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Cotempla XR-ODT (Generic Methylphenidate)

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WARNING

Methylphenidate has a tendency to create habits. Avoid exceeding the recommended dosage, taking it more frequently, keeping it in your system for longer, or taking it otherwise than how your doctor has instructed. When you use methylphenidate in excess, you run the risk of losing the ability to manage your symptoms, developing a strong desire to take more of it, and going through strange behavioural changes. Inform your physician if you currently use or have previously used excessive amounts of street drugs, alcohol, or prescription medications.

Without first consulting your doctor, do not discontinue taking methylphenidate, especially if you have taken it excessively. Your dose will likely be gradually reduced by your doctor, who will also closely watch you during this period. If you suddenly quit taking methylphenidate after abusing it excessively, you might have severe depression. Even if you haven’t misused methylphenidate, your doctor may need to keep a close eye on you after you stop taking it because stopping therapy could make your symptoms worse.

Avoid sharing, selling, or allowing others to use your medication. It is illegal to sell or give away methylphenidate because it may hurt other people. To prevent inadvertent or intentional consumption by others, store methylphenidate in a secure location. To find out if any medication is missing, keep track of how much is still in the bottle.

When you start therapy with methylphenidate and every time you acquire extra medicine, your doctor or pharmacist will give you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Why is this medication prescribed?

Methylphenidate is used to treat adults and children who have attention deficit hyperactivity disorder (ADHD; more trouble focusing, managing behaviours, and remaining still or quiet than other individuals their age). For the treatment of narcolepsy, methylphenidate (Methylin) is also utilised (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep). The pharmaceutical methylphenidate belongs to a group of drugs known as central nervous system (CNS) stimulants. It functions by altering the concentrations of specific organic compounds in the brain.

How should this medicine be used?

Methylphenidate is available as an immediate-release tablet, a chewable tablet, a liquid solution, a liquid long-acting (extended-release) suspension, a liquid intermediate-acting (extended-release) tablet, a liquid long-acting (extended-release) capsule, a liquid long-acting (extended-release) tablet, and a liquid long-acting (extended-release) orally disintegrating tablet (tablet that dissolves quickly in the mouth). Orally disintegrating pills, capsules, and long-acting tablets provide some of the drug straight away and release the remainder as a consistent dose of medication over a longer period of time. These methylphenidate dosages are all used orally. Adults often take the standard tablets, chewable tablets (Methylin), and solution (Methylin) two to three times daily, while kids typically take them once daily, ideally 35 to 40 minutes before meals. Adults who are taking three doses should take the final dose before 6:00 pm to avoid problems falling or staying asleep as a result of the drug. The intermediate-acting tablets are often given once or twice a day, 30 to 45 minutes before meals, preferably in the morning but occasionally in the early afternoon. The long-acting tablet (Concerta), long-acting chewable tablet (Quillichew ER), long-acting suspension (Quillivant XR), and long-acting capsules (Aptensio XR, Ritalin LA) are typically taken once daily in the morning with or without food. The long-acting capsule (Metadate CD) is typically taken once daily before breakfast. If taken with food, the long-acting suspension (Quillivant XR) will start working sooner. Both the long-acting orally disintegrating tablet (Cotempla XR-ODT) and the long-acting capsule (Adhansia XR) should be taken consistently, either always with food or always without food. They are typically used once daily in the morning. The long-acting capsule (Jornay PM) should be taken consistently, at the same time each evening, with or without food. It is typically used once daily in the evening (between 6:30 and 9:30 pm).

Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the medication instructions precisely.

Do not attempt to force the Cotempla XR-ODT extended-release orally disintegrating tablet through the blister pack foil. Instead, peel aside the foil wrapper with your dry hands. Take the tablet out right away, and put it in your mouth. There is no need for water to consume the tablet because it will instantly dissolve in saliva.

