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The mode of action in man is not completely understood, but
Ritalin presumably activates the brain stem arousal system and cortex to produce its stimulant effect.
There is neither specific evidence which clearly establishes the mechanism whereby methylphenidate produces its mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the CNS.
Ritalin is rapidly and extensively absorbed from the tablets following oral administration; however, owing to extensive first-pass metabolism, bioavailability is low (approx. 30%) and large individual differences exist (11 to 52%).
In one study, the administration of
Ritalin with food accelerated absorption, but had no effect on the amount absorbed.
Peak plasma concentrations of 10.8 and 7.8 ng/mL were observed, on average, 2 hours after administration of 0.30 mg/kg in children and adults, respectively. However, peak plasma concentrations showed marked variability between subjects. Both the area under the plasma concentration curve (AUC), and the peak plasma concentrations (C(max))
Ritalin is eliminated from the plasma with a mean
half-life of 2.4 hours in children and 2.1 hours in adults. The apparent mean
systemic clearance is 10.2 and 10.5 L/hr/kg in children and adults, respectively
for a 0.3 mg/kg dose. These data indicate that the pharmacokinetic behavior of
methylphenidate in hyperactive children is similar to that in normal adults. The
apparent distribution volume of
Ritalin in children was approximately 20 L/kg, with substantial variability (11 to 33 L/kg).
Following oral administration of
Ritalin, 78 to 97% of the dose is excreted in the urine and 1 to 3% in the feces in the form of metabolites within 48 to 96 hours. The main urinary metabolite is ritalinic acid (alpha-phenyl-2-piperidine acetic acid, PPAA); unchanged
Ritalin is excreted in the urine in small quantities
(<1%). Peak PPAA plasma concentrations occurred at approximately the same time as peak
Ritalin concentrations, however, levels were several-fold greater than those of the unchanged drug. The half-life of PPAA was approximately twice that of
Ritalin and its metabolites are distributed between plasma (57%) and erythrocytes (43%).
Ritalin and its metabolites exhibit low plasma protein binding (approx. 15%).
Ritalin in the extended-release tablets is more slowly but as extensively absorbed as in the regular tablets. Relative bioavailability of the Ritalin SR tablet, compared to the Ritalin tablet, measured by the urinary excretion of the
Ritalin major metabolite (PPAA), was 105% (49 to 168%) in children and 101% (85% to
152%) in adults. The time to peak rate in children was 4.7 hours (1.3 to 8.2 hours) for the extended-release tablets and 1.9 hours (0.3 to 4.4 hours) for the regular tablets. The elimination half-life and the cumulative urinary excretion of PPAA are not significantly different between the two dosage forms. An average of 67% of the
extended-release tablet dose was excreted in children as compared to 86% in adults.
Ritalin should not be used in children under 6 years of age, since safety and efficacy in this age group have not been established.
Although a causal relationship has not been established, suppression of growth (i.e. 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. In addition, the use of "Drug Holidays" is recommended, that is,
withholding the drug on weekends and during school holidays in as much as the clinical situation permits.
Ritalin should not be used for severe depression of either exogenous or endogenous origin. Clinical experience suggests that in psychotic children, administration of
Ritalin may exacerbate symptoms of behavior disturbance and thought disorder.
Ritalin should not be used for the prevention or treatment of normal fatigue states.
There is some clinical evidence that
Ritalin may lower the convulsive threshold in patients with prior history of seizures, with prior EEG abnormalities in absence of seizures and, very rarely, in patients with no prior EEG evidence nor history of seizures. Safe concomitant use of anticonvulsants and
Ritalin has not
been established. In the presence of seizures, the drug should be discontinued.
Use cautiously in patients with hypertension. Blood pressure should be monitored at appropriate intervals in all patients taking
Ritalin, especially those with hypertension.
Adequate animal reproduction studies to establish safe use of Ritalin during pregnancy have not been conducted. Therefore, until more information is available, the use of
Ritalin in pregnancy is not recommended.
It is not known whether the active substance of Ritalin and/or its metabolites pass into breast milk. For safety reasons, mothers taking
Ritalin should refrain from breast feeding their infants.
