Ritalin SR 20mg Tablets
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose in the morning. Some medications require food in the stomach, while others should be taken on an empty stomach. Consult your pharmacist to determine the best approach for this specific medication. Swallow the tablet whole, without chewing, breaking, or crushing it.
Storing and Disposing of Your Medication
Store this medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep the medication in a secure location, out of sight and reach of children, and inaccessible to others. Consider using a locked box or area to prevent unauthorized access. Also, keep all medications away from pets.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take the medication exactly as prescribed, usually once daily in the morning.
- Do not crush, chew, or divide Ritalin SR tablets, as this will destroy the sustained-release mechanism and could lead to a sudden release of the entire dose.
- Avoid alcohol, as it can cause the medication to be released too quickly.
- Maintain a regular sleep schedule, as stimulants can cause insomnia.
- Report any new or worsening heart problems, psychiatric symptoms, or unusual behaviors to your doctor immediately.
- For children, monitor height and weight regularly as advised by the doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Severe headache, dizziness, or fainting
Joint pain
Purple patches on the skin or mouth
Changes in vision or eye pain, swelling, or redness
Seizures
Shakiness or tremors
Difficulty controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Changes in sex drive
Weakness on one side of the body, trouble speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Sudden deaths have occurred in people with certain heart problems or defects. If you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor.
Heart-Related Side Effects:
If you experience any of the following symptoms, seek immediate medical attention:
Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting
Other Serious Side Effects:
Prolonged or painful erections (lasting more than 4 hours). If left untreated, this can lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking or behavior
+ Anger or hallucinations
+ Depression, suicidal thoughts, or anxiety
Serotonin syndrome, a potentially life-threatening condition that can occur when taking this medication with certain other drugs. Symptoms include:
+ Agitation
+ Balance problems
+ Confusion
+ Hallucinations
+ Fever
+ Abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, upset stomach, or vomiting
+ Severe headache
Common Side Effects:
Many people taking this medication may experience mild or no side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
Dizziness or headache
Drowsiness
Dry mouth
Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
Weight loss
Feeling nervous or excitable
Sleep disturbances
* Nose or throat irritation
Reporting Side Effects:
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (signs of heart problems)
- New or worsening aggression, hostility, or unusual behaviors
- Seeing or hearing things that are not real (psychosis)
- Feeling unusually high, irritable, or having racing thoughts (mania)
- Numbness, tingling, or color changes in fingers or toes (Raynaud's phenomenon)
- Unexplained wounds on fingers or toes
- Blurred vision or other eye problems
- Severe headache
- Seizures
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
If you or a family member has a history of:
+ Blood vessel disease
+ High blood pressure (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
If you have ever experienced a stroke
Recent use of certain medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
Current use of certain medications, such as:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. As directed by your doctor, undergo regular blood tests, blood pressure checks, and heart rate monitoring. Additionally, you may need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.
While taking this medication, it is recommended that you avoid consuming alcohol. Limit your intake of caffeine-containing products, such as tea, coffee, and cola, as well as chocolate, as combining these with this medication may cause nervousness, shakiness, and a rapid heartbeat.
If you have high blood pressure, consult with your doctor before using over-the-counter (OTC) products that may increase blood pressure, including cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.
Long-term or high-dose use of this medication may lead to tolerance, reducing its effectiveness and potentially requiring higher doses to achieve the same effect. If you notice that this medication is no longer working as well as it should, contact your doctor. Do not exceed the prescribed dose.
This medication may increase the risk of seizures in certain individuals, particularly those with a history of seizures. Discuss your risk of seizures with your doctor. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to determine the best course of action.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- 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
- Dryness of mucous membranes
What to Do:
Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is generally supportive, including gastric lavage, activated charcoal, and management of symptoms like hypertension, arrhythmias, and convulsions.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis.
Major Interactions
- Vasopressors (e.g., phenylephrine, pseudoephedrine) - risk of increased blood pressure.
