*An off-label use of a medication is a use that is not FDA-approved. Prescribers can decide to use a medication off-label because, in their professional judgment, they believe it may offer a benefit to someone.
Cotempla (methylphenidate) is a medication used in the treatment of attention deficit hyperactivity disorder (ADHD) in those 6 years and older. It is an orally dissolving tablet that is taken once in the morning and lasts all day in due part of its extended-release formulation. Common side effects associated with Cotempla are insomnia, mood changes, and decreased appetite.
If you’re considering Cotempla, you will be limited in your options for obtaining an assessment and prescription online. Klarity ADHD and Circle Medical are two online psychiatry platforms that can and will prescribe stimulant medications, which are controlled substances. They can provide an assessment and may offer you an Cotempla prescription if they determine the medication may help your symptoms.
Boxed Warning: Methylphenidate (Cotempla XR-ODT) – Risk of medication misuse or abuse
Methylphenidate, the active ingredient in Cotempla XR-ODT, has a black box warning. These are the most serious types of warnings from the Food and Drug Administration (FDA). Methylphenidate has a risk of misuse (abuse) which can lead to dependence on the medication.
Cotempla XR-ODT is a controlled substance, which means that it’s more likely to be misused or cause dependence. There are federal and state laws that limit the amount of medication that can be prescribed or dispensed within a certain period of time.
What Is Cotempla (Methylphenidate)?
Cotempla (methylphenidate) is a stimulant medication used in the treatment of attention deficit hyperactivity disorder (ADHD). It is one of many ADHD medications available that can help to control its symptoms, but it is unique in that it is orally disintegrating and works over a long period of time. It is unknown exactly how Cotempla works, but it is thought to raise the levels of natural chemicals in the brain, improving attention and behavior.1,2
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Is Cotempla the Same Thing as Ritalin?
Cotempla and Ritalin are similar but not the same medication. They share the same active ingredient which is methylphenidate, but they differ in how they release the medication as well as their dosage forms.
Ritalin is an immediate-release tablet, while Cotempla is an extended-release orally disintegrating tablet meant to work over a long period of time. There is also an extended-release capsule for Ritalin, called Ritalin LA, and a sustained-release tablet, called Ritalin-SR.3
Different medications can work differently in people. It’s important to discuss what the most appropriate medication is and why with a healthcare professional.
How is Cotempla XR-ODT Different From Other Brands of Methylphenidate?
There are many brands that use the active ingredient methylphenidate. Cotempla differs from these other brands by being the only orally disintegrating extended-release tablet.4 This dosage form is especially beneficial for children, providing long-term management of ADHD symptoms while also being an easy dosage form to tolerate. Unlike some of the other brands, Cotempla is specifically used in children aged 6 to 17 years old.
How Does Cotempla Work?
The exact mechanisms for how Cotempla works are not known, but it is thought to be due to the change in the number of natural chemicals in the brain by Cotempla. It is a stimulant that works on the central nervous system, increasing the amount of the chemicals norepinephrine and dopamine in the brain. These chemicals work in other parts of the body, so Cotempla’s presence may improve ADHD symptoms.
What Is Cotempla Used to Treat?
Cotempla is FDA-approved for the treatment of ADHD in adults and children 6 to 17 years old. FDA-approved means that the medication has been studied and reviewed where it is determined that it is both safe and effective for its indication. It may help to increase attention and to decrease impulsiveness and hyperactivity. It is unknown if it is safe and effective for children under the age of 6 years old.
Conversely, off-label use is a use that is not approved but may be prescribed by a doctor if they, using their professional judgment, believe there is more benefit than risk for an individual. Cotempla may be used off-label for some conditions, like depression, that do not respond to other therapies. If you’re interested in using Cotempla off-label, talk with your doctor.
Side Effects of Cotempla
Cotempla’s direct action on the central nervous system may result in side effects. Side effects can occur anywhere in the body, but Cotempla commonly affects a person’s mood, heart and blood, and the digestive tract.
When starting a new medication, you may experience temporary effects that should go away as your body adjusts to it. Side effects may persist for as long as you take the medication and can range from mild to serious, potentially life-threatening. If you experience side effects, consult your doctor or seek medical care.
