Ritalin-SR

Name: Ritalin-SR

What are the side effects of methylphenidate?

The most common side effects with methylphenidate are:

  • nervousness,
  • agitation,
  • anxiety, and
  • insomnia.

Insomnia can be limited by taking the drug before noon. For children taking methylphenidate for ADHD, the most common side effects are loss of appetite, abdominal pain, weight loss, and sleep problems. The rate and severity of these side effects are less than that seen with dextroamphetamine (Dexedrine).

Other important side effects of methylphenidate include:

  • nausea,
  • vomiting,
  • dizziness,
  • palpitations,
  • headache,
  • involuntary movements,
  • chest pain,
  • increased heart rate,
  • increased blood pressure, and
  • psychosis.

There have been rare reports of Tourette's syndrome, a syndrome in which there are uncontrollable tics such as grimacing occurring with methylphenidate use. Because of the potential for side effects, methylphenidate should be used with caution by patients who have relatives with Tourette's syndrome or have the syndrome themselves or who have severe anxiety, seizures, psychosis, emotional instability, major depression, glaucoma, or motor tics.

Sudden discontinuation of long-term methylphenidate therapy may unmask depression. Gradual withdrawal, under supervision, is recommended.

Methylphenidate is habit forming and should be used cautiously in individuals with a history of drug or alcohol abuse. Chronic abuse can lead to tolerance and psychological dependence leading to abnormal behavior.

Priapism defined as painful and nonpainful penile erection lasting more than 4 hours, have been reported in pediatric and adult patients treated with stimulants. The erection usually resolves when the drug is stopped. Prompt medical attention is required in the event of suspected priapism.

What is the dosage for methylphenidate?

The dose of methylphenidate is adjusted based on patients' responses. It may be given once, twice, or three times daily depending on formulation.

The recommended dose for Concerta is 18-72 mg once daily.

The recommended dose for Ritalin LA is 10-60 mg once daily and for regular Ritalin the recommended dose is 10-60 mg daily in 2 or 3 divided doses.

What else should I know about this drug?

What preparations of methylphenidate are available?
  • Tablets: 5, 10, and 20 mg (Ritalin);
  • Sustained-release tablets (Ritalin SR): 20 mg;
  • Long acting tablets (Ritalin LA): 20, 30, and 40 mg.
  • Extended release tablets (Concerta): 18, 27, 36, and 54 mg.
  • Chewable tablets (Methylin): 2.5, 5, and 10 mg;
  • Solution (Methylin): 5 mg/5 ml, 10 mg/5 ml.
  • Extended release tablets (Methylin ER, Metadate ER): 10, 20 mg.
  • Extended release capsules (Metadate): 10, 20, 30, 40, 50, and 60 mg.
How should I keep methylphenidate stored?

Tablets should be kept at room temperature, 15 C - 30 C (59 F - 86 F).

Side effects

Nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, nausea, vomiting, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: numbness/pain/skin color change/sensitivity to temperature in the fingers or toes, fast/pounding/irregular heartbeat, mental/mood/behavior changes (such as agitation, aggression, mood swings, abnormal thoughts), uncontrolled muscle movements (such as twitching, shaking), sudden outbursts of words/sounds that are hard to control, vision changes (such as blurred vision).Get medical help right away if you have any very serious side effects, including: fainting, seizure, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), symptoms of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion).Rarely, males (including young boys and teens) may have a painful or prolonged erection lasting 4 or more hours while using this medication. Caregivers/parents should also be watchful for this serious side effect in boys. If a painful or prolonged erection occurs, stop using this drug and get medical help right away, or permanent problems could occur. Ask your doctor or pharmacist for more details.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Ritalin SR?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Uses For Ritalin-SR

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.

Before Using Ritalin-SR

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 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.

