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Methylphenidate 10mg/5ml Oral Soln

Manufacturer TRIS PHARMA 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 (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
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. It can help improve focus, reduce hyperactivity, and control impulsive behavior.
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How to Use This Medicine

Taking Your Medication Correctly

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. When taking the liquid form, measure your dose accurately using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring tool.

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

Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. It's essential to store your medication in a safe and secure location, out of reach of children and pets, and inaccessible to others. Consider using a locked box or secure area to store your medication. Keep all medications away from pets.

When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs in your area.

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 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 dose.
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Lifestyle & Tips

  • Take exactly as prescribed by your doctor. Do not take more or less, or more often than prescribed.
  • Take the oral solution usually 30-45 minutes before meals. If it causes stomach upset, you may take it with food.
  • Measure the dose carefully using the provided measuring device, not a household spoon.
  • Do not stop taking this medication suddenly without talking to your doctor, as it can lead to withdrawal symptoms.
  • Avoid alcohol, as it can increase side effects.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Store safely to prevent misuse, especially due to its potential for abuse.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

ADHD: Initial: 5 mg orally twice daily. May increase by 5-10 mg weekly. Max: 60 mg/day.
Narcolepsy: Initial: 10 mg orally twice daily. May increase by 10 mg weekly. 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. May increase by 5-10 mg weekly. Max: 60 mg/day.
Adolescent: For ADHD (>=6 years): Initial: 5 mg orally twice daily. May increase by 5-10 mg weekly. 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 significantly dialyzable. No specific recommendations, use with caution.

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 therapeutic effects in ADHD are thought to be mediated through the increased availability of dopamine and norepinephrine in the prefrontal cortex.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 30% (due to first-pass metabolism)
Tmax: 1-2 hours (for immediate-release oral solution)
FoodEffect: Food may delay Tmax and decrease Cmax slightly, but does not significantly affect AUC.

Distribution:

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

Elimination:

HalfLife: Approximately 2-3 hours (for immediate-release)
Clearance: Approximately 10 L/hr/kg
ExcretionRoute: Primarily renal (90% as ritalinic acid, 1% as unchanged drug)
Unchanged: Less than 3%
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (for immediate-release oral solution)
PeakEffect: 1-2 hours
DurationOfAction: 3-5 hours (for immediate-release oral solution)

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 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 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 (pale, blue, gray, purple, or red) on 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
Sudden deaths have occurred in people with certain heart problems or defects; if you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor

If you experience any signs of heart problems, such as chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting, seek medical help immediately.

Erectile Dysfunction: Seek Medical Help Right Away

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

Mental Health Changes: Seek Medical Help Right Away

New or worsening behavioral 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 conditions, 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 help immediately.

Serotonin Syndrome: Seek Medical Help Right Away

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 help immediately.

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other side effects that bother you or do not go away, contact your doctor:

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

This is not a comprehensive list of all possible 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 psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • New manic symptoms (e.g., extreme energy, racing thoughts)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • Unexplained wounds on fingers or toes
  • Prolonged or painful erection (priapism)
  • Blurred vision or other vision changes
  • Unexplained fever, sore throat, or other signs of infection (rare, but possible blood dyscrasias)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is crucial to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reactions you have experienced.
 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 had a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline, as this may lead to very high blood pressure
 Current use of certain medications, such as:
+ Linezolid
+ Methylene blue

This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never 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. As directed by your doctor, have regular blood tests, blood pressure checks, and heart rate monitoring. You may also 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. Additionally, limit your intake of caffeine (found in tea, coffee, cola, and other products) and chocolate, as combining these with this 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 that this 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, 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 determine the best course of action.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial 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)
  • 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 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention. Overdose management typically involves supportive care, gastric lavage, activated charcoal, and management of symptoms like hypertension, hyperthermia, and seizures.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation) - risk of hypertensive crisis.
  • Alcohol (concurrent use with extended-release formulations due to dose dumping risk, though relevant for all forms due to additive CNS effects)
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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 of anticoagulants, requiring dose adjustment.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism of anticonvulsants, requiring dose adjustment.
  • Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine) - may inhibit metabolism of TCAs, requiring dose adjustment.
  • Selective Serotonin Reuptake Inhibitors (SSRIs) - potential for serotonin syndrome, though less common than with other stimulants.
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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.
  • Caffeine - additive stimulant effects.
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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. Baseline assessment is crucial.

