Psych Drug Truth

Common Ritalin Side Effects

Ritalin should not be reduced quickly.

Ritalin

Anxiety - Insomnia - Agitation - Enlarged Heart - Stunted Growth

Ritalin withdrawal

 
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Ritalin withdrawal. Ritalin withdrawal side effects, withdrawal warnings, withdrawal precautions, withdrawal adverse effects, overdose, withdrawal symptoms and natural alternatives. Before you begin the spiral down with Ritalin, try giving your body what it really wants.

Ritalin
(Methylphenidate) 

Ritalin Side Effects

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CNS Stimulant

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)) showed dose-proportionality.

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.

In blood, 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.

Warnings Back to top of page

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.

Pregnancy:
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.

Lactation:
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.

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 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.

 


Precautions   Back to top of page

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.

Occupational Hazards:
Because Ritalin may affect performance, patients should be cautioned against engaging in hazardous activities such as operation of automobiles or dangerous machinery.

Drug Interactions:
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 with methylphenidate.

 


Adverse Effects   Back to top of page

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 Ritalin was 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.

Gastrointestinal:
Nausea and abdominal pain may occur at the start of treatment and may be alleviated if taken with food.

Cardiovascular:
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.

Hematologic:
Isolated cases of leukopenia, thrombocytopenia and anemia.

Other:
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).

 


Overdose   Back to top of page

Symptoms:
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.

Treatment:
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

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.

 


Supplied

Ritalin:
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.

Ritalin SR:
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.

Back to top of page

FDA News

FOR IMMEDIATE RELEASE
P07-26
February 21, 2007

Media Inquiries:
Sandy Walsh, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


 

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 concerns.

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 low self-esteem.

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 individual product.

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 product) Tablets
  • Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
  • Concerta (methylphenidate hydrochloride) Extended-Release Tablets
  • Daytrana (methylphenidate) Transdermal System
  • Desoxyn (methamphetamine HCl) Tablets
  • Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
  • Focalin (dexmethylphenidate hydrochloride) Tablets
  • Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
  • Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
  • Methylin (methylphenidate hydrochloride) Oral Solution
  • Methylin (methylphenidate hydrochloride) Chewable Tablets
  • Ritalin (methylphenidate hydrochloride) Tablets
  • Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
  • Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
  • Strattera (atomoxetine HCl) Capsules

The draft Patient Medication Guides for each product can be found at http://www.fda.gov/cder/drug/infopage/ADHD/default.htm. For more information please visit www.fda.gov.