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Methylphenidate 5mg Tablets

Manufacturer MALLINCKRODT 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.
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Drug Class
Central Nervous System (CNS) Stimulant
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Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
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Pregnancy Category
Category C
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FDA Approved
Mar 1955
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DEA Schedule
Schedule II

Overview

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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, helping to improve focus and reduce hyperactivity and impulsivity.
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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 30 to 45 minutes before meals. If you take this medication more than once a day, be sure to take your last dose before 6 PM.

Storing and Disposing of Your Medication

Keep your medication at room temperature, away from light and moisture. Store it in a dry place, such as a closet or cupboard, and avoid storing it in a 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 area 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 potential drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, do not take a missed dose after 6 PM. If it's close to the 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.
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Lifestyle & Tips

  • Take exactly as prescribed by your doctor. Do not take more or less than directed.
  • Take the medication 30-45 minutes before meals for best absorption, if tolerated.
  • Avoid taking the last dose too late in the day (e.g., after 6 PM) to prevent sleep problems.
  • Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
  • Do not stop taking this medication suddenly without consulting your doctor, as withdrawal symptoms may occur.
  • For children, regular monitoring of height and weight is important to check for potential growth effects.
  • Maintain a healthy diet and regular exercise routine.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: For ADHD: Initial 5 mg orally two or three times daily, 30-45 minutes before meals. For Narcolepsy: Initial 10 mg orally two or three times daily. Titrate weekly.
Dose Range: 5 - 60 mg

Condition-Specific Dosing:

ADHD: Initial 5 mg BID or TID, titrate weekly by 5-10 mg. Max 60 mg/day.
Narcolepsy: Initial 10 mg BID or TID, titrate weekly by 10 mg. Max 60 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For ADHD (>=6 years): Initial 5 mg orally twice daily (before breakfast and lunch). Increase dosage weekly by 5-10 mg. Max 60 mg/day.
Adolescent: For ADHD: Initial 5 mg orally twice daily (before breakfast and lunch). Increase dosage weekly by 5-10 mg. Max 60 mg/day.
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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 well studied. Use with caution and monitor for adverse effects.

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.

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 exact mechanism by which it produces its therapeutic effects in ADHD and narcolepsy is not fully understood.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 30%
Tmax: 1-2 hours (for immediate-release tablets)
FoodEffect: Food can delay Tmax and decrease Cmax, but overall extent of absorption (AUC) is generally not significantly affected.

Distribution:

Vd: Approximately 2.6 L/kg
ProteinBinding: Approximately 15%
CnssPenetration: Yes

Elimination:

HalfLife: 2-3 hours (for immediate-release tablets)
Clearance: Not available
ExcretionRoute: Primarily renal (urine)
Unchanged: Less than 1% of the dose is excreted unchanged in the urine.
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Pharmacodynamics

OnsetOfAction: 30-45 minutes (for immediate-release tablets)
PeakEffect: 1-2 hours (for immediate-release tablets)
DurationOfAction: 3-6 hours (for immediate-release tablets)

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including methylphenidate, have a high potential for abuse and dependence. Administration of CNS stimulants for prolonged periods of time may lead to drug dependence. Misuse of CNS stimulants may cause sudden death and serious cardiovascular adverse events. Patients should be carefully evaluated for a history of drug abuse and observed for signs of misuse or abuse.
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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
+ 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
 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

Important Heart-Related Warnings

If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or has died suddenly, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, including:

Chest pain
 Abnormal heartbeat
Shortness of breath
 Severe dizziness or fainting

Other Serious Side Effects

Prolonged or painful erections (lasting more than 4 hours) can lead to permanent sexual dysfunction if not treated promptly.
 New or worsening behavioral and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
If you or a family member have a history of mental or mood disorders, 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, including 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, can occur when taking this medication with certain other drugs. Seek immediate medical attention 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 severe side effects, but some may encounter mild or moderate side effects. If you experience any of the following, 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
 Trouble sleeping
* 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 (seek immediate medical attention)
  • New or worsening aggression, hostility, or irritability
  • New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • New or worsening manic symptoms (e.g., feeling unusually excited, restless, or irritable)
  • New or worsening tics (uncontrolled repetitive movements or sounds)
  • Numbness, coolness, or pain in fingers or toes, or unexplained wounds on fingers or toes (signs of circulation problems)
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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, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
 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 experienced 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 this medication with these drugs can lead to 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 needs 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.
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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. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. 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 and limit your intake of caffeine (found in tea, coffee, cola) and chocolate, as combining these substances with the medication may cause nervousness, shakiness, and a rapid heartbeat.

If you have high blood pressure, it is crucial to discuss with your doctor before using any 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 that the 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. Consult with your doctor to determine if you are at a higher risk of seizures while taking this medication.

