Methylin

Pronunciation

Generic Name: methylphenidate (Oral route)

meth-il-FEN-i-date

Oral route(Tablet;Tablet, Extended Release;Tablet, Chewable;Solution)

Use cautiously in emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because of abuse potential. Chronic abuse can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior, including psychotic episodes. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked .

Oral route(Powder for Suspension, Extended Release)

CNS stimulants, including methylphenidate hydrochloride, 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 .

Oral route(Capsule, Extended Release)

Use caution when prescribing to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with abnormal behavior. Psychotic episodes can occur, especially with parenteral abuse. Carefully supervise withdrawal from abusive use to avoid the onset of severe depression. Follow-up may be required following withdrawal from chronic therapeutic use, as symptoms of the underlying disorder may emerge .

Commonly used brand name(s)

In the U.S.

  • Concerta
  • Metadate CD
  • Metadate ER
  • Methylin
  • Methylin ER
  • Quillivant XR
  • Ritalin
  • Ritalin LA
  • Ritalin-SR

Available Dosage Forms:

  • Tablet, Extended Release
  • Capsule, Extended Release
  • Powder for Suspension, Extended Release
  • Tablet, Chewable
  • Solution
  • Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine Related

Uses For Methylin

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.

Slideshow: Does Your Child Have ADHD? Recognizing Signs & Treatment Options

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.

Before Using Methylin

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. 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 Concerta® extended release tablets and Quillivant™ XR extended-release suspension have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

No information is available on the relationship of age to the effects of Metadate CD®, Ritalin®, Ritalin LA®, and Ritalin SR® in geriatric patients.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

  • Brofaromine
  • Clorgyline
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Lazabemide
  • Linezolid
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Selegiline
  • Toloxatone
  • 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.

  • Bupropion

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

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Agitation, severe or
  • Anxiety, severe or
  • Glaucoma or
  • Motor tics (repeated muscle movements) or
  • Tension, severe or
  • Tourette's syndrome, or family history of—Should not be used in patients with these conditions.
  • Alcohol abuse, history of or
  • Drug abuse or dependence, history of—Use with caution. Dependence may be more likely to develop.
  • Angina pectoris (chest pain), severe or
  • Arrhythmia (heart rhythm problem), severe or
  • Fructose intolerance (rare hereditary problem) or
  • Glucose-galactose malabsorption (rare hereditary problem) or
  • Heart attack, recent or
  • Heart failure or
  • Hypertension (high blood pressure), severe or
  • Hyperthyroidism (overactive thyroid) or
  • Sucrase-isomaltase insufficiency (rare hereditary problem) or
  • Surgery—Metadate CD® extended release capsules should not be used in patients with these conditions.
  • Bipolar disorder (manic-depressive illness), history of or
  • Blood vessel problems (eg, Raynaud disease) or
  • Coronary artery disease or
  • Depression, history of or
  • Heart attack, recent or
  • Heart disease (eg, cardiomyopathy) or
  • Heart failure or
  • Heart rhythm problems (eg, ventricular arrhythmia), history of or
  • Hypertension (high blood pressure) or
  • Hyperthyroidism (overactive thyroid) or
  • Priapism (painful or prolonged erection of the penis) or
  • Psychosis (mental illness), history of or
  • Seizures, history of or
  • Stroke, history of or
  • Tachycardia (rapid heart rate)—Use with caution. May make these conditions worse.
  • Cystic fibrosis or
  • Stomach or bowel problems (eg, bowel blockage, Meckel's diverticulum, peritonitis, short gut syndrome) or
  • Trouble with swallowing—Concerta® extended release tablets should not be given in patients with these conditions.

Proper Use of methylphenidate

This section provides information on the proper use of a number of products that contain methylphenidate. It may not be specific to Methylin. Please read with care.

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. If you think this medicine is not working properly after you have taken it for several weeks, check with your doctor and do not increase the dose.

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 long-acting forms of this medicine:

  • The Concerta® extended release tablets, 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 are unable to swallow the 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® 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® extended release tablets with or without food.
  • 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.