Common Side Effects of Cotempla
Some people may experience side effects while taking Cotempla. Common side effects of Cotempla include a change in mood, GI upset or lack of appetite, and effects on blood pressure. Cotempla, as a stimulant, may also cause sleep issues. These side effects do not typically constitute emergencies, but they may require medical intervention, especially if preexisting conditions are exacerbated.
Common side effects of Cotempla include:1,2
- Decreased appetite
- Insomnia
- Nausea or Vomiting
- Indigestion
- Abdominal pain
- Irritability, anxiety, or rapid, exaggerated changes in mood
- Fast heart rate
- Increased blood pressure
*All medications, including Cotempla, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor about any questions you have and to understand the potential side effects and benefits of any medication.
Serious Side Effects of Cotempla
Serious side effects may occur with Cotempla. It is a central nervous system stimulant so there is a potential for adverse events, especially in relation to a person’s blood flow and heart rate. These side effects are considered serious and require immediate medical care. In the event of a person having a change in consciousness, breathing, or awareness, call 911 or go to your nearest emergency room.
Serious side effects of Cotempla may include:1,2
- Prolonged, painful erections
- Vision changes (such as blurred vision)
- Blood flow problems (especially in fingers or toes)
- Fast, pounding, or irregular heartbeat
- Stroke or heart attack
*All medications, including Cotempla, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor about any questions you have and to understand the potential side effects and benefits of any medication.
Allergic Reactions to Cotempla
Some patients may be sensitive to Cotempla or the ingredients within Cotempla, resulting in allergic reactions. A very serious allergic reaction is rare, but those who have had allergic reactions to methylphenidate should consider avoiding Cotempla. There is also a possibility for people to have an allergic reaction to the inactive ingredients within the medication, which can be accessed in its package inserts.
Allergic reactions to Cotempla may include:
- Hives (rash with raised red patches)
- Nausea or Vomiting
- Difficulty breathing
- Swelling of the throat and tongue
- Feeling dizzy, confused, or fainting
If a person experiences an allergic reaction to Cotempla, they should seek medical care as it could be life-threatening. Once the reaction has been managed, your provider may take you off the medication to avoid another event. There are other ADHD medication options that can be started in place of Cotempla, providing you with similar benefits and managing your symptoms.
Get Personalized, Affordable ADHD Treatment
The providers on Klarity offer comprehensive, personalized ADHD treatment. From diagnosis to therapy to medication management, a Klarity provider will be there for you. And, if needed, they’re able to prescribe controlled substances, like Adderall and Concerta.
Cotempla Warnings & Precautions
Cotempla carries a risk of serious health issues that may be increased in certain populations. Cotempla may cause problems with your circulation or heart and may cause worsening or new psychiatric conditions and tics.
As a stimulant, Cotempla carries a risk of abuse and addiction, which your doctor and pharmacist will work to prevent through strict regulations. Some of these side effects may be serious and require immediate medical attention. If you are concerned about taking Cotempla, talk with your doctor or pharmacist if this medication is right for you.
Precautions for taking Cotempla address:1,2
- Taking Cotempla during pregnancy or breastfeeding: There is a potential risk of exposure of the fetus or baby in pregnancy and breastfeeding. There is limited data of Cotempla on pregnant women, but those breastfeeding while on the medication should have their infants monitored for side effects, such as agitation, insomnia, weight loss or reduced weight gain.
- Abuse, misuse, and addiction: There is a high potential for dependence and addiction with Cotempla. It is important to take Cotempla as prescribed and to not change your dosage without consulting a doctor first.
- Risk to patients with serious cardiac disease: In rare cases, Cotempla may cause sudden death in patients with serious heart disease or structural abnormality. Cotempla should be avoided in these patients.
- Increased blood pressure and heart rate: Some patients may experience a large increase in blood pressure and heart rate. Patients should be monitored for high blood pressure and fast heart rate.
- Priapism: Though rare, Cotempla may cause a prolonged and painful erection that requires medical intervention. If you develop an erection that lasts longer than 4 hours, get immediate medical attention.
- Psychiatric reactions: Stimulants like Cotempla may cause new or worsening mental health problems, such as mania, delusions, and hallucinations.
- Long-term suppression of growth in children: Cotempla can cause weight loss and slowed growth in height and weight in children. Children on Cotempla should have their height and weight monitored.
