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Methylphenidate hcl  a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control. Methylphenidate hcl  is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.

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Description

Methylphenidate hcl Uses

This medication is used to treat attention deficit hyperactivity disorder – ADHD. It works by changing the amounts of certain natural substances in the brainMethylphenidate belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.

This medication is also used to treat a certain sleep disorder (narcolepsy).

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How to use methylphenidate hcl

Read the Medication Guide provided by your pharmacist before you start taking methylphenidate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

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Take this medication by mouth as directed by your doctor, usually 2 or 3 times a day. This medication is best taken 30 to 45 minutes before a meal. However, if you have stomach upset, you may take this medication with or after a meal or snack. Taking this medication late in the day may cause trouble sleeping (insomnia).

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Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

The dosage is based on your medical condition and response to treatment. Your doctor may direct you to gradually increase or decrease your dose. Also, if you have used it for a long time, do not suddenly stop using this drug without consulting your doctor.

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If you suddenly stop using this medication, you may have withdrawal symptoms (such as depressionsuicidal thoughts, or other mental/mood changes). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used methylphenidate for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

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When used for a long time, this medication may not work as well. Talk with your doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

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Tell your doctor if your condition does not improve or if it worsens.

Methylphenidate hcl Effects

Nervousness, trouble sleeping, loss of appetite, weight lossdizzinessnauseavomiting, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

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This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: signs of blood flow problems in the fingers or toes (such as coldness, numbness, pain, or skin color changes), unusual wounds on the fingers or toes, fast/pounding/irregular heartbeat, mental/mood/behavior changes (such as agitation, aggression, mood swings, abnormal thoughts, thoughts of suicide), uncontrolled muscle movements (such as twitching, shaking), sudden outbursts of words/sounds that are hard to control, vision changes (such as blurred vision).

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Get medical help right away if you have any very serious side effects, including: faintingseizure, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), symptoms of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion).

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Rarely, males (including young boys and teens) may have a painful or prolonged erection lasting 4 or more hours while using this medication. Caregivers/parents should also be watchful for this serious side effect in boys. If a painful or prolonged erection occurs, stop using this drug and get medical help right away, or permanent problems could occur. Ask your doctor or pharmacist for more details.

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A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rashitching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Before taking methylphenidate, tell your doctor or pharmacist if you are allergic to it; or to dexmethylphenidate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressureblood circulation problems (such as Raynaud’s disease), glaucomaheart problems (such as irregular heartbeat, heart failure, previous heart attack, problems with heart structure), family history of heart problems (such as sudden cardiac death, irregular heartbeat), mental/mood conditions (especially anxiety, tension, agitation), personal/family history of mental/mood disorders (such as bipolar disorderdepressionpsychosissuicidal thoughts), personal/family history of uncontrolled muscle movements (motor ticsTourette’s syndrome), overactive thyroid (hyperthyroidism), seizure disorder.

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This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If used for a long time, this drug may affect a child’s growth rate, weight, and final adult height. To reduce the risk, the doctor may recommend briefly stopping the medication from time to time. Check the child’s weight and height regularly, and consult your doctor or pharmacist for more details.

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Older adults may be more sensitive to the side effects of this drug, especially trouble sleepingweight loss, or chest pain.

During pregnancy, methylphenidate should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

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Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazidlinezolid, methylene blue, moclobemide, phenelzineprocarbazinerasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Methylphenidate is very similar to dexmethylphenidate. Do not use medications containing dexmethylphenidate while using methylphenidate.

This medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson’s disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vomiting, agitation, confusion, sweating, flushing, muscle twitchinghallucinationsseizures, loss of consciousness.

Notes

Do not share this medication with others. Sharing it is against the law.

Laboratory and/or medical tests (such as blood pressurecomplete blood count, height/weight monitoring in children) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

There are different brands and forms of this medication available. Not all have the same effects. Do not change brands or forms without consulting your doctor or pharmacist.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near bedtime or near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised March 2019.

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Therapeutic indications

Ritalin is indicated as a part of a comprehensive treatment programme for attention-deficit hyperactivity disorder (ADHD) in children aged 6 years of age and over when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to DSM criteria or the guidelines in ICD and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptom.

The specific aetiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and specialised psychological, educational and social resources.

A comprehensive treatment programme typically includes psychological, educational and social measures as well as pharmacotherapy and is aimed at stabilising children with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal EEG. Learning may or may not be impaired.

Methylphenidate treatment is not indicated in all children with this syndrome and the decision to use the drug must be based on a very thorough assessment of the severity and the chronicity of the child’s symptoms in relation to the child’s age.

Appropriate educational placement is essential, and psychosocial intervention is generally necessary. Where remedial measures alone prove insufficient, the decision to prescribe a stimulant must be based on rigorous assessment of the severity of the child’s symptoms. The use of methylphenidate should always be used in the way according to the licensed indication and according to the prescribing/diagnostics guidelines.

Dose titration

Careful dose titration is necessary at the start of treatment with methylphenidate. Dose titration should be started at the lowest possible dose.

The maximum daily dose is 60mg.

Other strengths of this medicinal product and other methylphenidate containing products may be available.

Children: (over 6 years). Begin with 5mg once or twice daily (e.g. at breakfast and lunch), increasing the dose and frequency of administration if necessary by weekly increments of 5-10mg in the daily dose. Doses above 60mg daily are not recommended. The total daily dose should be administered in divided doses. Ritalin is not indicated in children less than 6 years of age.

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 may help to solve this problem.

Long term (more than 12 months) use in children and adolescents

The safety and efficacy of long term use of methylphenidate has not been systematically evaluated in controlled trials. Methylphenidate treatment should not and need not, be indefinite. Methylphenidate treatment is usually discontinued during or after puberty. The physician who elects to use methylphenidate for extended periods (over 12 months) in children and adolescents with ADHD should periodically re-evaluate the long term usefulness of the drug for the individual patient with trial periods off medication to assess the patient’s functioning without pharmacotherapy. It is recommended that methylphenidate is de-challenged at least once yearly to assess the child’s condition (preferable during school holidays). Improvement may be sustained when the drug is either temporarily or permanently discontinued.

Dose reduction and discontinuation

Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a one-month period. If paradoxical aggravation of symptoms or other serious adverse events occur, the dosage should be reduced or discontinued.

• Adults

Ritalin Tablets are not licensed for use in adults with ADHD. Safety and efficacy have not yet been established in this age group.

• Elderly

Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in this age group.

• Children under 6 years of age

Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.

• Hepatic impairment

Ritalin has not been studied in patients with hepatic impairment. Caution should be exercised in these patients.

• Renal impairment

Ritalin has not been studied in patients with renal impairment. Caution should be exercised in these patients.

Contraindications

• Known sensitivity to methylphenidate or to any of the excipients in Ritalin.

• Glaucoma

• Phaechromocytoma

• During treatment with monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to risk of hypertensive crisis

• Hyperthyroidism or thyrotoxicosis

• Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder.

• Diagnosis or history of severe and episodic (Type 1) Bipolar (affective) disorder (that is not well controlled)

• Pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels)

• Pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities including vasculitis or stroke or known risk factors for cerebrovascular disorders

Special warnings and precautions for use

Methylphenidate treatment is not indicated in all children with ADHD and the decision to use the drug must be based on a very thorough assessment of the severity and chronicity of the child’s symptoms in relation to the child’s age.

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