The immediate-release chewable tablets should be thoroughly chewed before being followed by a full glass (at least 8 ounces [240 millilitres]) of water or another beverage. The immediate-release chewable pill may enlarge, clog your throat, and even make you choke if you eat it without adequate drink. After ingesting the chewable pill, if you get chest pain, nausea, or difficulty breathing or swallowing, call your doctor or seek emergency medical attention right away.

Do not split, chew, or crush the intermediate- and long-acting tablets and capsules. Instead, swallow them whole. If you are unable to swallow the long-acting capsules (Aptensio XR, Jornay PM, Metadate CD, Ritalin LA), you can carefully open the capsules and sprinkle the entire contents on a tablespoon of cool or room temperature applesauce. Alternatively, if you are taking the long-acting capsule (Adhansia XR), you can carefully open the capsules and sprinkle the entire contents on a tablespoon of applesauce or yoghurt After prepared (within 10 minutes if taking Adhansia XR), immediately ingest this mixture (without chewing), followed by a glass of water to ensure complete absorption. Never keep the combination on hand for later usage.

The 20 mg or 30 mg long-acting chewable tablet should be carefully broken along the lines that have been scored into it if your doctor has instructed you to do so while taking the long-acting chewable tablet (Quillichew ER). The chewable 40 mg long-acting tablet is not scored, and it cannot be split or divided.

The steps for measuring the dose for the long-acting suspension (Quillivant XR) are as follows:

  • Take the drug bottle and dosing device out of the box. Verify if the bottle contains liquid medication by opening it up. If the bottle contains powder or if the package lacks a dosing dispenser, call your pharmacist before using the medication.
  • Shake the bottle vigorously for at least 10 seconds to evenly distribute the medication.
  • Take the bottle cap off. Verify that the bottle adapter is placed all the way into the bottle’s top.
  • If the bottle adapter hasn’t already been fitted into the top of the bottle, do so now by inserting the adapter’s bottom into the aperture and pressing down firmly with your thumb. If a bottle adapter is missing from the box, contact your pharmacist. After inserted, do not take the bottle adapter out of the bottle.
  • Insert the dosing dispenser’s tip into the bottle adapter and fully depress the plunger.
  • Reverse the bottle’s orientation.
  • To take the recommended dosage of oral suspension, pull the plunger back. Ask your doctor or pharmacist for assistance if you are unsure about how to accurately measure the dose they have prescribed.
  • You or your child should slowly dribble the oral suspension into their mouth after removing the dosing dispenser.
  • Close the bottle carefully after replacing the cap.
  • After each use, rinse the dosage dispenser with tap water or put it in the dishwasher to clean it.

A low dose of methylphenidate may be prescribed by your doctor, who will then progressively increase it up to once per week.

Throughout your treatment, your condition ought to become better. If your symptoms get worse at any point while you’re receiving therapy or if they don’t get better after a month, call your doctor.

Periodically, your doctor might advise you to stop taking methylphenidate in order to determine if you still require the drug. Pay close attention to these guidelines.

It’s possible that some methylphenidate products can’t be switched out for another. If you have any concerns regarding the kind of methylphenidate product your doctor has recommended, speak with your pharmacist.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking methylphenidate,