- Circulation problems: Cotempla has been associated with circulation problems in the extremities, including Raynaud’s phenomenon. If you experience a change in color in your fingers or toes, usually from pale to blue or red, and have a cold, numb, or painful feeling, then contact your doctor.
- Visual disturbances: It has been reported that Cotempla may cause increased pressure within the eye. Patients with open-angle glaucoma or abnormally increased intraocular pressure should be cautious while taking this medication.
- Motor and verbal tics, worsening of Tourette syndrome: Due to Cotempla’s effects on the central nervous system, it has been associated with causing motor or verbal tics and potentially worsening Tourette’s Syndrome. Those with a family history of tics or Tourette’s should be cautious when starting Cotempla.
Interactions With Cotempla
Drug interactions may change how your medications work. It can increase the risk of side effects and can be potentially dangerous. When starting Cotempla, discuss with your doctor and pharmacist all medications, over-the-counter drugs, herbals, and substances you take as to avoid the potential for an interaction. Do not start, stop, or change the dosage of any of your medications without the approval of your physician.
4 substances you should avoid while taking Cotempla include:
- Monoamine oxidase inhibitors (MAOI): The use of MAOIs and central nervous system stimulants can cause a serious increase in blood pressure that may be life-threatening. Cotempla should not be taken with MAOIs and within 14 days after stopping an MAOI.
- Acid reflux drugs: Medications like antacids (ie: TUMS), H2 lockers (ie, Zantac), and proton pump inhibitors (ie Prilosec) may increase the level of Cotempla in the body, increasing the risk of side effects.
- Blood pressure medications: Cotempla may decrease the effectiveness of drugs that are meant to treat high blood pressure. While taking Cotempla, blood pressure should be monitored, and the dosage of the blood pressure medication adjusted as needed.
- Risperidone: When combined with Cotempla, when there is a change in dosage in either medication, may increase the risk of movement problems associated with Parkinson’s.
Cotempla Dosages for FDA-Approved Treatment
The recommended starting dose for Cotempla is 17.3 mg daily in the morning for those aged 6 to 17 years. The dosage may be increased by 8.6 mg to 17.3 mg weekly until the desired response is reached. Doses above 51.8 mg have not been studied and thus are not recommended. Also, doses may vary between individuals and are dependent on personal factors, such as age and the condition being treated.
Cotempla Forms & Strengths
Cotempla is provided as a disintegrating tablet that dissolves in the mouth with your saliva. It comes in a blister card with 6 tablets in each and a reusable travel case for these cards. There are three different strengths of Cotempla, and it is an extended-release formula. The strength of Cotempla that you need will depend on individual factors as well as your response to the medication. All of this will be screened by your provider to determine what is the right fit.
Cotempla is available in the following forms and strengths:1,2
- 8.6 milligrams (mg) oral disintegrating tablet
- 17.3 milligrams (mg) oral disintegrating tablet
- 25.9 milligrams (mg) oral disintegrating tablet
How Long Does it Take for Cotempla to Work?
Cotempla works over a long period of time, given its extended-release formulation. In clinical trials, patients experienced an improvement in ADHD symptoms an hour after Cotempla was taken. This medication is formulated to work over a long period of time and can work up to 12 hours.6
Get Personalized, Affordable ADHD Treatment
The providers on Klarity offer comprehensive, personalized ADHD treatment. From diagnosis to therapy to medication management, a Klarity provider will be there for you. And, if needed, they’re able to prescribe controlled substances, like Adderall and Concerta.
How Should I Take Cotempla
When taking Cotempla, remove the tablet from the blister foil pack with dry hands, peeling the foil back as opposed to pushing it through the foil. You should take your tablet immediately after opening the blister pack, while the other tablets should remain in the blister pack until you’re ready to take it.
Place the tablet on your tongue and allow it to disintegrate. Do not chew or crush the tablet. Your saliva will dissolve the tablet, no other liquids are needed. Once again, it is important to take the medication as prescribed to ensure it works as intended. Below are medications that contain the same active ingredient, methylphenidate, and how to take them.5
- Short-acting tablet (Ritalin, Focalin): Immediate-release tablets are usually taken by mouth two to three times a day 30 to 45 minutes before a meal.
- Oral suspension (immediate release Ritalin): This tablet is prescribed to be taken 2 to 3 times daily, 30 to 45 minutes before a meal.
