate or product components. ( 4 ) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days.
( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Methylphenidate in United States of America.
Know a brand we are missing in United States of America? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
These adverse reactions are as follows:
Blood and Lymphatic System Disorders : Pancytopenia, Thrombocytopenia, Thrombocytopenic purpura Cardiac Disorders : Angina pectoris, Bradycardia, Extrasystole, Supraventricular tachycardia, Ventricular extrasystole Eye Disorders : Diplopia, Increased intraocolar pressure, Mydriasis, Visual impairment General Disorders : Chest pain, Chest discomfort, Hyperpyrexia Immune System Disorders : Hypersensitivity reactions such as Angioedema, Anaphylactic reactions, Auricular swelling, Bullous conditions, Exfoliative conditions, Urticarias, Pruritis NEC, Rashes, Eruptions, and Exanthemas NEC Investigations : Alkaline phosphatase increased, Bilirubin increased, Hepatic enzyme increased, Platelet count decreased, White blood cell count abnormal Musculoskeletal, Connective Tissue and Bone Disorders : Arthralgia, Myalgia, Muscle twitching, Rhabdomyolysis Nervous System Disorders : Convulsion, Grand mal convulsion, Dyskinesia, Serotonin syndrome in combination with serotonergic drugs, Motor and Verbal Tics Psychiatric Disorders : Disorientation, Hallucination, Hallucination auditory, Hallucination visual, Libido changes, Mania Urogenital System : Priapism Skin and Subcutaneous Tissue Disorders : Alopecia, Erythema Vascular Disorders : Raynaud's phenomenon
Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate. 1 Abuse, Misuse, and Addiction COTEMPLA XR-ODT has a high potential for abuse and misuse. The use of COTEMPLA XR-ODT exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction.
2)] . Misuse and abuse of CNS stimulants, including COTEMPLA XR-ODT, can result in overdose and death [see Overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing COTEMPLA XR-ODT, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store COTEMPLA XR-ODT in a safe place, preferably locked, and instruct patients to not give COTEMPLA XR-ODT to anyone else.
Throughout COTEMPLA XR-ODT treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. 2 Risks to Patients with Serious Cardiac Disease Sudden death has occurred in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosages.
Avoid COTEMPLA XR-ODT use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. 3 Increased Blood Pressure and Heart Rate 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).
Some patients may have larger increases. Monitor all COTEMPLA XR-ODT-treated patients for hypertension and tachycardia. 5 Priapism Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in both adult and pediatric male patients.
Although priapism was not reported with methylphenidate initiation, it developed after some time on methylphenidate, often subsequent to an increase in dosage. Priapism also occurred during methylphenidate withdrawal (drug holidays or during discontinuation).
COTEMPLA XR-ODT-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention. 4 Psychiatric Adverse Reactions Exacerbation of 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. g. comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).
, hallucinations, delusional thinking or mania) in patients without a prior history of psychotic illness or mania. 1% of CNS stimulant-treated patients, compared to 0% of placebo-treated patients. If such symptoms occur, consider discontinuing COTEMPLA XR-ODT.
6 Peripheral 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, sequelae have included digital ulceration and/or soft tissue breakdown.
Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports and at the therapeutic dosages of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant.
Careful observation for digital changes is necessary during COTEMPLA XR-ODT treatment. , rheumatology referral) may be appropriate for COTEMPLA XRODT-treated patients who develop signs or symptoms of peripheral vasculopathy. 4)]. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.
7 kg less growth in weight over 3 years), without evidence of growth rebound during this development period. Closely monitor growth (weight and height) in COTEMPLA XR-ODT-treated pediatric patients. Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
8 Acute Angle Closure Glaucoma There have been reports of angle closure glaucoma associated with methylphenidate treatment. , patients with significant hyperopia) should be evaluated by an ophthalmologist. 2)] . Prescribe COTEMPLA XR-ODT to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.
Closely monitor COTEMPLA XR-ODT-treated patients with a history of abnormally increased IOP or open angle glaucoma. 10 Motor and Verbal Tics, and Worsening of Tourette's Syndrome CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics.
2)] . Before initiating COTEMPLA XR-ODT, assess the family history and clinically evaluate patients for tics or Tourette's syndrome. Regulary monitor COTEMPLA XR-ODT-treated patients for the emergence or worsening of tics or Tourette's syndrome, and discontine treatment if clinically appropriate.