In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need 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)
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia (very high fever)
  • Tachycardia (fast heart rate)
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension (high blood pressure)
  • Mydriasis (dilated pupils)
  • Dry mucous membranes

What to Do:

In case of overdose, call your poison control center at 1-800-222-1222. If the person has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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)
  • Patients with marked anxiety, tension, and agitation
  • Patients with glaucoma
  • Patients with motor tics or Tourette's syndrome or family history of Tourette's syndrome
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Major Interactions

  • Vasopressor agents (e.g., phenylephrine, pseudoephedrine) - potentiates pressor effects
  • Halogenated anesthetics (e.g., halothane, isoflurane) - risk of sudden increases in blood pressure and heart rate during surgery
  • Tricyclic Antidepressants (TCAs) - may potentiate effects of TCAs
  • Antipsychotics (e.g., haloperidol) - may antagonize effects of antipsychotics or increase risk of extrapyramidal symptoms
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Moderate Interactions

  • Anticoagulants (e.g., warfarin) - may inhibit metabolism, requiring dose adjustment
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, requiring dose adjustment
  • Antihypertensive drugs - may reduce the effectiveness of antihypertensive agents
  • Selective Serotonin Reuptake Inhibitors (SSRIs) - caution due to potential for serotonin syndrome, though less common than with MAOIs
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Minor Interactions

  • Not available

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: To monitor for potential growth suppression in pediatric patients.

Timing: Prior to initiation of therapy.

Psychiatric History (e.g., bipolar disorder, psychosis, tics/Tourette's syndrome)

Rationale: To assess risk of new or worsening psychiatric symptoms.

Timing: Prior to initiation of therapy.

Family History of Sudden Cardiac Death or Arrhythmias

Rationale: To identify patients at increased risk for cardiovascular events.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit or at least every 3-6 months.

Target: Within normal limits for age/sex.

Action Threshold: Persistent elevation (e.g., >95th percentile for age/sex or clinically significant increase) warrants dose reduction or discontinuation.

Height and Weight (for pediatric patients)

Frequency: Every 3-6 months.

Target: Consistent growth along growth curves.

Action Threshold: Significant deviation from expected growth curve or growth deceleration warrants evaluation and potential dose adjustment or drug holiday.

Psychiatric Status (e.g., emergence of new or worsening psychosis, mania, tics, aggression)

Frequency: At each visit.

Target: Stable mood, absence of psychotic symptoms or tics.

Action Threshold: Emergence of new or worsening symptoms warrants immediate evaluation and potential discontinuation.

ADHD Symptom Control

Frequency: At each visit.

Target: Improved focus, reduced impulsivity and hyperactivity.

Action Threshold: Lack of efficacy or intolerable side effects warrants dose adjustment or alternative therapy.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope (fainting)
  • Palpitations
  • New or worsening aggression
  • New or worsening psychotic symptoms (e.g., hallucinations, paranoia)
  • New or worsening manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
  • New or worsening tics
  • Unexplained wounds on fingers or toes (due to peripheral vasculopathy)

Special Patient Groups

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Pregnancy

Methylphenidate is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited human data; animal studies show some evidence of developmental toxicity at high doses.
Second Trimester: Limited human data; continued monitoring for fetal growth and development is advised if continued.
Third Trimester: Limited human data; potential for withdrawal symptoms in the neonate if used close to delivery.
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Lactation

Methylphenidate is excreted into human 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, or weight loss.

Infant Risk: L3 (Moderately safe; limited controlled studies show no adverse effect, or only minor non-serious adverse effects. Risk of adverse effects is possible.)
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Pediatric Use

Approved for use in children 6 years of age and older for ADHD. Long-term safety and efficacy in children younger than 6 years have not been established. Monitor growth (height and weight) regularly due to potential for growth suppression.

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Geriatric Use

Use with caution in elderly patients. Start with lower doses and titrate slowly, as elderly patients may be more sensitive to the effects of CNS stimulants, particularly cardiovascular effects. Monitor for cardiovascular adverse events and psychiatric symptoms.

Clinical Information

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Clinical Pearls

  • Methylphenidate immediate-release (IR) typically has a duration of action of 3-6 hours, requiring multiple daily doses.
  • To minimize insomnia, the last dose of IR methylphenidate should generally be given before 6 PM.
  • Monitor children's growth (height and weight) closely, as stimulants can be associated with growth suppression.
  • Patients should be screened for pre-existing cardiac conditions and psychiatric disorders before initiating therapy.
  • Due to its potential for abuse and dependence, methylphenidate is a Schedule II controlled substance; prescriptions cannot be refilled and require a new prescription each time.
  • Advise patients to avoid alcohol consumption while on methylphenidate, as it may increase plasma levels of methylphenidate and exacerbate adverse effects.
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Alternative Therapies

  • Atomoxetine (Strattera) - non-stimulant, selective norepinephrine reuptake inhibitor.
  • Guanfacine extended-release (Intuniv) - alpha-2A adrenergic agonist.
  • Clonidine extended-release (Kapvay) - alpha-2 adrenergic agonist.
  • Bupropion (Wellbutrin) - antidepressant with some dopaminergic and noradrenergic activity, sometimes used off-label for ADHD.
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 5mg IR)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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 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 quantity, and the time it occurred.