  • If you are taking Adhansia XR, inform your doctor and pharmacist if you have any allergies to aspirin, tartrazine dye (a yellow dye found in some processed foods and medications), methylphenidate, other medications, aspirin, other medications, or any of the ingredients in the methylphenidate product you are taking. For a list of the ingredients, speak with your doctor or consult the medication guide.
  • Inform your doctor if you are currently using, or have recently stopped taking, monoamine oxidase (MAO) inhibitors, such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate). When you previously took an MAO inhibitor, your doctor probably advised you to wait at least 14 days before taking methylphenidate.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Incorporate any of the following: drugs that prevent clotting (sometimes known as “blood thinners”); antidepressants including clomipramine (Anafranil), desipramine (Norpramin), and imipramine (Tofranil); medications for high blood pressure, drugs for seizures like phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline), decongestants (cough and cold medicines), drugs for heartburn or ulcers like esomeprazole (Nexium, in Vimovo), famotidine (Pepcid), omeprazole (Prilosec, in Zegerid), or pantoprazole (Protonix); venlafaxine; sodium bicarbonate (Arm and Hammer Baking Soda, Soda Mint); methyldopa; selective serotonin reuptake inhibitors (SSRIs) like citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax, and others), fluvoxamine (Luvox), paroxetine (Bris (Effexor). When taking Ritalin LA, be sure to let your doctor know if you also take antacids or drugs for heartburn or ulcers. The dosage of your drugs may need to be adjusted, and your health may need to be closely watched for any negative effects.
  • Inform your doctor if you or anybody in your family has or has ever had Tourette’s syndrome, which is characterised by the need to repeat sounds, words, or facial expressions, facial tics, physical tics, or verbal tics (repetition of sounds or words that is hard to control). Moreover, let your doctor know if you suffer from glaucoma (increased eye pressure that can lead to vision loss), an overactive thyroid, or agitation, tension, or worry. If you suffer from any of these problems, your doctor will likely advise you to avoid using methylphenidate.
  • Inform your doctor if anyone in your family has ever experienced a sudden death or has an abnormal heartbeat. Additionally, let your doctor know if you’ve recently suffered from a heart attack, or if you’ve ever experienced any of the following: a heart defect, high blood pressure, an irregular heartbeat, a heart or blood vessel disease, artery hardening, cardiomyopathy (a thickening of the heart muscle), or any other heart issues. If you are at a high risk of developing a cardiac issue or already have one, your doctor will likely advise against taking methylphenidate.
  • Inform your doctor if you or anyone in your family is currently experiencing or has ever experienced depression, mania (a frantic, unusually exuberant mood), bipolar disorder (a mood that varies from depressed to excited), or has attempted or thought about attempting suicide. Furthermore let your doctor know if you suffer from or have previously suffered from mental illness, seizures, abnormal electroencephalograms (EEGs), which assess electrical activity in the brain, circulation issues in your fingers or toes, or any other conditions. Inform your doctor if you have a digestive obstruction or narrowing if you are using the long-acting Concerta tablet.
  • If you are pregnant or plan to become pregnant, let your doctor know. Call your doctor if you get pregnant while taking methylphenidate.
  • If you are currently breastfeeding or intend to do so, let your doctor know. Your doctor might advise you to keep a close eye on your infant if you’re taking methylphenidate and breastfeeding in order to spot any unusual agitation, trouble falling asleep, poor appetite, or weight loss.
  • If you are 65 years of age or older, discuss the advantages and disadvantages of taking methylphenidate with your doctor. Methylphenidate is typically not recommended for older persons since it is less safe than alternative drugs that can be used to treat the same issue.
  • Inform your doctor or dentist that you are taking methylphenidate if you are getting surgery, including dental surgery.
  • Be advised that drinking alcohol should not be done while consuming the long-acting chewable tablet (Quillichew ER), long-acting orally disintegrating tablet (Cotempla® XR-ODT), or the long-acting capsule (Adhansia XR or Jornay PM).
  • You should be aware that the immediate-release and long-acting chewable tablets contain aspartame, which converts to phenylalanine if you have phenylketonuria (PKU), an inherited condition that requires adherence to a special diet to prevent brain damage that can result in severe intellectual disability.
  • You should be aware that methylphenidate should be used in conjunction with other therapies, such as counselling and specialised instruction, in order to effectively treat ADHD. Ensure that you adhere to all recommendations from your therapist or doctor.s.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. In order to avoid having trouble falling or staying asleep, ask your doctor or pharmacist how late in the day you should take a missed dose of your prescription. If your next dose is approaching, skip the missed one and carry on with your regular dosing regimen. Take the missing dose of the long-acting capsule (Jornay PM) as soon as you remember it that evening. To continue with your regular dosing plan, skip the missing long-acting capsule (Jornay PM) if it is already the following morning. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Side effects from methylphenidate are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nervousness
  • Irritability
  • Difficulty Sleeping or remaining asleep
  • Dizziness
  • Nausea
  • Vomiting
  • Reduced appetite
  • Slim down
  • Abdominal pain
  • Diarrhea
  • Heartburn
  • Mouth ache
  • Headache
  • Muscular tension
  • Drowsiness
  • Body component movement that is out of control
  • Restlessness
  • Less sexual arousal
  • Heavy perspiration
  • Back ache

