Methylin ER

Generic name: Methylphenidate
Drug class: CNS stimulants

Usage of Methylin ER

Methylphenidate is used to treat attention deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Methylphenidate is also used to treat narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.

Methylphenidate works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with your doctor's prescription.

Methylin ER side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Fast heartbeat

Less common

Chest pain

fever

joint pain

skin rash or hives

Rare

Black, tarry stools

blood in the urine or stools

blurred vision or other changes in vision

crusting, dryness, or flaking of the skin

muscle cramps

pinpoint red spots on the skin

scaling, severe redness, soreness, or swelling of the skin

seizures

uncontrolled vocal outbursts or tics (uncontrolled and repeated body movements)

unusual bleeding or bruising

Incidence not known

Agitation

arm, back or jaw pain

bleeding gums

bloody nose

chest discomfort, tightness, or heaviness

chills

clenching, gnashing, or grinding teeth

confusion

cough

dark urine

decreased interest in sexual intercourse

diarrhea

difficulty with speaking

difficulty with swallowing

discouragement

dizziness

double vision

drowsiness

fainting

fast, pounding, or irregular heartbeat or pulse

feeling like surroundings are not real

feeling sad or empty

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

feeling, seeing, or hearing things that are not there

headache

heavier menstrual periods

inability to have or keep an erection

inability to move the arms, legs, or facial muscles

inability to speak

irritability

itching skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

loss in sexual ability, desire, drive, or performance

loss of interest or pleasure

mood swings

muscle pain, stiffness, or spasms

nausea

nervousness

numbness of the hands

overactive reflexes

painful or difficult urination

pale skin

paleness or cold feeling in the fingertips and toes

poor coordination

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red, irritated eyes

red, swollen, or scaly skin

redness, soreness, or itching skin

restlessness

right upper stomach tenderness

seeing, hearing, or feeling things that are not there

severe or sudden headache

shivering

slow speech

slowed growth in children

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stuffy or runny nose

sudden loss of coordination

sudden slurring of speech

sweating

swollen glands

talking or acting with excitement you cannot control

tingling or pain in the fingers or toes when exposed to cold temperatures

trembling or shaking

tremor

trouble concentrating

trouble sleeping

trouble breathing

twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

unusual behavior

unusual tiredness or weakness

weight loss

yellow skin or eyes

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

anxiety

bigger, dilated, or enlarged pupils of the eyes

blurred vision

change in consciousness

chest pain or discomfort

confusion as to time, place, or person

dark urine

diarrhea

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry eyes, mouth, nose, or throat

false or unusual sense of well-being

fast, slow, irregular, pounding, or racing heartbeat or pulse

fever

headache

holding false beliefs that cannot be changed by fact

inability to speak

increased sensitivity of the eyes to light

loss of consciousness

muscle pain, cramps, stiffness, or twitching

nausea

nervousness

overactive reflexes

pain or discomfort in the arms, jaw, back, or neck

pale, clammy skin

palpitations

pounding in the ears

rapid, shallow breathing

seeing, hearing, or feeling things that are not there

seizures

shivering

slurred speech

sweating

talking or acting with excitement you cannot control

temporary blindness

thirst

trembling or shaking

trouble breathing

unusual excitement, nervousness, or restlessness

unusual tiredness or weakness

vomiting

weakness in the arm or leg on one side of the body, sudden and severe

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Loss of appetite

stomach pain

Less common

Acid or sour stomach

anger

belching

fear

heartburn

indigestion

irritability

scalp hair loss

stomach discomfort or upset

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Methylin ER

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methylphenidate in children 6 years of age and older (6 to 12 years of age for Ritalin LA®). Safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies on the relationship of age to the effects of methylphenidate have not been performed in the geriatric population.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Isocarboxazid

Linezolid

Methylene Blue

Ozanimod

Phenelzine

Procarbazine

Rasagiline

Safinamide

Selegiline

Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol

Amifampridine

Bupropion

Cimetidine

Citalopram

Clomipramine

Desflurane

Desipramine

Dexlansoprazole

Donepezil

Ebrotidine

Enflurane

Escitalopram

Esomeprazole

Famotidine

Fluoxetine

Fluvoxamine

Fosphenytoin

Halothane

Imipramine

Iobenguane I 131

Isoflurane

Lansoprazole

Methoxyflurane

Nizatidine

Omeprazole

Pantoprazole

Paroxetine

Phenobarbital

Phenprocoumon

Phenytoin

Primidone

Rabeprazole

Ranitidine

Ranitidine Bismuth Citrate

Risperidone

Roxatidine

Sertraline

Sevoflurane

Vilazodone

Vortioxetine

Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Carbamazepine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Relate drugs

How to use Methylin ER

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming and cause mental or physical dependence.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

To help prevent trouble with sleeping, take the last dose of the short-acting tablets before 6 PM, unless your doctor gives you a different time.