  • Brofaromine
  • Clorgyline
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Lazabemide
  • Linezolid
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Safinamide
  • 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
  • Donepezil

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:

  • Alcohol abuse, history of or
  • Drug abuse or dependence, history of—Use with caution. Dependence may be more likely to develop.
  • Bipolar disorder (manic-depressive illness), history of or
  • Depression, history of or
  • Hypertension (high blood pressure) or
  • Priapism (painful or prolonged erection of the penis) or
  • Psychosis (mental illness), history of or
  • Raynaud disease or
  • Seizures, history of or
  • Tachycardia (rapid heart rate)—Use with caution. May make these conditions worse.
  • Coronary artery disease or
  • Heart attack, recent or
  • Heart disease (eg, cardiomyopathy) or
  • Heart failure or
  • Heart rhythm problems (eg, ventricular arrhythmia), history of or
  • Hyperthyroidism (overactive thyroid) or
  • Stroke, history of—Use with caution. May make side effects become worse.
  • Phenylketonuria—The chewable tablet contains aspartame, which can make this condition worse.

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 Ritalin-SR. 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 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® extended release tablets, 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 are unable to swallow the Aptensio XR™, 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, Aptensio XR™ 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.

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 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—Use and dose must be determined by the doctor.
    • For short-acting oral dosage form (tablets):
      • Adults—5 to 20 milligrams (mg) 2 or 3 times a day, taken 30 to 45 minutes before meals.
      • Children 6 years and older—At first, 5 mg two 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—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 and children 6 years 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—Use and dose must be determined by the doctor.
      • Patients who are already taking methylphenidate:
        • Adults and children 6 years and older—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—Use and dose must be determined by the doctor.
    • For long-acting oral dosage form (extended-release suspension):
      • Adults and children 6 years 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—Use and dose must be determined by the doctor.
    • For long-acting oral dosage form (extended-release chewable tablets):
      • Adults and children 6 years 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—Use and dose must be determined by the doctor.
    • For long-acting oral dosage form (extended-release disintegrating tablets):
      • Adults and children 6 years 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—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 adjust your dose as needed. However, the dose is usually not more than 72 mg per day.
        • Children 6 years and older—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 younger than 6 years—Use and dose must be determined by your doctor.
      • For patients already using Concerta®:
        • Adults and children 6 years 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—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 6 years 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—Use and dose must be determined by the doctor.
    • For short-acting oral dosage form (tablets):
      • Adults—5 to 20 milligrams (mg) 2 or 3 times a day, taken 30 to 45 minutes before meals.
      • Children 6 years 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—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 used for the first time.

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

For the Consumer

Applies to methylphenidate: oral capsule extended release, oral powder for suspension extended release, oral solution, oral tablet, oral tablet chewable, oral tablet extended release, oral tablet extended release chewable

Other dosage forms:

  • transdermal patch extended release

Along with its needed effects, methylphenidate (the active ingredient contained in Ritalin-SR) 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 while taking methylphenidate:

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
  • Confusion
  • depression
  • feeling like surroundings are not real
  • 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
  • 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

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

Symptoms of overdose
  • Agitation
  • anxiety
  • bigger, dilated, or enlarged pupils of the eyes
  • confusion as to time, place, or person
  • dark-colored 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
  • holding false beliefs that cannot be changed by fact
  • increased sensitivity of the eyes to light
  • loss of consciousness
  • muscle pain or stiffness
  • muscle twitching
  • nervousness
  • overactive reflexes
  • pounding in the ears
  • rapid, shallow breathing
  • sweating
  • tremors
  • unusual excitement, nervousness, or restlessness

Some side effects of methylphenidate 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
  • Headache
  • loss of appetite
  • nervousness
  • stomach pain
  • stuffy nose
  • trouble sleeping
  • unusually warm skin
Less common
  • Anger
  • decreased appetite
  • dizziness
  • drowsiness
  • fear
  • irritability
  • muscle aches
  • nausea
  • runny nose
  • scalp hair loss
  • talking, feeling, and acting with excitement
  • vomiting

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