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Ritalin is a prescription medicine used to treat the symptoms of attention deficit hyperactivity disorder ADHD and narcolepsy. Ritalin may be used alone or with other medications. These are not all the possible side effects of Ritalin. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system CNS stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral administration.
Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is Inactive Ingredients. Ritalin-SR tablets: Cellulose compounds, cetostearyl alcohol, lactose, magnesium stearate, mineral oil, povidone, titanium dioxide, and zein.
Prior to treating pediatric patients and adults with central nervous system CNS stimulants, including Ritalin or Ritalin- SR, assess for the presence of cardiac disease i. Assess the risk of abuse prior to prescribing, and monitor for s of abuse and dependence while on therapy. Start with 5 mg orally twice daily before breakfast and lunch. Increase dosage gradually, in increments of 5 to 10 mg weekly. Daily dosage above 60 mg is not recommended.
Average dosage is 20 to 30 mg daily. Administer orally in divided doses 2 or 3 times daily, preferably 30 to 45 minutes What does methylphenidate do meals. Maximum total daily dosage is 60 mg. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p. Ritalin-SR tablets have a duration of action of approximately 8 hours. Therefore, Ritalin-SR tablets 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 crushed or chewed. Pharmacological treatment of ADHD may be needed for extended periods. Periodically re-evaluate the long-term use of Ritalin and Ritalin-SR, and adjust dosage as needed. If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue Ritalin or Ritalin-SR. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
Comply with local laws and regulations on drug disposal of CNS stimulants.
Dispose of remaining, unused, or expired Ritalin and Ritalin-SR by a medicine takeback program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix Ritalin or Ritalin-SR with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard Ritalin or Ritalin-SR in the household trash. Revised: Jan The following adverse reactions associated with the use of all Ritalin, Ritalin-SR, and other methylphenidate products were identified in clinical trials, spontaneous reports, and literature.
Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis. Metabolism and Nutrition Disorders: decreased appetite, reduced weight gain, and suppression of growth during prolonged use in pediatric patients.
Psychiatric Disorders: insomnia, anxiety, restlessness, agitation, psychosis sometimes with visual and tactile hallucinationsdepressed mood. Nervous System Disorders: headache, dizziness, tremor, dyskinesia including choreoatheetoid movements, drowsiness, convulsions, cerebrovascular disorders including vasculitis, cerebral hemorrhages and cerebrovascular accidentsserotonin syndrome in combination with serotonergic drugs.
Cardiac Disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris. Hepatobiliary Disorders: abnormal liver What does methylphenidate do, ranging from transaminase elevation to severe hepatic injury. Skin and Subcutaneous Tissue Disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura. Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis.
The list below shows adverse reactions not listed for Ritalin and Ritalin-SR that have been reported with other methylphenidate-containing products. Immune System Disorders: hypersensitivity reactions such as auricular swelling, bullous conditions, eruptions, exanthemas.
Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole. Skin and Subcutaneous Tissue Disorders: angioneurotic edema, erythema, fixed drug eruption. Intervention Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.
Examples Potassium-sparing and thiazide diuretics, calcium channel blockers, angiotensin-converting-enzyme ACE inhibitors, angiotensin II receptor blockers ARBsbeta blockers, centrally acting alpha-2 receptor agonists Halogenated Anesthetics Clinical Impact Concomitant use of halogenated anesthestics and Ritalin or Ritalin-SR may increase the risk of sudden blood pressure and heart rate increase during surgery.
Intervention Avoid use of Ritalin or Ritalin-SR in patients being treated with anesthetics on the day of surgery. Examples halothane, isoflurane, enflurane, desflurane, sevoflurane. Abuse is characterized by impaired control over drug use despite harm, and craving. Anxiety, psychosishostility, aggression, and suicidal or homicidal ideation have also been observed. Physical dependence which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist may occur in patients treated with CNS stimulants including Ritalin and Ritalin-SR.
Withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams ; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. CNS stimulants, including Ritalin and Ritalin-SR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence.
Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious What does methylphenidate do problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known serious structural cardiac abnormalities, cardiomyopathyserious heart rhythm abnormalities, coronary artery diseaseand other serious heart problems.
Further evaluate patients who develop exertional chest pain, unexplained syncopeor arrhythmias during Ritalin and Ritalin-SR treatment. CNS stimulants cause an increase in blood pressure mean increase approximately 2 to 4 mmHg and heart rate mean increase approximately 3 to 6 bpm. Individuals may have larger increases.
Monitor all patients for hypertension and tachycardia.
CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode e. CNS stimulants, at recommended doses, may cause psychotic or manic symptoms e. If such symptoms occur, consider discontinuing Ritalin and Ritalin-SR.
In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0. Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients.
Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal drug holidays or during discontinuation. Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
s and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation e. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated patients over 36 months to the ages of 10 to 13 yearssuggests that consistently medicated pediatric patients i.
Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted. Advise patients that Ritalin and Ritalin-SR are controlled substances, and they can be abused and lead to dependence. Instruct patients that they should not give Ritalin or Ritalin-SR to anyone What does methylphenidate do. Advise patients to store Ritalin and Ritalin- SR in a safe place, preferably locked, to prevent abuse. Advise patients to comply with laws and regulations on drug disposal. Advise patients that there is a potential serious cardiovascular risk including sudden death, myocardial infarctionstroke, and hypertension with Ritalin and Ritalin-SR use.
Advise patients of the possibility of painful or prolonged penile erections priapism. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any s of unexplained wounds appearing on fingers or toes while taking Ritalin and Ritalin-SR.
Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors. Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay, in the in vitro mouse lymphoma cell forward mutation assay, or in the in vitro chromosomal aberration assay using human lymphocytes. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary CHO cells.
Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay. No human data on the effect of methylphenidate on fertility are available. Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an week continuous breeding study.
Adequate and well-controlled studies in pregnant women have not been conducted. Ritalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether methyphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Ritalin is administered to a nursing woman. The safety and effectiveness of Ritalin and Ritalin-SR in pediatric patients less than 6 years have not been established.
Growth should be monitored during treatment with stimulants, including Ritalin and Ritalin-SR. The clinical ificance of the long-term behavioral effects observed in rats is unknown. s and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitchingconvulsions which may be followed by comaeuphoriaconfusion, hallucinations, deliriumsweating, flushing, headache, hyperpyrexia, tachycardia, palpitationscardiac arrhythmias, hypertension, hypotensiontachypneamydriasisdryness of mucous membranes, and rhabdomyolysis.
Methylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD and narcolepsy is not known. Methylphenidate is a racemic mixture comprised of the d- and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer. Methylphenidate is thought to block the reuptake of norepinephrine and What does methylphenidate do into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
The effect of dexmethylphenidate, the pharmacologically active d-enantiomer of Ritalin, on the QT interval was evaluated in a double-blind, placebo- and open-label active moxifloxacin -controlled study following single doses of dexmethlyphenidate XR 40 mg maximum recommended adult total daily dosage in 75 healthy volunteers. Electrocardiograms ECGs were collected up to 12 hours postdose. This was below the threshold of clinical concern and there was no evident exposure response relationship.
Ritalin in the SR tablets is more slowly but as extensively absorbed as in the regular tablets. The time to peak rate in children was 1. Time to Cmax Tmax is faster after a high-fat meal median Tmax: 2. The volume of distribution was 2. The systemic clearance is 0. Methylphenidate is metabolized primarily by de-esterification to alpha-phenyl-piperidine acetic acid ritalinic acidwhich has little or no pharmacologic activity. The cumulative urinary excretion of alpha-phenylpiperidine acetic acid are not ificantly different for Ritalin-SR tablets.
No gender differences were observed for Ritalin plasma concentration in the same subjects. There is insufficient experience with the What does methylphenidate do of Ritalin and Ritalin-SR to detect ethnic variations in pharmacokinetics. Ritalin has not been studied in renally-impaired patients.What does methylphenidate do
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Methylphenidate: ADHD Medication Overview