from the Physicians' Desk Reference®
Pronounced: RIT-ah-lin
Generic name: Methylphenidate hydrochloride
Other brand names: Concerta, Metadate, Methylin
RITALIN-SR® methylphenidate hydrochloride USP sustained-release tablets.
- Ritalin should not be used in children under six years, since safety and efficacy in this age group have not been established. Sufficient data on safety and efficacy of long-term use of Ritalin in children are not yet available. Although a causal relationship has not been established, suppression of growth (ie, weight gain, and/or height) has been reported with the long-term use of stimulants in children. Therefore, patients requiring long-term therapy should be carefully monitored.
ADVERSE REACTIONS
Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizzines; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy. There have been rare reports of Tourette's syndrome. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: leukopenia and/or anemia; a few instances of scalp hair loss. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.
DRUG DEPENDENCE
Ritalin should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative. Chronically abusive use can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parental abuse. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic over activity can be unmasked. Long-term follow-up may be required because of the patient's basic personality disturbances.
Why is this drug prescribed?
Ritalin and other brands of methylphenidate are mild central nervous system stimulants used in the treatment of attention deficit hyperactivity disorder in children. With the exception of Ritalin LA, Concerta and Metadate CD, these products are also used in adults to treat narcolepsy (an uncontrollable desire to sleep).
When given for attention deficit disorder, this drug should be an integral part of a total treatment program that includes psychological, educational, and social measures. Symptoms of attention deficit disorder include continual problems with moderate to severe distractibility, short attention span, hyperactivity, emotional changeability, and impulsiveness.
Most important fact about this drug
Excessive doses of this drug over a long period of time can produce addiction. It is also possible to develop tolerance to the drug, so that larger doses are needed to produce the original effect. Because of these dangers, be sure to check with your doctor before making any change in dosage; and withdraw the drug only under your doctor's supervision.
How should you take this medication?
Follow your doctor's directions carefully. It is recommended that methylphenidate be taken 30 to 45 minutes before meals. If the drug interferes with sleep, give the child the last dose before 6 p.m. Ritalin-SR, Ritalin LA, Metadate CD, Methylin ER, and Concerta are long-acting forms of the drug, taken less frequently. They should be swallowed whole, never crushed or chewed. (Ritalin LA and Metadate CD may also be given by sprinkling the contents of the capsule on a tablespoon of cool applesauce and administering immediately, followed by a drink of water.)
--If you miss a dose...
Give it to the child as soon as you remember. Give the remaining doses for the day at regularly spaced intervals. Do not give 2 doses at once.
--Storage instructions...
Keep out of reach of children. Store below 86 degrees Fahrenheit in a tightly closed, light-resistant container. Protect Ritalin-SR from moisture.
What side effects may occur?
Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue giving this drug.
More common side effects may include:
Inability to fall or stay asleep, nervousness
These side effects can usually be controlled by reducing the dosage and omitting the drug in the afternoon or evening.
In children, loss of appetite, abdominal pain, weight loss during long-term therapy, inability to fall or stay asleep, and abnormally fast heartbeat are more common side effects.
Less common or rare side effects may include:
Abdominal pain, abnormal heartbeat, abnormal muscular movements, blood pressure changes, chest pain, dizziness, drowsiness, fever, hair loss, headache, hives, jerking, joint pain, loss of appetite, nausea, palpitations (fluttery or throbbing heartbeat), pulse changes, rapid heartbeat, reddish or purplish skin spots, skin reddening, skin inflammation with peeling, skin rash, Tourette's syndrome (severe twitching), weight loss during long-term treatment
Why should this drug not be prescribed?
This drug should not be prescribed for anyone experiencing anxiety, tension, and agitation, since the drug may aggravate these symptoms.
Anyone sensitive or allergic to this drug should not take it.
This medication should not be taken by anyone with the eye condition known as glaucoma, anyone who suffers from tics (repeated, involuntary twitches), or someone with a family history of Tourette's syndrome (severe and multiple tics).
This drug is not intended for use in children whose symptoms may be caused by stress or a psychiatric disorder.
This medication should not be used for the prevention or treatment of normal fatigue, nor should it be used for the treatment of severe depression.
This drug should not be taken during treatment with drugs classified as monoamine oxidase inhibitors, such as the antidepressants Nardil and Parnate, nor for the 2 weeks following discontinuation of these drugs.
Special warnings about this medication
Your doctor will do a complete history and evaluation before prescribing this drug. He or she will take into account the severity of the symptoms, as well as your child's age.
This drug should not be given to children under 6 years of age; safety and effectiveness in this age group have not been established.
There is no information regarding the safety and effectiveness of long-term treatment in children. However, suppression of growth has been seen with the long-term use of stimulants, so your doctor will watch your child carefully while he or she is taking this drug.
Blood pressure should be monitored in anyone taking this drug, especially those with high blood pressure.
Some people have had visual disturbances such as blurred vision while being treated with this drug.
The use of this drug by anyone with a seizure disorder is not recommended. Be sure your doctor is aware of any problem in this area. Caution is also advisable for anyone with a history of emotional instability or substance abuse, due to the danger of addiction.
Possible food and drug interactions
when taking this medication
If this medication is taken with certain other drugs, the effects of either can be increased, decreased, or altered. It is especially important to check with your doctor before combining this drug with the following:
Antiseizure drugs such as phenobarbital, Dilantin and Mysoline
Antidepressant drugs such as Tofranil, Anafranil, Norpramin, and Effexor
Blood thinners such as Coumadin
Clonidine (Catapres-TTS)
Drugs that restore blood pressure, such as EpiPen
Guanethidine (Ismelin)
MAO inhibitors (drugs such as the antidepressants Nardil and Parnate)
Phenylbutazone
This drug should not be given to children under 6 years of age. Drug treatment should not, and need not, be indefinite and usually can be discontinued after puberty.
Overdosage
If you suspect an overdose, seek medical attention immediately.
Symptoms of Ritalin overdose may include:
Agitation, confusion, convulsions (may be followed by coma), delirium, dryness of mucous membranes, enlarging of the pupil of the eye, exaggerated feeling of elation, extremely elevated body temperature, flushing, hallucinations, headache, high blood pressure, irregular or rapid heartbeat, muscle twitching, sweating, tremors, vomiting
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