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 parenteral abuse. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked.
Long-term follow-up may be required because of the patient's basic personality disturbances.
Available clinical data indicate that treatment with
Ritalin during childhood and/or adolescence does not seem to result in increased predisposition for addiction.
Patients with an element of agitation may react adversely; discontinue therapy if necessary.
Periodic CBC, differential, and platelet counts are advised during prolonged therapy.
Drug treatment is not indicated in all cases of Attention Deficit Hyperactivity Disorders and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe methylphenidate should depend on the physician's assessment of the chronicity and severity of the child's symptoms and their
appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics. When these symptoms are associated with acute stress reactions, treatment with methylphenidate is usually not indicated.
Long-term effects of
Ritalin in children have not been well established.
Because Ritalin may affect performance, patients should be cautioned against engaging in hazardous activities such as operation of automobiles or dangerous machinery.
Ritalin may decrease the hypotensive effect of guanethidine. Use cautiously with pressor agents and MAO inhibitors.
Human pharmacologic studies have shown that
Ritalin may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone and tricyclic antidepressants (imipramine, desipramine). Downward dosage adjustments of these drugs may be required when given concomitantly
Nervousness and insomnia are the most common adverse reactions reported with methylphenidate but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Decreased appetite is also common but usually transient.
Central and Peripheral Nervous System:
Dizziness, drowsiness, headache, and dyskinesia may occur. Isolated cases of the following have been reported: hyperactivity, convulsions, muscle cramps, choreo-athetoid movements, tics, or exacerbation of pre-existing tics, Tourette's syndrome, and psychotic episodes including hallucinations which subsided when
discontinued. Psychic dependence in emotionally unstable persons has occurred rarely with chronic treatment. Although a definite causal relationship has not been established, isolated cases of transient depressed mood have been reported.
Symptoms of visual disturbances have been encountered in rare cases. Difficulties with accommodation and blurring of vision have been reported.
Nausea and abdominal pain may occur at the start of treatment and may be alleviated if taken with food.
Palpitations, blood pressure and pulse changes (both up and down), tachycardia, angina and cardiac arrhythmias.
Skin and/or Hypersensitivity:
Rash, pruritus, urticaria, fever, arthralgia, and alopecia. Isolated cases of exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura.
Isolated cases of leukopenia, thrombocytopenia and anemia.
Weight loss during prolonged therapy.
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. Minor retardation of growth may also occur during prolonged therapy in children (see Warnings).
Signs and symptoms of acute overdosage, resulting principally from CNS overstimulation and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors,
hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache,
hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis and dryness of mucous membranes.
Appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. If signs and symptoms are not too severe and the patient is conscious, gastric contents may be evacuated by induction of emesis or gastric lavage. In the presence of severe
intoxication, use a carefully titrated dosage of short-acting barbiturate before performing gastric lavage.
Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
Efficacy of peritoneal dialysis or extracorporeal hemodialysis for methylphenidate overdosage has not been established.
Dosage should be individualized according to the needs and responses of the patient.
Children (6 years and over): Ritalin tablets:
Should be initiated in small doses, (e.g. 5 to 10 mg 3 times daily) with weekly increments of 5 to 10 mg in the daily dosage. Dosage should be individualized on the basis of factors such as age, body weight and individual response. Timing of drug administration should be aimed to coincide with periods of greatest academic, behavioral and
social difficulties for the patient.
Daily dosage above 60 mg is not recommended.
If improvement is not observed after appropriate dosage adjustments over a 1 month period, the drug should be discontinued.
Ritalin SR (extended-release) tablets:
Ritalin SR tablets have a duration of action of approximately 8 hours. Therefore, they may be used in place of Ritalin tablets when the 8 hour dosage of Ritalin SR corresponds to the titrated 8 hour dosage of Ritalin. Ritalin SR tablets must be swallowed whole and never be crushed or chewed.
If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or if necessary, discontinue the drug.
Ritalin should be periodically discontinued to assess the child's condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.
