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Methylphenidate 5mg/5ml Oral Soln

Manufacturer TRIS Active Ingredient Methylphenidate Oral Solution(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
Dopamine and Norepinephrine 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?

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. This oral solution is a liquid form that is taken by mouth.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
 Read all the information provided with your medication and follow the instructions carefully.
Take your medication 30 to 45 minutes before meals.
 If you are taking a liquid dose, measure it carefully using the measuring device that comes with your medication. If you don't have one, ask your pharmacist for a device to measure your medication accurately.

If you need to take your medication more than once a day, be sure to take your last dose before 6 PM.

Storing and Disposing of Your Medication

To keep your medication safe and effective:

Store it 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 a bathroom.
Store your medication in a secure location where children and pets cannot access it. Consider using a locked box or area to keep it safe.
 Keep all medications out of reach of pets.
When you no longer need your medication or it has 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 consider participating in a drug take-back program in your area.

What to Do If You Miss a Dose

If you miss a dose of your medication:

 Take it as soon as you remember, unless it is close to the time for your next dose.
Do not take your medication after 6 PM.
 If it is almost time for your next dose, skip the missed dose and return to your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take exactly as prescribed by your doctor. Do not take more or less than directed.
  • Take 30-45 minutes before meals for best absorption, but can be taken with food if stomach upset occurs.
  • Do not take late in the day (e.g., after 6 PM) to avoid sleep problems.
  • Store at room temperature, away from light and moisture.
  • Keep out of reach of children and pets.
  • Avoid alcohol while taking this medication.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

ADHD: Average dose 20-30 mg/day, administered in 2 or 3 divided doses. Max 60 mg/day.
Narcolepsy: 10 mg to 60 mg daily in 2 or 3 divided doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial (6 years and older): 5 mg orally twice daily (before breakfast and lunch). Increase by 5-10 mg weekly. Max 60 mg/day.
Adolescent: Initial: 5 mg orally twice daily (before breakfast and lunch). Increase by 5-10 mg weekly. Max 60 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; monitor for adverse effects. No specific dose adjustment recommended due to limited data.
Dialysis: Not dialyzable. Use with caution; monitor for adverse effects.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; monitor for adverse effects. No specific dose adjustment recommended due to limited data.

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 thought to be mediated through the modulation of dopaminergic and noradrenergic neurotransmission in the frontal cortex and subcortical regions.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified, but rapid and extensive.
Tmax: 1-2 hours (for immediate-release oral solution)
FoodEffect: Food may delay Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: 2.65 L/kg (adults)
ProteinBinding: 10-15%
CnssPenetration: Yes

Elimination:

HalfLife: 2-4 hours (for immediate-release)
Clearance: Not readily available, but rapid.
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: <1% (methylphenidate), ~80% (ritalinic acid)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 1-2 hours
DurationOfAction: 3-5 hours (for immediate-release oral solution)
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 experience 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
 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 trouble urinating
Changes in sex interest
 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. If you have a heart condition or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, tell 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 (even when not having sex). If left untreated, this can lead to lasting sexual problems.
 New or worsening behavior and mood changes, such as:
+ Changes in thinking
+ Anger
+ 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 lack of interest in life
 A severe and potentially life-threatening condition called serotonin syndrome 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
 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, 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.
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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., hallucinations, delusions)
  • New manic symptoms (e.g., extreme energy, racing thoughts)
  • Unexplained numbness, pain, skin color change, or sensitivity to temperature in fingers or toes
  • Uncontrolled muscle movements or tics
  • Blurred vision or other vision changes
  • Severe headache
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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
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug 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. 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 any 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. If you experience a decrease in the medication's effectiveness, 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. Regular growth checks may be necessary. Consult your doctor to discuss this potential effect.