If you are taking the chewable tablet, drink at least 8 ounces of water or other liquid when you chew the tablet. Take it preferably 30 to 45 minutes before meals.

Shake the oral liquid gently just before using it. Use a marked measuring spoon, oral syringe, or medicine cup to measure the right dose. Take it preferably 30 to 45 minutes before meals.

If you are taking the long-acting forms of this medicine:

The Concerta® or Relexxii® extended release tablets, Adhansia XR®, Aptensio XR™, Metadate CD®, or Ritalin LA® capsules, and Ritalin SR® tablets are to be swallowed whole with water or other liquids. Do not break, open, crush, or chew them before swallowing.

If you cannot swallow the Adhansia XR® extended-release capsule whole, you may open it and sprinkle the medicine onto a tablespoon of applesauce or yogurt. Swallow this mixture without chewing, right away or within 10 minutes. Do not store this mixture for later use.

If you are unable to swallow the Aptensio XR™, Jornay PM®, Metadate CD®, or Ritalin LA® extended-release capsule whole, carefully open the capsule and sprinkle the small beads over a spoonful of applesauce. The mixture of drug and applesauce should be taken right away without chewing. The drug and applesauce mixture should not be stored for future use.

If you are taking the Concerta® or Relexxii® extended-release tablets, you may sometimes notice what looks like a tablet in your stool. This is the empty tablet shell that is left after the medicine has been absorbed into your body.

You may take Concerta® or Relexxii® extended release tablets, Adhansia XR®, Aptensio XR™, or Jornay PM® extended-release capsules, or Cotempla XR-ODT™ extended release disintegrating tablets with or without food.

If you are taking the Cotempla XR-ODT™ extended release disintegrating tablet, make sure your hands are dry before you handle it. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet in your mouth. It should melt quickly. Do not crush or chew it.

If you are taking the Quillivant® XR extended-release suspension, shake the bottle well for at least 10 seconds before measuring each dose. Use only the oral dosing dispenser provided in the package to get the right dose. You may take it with or without food.

If you are taking the Quillichew ER™ tablets, you may cut the 20- and 30-milligram (mg) scored chewable tablets into two if needed.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way. If you are switching from other brands of this medicine, your doctor may tell you to stop using other methylphenidate products and adjust your dose of Quillivant® XR extended-release suspension.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For attention deficit hyperactivity disorder (ADHD):

For short-acting oral dosage forms (chewable tablets or solution):

Adults—Administer 2 or 3 times a day and take 30 to 45 minutes before meals. The average dose is 20 to 30 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.

Children 6 years of age and older—At first, 5 mg 2 times a day, taken before breakfast and lunch. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.

Children younger than 6 years of age—Use and dose must be determined by the doctor.

For short-acting oral dosage form (tablets):

Adults—20 to 30 milligrams (mg) given in divided doses 2 or 3 times a day, taken 30 to 45 minutes before meals. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.

Children younger than 6 years of age—Use and dose must be determined by the doctor.

For long-acting oral dosage form (extended-release capsules):

Patients who have not been treated with methylphenidate:

Adhansia XR®:

Adults and children 6 years of age and older—At first, 25 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg per day for adults and 85 mg for children.

Children younger than 6 years of age—Use and dose must be determined by the doctor.

Aptensio XR™, Metadate CD®, Ritalin LA®:

Adults and children 6 years of age and older—At first, 10 to 20 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.

Children younger than 6 years of age—Use and dose must be determined by the doctor.

Jornay PM®:

Adults and children 6 years of age and older—At first, 20 milligrams (mg) once a day, taken in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg per day.

Children younger than 6 years of age—Use and dose must be determined by the doctor.

Patients who are already taking methylphenidate:

Adults and children 6 to 12 years of age—10 to 60 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.

Children younger than 6 years of age—Use and dose must be determined by the doctor.

For long-acting oral dosage form (extended-release suspension):

Adults and children 6 years of age and older—At first, 20 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.

Children younger than 6 years of age—Use and dose must be determined by the doctor.

