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This medication is used to treat attention deficit hyperactivity disorder – ADHD. It works by changing the amounts of certain natural substances in the brain. Methylphenidate 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.
How to use Ritalin
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).
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.
If you suddenly stop using this medication, you may have withdrawal symptoms (such as depression, suicidal 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.
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.
Tell your doctor if your condition does not improve or if it worsens.
RITALIN SIDE EFFECTS
The following are discussed in more detail in other sections of the labeling:
- Abuse and Dependence [see BOX WARNING , WARNINGS AND PRECAUTIONS , Drug Abuse And Dependence]
- Known hypersensitivity to methylphenidate or other ingredients of Ritalin and Ritalin-SR [see CONTRAINDICATIONS]
- Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS , DRUG INTERACTIONS]
- Serious Cardiovascular Reactions [see WARNINGS AND PRECAUTIONS]
- Blood Pressure and Heart Rate Increases [see WARNINGS AND PRECAUTIONS]
- Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Priapism [see WARNINGS AND PRECAUTIONS]
- Peripheral Vasculopathy, including Raynaud’s Phenomenon [see WARNINGS AND PRECAUTIONS]
- Long-term Suppression of Growth [see WARNINGS AND PRECAUTIONS]
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.
Adverse Reactions Reported With Ritalin And Ritalin-SR
Infections and Infestations: nasopharyngitis
Blood and the Lymphatic System Disorders: leukopenia, thrombocytopenia, anemia
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 hallucinations), depressed mood
Nervous System Disorders: headache, dizziness, tremor, dyskinesia including choreoatheetoid movements, drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs
Eye Disorders: blurred vision, difficulties in visual accommodation
Cardiac Disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris
Respiratory, Thoracic and Mediastinal Disorders: cough
Gastrointestinal Disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia
Hepatobiliary Disorders: abnormal liver function, 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
Investigations: weight loss (adult ADHD patients)
Additional Adverse Reactions Reported With Other Methylphenidate-Containing Products
The list below shows adverse reactions not listed for Ritalin and Ritalin-SR that have been reported with other methylphenidate-containing products.
Blood and Lymphatic Disorders: pancytopenia
Immune System Disorders: hypersensitivity reactions such as auricular swelling, bullous conditions, eruptions, exanthemas
Psychiatric Disorders: affect lability, mania, disorientation and libido
Nervous System Disorders: migraine
Eye Disorders: diplopia, mydriasis
Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole
Vascular Disorders: peripheral coldness, Raynaud’s phenomenon
Respiratory, Thoracic and Mediastinal Disorders: pharyngolaryngeal pain, dyspnea
Gastrointestinal Disorders: diarrhea, constipation
Skin and Subcutaneous Tissue Disorders: angioneurotic edema, erythema, fixed drug eruption
Musculoskeletal, Connective Tissue and bone Disorders: myalgia, muscle twitching
Renal and Urinary Disorders: hematuria
Reproductive System and Breast Disorders: gynecomastia
General Disorders: fatigue, hyperpyrexia
Urogenital Disorders: priapism
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic drugs (such as lisdexamfetamine); 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (such as Raynaud’s disease), certain mental/mood conditions (such as agitation, psychosis), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychotic disorder, suicidal thoughts), heart problems (including irregular heartbeat/rhythm, coronary artery disease, heart failure, cardiomyopathy, problems with the heart structure such as valve problems), family history of heart problems (such as sudden death/irregular heartbeat/rhythm), history of stroke, high blood pressure, overactive thyroid (hyperthyroidism), a certain eye problem (glaucoma), seizures, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), personal or family history of uncontrolled muscle movements (such as Tourette’s syndrome), kidney disease, liver disease.
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).
Children may be more sensitive to the side effects of this drug, especially weight loss. This medication may slow down a child’s growth. The doctor may recommend temporarily stopping the medication from time to time to reduce this risk. Monitor your child’s weight and height. Consult your doctor or pharmacist for more details.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who are dependent on this medication may be born too soon (premature) and have low birth weight. They may also have withdrawal symptoms. Tell your doctor right away if you notice possible mood changes, agitation, or unusual tiredness in your newborn.
This medication passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
Clinically Important Interactions With Ritalin And Ritalin-SR
Table 1 presents clinically important drug interactions with Ritalin and Ritalin-SR
Table 1: Clinically Important Drug Interactions with Ritalin and Ritalin-SR
|Monoamine Oxidase Inhibitors (MAOI)|
|Clinical Impact||Concomitant use of MAOIs and CNS stimulants, including Ritalin and Ritalin-SR can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see CONTRAINDICATIONS].|
|Intervention||Concomitant use of Ritalin or Ritalin-SR with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment is contraindicated.|
|Examples||selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue|
|Clinical Impact||Ritalin and Ritalin-SR may decrease the effectiveness of drugs used to treat hypertension [see WARNINGS AND PRECAUTIONS].|
|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 (ARBs), beta blockers, centrally acting alpha-2 receptor agonists|
|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|
Drug Abuse And Dependence
Ritalin and Ritalin-SR contain methylphenidate hydrochloride, a Schedule II controlled substance.
CNS stimulants, including Ritalin and Ritalin-SR, have a high potential for abuse. Abuse is characterized by impaired control over drug use despite harm, and craving.
Signs and symptoms of CNS stimulant abuse include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed. Abusers of CNS stimulants may chew, snort, inject, or use other unapproved routes of administration which may result in overdose and death [see OVERDOSE].
To reduce the abuse of CNS stimulants including Ritalin and Ritalin-SR, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants [see HOW SUPPLIED], monitor for signs of abuse while on therapy, and reevaluate the need for Ritalin and Ritalin-SR use.
Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug’s desired and/or undesired effects over time) can occur during chronic therapy with CNS stimulants, including Ritalin and Ritalin-SR.
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.
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 twitching, hallucinations, seizures, loss of consciousness.
Do not share this medication with others. Sharing it is against the law.
Laboratory and/or medical tests (such as blood pressure, complete 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.
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.
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.