Ritalin SR 20mg Tablets

Manufacturer NOVARTIS Active Ingredient Methylphenidate Controlled- Release Tablets(meth il FEN i date) Pronunciation METH-il-FEN-i-date
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It is used to treat narcolepsy.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Central Nervous System Stimulant
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Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor
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Pregnancy Category
Category C
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FDA Approved
Aug 1955
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Ritalin SR is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain that are involved in attention and impulse control. The 'SR' means 'sustained release,' so the tablet releases the medicine slowly over several hours, usually allowing for once-daily dosing.
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How to Use This Medicine

Taking Your Medication

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.
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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.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial 20 mg once daily in the morning. May increase by 10-20 mg weekly.
Dose Range: 20 - 60 mg

Condition-Specific Dosing:

ADHD: Initial 20 mg once daily in the morning. Dosage may be adjusted in increments of 10-20 mg weekly. Maximum daily dose is 60 mg.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 6 years and older: Initial 20 mg once daily in the morning. Dosage may be adjusted in increments of 10-20 mg weekly. Maximum daily dose is 60 mg.
Adolescent: Initial 20 mg once daily in the morning. Dosage may be adjusted in increments of 10-20 mg weekly. Maximum daily dose is 60 mg.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution. Monitor for adverse effects.
Dialysis: Not available

Hepatic Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution. Monitor for adverse effects.
Confidence: Medium

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The therapeutic effect in ADHD is believed to be related to its ability to increase dopamine and norepinephrine levels in the prefrontal cortex, improving attention, focus, and impulse control.
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Pharmacokinetics

Absorption:

Bioavailability: ~30% (due to first-pass metabolism)
Tmax: Ritalin SR: Biphasic release, with initial peak at 1-2 hours and a second peak at approximately 6.8 hours.
FoodEffect: Food may delay Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Not available (widely distributed)
ProteinBinding: 10-15%
CnssPenetration: Yes

Elimination:

HalfLife: Ritalin SR: Approximately 3.5 hours (for methylphenidate).
Clearance: Not available
ExcretionRoute: Renal (urine)
Unchanged: <1% (as unchanged drug)
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Pharmacodynamics

OnsetOfAction: Ritalin SR: Approximately 1-2 hours (initial effect)
PeakEffect: Ritalin SR: Approximately 6.8 hours (second peak)
DurationOfAction: Ritalin SR: Approximately 8 hours
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence during therapy.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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.
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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
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

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.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.

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.
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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

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis.
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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.
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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.
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Minor Interactions

  • Alcohol - may accelerate the release of methylphenidate from extended-release formulations, leading to higher peak plasma levels.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: CNS stimulants can cause dose-related increases in BP and HR.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: Growth suppression has been reported with long-term stimulant use in children.

Timing: Prior to initiation of therapy (pediatric patients).

Cardiac History and Physical Exam

Rationale: To screen for pre-existing cardiac conditions that may contraindicate stimulant use.

Timing: Prior to initiation of therapy.

Psychiatric History

Rationale: To screen for pre-existing psychiatric conditions (e.g., bipolar disorder, psychosis) that may be exacerbated.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

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.

Height and Weight

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.

Psychiatric Symptoms

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.

ADHD Symptom Control

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.

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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

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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:

First Trimester: Possible increased risk of cardiac malformations (inconsistent data).
Second Trimester: Limited data, potential for fetal growth restriction.
Third Trimester: Limited data, potential for neonatal withdrawal symptoms (agitation, tremor, poor feeding) if used near term.
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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.

Infant Risk: Low to moderate risk of adverse effects. Monitor for irritability, sleep disturbances, and feeding issues.
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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.

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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

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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.
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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)
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Cost & Coverage

Average Cost: $100 - $300 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for brand name), Tier 1 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.