Ritalin 10mg Tablets

Manufacturer NOVARTIS Active Ingredient Methylphenidate 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.
đŸˇī¸
Drug Class
Central Nervous System (CNS) Stimulant
đŸ§Ŧ
Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
🤰
Pregnancy Category
Category C
✅
FDA Approved
Mar 1955
âš–ī¸
DEA Schedule
Schedule II

Overview

â„šī¸

What is this medicine?

Methylphenidate is a medication used to treat attention-deficit/hyperactivity disorder (ADHD) and narcolepsy. It works by affecting certain natural chemicals in the brain that are involved in attention and impulse control. It can help improve focus, reduce hyperactivity, and manage sleepiness.
📋

How to Use This Medicine

Taking Your Medication

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication 30 to 45 minutes before meals. If you need to take this medication more than once a day, be sure to take your last dose before 6 PM.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. To prevent accidental ingestion, store your medication in a safe and secure location where children and pets cannot access it. Consider using a locked box or cabinet to keep your medication out of reach. When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about any local drug take-back programs.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, do not take your medication after 6 PM. If it's almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
💡

Lifestyle & Tips

  • Take exactly as prescribed by your doctor. Do not take more or less than directed.
  • Take the immediate-release tablets 30-45 minutes before meals.
  • Avoid taking doses late in the day (after 6 PM) to prevent sleep problems.
  • Do not crush, chew, or break extended-release forms of methylphenidate.
  • Avoid alcohol consumption while taking this medication.
  • Store in a safe place to prevent misuse or abuse.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • Maintain a healthy diet and regular exercise, especially for children, to support overall health and growth.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Initial: 5 mg orally 2 or 3 times daily, preferably 30-45 minutes before meals. Titrate weekly.
Dose Range: 10 - 60 mg

Condition-Specific Dosing:

ADHD: Initial: 5 mg orally 2 or 3 times daily. Max: 60 mg/day (immediate-release).
Narcolepsy: Initial: 10 mg orally 2 or 3 times daily. Max: 60 mg/day (immediate-release).
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial (â‰Ĩ6 years): 5 mg orally twice daily (before breakfast and lunch). Titrate weekly by 5-10 mg. Max: 60 mg/day (immediate-release).
Adolescent: Initial (â‰Ĩ6 years): 5 mg orally twice daily (before breakfast and lunch). Titrate weekly by 5-10 mg. Max: 60 mg/day (immediate-release).
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: Use with caution; consider lower initial doses and careful monitoring due to potential for accumulation of metabolites.
Dialysis: Not available; methylphenidate is not significantly dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; consider lower initial doses and careful monitoring due to extensive hepatic metabolism.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic effects in ADHD and narcolepsy are thought to be mediated through the blockade of norepinephrine and dopamine reuptake into the presynaptic neuron and increasing the release of these monoamines into the extraneuronal space. This leads to increased concentrations of norepinephrine and dopamine in the synaptic cleft.
📊

Pharmacokinetics

Absorption:

Bioavailability: Approximately 22-30% (due to first-pass metabolism)
Tmax: 1-2 hours (for immediate-release tablets)
FoodEffect: Food can delay Tmax and slightly decrease Cmax, but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 2.6 L/kg
ProteinBinding: Approximately 15%
CnssPenetration: Yes, readily crosses the blood-brain barrier.

Elimination:

HalfLife: Approximately 2-3 hours (for immediate-release tablets)
Clearance: Not available (highly variable)
ExcretionRoute: Primarily renal (approximately 90% excreted in urine as ritalinic acid)
Unchanged: Less than 1% of the dose is excreted unchanged in the urine.
âąī¸

Pharmacodynamics

OnsetOfAction: 30-60 minutes (for immediate-release tablets)
PeakEffect: 1-2 hours (for immediate-release tablets)
DurationOfAction: 3-4 hours (for immediate-release tablets)
Confidence: Medium

Safety & Warnings

âš ī¸

BLACK BOX WARNING

CNS stimulants, including Ritalin, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing Ritalin, and monitor patients for signs of abuse and dependence while on therapy.
âš ī¸

Side Effects

Important Side Effects to Report to Your Doctor Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ 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
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color, such as pale, blue, gray, purple, or red hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in the hands or feet
Sores or wounds on the 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, changes in balance, drooping on one side of the face, or blurred vision

Heart Problems

If you have a heart condition or defect, inform your doctor. Sudden deaths have occurred in people with certain heart problems. If you experience any signs of heart problems, such as chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting, seek medical attention immediately.