Adults: Ritalin tablets:
Administer in divided doses 2 or 3 times daily, preferably 30 to 40 minutes before meals. Average daily dosage is 20 to 30 mg. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day, should take the last dose before 6 p.m.
Ritalin SR (extended-release) tablets:
SR tablets have a duration of action of approximately 8 hours. Therefore, they may be used in place of Ritalin tablets when the 8 hour dosage of Ritalin SR corresponds to the titrated 8 hour dosage of Ritalin. Ritalin SR tablets must be swallowed whole and never be crushed or chewed.
Each pale blue, round, scored tablet, imprinted CIBA on one side and AB on the other, contains: Methylphenidate HCl 10 mg. Energy: 1.88 kJ (0.45 kcal). Each light yellow, round, scored tablet, imprinted CIBA on one side and PN on the other, contains: Methylphenidate HCl 20 mg. Energy: 2.4 kJ (0.58 kcal). Both strengths contain lactose.
Alcohol-free, bisulfite-free, gluten-free, parabens-free, sodium-free and
tartrazine-free. Bottles of 100 and 500.
Protect from heat and humidity.
Each white, round, coated extended-release tablet, imprinted CIBA on one side and 16 on the other, contains: Methylphenidate HCl 20 mg. Energy: 1.55 kJ (0.37 kcal). Also contains lactose. Alcohol-free, bisulfite-free, gluten-free, parabens-free, sodium-free and tartrazine-free free. Bottles of 100.
Sandy Walsh, 301-827-6242 Consumer Inquiries:
FDA Directs ADHD
Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and
Psychiatric Adverse Events
The U.S. Food and Drug Administration (FDA) today directed the
manufacturers of all drug products approved for the treatment of Attention
Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to
alert patients to possible cardiovascular risks and risks of adverse psychiatric
symptoms associated with the medicines, and to advise them of precautions that
can be taken.
"Medicines approved for the treatment of ADHD have real
benefits for many patients but they may have serious risks as well," said Steven
Galson, M.D., Director, Center for Drug Evaluation and Research (CDER). "In our
ongoing commitment to strengthen drug safety, FDA is working closely with
manufacturers of all ADHD medicines to include important information in the
product labeling and in developing new Patient Medication Guides to better
inform doctors and patients about these concerns."
Patient Medication Guides are handouts given to patients,
families and caregivers when a medicine is dispensed. The guides contain
FDA-approved patient information that could help prevent serious adverse events.
Patients being treated with ADHD products should read the information before
taking the medication and talk to their doctors if they have any questions or
ADHD is a condition that affects approximately 3 percent to 7
percent of school-aged children and approximately 4 percent of adults. The three
main symptoms are inattention, hyperactivity, and impulsivity. People with ADHD
may have difficulty in school, troubled relationships with family and peers, and
An FDA review of reports of serious cardiovascular adverse
events in patients taking usual doses of ADHD products revealed reports of
sudden death in patients with underlying serious heart problems or defects, and
reports of stroke and heart attack in adults with certain risk factors.
Another FDA review of ADHD medicines revealed a slight
increased risk (about 1 per 1,000) for drug-related psychiatric adverse events,
such as hearing voices, becoming suspicious for no reason, or becoming manic,
even in patients who did not have previous psychiatric problems.
FDA recommends that children, adolescents, or adults who are
being considered for treatment with ADHD drug products work with their physician
or other health care professional to develop a treatment plan that includes a
careful health history and evaluation of current status, particularly for
cardiovascular and psychiatric problems (including assessment for a family
history of such problems).
As part of the Agency’s ongoing regulatory activity, in May
2006 the FDA directed manufacturers of these products to revise product labeling
for doctors to reflect concerns about adverse cardiovascular and psychiatric
events. These changes were based on recommendations from the FDA Pediatric
Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
To help patients understand these risks, an additional part of this revised
labeling process is the creation of a Patient Medication Guide for each
The medicines that are the focus of the revised labeling and
new Patient Medication Guides include the following 15 products:
Adderall (mixed salts of a single entity amphetamine
Adderall XR (mixed salts of a single entity amphetamine
product) Extended-Release Capsules