Some adverse effects may be severe. Call your doctor right away or seek emergency medical attention if you have any of the following symptoms:

  • Hammering, rapid, or erratic heartbeat
  • Chest discomfort
  • Breathing difficulty
  • Excessive fatigue
  • Slow or challenging speech
  • Fainting
  • Arm or leg weakness or numbness
  • Seizures
  • Eyesight alterations or blurry vision
  • Agitation
  • Assuming falsehoods to be true
  • Feeling unusually wary about other people
  • Hallucinating (seeing objects or hearing sounds that do not exist)
  • Verbal or motor tics
  • Depression
  • Nusually ecstatic mood
  • Mood shifts
  • Regular, uncomfortable erections
  • Longer than four-hour erection
  • Tingling, numbness, or pain in the fingers or toes, or sensitivity to temperature
  • In the fingers or toes, the skin’s colour might vary from pale to blue to red.
  • Sores on the fingers or toes that are mysterious
  • Unexplained wounds on the fingers or toes
  • Fever
  • Hives
  • Rash
  • Skin that is swollen or peeling
  • Itching
  • Swelling of the throat, mouth, tongue, lips, or eyes
  • Hoarseness
  • Breathing or swallowing challenges

Methylphenidate may inhibit children’s weight gain or growth. The physician for your child will keep a close eye on their development. If you are worried about your child’s weight gain or growth while taking this medicine, talk to your child’s doctor. Consult your child’s doctor about the dangers of giving them methylphenidate.

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it at ambient temperature and shield it from light, too much heat, and moisture (not in the bathroom). Methylphenidate should be kept in a secure location to prevent accidental or intentional consumption by others. Keep track of how many tablets, capsules, or liquids are remaining so you can identify any missing medications.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Vomiting
  • Nausea
  • Diarrhea
  • Fainting, fuzzy eyesight, or lightheadedness
  • Restlessness
  • Unusually quick breathing
  • Anxiety
  • Agitation
  • Body part shaking that is uncontrollable
  • Muscle jerking
  • Seizures
  • Consciousness is lost
  • Unsuitable happiness
  • Confusion
  • Hallucinating (seeing objects or hearing sounds that do not exist)
  • Sweating
  • Flushing
  • Headache
  • Fever
  • Hammering, rapid, or erratic heartbeat
  • Enlargement of pupils (black circles in the middle of the eyes)
  • Dry nose or mouth
  • Muscular deterioration, exhaustion, or dark urine

What other information should I know?

You might see anything that resembles a pill in your faeces if you’re taking methylphenidate long-acting tablets (Concerta). The fact that the tablet is empty does not imply that you did not take the whole prescribed amount of medication.

Keep all of your appointments with your physician and the lab. To determine how you are responding to methylphenidate, your doctor may monitor your blood pressure, heart rate, and request a few lab tests.

This medication cannot be renewed. In order to prevent running out of medication, make sure you plan regular doctor’s appointments.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Adhansia XR®
  • Aptensio XR®
  • Concerta®
  • Cotempla® XR-ODT
  • Jornay PM®
  • Metadate® CD
  • Metadate® ER
  • Methylin®
  • Methylin® ER
  • Quillichew® ER
  • Quillivant® XR
  • Ritalin®
  • Ritalin® LA
  • Ritalin® SR
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