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  • Ritalin
    / Novartis


    Active Ingredient
    Methylphenidate HCl 10 mg, 20 mg, 30 mg, 40 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    30 X 10 mg

    full basket chart 1908 18070

    Tablets

    30 X 20 mg SR

    partial basket chart 23358 18292

    Modified-Release Capsules

    30 X 10 mg LA

    full basket chart 10222 18473

    Modified-Release Capsules

    30 X 20 mg LA

    full basket chart 61781 18324

    Modified-Release Capsules

    30 X 30 mg LA

    full basket chart 61782 18325

    Modified-Release Capsules

    30 X 40 mg LA

    full basket chart 61783 18326

    Related information


    Dosage

    General: The dosage of Ritalin should be individualised according to the patient’s clinical needs and responses. In the treatment of ADHD, an attempt should be made to time administration to coincide with the periods of greatest academic, behavioural, or social stress. Ritalin should be started at a low dose, with increments at weekly intervals. Daily doses above 60 mg are not recommended for the treatment of narcolepsy, or for the treatment of ADHD in children. Daily doses above 80 mg are not recommended for the treatment of ADHD in adults. If symptoms do not improve after dose titration over a period of one month, the drug should be discontinued. If symptoms worsen or other adverse effects occur, the dosage should be reduced or, if necessary, the drug discontinued. If the effect of the drug wears off too early in the evening, disturbed behaviour and/or inability to go to sleep may recur. A small evening dose of Ritalin tablet or an afternoon dose of the Ritalin SR tablet may help to solve this problem.
    Special populations
    Renal impairment: No studies have been performed in renally impaired patients.
    Hepatic impairment: No studies have been performed in hepatically impaired patients.
    Geriatric patients: No studies have been performed in patients over 60 years of age.
    Pre-treatment screening: Before initiating Ritalin treatment, patients should be assessed for pre-existing cardiovascular and psychiatric disorders and a family history of sudden death, ventricular arrhythmia and psychiatric disorders.
    ADHD
    Children (6 years and over) and adolescents:

    Ritalin Tablets: Start with 5 mg once or twice daily (e.g. at breakfast and lunch) with weekly increments of 5 to 10 mg. The total daily dosage should be administered in divided doses.
    Ritalin SR Tablets: Ritalin SR tablets have a duration of action of about 8 hours. They may therefore be used when a prolonged effect is desired exceeding the duration of action of standard Ritalin tablets.
    Ritalin LA Capsules: Ritalin LA (methylphenidate hydrochloride modified-release capsules) is for oral administration once daily in the morning. The recommended starting dose of Ritalin LA is 20 mg. When in the judgement of the clinician a lower initial dose is appropriate, patients may begin treatment with Ritalin LA 10 mg. A maximum daily dose of 60 mg should not be exceeded.
    Adults:
    Ritalin LA Capsules: Ritalin LA is administered as a single dose once daily. Ritalin LA provides comparable overall exposure (AUC) of methylphenidate compared to the same total dose of Ritalin tablets administered twice daily.
    Patients new to methylphenidate: The recommended starting dose of Ritalin LA in patients who are not currently taking methylphenidate is 20 mg once daily.
    Patients currently using methylphenidate: Treatment may be continued with the same daily dose. A maximum daily dose of 80 mg should not be exceeded. There is no difference in dosing recommended between male and female adult patients.
    Narcolepsy
    Only the Ritalin and Ritalin SR formulations are approved in the treatment of narcolepsy in adults.
    It may be necessary to use a combination of the standard immediate release and SR tablets in some patients to achieve the optimal clinical response.
    Adults:
    Ritalin Tablets: The average daily dose is 20 to 30 mg, given in 2 to 3 divided doses. Some patients may require 40 to 60 mg daily, while for 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 Tablets: Ritalin SR tablets have duration of action of about 8 hours. They may therefore be used when a prolonged effect is desired exceeding the duration of action of standard Ritalin tablets. The total daily dose should be similar to that required if the immediate formulation is used. In the fasted state, Ritalin SR 20 mg gives similar blood concentration to those expected following two Ritalin 10 mg immediate release tablets (with the second being taken four hours after the first). A maximum daily dose of 60 mg should not be exceeded.
    For full details see prescribing information.


    Indications

    Ritalin 10 mg, Ritalin SR 20 mg, Ritalin LA 10mg, 20mg, 30mg, 40mg: Attention deficit hyperactivity disorder (ADHD).
    Ritalin and Ritalin SR only: Ritalin/Ritalin SR is indicated in the treatment of narcolepsy.


    Contra-Indications

    Hypersensitivity to methylphenidate or to any of the excipients. Anxiety, tension. Agitation. Hyperthyroidism. Pre-existing cardiovascular disorders including severe hypertension, angina, arterial occlusive disease; heart failure, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels). During treatment with monoamine oxidase (MAO) inhibitors, or within a minimum of 2 weeks of discontinuing those drugs, due to risk of hypertensive crisis. Glaucoma. Phaeochromocytoma. Diagnosis or family history of Tourette’s syndrome.