- Chewable tablets (immediate release Ritalin): Chew the tablet and then drink a full glass of water or other liquid. The medication may swell and cause you to choke if it’s not taken with enough liquid.
- Chewable tablets (extended-release Quillichew ER): Chew the tablet in the morning and then drink a full glass of water or other liquid.
- Oral suspension (extended-release Quillivant XR): Shake the bottle for 10 seconds and use the dosing dispenser provided in the box. This capsule is taken in the morning with or without food.
- Extended-release capsule (Aptensio XR, Ritalin LA): This capsule is taken in the morning with or without food.
- Extended-release capsule (Jornay PM): This is taken in the evening and always with or without food.
- Patches (Daytrana): Patches are applied to the skin once in the morning or 2 hours before an effect is needed, and are left in place for up to 9 hours.
What Happens If I Miss a Dose of Cotempla?
If you miss a dose of Cotempla, take the dose as soon as you remember it. If it is almost time for your next dose, skip the missed dose and continue your regular schedule. Be aware that this is an extended-release medication, and taking it later in the day may cause problems like falling asleep or staying asleep. Discuss with your doctor how late in the day you can take this medication.
It is important not to stop taking Cotempla abruptly or try to catch up with extra doses as it may increase your risk of side effects.
Can You Become Addicted to Cotempla?
Cotempla is classified as a Schedule II medication by the DEA, which means that it is a drug that has a high potential for physical and mental dependence. There is a risk of someone becoming addicted to this medication, especially when it is misused or abused. To prevent misuse of prescription stimulants, follow the instructions given to you by your prescriber and do not take more than intended, even if you miss a dose.
Some physicians may ask you to schedule follow-up visits to make sure that your therapy is going as intended. Your prescription will have a limited quantity written on it, and it is only valid for 6 months from the day it is written to prevent misuse or abuse from patients. This medication poses a risk of substance abuse. If substance use develops, medical intervention for treatment of substance abuse, as well as discontinuation of this medication, is necessary.
Can You Overdose on Cotempla?
You can overdose on Cotempla, whether by accident or on purpose. It is important to keep Cotempla away from children and to keep it in a safe, secure place as it is habit-forming. Misuse or abuse of Cotempla can lead to serious side effects, including death. Signs and symptoms of overdose on Cotempla include fast heart rate, high or low blood pressure, heart attack, confusion, agitation, restlessness, agitation, hallucination, seizures, Serotonin Syndrome, coma, and even death. It should be noted that this is not a comprehensive list.
What Should You Do If You Take Too Much Cotempla?
If you take too much Cotempla, you can call 1-800-222-1222 or go to Poison Control’s website, both of which are available for free 24/7. There is a medical professional on staff who will ask you what you took, how much, and how long ago, and then they will direct you on what to do. If you are showing serious signs or symptoms of an overdose, immediately call 911 and get immediate medical care, as it may be life-threatening.
Questions to Ask Your Healthcare Provider About Cotempla
Ask your doctor, psychiatrist, or therapist questions about how Cotempla may affect you and your treatment plan. Online psychiatry services may be a good option if you need to change prescribers or are looking for remote access to healthcare providers.
Questions to ask your care team about Cotempla include:
- How long will it take for me to adjust to taking Cotempla?
- Am I at risk for more serious symptoms if I am already taking medication treatments for other mental health disorders?
- What is the best dosage to ensure fewer side effects?
- When should I reach out to you if I am experiencing sexual side effects?
- Is there anything I should tell my therapist about this new medication?
- What are drug holidays, and are they safe?
- What should I do if this medication does not work well for my child?
- What substances or medications should be avoided while on this medication?
- Are there discounts or coupons for Quillivant or Jornay PM to help me save money on my methylphenidate prescription?
- How much does Cotempla cost and how do I find discounts?
In My Experience
In my experience, Cotempla is a good medication option for young children with ADHD. It lasts throughout the school day, so they only need to take them at home. Oral dissolvable tablets are easier for children to take as well. Managing ADHD symptoms in children can be challenging for both parent and child, so finding ways to help a child take their medication consistently can make a big difference. Support groups can provide social support for families with ADHD, making them feel less alone. Often, children need behavioral therapy alongside their medication treatment, and it is important for caregivers to receive similar help.
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