For long-acting oral dosage form (extended-release chewable tablets):

Children younger than 6 years of age—Use and dose must be determined by the doctor.

For long-acting oral dosage form (extended-release disintegrating tablets):

Adults and children 6 years of age and older—At first, 17.3 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 51.8 mg per day.

Children younger than 6 years of age—Use and dose must be determined by the doctor.

For long-acting oral dosage form (extended-release tablets):

For patients who have not been treated with methylphenidate:

Adults—At first, 18 to 36 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 72 mg per day.

Teenagers 13 to 17 years of age—At first, 18 mg once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 72 mg per day.

Children 6 to 12 years of age—At first, 18 mg once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 54 mg per day.

Children younger than 6 years of age—Use and dose must be determined by your doctor.

For patients already using methylphenidate:

Adults and children 6 years of age and older—At first, 18 to 72 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 72 mg per day.

Children younger than 6 years of age—Use and dose must be determined by your doctor.

For narcolepsy:

For short-acting oral dosage forms (chewable tablets or solution):

Adults—Administer 2 or 3 times a day and take 30 to 45 minutes before meals. Average dose is 20 to 30 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.

Children younger than 6 years of age—Use and dose must be determined by the doctor.

For short-acting oral dosage form (tablets):

Adults—20 to 30 milligrams (mg) given in divided doses 2 or 3 times a day, taken 30 to 45 minutes before meals (breakfast and lunch). Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.

Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of Adhansia XR®, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

For the extended-release suspension: Dispose of any unused suspension 4 months after it is used for the first time.

Store the extended release disintegrating tablets in the reusable travel case after you remove it from the carton.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Warnings

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

You or your child will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

You or your child should not use this medicine if you are using or have used a drug for depression, called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, within the past 14 days.

Methylphenidate may cause dizziness, drowsiness, or changes in vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Methylphenidate may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child has chest pain, trouble breathing, fainting, or a fast, irregular heartbeat while using this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, including an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you feel, see, or hear things that are not there, or have any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause slow growth and weight loss. If your child is using this medicine, the doctor will need to keep track of his height and weight to make sure that he is growing properly.

Methylphenidate may cause a condition called Raynaud's phenomenon. Check with your doctor right away if you or your child has tingling or pain in the fingers or toes when exposed to cold temperatures, paleness or a cold feeling in the fingertips and toes, or a skin color change in your fingers.

Make sure any doctor or dentist who treats you knows that you are using Metadate CD®, Relexxii®, Ritalin®, Ritalin LA®, or Ritalin-SR®. You may need to stop using this medicine before you have surgery.

Avoid drinking alcohol while using Concerta®, Cotempla XR-ODT™ extended release disintegrating tablets, Adhansia XR®, Aptensio XR™, Metadate CD®, or Ritalin LA® extended-release capsules, Quillichew ER™ extended-release chewable tablets, or Quillivant® XR extended-release suspension.

If you or your child experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.

Adhansia XR® contains a yellow dye called tartrazine, which may cause severe allergic reactions. Tell your doctor if you have any allergies (including an aspirin allergy).

Symptoms of overdose include: agitation, blurred vision, change in consciousness, chest pain or discomfort, confusion, dark urine, diarrhea, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast, pounding, or irregular heartbeat or pulse, fever, headache, inability to speak, loss of consciousness, muscle cramps, spasms, pain, or stiffness, nausea, nervousness, overactive reflexes, pain or discomfort in the arms, jaw, back, or neck, pale, clammy skin, palpitations, pounding in the ears, seeing, hearing, or feeling things that are not there, seizures, shivering, slow or fast heartbeat, slurred speech, sweating, talking or acting with excitement you cannot control, temporary blindness, thirst, trembling or shaking, trouble breathing, unusual tiredness or weakness, vomiting, or weakness in the arm or leg on one side of the body, sudden and severe. Call your doctor right away if you notice these symptoms.

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor right away. Some signs of dependence may include:

A strong desire or need to continue using the medicine.

A need to increase the dose to receive the same effects.

Withdrawal effects after stopping the medicine, including irritability, anxiety, unusual tiredness or weakness, nightmares, trouble sleeping or oversleeping, increased appetite, agitation, or slowing of mental and physical activity.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Methylin ER

Usage of Methylin ER

Methylin ER side effects

Before taking Methylin ER

Allergies

Pediatric

Geriatric

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Relate drugs

How to use Methylin ER

Dosing

Missed Dose

Storage

Warnings

Disclaimer

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