    Special Precautions

    General: Treatment with Ritalin is not indicated in all cases of Attention-Deficit/Hyperactivity disorder, and should be considered only after detailed history-taking and evaluation. The decision to prescribe Ritalin should depend on an assessment of the severity of symptoms and in paediatric patients, the appropriateness to the child’s age, and not simply on the presence of one or more abnormal behavioural characteristics. Where these symptoms are associated with acute stress reactions, treatment with Ritalin is usually not indicated.
    Cardiovascular
    Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems: Sudden death has been reported in association with the use of stimulants of the central nervous system at usual doses in patients with structural cardiac abnormalities or other serious problems.
    Cardiovascular Conditions: Ritalin is contraindicated in patients with severe hypertension.
    Misuse and Cardiovascular Events: Misuse of stimulants of the central nervous system, including Ritalin, may be associated with sudden death and other serious cardiovascular adverse events.
    Cerebrovascular
    Cerebrovascular conditions:
    Patients with pre-existing central nervous system (CNS) abnormalities, e.g., cerebral aneurysm and/or other vascular abnormalities such as vasculitis or pre-existing stroke should not be treated with Ritalin. Patients with additional risk factors (history of cardiovascular disease, concomitant medications that elevate blood pressure) should be assessed regularly for neurological/psychiatric signs and symptoms after initiating treatment with Ritalin.
    Psychiatric: Co-morbidity of psychiatric disorders in ADHD is common and should be taken into account when prescribing stimulant products. Prior to initiating treatment with Ritalin, patients should be assessed for pre-existing psychiatric disorders and a family history of psychiatric disorders. Treatment of ADHD with stimulant products including Ritalin should not be initiated in patients with acute psychosis, acute mania or acute suicidality. These acute conditions should be treated and controlled before ADHD treatment is considered. In the case of emergent psychiatric symptoms or exacerbation of pre-existing psychiatric symptoms, Ritalin should not be given to patients unless the benefit outweighs the potential risk.
    Serotonin syndrome: Serotonin syndrome has been reported following co-administration of methylphenidate with serotonergic drugs such as selective serotonin reuptake inhibitors (SSRIs) and serotoninnorepinephrine reuptake inhibitors (SNRIs). The concomitant use of methylphenidate and serotonergic drugs is not recommended as this may lead to the development of serotonin syndrome. The symptoms of serotonin syndrome may include mental status changes (e.g. agitation, hallucinations, delirium, and coma), autonomic instability (e.g. tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g. tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Prompt recognition of these symptoms is important so that treatment with methylphenidate and serotonergic drugs can be immediately discontinued and appropriate treatment instituted.
    Growth retardation: Moderately reduced weight gain and slight growth retardation have been reported with the long-term use of stimulants, including Ritalin, in children.
    Seizures: Ritalin should be used with caution in patients with epilepsy as clinical experience has shown that it can cause an increase in seizure frequency in a small number of such patients. If seizure frequency increases, Ritalin should be discontinued.
    Withdrawal: Careful supervision is required during drug withdrawal, since this may unmask depression as well as the effects of chronic over activity. Some patients may require long-term follow-up.
    Paediatric patients (under 6 years of age): Ritalin should not be used in children under 6 years of age, since safety and efficacy in this age group have not been established.
    Driving and using machines: Ritalin may cause dizziness, drowsiness, blurred vision, hallucinations or other CNS side effects. Patients experiencing such side effects should refrain from driving, operating machinery, or engaging in other potentially hazardous activities.
    For full details see prescribing information.


    Side Effects

    Nervousness and insomnia are very common adverse reactions which occur at the beginning of Ritalin treatment but can usually be controlled by reducing the dosage and/or omitting the afternoon or evening dose. Decreased appetite is also very common but usually transient. Abdominal pain, nausea and vomiting are common to very common, usually occur at the beginning of treatment and may be alleviated by concomitant food intake.
    Infections and infestations Very common: Nasopharyngitis
    Metabolism and nutrition disorders  Common: Decreased appetite
    Psychiatric disorders  Very common: Nervousness, insomnia. Common: Anxiety, restlessness, sleep disorder, agitation
    Nervous system disorders  Common: Dyskinesia, tremor, headache, drowsiness, dizziness
    Cardiac disorders  Common: Tachycardia, palpitation, arrhythmias, changes in blood pressure and heart rate (usually an increase).
    Respiratory, Thoracic and mediastinal disorders Common: Cough
    Gastrointestinal disorders Very common: nausea, dry mouth. Common: Abdominal pain, vomiting, dyspepsia, toothache
    Skin and subcutaneous tissue disorders  Common: Rash, pruritus, urticaria, fever, scalp hair loss, hyperhidrosis
    Musculoskeletal and connective tissue disorders  Common: Arthralgia.
    General disorders and administration site conditions Common: Feeling jittery
    Investigations Common: Weight decreased
    For full details see prescribing information.