Erectile Dysfunction

If you experience a painful erection or an erection that lasts longer than 4 hours, seek medical attention immediately. This can occur even when you are not having sex. If left untreated, it may lead to lasting sexual problems.

Mental Health Changes

New or worsening behavior and mood changes, such as changes in thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental health problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. If you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life, seek medical attention immediately.

Serotonin Syndrome

A severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. If you experience agitation, changes in balance, confusion, hallucinations, fever, fast or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, upset stomach, or vomiting, or severe headache, seek medical attention immediately.

Other Side Effects

Most people do not experience side effects or only experience minor side effects. However, if you experience any of the following side effects or any other side effects that bother you or do not go away, inform your doctor:

Dizziness or headache
Feeling sleepy
Dry mouth
Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
Weight loss
Feeling nervous and excitable
Trouble sleeping
* Nose or throat irritation

Reporting Side Effects

If you have questions about side effects or want to report a side effect, call 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 (seek immediate medical attention)
  • New or worsening aggression, hostility, or irritability
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • New manic symptoms (e.g., extreme energy, racing thoughts)
  • Unexplained numbness, tingling, or coldness in fingers or toes
  • Prolonged or painful erections (priapism)
  • Blurred vision
  • Unexplained fever, sore throat, or other signs of infection (rare blood dyscrasias)
📋

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 conditions and situations to ensure safe treatment:

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)
A family history of:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
If you have ever experienced a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications 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 disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to your doctor and pharmacist. They will help you determine whether 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.
âš ī¸

Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before undergoing surgery, discuss this with your doctor.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. Regularly monitor your blood work, blood pressure, and heart rate as advised by your doctor. You may need to undergo certain heart tests before starting this medication; if you have questions or concerns, consult your doctor.

While taking this medication, it is recommended to avoid consuming alcohol. Additionally, limit your intake of caffeine (found in tea, coffee, cola) and chocolate, as combining these with the medication may cause nervousness, shakiness, and a rapid heartbeat.

If you have high blood pressure, consult your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Long-term use or high doses of this medication may lead to tolerance, reducing its effectiveness and potentially requiring higher doses to achieve the same effect. If you notice the medication is not working as well, contact your doctor. Do not exceed the prescribed dose.

This medication may increase the risk of seizures in certain individuals, including those with a history of seizures. Discuss your risk with your doctor. In some cases, this medication may affect growth in children and teenagers, requiring regular growth checks; consult your doctor for guidance.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to 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 (very high fever)
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis (dilated pupils)
  • Dry mouth and mucous membranes

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive, including gastric lavage, activated charcoal, and management of symptoms (e.g., benzodiazepines for agitation/seizures, alpha-blockers for hypertension).

Drug Interactions

đŸšĢ

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.
  • Anticoagulants (e.g., coumarin) - may inhibit metabolism, increasing anticoagulant effect.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, increasing anticonvulsant levels.
  • Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine) - may inhibit metabolism, increasing TCA levels and risk of adverse effects.
  • Selective Serotonin Reuptake Inhibitors (SSRIs) - potential for serotonin syndrome, though less common than with other stimulants.
🟡

Moderate Interactions

  • Antihypertensives - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
  • Dopaminergic drugs (e.g., levodopa, bromocriptine) - potential for additive dopaminergic effects.
  • Alcohol - may increase plasma levels of methylphenidate and exacerbate adverse effects.
đŸŸĸ

Minor Interactions

  • Caffeine - additive stimulant effects.

Monitoring

đŸ”Ŧ

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 (Pediatric Patients)

Rationale: Stimulants have been associated with growth suppression.

Timing: Prior to initiation of therapy.

Psychiatric History and Status

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

Timing: Prior to initiation of therapy.

Cardiac History and Physical Exam

Rationale: To screen for pre-existing cardiac conditions that may contraindicate use or require caution.

Timing: Prior to initiation of therapy.

📊

Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each dose adjustment and at least every 3-6 months thereafter.