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 form (tablets):
      • Adults—5 to 20 milligrams (mg) two or three times a day, taken 30 to 45 minutes before meals.
      • Teenagers and children 6 years of age and older—At first, 5 mg two times a day, taken before breakfast and lunch. If needed, your doctor may increase the dose once a week by 5 to 10 mg per day until symptoms improve or a maximum dose of 60 mg is reached.
      • 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:
        • Adults, teenagers, and children 6 years of age and older—At first, 10 to 20 milligrams (mg) once a day, taken in the morning. If needed, your doctor may increase the dose once a week by 10 mg per day as needed to a maximum dose of 60 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, teenagers, and children 6 years of age and older—10 to 60 milligrams (mg) once a day, taken in the morning. If needed, your doctor may increase the dose once a week by 10 mg per day as needed up to 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, teenagers, and children 6 years of age and older—At first, 20 milligrams (mg) once a day, taken in the morning. If needed, your doctor may increase the dose once a week by 10 to 20 mg per day as needed up to 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 tablets):
      • For patients who have not been treated with Concerta®:
        • Adults—At first, 18 to 36 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg per day.
        • Teenagers and children 6 years of age and older—At first, 18 mg once a day in the morning. Your doctor may increase 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 patients already using Concerta®:
        • Adults, teenagers, and children 6 years of age and older—At first, 18 to 72 milligrams (mg) once a day in the morning, depending on your previous dose of methylphenidate. Your doctor may increase 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 long-acting oral dosage form (sustained-release tablets):
      • Adults, teenagers, and children 6 years of age and older—The dose must be determined by the doctor.
      • Children younger than 6 years of age—Use and dose must be determined by the doctor.
  • For narcolepsy:
    • For short-acting oral dosage form (tablets):
      • Adults—5 to 20 milligrams (mg) two or three times a day, taken 30 to 45 minutes before meals.
      • Teenagers and children 6 years of age and older—At first, 5 mg two times a day, taken before breakfast and lunch. If needed, your doctor may increase the dose once a week by 5 to 10 mg per day until symptoms improve or a maximum dose of 60 mg is reached.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    • For long-acting oral dosage form (sustained-release tablets):
      • Adults and teenagers and children 6 years of age and older—The dose must be determined by the doctor.
      • 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.

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: Throw away any unused suspension 4 months after it is dispensed.

Precautions While Using Methylin

Your doctor should check your 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.

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

Methylphenidate may cause dizziness, drowsiness, or changes in vision. Do not drive a car, ride a bicycle, operate machinery, or do other things that might 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 have chest pain, shortness of breath, or fainting while using this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause slow growth. 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 phenomenon. Check with your doctor right away if you have tingling or pain in the fingers or toes when exposed to cold, 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®. You may need to stop using this medicine before you have surgery.

Avoid drinking alcohol while taking the Metadate CD® or Ritalin LA® extended-release capsules.

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.

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.

Methylin 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
  • convulsions
  • crusting, dryness, or flaking of the skin
  • muscle cramps
  • pinpoint red spots on the skin
  • scaling, severe redness, soreness, or swelling of the skin
  • uncontrolled vocal outbursts or tics (uncontrolled and repeated body movements)
  • unusual bleeding or bruising
Incidence not known
  • Confusion
  • feeling like surroundings are not real
  • depression
  • hives or welts
  • numbness of the hands
  • painful or difficult urination
  • pale skin
  • paleness or cold feeling in the fingertips and toes
  • red, irritated eyes
  • red, swollen, or scaly skin
  • seeing, hearing, or feeling things that are not there
  • severe or sudden headache
  • shortness of breath
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden loss of coordination
  • sudden slurring of speech
  • tingling or pain in the fingers or toes when exposed to cold
  • unusual behavior
  • unusual tiredness or weakness
  • weight loss
  • yellow skin or eyes

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
  • Abdominal or stomach pain
  • headache
  • loss of appetite
  • nervousness
  • stuffy nose
  • trouble sleeping
  • unusually warm skin
Less common
  • Anger
  • dizziness
  • drowsiness
  • fear
  • irritability
  • muscle aches
  • nausea
  • runny nose
  • scalp hair loss
  • talking, feeling, and acting with excitement

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.

See also: Side effects (in more detail)

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