Ritalin 5mg 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 precise mechanism of action in ADHD is not fully understood but is thought to involve modulation of dopaminergic and noradrenergic pathways in the brain, particularly in the prefrontal cortex.

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 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 eyesight or eye pain, swelling, or redness
Seizures
Shakiness
Trouble controlling body movements
Difficulty controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color, including pale, blue, gray, purple, or red discoloration of 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, 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. If a family member has an abnormal heartbeat or died suddenly, notify your doctor. 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, which can occur even when not having sex. If left untreated, this may lead to lasting sexual problems.
New or worsening behavior and mood changes, such as changes in thinking, anger, or hallucinations. 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, inform your doctor. Seek medical help immediately if you experience:
+ Hallucinations
+ Changes in behavior
+ Signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life
Serotonin syndrome, a potentially life-threatening condition, may occur if you take this medication with certain other drugs. Seek medical help immediately 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
+ Severe headache

Common Side Effects

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

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

Reporting Side Effects

If you have questions about side effects or experience any side effects not listed here, 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.

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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
A family 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
Recent use of certain medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
Current use of:
+ Linezolid
+ Methylene blue

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. Never 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, have 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 any questions or concerns, consult with 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 with 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 or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you notice the medication is not working as well as it previously did, 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, and regular growth checks may be necessary. Consult with your doctor to discuss this further.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of this medication to both you and your baby.

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

• 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., 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 cardiovascular effects.
• Selective Serotonin Reuptake Inhibitors (SSRIs) - potential for serotonin syndrome (rare, but possible with high doses or other serotonergic agents).

• Antihypertensive medications - methylphenidate may reduce the effectiveness of antihypertensive drugs.
• Alcohol - may increase plasma levels of methylphenidate and lead to dose dumping with extended-release formulations.
• Dopaminergic drugs (e.g., levodopa) - theoretical risk of additive dopaminergic effects.

• Caffeine - additive stimulant effects.

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening tics
• Aggression
• Hostility
• New psychotic symptoms (e.g., hallucinations, delusions)
• Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
• Severe anxiety or agitation
• Unexplained weight loss
• Insomnia
• Anorexia

Methylphenidate is Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Methylphenidate is excreted into breast milk. The American Academy of Pediatrics considers methylphenidate to be a drug for which the effect on the nursing infant is unknown but may be of concern. Monitor infants for irritability, poor feeding, and sleep disturbances. L3 (Moderate Risk).

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) and cardiovascular parameters. Assess for emergence of psychiatric symptoms (e.g., tics, psychosis, mania). Not recommended for children under 6 years due to insufficient data on safety and efficacy.

Use with caution in elderly patients, as they may be more sensitive to the effects of stimulants, particularly cardiovascular and psychiatric adverse effects. Start with lower doses and titrate slowly. Monitor blood pressure, heart rate, and psychiatric status closely.

• Immediate-release methylphenidate has a short duration of action, requiring multiple daily doses, which can be challenging for adherence.
• Consider a 'drug holiday' (e.g., weekends or school breaks) for pediatric patients to assess baseline symptoms, minimize growth suppression, and reduce tolerance, but this should be discussed with a physician.
• Patients should be screened for pre-existing cardiac conditions and psychiatric disorders before initiating methylphenidate.
• Educate patients and caregivers about the potential for abuse and dependence.
• Food can delay absorption but does not significantly affect the total amount absorbed (AUC) for immediate-release formulations, so it can be taken with food if stomach upset occurs.
• The 5mg tablet is often used for initial titration or for fine-tuning doses in patients who are sensitive to the medication.

• Other CNS Stimulants (e.g., Amphetamine salts (Adderall), Lisdexamfetamine (Vyvanse), Dexmethylphenidate (Focalin))
• Non-stimulants (e.g., Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay))
• Behavioral therapy (e.g., Cognitive Behavioral Therapy, Parent Training in Behavior Management)

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. 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 consumed, and the time it occurred.