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.
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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 (very high fever)
  • Tachycardia (fast heart rate)
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension (high blood pressure)
  • Mydriasis (dilated pupils)
  • Dry mouth and mucous membranes

What to Do:

Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222. Seek immediate medical attention. Management is primarily supportive, including gastric lavage, activated charcoal, and symptomatic treatment for agitation, hyperthermia, and cardiovascular effects.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis (concurrent use or within 14 days of MAOI discontinuation)
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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
  • 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
  • Selective Serotonin Reuptake Inhibitors (SSRIs) - potential for serotonin syndrome (rare, but possible with high doses or other serotonergic agents)
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Moderate Interactions

  • Antihypertensive agents - methylphenidate may reduce the effectiveness of these drugs
  • Dopaminergic agents (e.g., levodopa, bromocriptine) - potential for additive dopaminergic effects
  • Alcohol - may increase plasma levels of methylphenidate and lead to more rapid absorption of methylphenidate from some extended-release formulations (not directly applicable to oral solution, but general caution)
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Minor Interactions

  • Caffeine - additive stimulant effects

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

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

Timing: Prior to initiation of therapy.

Height and Weight (Pediatric)

Rationale: Stimulants have been associated with modest growth suppression in children.

Timing: Prior to initiation of therapy.

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 bipolar disorder, psychosis, or other psychiatric conditions that may be exacerbated by stimulants.

Timing: Prior to initiation of therapy.

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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/individual.

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

Height and Weight (Pediatric)

Frequency: Every 3-6 months.

Target: Normal growth trajectory.

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

ADHD Symptom Control and Functioning

Frequency: Regularly, at each visit.

Target: Improved attention, reduced hyperactivity/impulsivity, improved academic/social functioning.

Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or re-evaluation of diagnosis.

Emergence/Worsening of Psychiatric Symptoms (e.g., psychosis, mania, aggression, anxiety)

Frequency: Regularly, at each visit.

Target: Absence of new or worsening symptoms.

Action Threshold: Prompt evaluation and potential discontinuation.

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Symptom Monitoring

  • Changes in appetite or weight
  • Sleep disturbances (insomnia)
  • Headaches
  • Stomach upset
  • Nervousness or irritability
  • Anxiety or agitation
  • Tics or abnormal movements
  • Chest pain, shortness of breath, or syncope (report immediately)
  • Hallucinations, delusions, or manic symptoms (report immediately)

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cardiac malformations (e.g., atrial septal defects) based on some observational studies, though data are conflicting and overall risk appears low.
Second Trimester: No specific unique risks identified beyond general stimulant effects.
Third Trimester: Potential for premature birth, low birth weight, and withdrawal symptoms (e.g., tremors, irritability) in the neonate if used close to delivery.
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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 infants for irritability, poor feeding, and sleep disturbances. L3 (Moderate Risk).

Infant Risk: Low to moderate. Monitor for agitation, insomnia, decreased weight gain, and poor feeding. Consider using the lowest effective dose and monitoring infant closely.
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) regularly. Stimulants have been associated with modest growth suppression. Assess for emergence or worsening of psychiatric symptoms.

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Geriatric Use

Use with caution in elderly patients due to increased risk of cardiovascular adverse events (e.g., hypertension, tachycardia) and potential for exacerbation of pre-existing psychiatric conditions. Start with lower doses and titrate slowly. Monitor cardiovascular status closely.

Clinical Information

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Clinical Pearls

  • Methylphenidate oral solution is an immediate-release formulation, requiring multiple daily doses.
  • The oral solution is useful for patients who have difficulty swallowing tablets or require precise dose titration.
  • Administer the last dose early enough in the day (e.g., before 6 PM) to avoid insomnia.
  • Patients should be screened for cardiac disease and psychiatric conditions before starting therapy.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
  • Consider drug holidays (e.g., weekends, school breaks) to assess ongoing need for medication and to mitigate potential growth suppression in children, though this should be discussed with a healthcare provider.
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Alternative Therapies

  • Other CNS stimulants (e.g., amphetamine, lisdexamfetamine, dexmethylphenidate)
  • Non-stimulant medications (e.g., atomoxetine, guanfacine, clonidine)
  • Behavioral therapy and psychotherapy (often used in conjunction with medication for ADHD)
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Cost & Coverage

Average Cost: $30 - $100 per 120 mL of 5mg/5ml oral solution
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult with 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.