- Halogenated Anesthetics (e.g., halothane, isoflurane) - risk of sudden blood pressure and heart rate increases during surgery.
- Coumarin Anticoagulants (e.g., warfarin) - may inhibit metabolism of coumarin anticoagulants, requiring dose adjustment.
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism of these drugs, requiring dose adjustment.
- Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine) - may inhibit metabolism of TCAs, requiring dose adjustment.
Moderate Interactions
- Antihypertensive medications - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
- Dopaminergic drugs (e.g., levodopa, bromocriptine) - potential for additive dopaminergic effects.
Minor Interactions
- Alcohol - may accelerate the release of methylphenidate from extended-release formulations, leading to higher peak plasma levels.
Monitoring
Baseline Monitoring
Rationale: CNS stimulants can cause dose-related increases in BP and HR.
Timing: Prior to initiation of therapy.
Rationale: Growth suppression has been reported with long-term stimulant use in children.
Timing: Prior to initiation of therapy (pediatric patients).
Rationale: To screen for pre-existing cardiac conditions that may contraindicate stimulant use.
Timing: Prior to initiation of therapy.
Rationale: To screen for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis) that may be exacerbated.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Regularly (e.g., at each visit or every 3-6 months)
Target: Within normal limits for age/patient
Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm HR) warrant investigation and potential dose adjustment or discontinuation.
Frequency: Every 3-6 months (pediatric patients)
Target: Normal growth trajectory
Action Threshold: Significant growth deceleration or weight loss warrants investigation and potential drug holiday or alternative therapy.
Frequency: Regularly (e.g., at each visit)
Target: Stable mood, absence of new or worsening psychotic/manic symptoms
Action Threshold: Emergence or worsening of aggression, hostility, new psychotic symptoms, or manic episodes warrants immediate evaluation and potential discontinuation.
Frequency: Regularly (e.g., at each visit)
Target: Improved attention, reduced hyperactivity/impulsivity
Action Threshold: Lack of efficacy or intolerable side effects warrant dose adjustment or change in therapy.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- New or worsening aggression
- Hostility
- Psychotic symptoms (e.g., hallucinations, delusions)
- Manic symptoms (e.g., elevated mood, increased energy, decreased need for sleep)
- Anxiety
- Insomnia
- Loss of appetite
- Nervousness
- Dizziness
- Headache
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data from observational studies suggest a possible increased risk of cardiac malformations with first-trimester exposure to methylphenidate, but these findings are inconsistent.
Trimester-Specific Risks:
Lactation
L3 (Moderately safe). Methylphenidate is excreted into breast milk. Monitor breastfed infants for agitation, insomnia, decreased appetite, or poor weight gain. Consider alternative therapies or close monitoring.
Pediatric Use
Approved for children 6 years and older. Long-term use in children has been associated with growth suppression (weight and height). Monitor growth parameters regularly. Cardiovascular and psychiatric risks also apply.
Geriatric Use
Safety and efficacy have not been established in geriatric patients. Use with caution due to potential for increased sensitivity to stimulant effects, including cardiovascular and psychiatric adverse events. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- Ritalin SR is a sustained-release formulation, designed for once-daily dosing, typically in the morning, to provide effect throughout the school/work day.
- Patients should be advised not to crush, chew, or divide the tablets to maintain the sustained-release properties and prevent dose dumping.
- Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial due to potential cardiovascular and growth-related side effects.
- Careful psychiatric screening is necessary before initiation, as stimulants can exacerbate pre-existing psychotic or manic conditions.
- Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
- Consider drug holidays or dose adjustments if growth suppression is observed in pediatric patients.
- Avoid concomitant use with MAOIs due to the risk of hypertensive crisis.
Alternative Therapies
- Other methylphenidate formulations (e.g., Concerta, Daytrana, Focalin, Quillivant XR, Aptensio XR, Jornay PM)
- Amphetamine-based stimulants (e.g., Adderall, Vyvanse, Dexedrine)
- Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy (often used in conjunction with pharmacotherapy for ADHD)