    Drug interactions

    Pharmacodynamic interactions
    Anti-hypertensive drugs:  Methylphenidate may decrease the effectiveness of drugs used to treat hypertension.
    Use with drugs that elevate blood pressure: This drug should be used with caution in patients being treated with drugs that elevate blood pressure. Because of possible hypertensive crisis, it is contraindicated in patients being treated (currently or within the preceding 2 weeks) with MAO-inhibitors.
    Use with alcohol: Alcohol may exacerbate the adverse CNS effects of psychoactive drugs. It is therefore advisable for patients to abstain from alcohol during treatment.
    Use with anesthetics: There is a risk of sudden blood pressure and heart rate increase during surgery. If surgery is planned, it should not be taken on the day of surgery.
    Use with centrally acting alpha-2 agonists (e.g. clonidine): Serious adverse events including sudden death have been reported in concomitant use with clonidine, although no causality for the combination has been established.
    Use with dopaminergic drugs: As an inhibitor of dopamine reuptake, this drug may be associated with pharmacodynamic interactions when co-administered with direct and indirect dopamine agonists (including DOPA and tricyclic antidepressants) as well as dopamine antagonists (antipsychotics, e.g. haloperidol). The co-administration of this drug with antipsychotics is not recommended because of the counteracting mechanism of action.
    Use with serotonergic drugs: The concomitant use of methylphenidate and serotonergic drugs is not recommended as this may lead to the development of serotonin syndrome. Methylphenidate has been shown to increase extracellular serotonin and norepinephrine and appears to have weak potency in binding serotonin transporter.
    Pharmacokinetic interactions: Methylphenidate is not metabolized by cytochrome P450 to a clinically relevant extent. Inducers or inhibitors of cytochrome P450 are not expected to have any relevant impact on pharmacokinetics. Conversely, the d- and l- enantiomers of methylphenidate did not relevantly inhibit cytochrome P450 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A. Co-administration did not increase plasma concentrations of the CYP2D6 substrate desipramine. Case reports suggested a potential interaction with coumarin anticoagulants, some anticonvulsants (e.g. phenobarbital, phenytoin, primidone), phenylbutazone, and tricyclicantidepressants but pharmacokinetic interactions were not confirmed when explored at larger sample sizes. The dosage of these drugs might have to be reduced. An interaction with the anticoagulant ethylbiscoumacetate in 4 subjects was not confirmed in a subsequent study with a larger sample size (n=12). Other specific drug-drug interaction studies have not been performed in vivo.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy: There is insufficient experience with use of methylphenidate in pregnant women. This drug should not be given to pregnant women unless the potential benefit outweighs the risk to the fetus. Methylphenidate is potentially teratogenic in rabbits.
    Breast-feeding: Case reports showed that methylphenidate was distributed into breast milk reaching a milk-to-plasma ratio of approximately 2.5. A decision should be made whether to abstain from breast-feeding or to abstain from the therapy, taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.
    For full details see prescribing information.


    Overdose

    Signs and symptoms: Signs and symptoms of acute overdose, mainly due to overstimulation of the central and sympathetic nervous systems, may include: vomiting, agitation, tremor, hyperreflexia, muscle twitching, convulsions (possibly followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitation, cardiac arrhythmias, hypertension, mydriasis, dryness of mucous membranes and rhabdomyolysis.
    Management: When treating an overdose, practitioners should bear in mind that a second release of methylphenidate from methylphenidate hydrochloride modified-release capsules occurs approximately four hours after administration. Management consists in providing supportive measures, and symptomatic treatment of life-threatening events, e.g. hypertensive crisis, cardiac arrhythmias, convulsions. For the most current guidance for treatment of symptoms of overdose, the practitioner should consult a certified Poison Control Center or current toxicological publication. Supportive measures include preventing self-injury and protecting the patient from external stimuli that would exacerbate the overstimulation already present. If the overdose is oral and the patient is conscious, the stomach could be evacuated by induction of vomiting, followed by administration of activated charcoal. Airway protected gastric lavage is necessary in hyperactive or unconscious patients, or those with depressed respiration. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required to reduce hyperpyrexia. The efficacy of peritoneal dialysis or extracorporeal hemodialysis for methylphenidate overdose has not been established. Clinical experience with acute overdose is limited. Patients who have received doses higher than those recommended should be carefully monitored. In the event of overdose leading to clinically significant hypocalcaemia, reversal may be achieved with supplemental oral calcium and/or an infusion of calcium gluconate.
    For full details see prescribing information.


    Important notes

    Storage: Ritalin tablet 10 mg: Do not store above 25°C. Store in the original package in order to protect from moisture.
    Ritalin SR tablet 20 mg: Store below 25°C. Store in the original package in order to protect from moisture.
    Ritalin LA capsules 10mg, 20 mg, 30 mg and 40mg: Store below 30°C. Keep the bottle tightly closed in order to protect from moisture. After first opening of the bottle use within 6 months.


    Manufacturer
    Novartis Pharma Stein AG Switzerland
    Licence holder
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