Timing: Prior to initiation of therapy

Height and Weight (Pediatric patients)

Rationale: Stimulants have been associated with growth suppression in pediatric patients.

Timing: Prior to initiation of therapy

Psychiatric History and Family History of Sudden Cardiac Death/Arrhythmias

Rationale: To identify pre-existing psychiatric conditions or cardiac risks 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 visit or at least every 3-6 months

Target: Within normal limits for age and clinical status

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

Height and Weight (Pediatric patients)

Frequency: Every 3-6 months

Target: Normal growth trajectory

Action Threshold: Significant growth deceleration (e.g., crossing two major percentile lines) may warrant drug holiday or alternative therapy.

Psychiatric Symptoms (e.g., agitation, psychosis, mania, aggression, suicidal ideation)

Frequency: At each visit

Target: Stable or improved

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

ADHD Symptom Control

Frequency: At each visit

Target: Improved attention, reduced hyperactivity/impulsivity

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

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Anxiety
  • Agitation
  • Depression
  • Suicidal thoughts
  • Unexplained wounds on fingers/toes (Raynaud's phenomenon)
  • Priapism (rare)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data are limited, but some studies suggest a possible association with cardiac malformations when used in the first trimester, though findings are inconsistent.

Trimester-Specific Risks:

First Trimester: Possible increased risk of cardiac malformations (e.g., atrial septal defects, ventricular septal defects), though data are conflicting and overall risk appears low.
Second Trimester: Limited data, generally considered lower risk than first trimester for structural malformations.
Third Trimester: Potential for neonatal withdrawal symptoms (e.g., agitation, tremors, feeding difficulties) 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 breastfed infants for agitation, insomnia, decreased weight gain, or poor feeding. Consider alternative therapies or weigh risks/benefits carefully.

Infant Risk: Low to moderate risk. Monitor for irritability, sleep disturbances, and weight changes.
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Pediatric Use

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) and cardiovascular parameters. Psychiatric adverse events (e.g., psychosis, mania, aggression) can occur. Long-term safety and efficacy in children younger than 6 years have not been established.

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Geriatric Use

Use with caution in elderly patients, generally starting with lower doses and titrating slowly, due to increased sensitivity to adverse effects, particularly cardiovascular and psychiatric effects. Elderly patients may have comorbid conditions and be on multiple medications, increasing interaction risk.

Clinical Information

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Clinical Pearls

  • Methylphenidate oral solution is an immediate-release formulation, requiring multiple daily doses.
  • Dosing should be individualized based on patient response and tolerability.
  • Administer the last dose of the day several hours before bedtime to avoid insomnia.
  • Consider a 'drug holiday' (e.g., weekends or school breaks) to assess the need for continued therapy and to potentially mitigate growth suppression, though this should be discussed with a healthcare provider.
  • Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
  • Monitor for signs of cardiovascular issues (e.g., chest pain, syncope) and psychiatric symptoms (e.g., new-onset psychosis, mania).
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Alternative Therapies

  • Other CNS stimulants (e.g., amphetamine/dextroamphetamine, lisdexamfetamine, dexmethylphenidate)
  • Non-stimulants (e.g., atomoxetine, guanfacine extended-release, clonidine extended-release)
  • Behavioral therapy (often used in conjunction with pharmacotherapy for ADHD)
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Cost & Coverage

Average Cost: Varies widely by pharmacy and formulation (generic oral solution typically less expensive) per 120 mL (10mg/5mL)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
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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 use, do not share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides important information. 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 seeking help, be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.