Target: Within normal limits for age.

Action Threshold: Significant or sustained increases (e.g., >10-20 mmHg systolic/diastolic or >10-20 bpm HR) may require dose reduction or discontinuation.

Height and Weight (Pediatric Patients)

Frequency: Every 3-6 months.

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration may require drug holiday or alternative therapy.

Psychiatric Status (e.g., mood, anxiety, psychosis, aggression)

Frequency: Regularly, especially during dose titration and with any behavioral changes.

Target: Stable mood, absence of new or worsening psychiatric symptoms.

Action Threshold: Emergence of psychotic symptoms, mania, severe anxiety, or aggression requires immediate evaluation and potential discontinuation.

ADHD Symptom Control

Frequency: Regularly, to assess therapeutic efficacy.

Target: Improved attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.

đŸ‘ī¸

Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Manic symptoms
  • Severe anxiety
  • Persistent insomnia
  • Significant appetite suppression or weight loss
  • Blurred vision
  • Priapism (rare)

Special Patient Groups

🤰

Pregnancy

Methylphenidate is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown some evidence of developmental toxicity at high doses. Human data are limited but suggest a possible association with cardiac malformations and fetal growth restriction, though confounding factors are often present.

Trimester-Specific Risks:

First Trimester: Limited data, but some studies suggest a small increased risk of cardiac malformations (e.g., atrial septal defects) if exposed early in pregnancy. Data are inconsistent.
Second Trimester: Potential for fetal growth restriction and reduced birth weight, particularly with continued use.
Third Trimester: Potential for fetal growth restriction and reduced birth weight. Neonatal withdrawal symptoms (e.g., agitation, tremors) have been reported with chronic maternal use near term.
🤱

Lactation

Methylphenidate is excreted into breast milk. The American Academy of Pediatrics considers it a drug for which the effect on the nursing infant is unknown but may be of concern. Monitor breastfed infants for agitation, insomnia, poor feeding, and weight loss. Consider alternative therapies or discontinuing breastfeeding, especially in neonates or infants with underlying health issues. Lactation Risk Category L3 (Moderately Safe).

Infant Risk: Low to moderate. Potential for irritability, insomnia, decreased appetite, and weight loss in the infant. Long-term effects on neurodevelopment are unknown. Consider timing doses immediately after feeding to minimize infant exposure.
đŸ‘ļ

Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) regularly due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression). Use with caution in children with pre-existing cardiac conditions.

👴

Geriatric Use

Use with caution in elderly patients, generally starting with lower doses and titrating slowly, due to increased sensitivity to stimulant effects and higher prevalence of cardiovascular disease. Monitor blood pressure and heart rate closely.

Clinical Information

💎

Clinical Pearls

  • Immediate-release methylphenidate (Ritalin) has a short duration of action (3-4 hours), requiring multiple daily doses. This can be beneficial for flexible dosing (e.g., drug holidays on weekends) but may lead to 'rebound' effects as the drug wears off.
  • Food can delay the absorption of immediate-release methylphenidate, so it is often recommended to take it 30-45 minutes before meals.
  • Methylphenidate is primarily metabolized by carboxylesterase 1A1 (CES1A1) to an inactive metabolite, ritalinic acid, rather than CYP450 enzymes, which can simplify drug interaction profiles compared to some other stimulants.
  • Patients should be screened for cardiac abnormalities and psychiatric history (especially bipolar disorder or psychosis) before initiating therapy.
  • Growth suppression is a concern in pediatric patients; regular monitoring of height and weight is crucial. Drug holidays may be considered to mitigate this effect.
  • High potential for abuse and dependence; careful prescribing practices and monitoring for signs of misuse are essential.
🔄

Alternative Therapies

  • Amphetamine/dextroamphetamine (Adderall)
  • Lisdexamfetamine (Vyvanse)
  • Dexmethylphenidate (Focalin)
  • Atomoxetine (Strattera) - non-stimulant
  • Guanfacine extended-release (Intuniv) - non-stimulant
  • Clonidine extended-release (Kapvay) - non-stimulant
  • Bupropion (Wellbutrin) - off-label for ADHD
💰

Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (generic 10mg IR)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 or 4 (brand)
📚

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 provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.