Ritalin 20mg Tablets

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 thought to be due to increased dopamine and norepinephrine in the prefrontal cortex, improving attention and executive function.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Severe headache, dizziness, or fainting
Joint pain
Purple patches on the skin or mouth
Changes in eyesight 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 (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold feeling 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, changes in balance, drooping on one side of the face, or blurred vision

Heart Problems: Important Warning

Sudden deaths have occurred in people with certain heart problems or defects. Inform your doctor if you have any heart condition or defect. Also, let your doctor know if a family member has an abnormal heartbeat or died suddenly. Seek medical help immediately if you experience any signs of heart problems, such as:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting

Other Serious Side Effects

Painful erection (hard penis) or an erection lasting longer than 4 hours (even when not having sex). If not treated promptly, this may lead to lasting sexual problems.
New or worsening behavior and mood changes, such as changes in thinking, anger, or hallucinations. Inform your doctor if you or a family member have a history of mental or mood problems, such as depression or bipolar illness, or if a family member has committed suicide.

Serotonin Syndrome: A Potentially Life-Threatening Condition

This condition may occur if you take this medication with certain other drugs. Seek medical help immediately if you experience any of the following symptoms:

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
Severe headache

Common Side Effects

Most people do not experience serious side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

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 any, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects online at https://www.fda.gov/medwatch.

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, such as foods or drugs. Describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ 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 had a stroke
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can cause very high blood pressure)
If you are currently taking:
+ Linezolid
+ Methylene blue

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:

Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins

Your doctor and pharmacist need to be aware of all your medications and health conditions to ensure it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without consulting your doctor first.

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. As directed by your doctor, undergo regular blood tests, blood pressure checks, and heart rate monitoring. You may need to undergo certain heart tests before starting this medication; if you have questions, 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. If you find that the medication is no longer 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 of seizures with your doctor. In some cases, this medication may affect growth in children and teenagers, requiring regular growth checks; consult your doctor about this.

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.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation)

• Vasopressors (e.g., phenylephrine, pseudoephedrine): May potentiate pressor effects.
• Halogenated Anesthetics (e.g., halothane, isoflurane): Risk of sudden blood pressure and heart rate increases during surgery.
• Anticoagulants (e.g., warfarin): 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.

• Antihypertensives: May counteract the blood pressure lowering effect.
• Dopaminergic drugs (e.g., levodopa): May potentiate dopaminergic effects.
• Alcohol: May increase plasma levels of methylphenidate and lead to dose dumping with extended-release formulations.

• Caffeine: Additive stimulant effects.

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening aggression
• Hallucinations
• Delusions
• Mania
• Suicidal ideation
• Unexplained wounds on fingers/toes (Raynaud's phenomenon)
• Persistent priapism

Methylphenidate is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data from observational studies have not shown an increase in the overall rate of major birth defects or a consistent pattern of specific birth defects with methylphenidate exposure during the first trimester.

Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding. However, monitor breastfed infants for adverse reactions such as agitation, insomnia, or decreased weight gain.

Approved for use in 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). Long-term safety and efficacy in children under 6 years have not been established.

Use with caution in elderly patients. Start with lower doses and titrate slowly due to increased sensitivity to adverse effects, particularly cardiovascular and psychiatric effects. No specific dosage adjustments are generally recommended based solely on age, but individual patient factors should be considered.

• Methylphenidate IR has a short duration of action (3-4 hours), requiring multiple daily doses. Extended-release formulations are available for once-daily dosing.
• Timing of doses is crucial to optimize therapeutic effect and minimize sleep disturbances. Avoid late afternoon/evening doses of IR formulations.
• Patients should be screened for pre-existing cardiac conditions and psychiatric disorders before initiating therapy.
• Regular monitoring of blood pressure, heart rate, and growth (in children) is essential.
• Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
• Consider a 'drug holiday' (e.g., weekends or school breaks) in pediatric patients to assess the need for continued therapy and potentially mitigate growth suppression, though this practice is controversial and should be discussed with a physician.

• Other CNS Stimulants (e.g., Amphetamine salts, Lisdexamfetamine, Dexmethylphenidate)
• Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
• Antidepressants (e.g., Bupropion - off-label for ADHD)
• Behavioral therapy
• Cognitive behavioral therapy (CBT)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 your prescription is refilled. 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.