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Methylphenidate 30mg/9hr TD Patches

Manufacturer PADAGIS Active Ingredient Methylphenidate Transdermal System(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 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
Apr 2006
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Methylphenidate transdermal patch is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by helping to increase the levels of certain natural substances in the brain that are important for attention and focus. The patch is applied to the hip once a day and delivers the medicine slowly over several hours.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully to ensure safe and effective use.

Do not cut or divide the patches, and do not use patches that are damaged.
 Before and after handling the patch, wash your hands thoroughly.
Apply the patch to clean, dry, healthy skin on the hip, avoiding the waistline. Do not apply the patch to cuts, scrapes, eczema, or damaged skin.
 Put on the patch in the morning and remove it 9 hours later, or as directed by your doctor.
Each time you change the patch, apply it to a new area of skin.
 Be aware that water from bathing, swimming, or showering may cause the patch to lose its adhesion or fall off. If the patch falls off, avoid touching the sticky side with your fingers.
If the patch falls off, apply a new one to a different area of the same hip. Remove the new patch at the usual time.

Storage and Disposal

To maintain the quality and effectiveness of this medication:

 Store it at room temperature, protected from light.
Keep it in a dry place, avoiding storage in a bathroom.
 Store the patches in their original pouch.
* Use the patches within 2 months of opening the tray.

Missed Dose

If you miss a dose, you may apply the patch later in the day. Then, remove the patch at your usual time. Do not apply two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Apply the patch to a clean, dry area of the hip in the morning, approximately 45 minutes before a desired effect is needed.
  • Wear the patch for no more than 9 hours. Remove it at or before 9 hours to avoid difficulty sleeping.
  • Alternate application sites daily (e.g., right hip one day, left hip the next). Avoid applying to the same spot for 7 days.
  • Wash hands thoroughly after applying and removing the patch.
  • Dispose of used patches by folding the adhesive sides together and flushing down the toilet or placing in a lidded trash can out of reach of children and pets.
  • Avoid exposing the patch to external heat sources (e.g., heating pads, electric blankets, prolonged sun exposure, hot tubs) as this can increase drug absorption and lead to overdose.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Avoid alcohol consumption while using this medication.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically indicated for adults; however, if used off-label, titration from lower doses (e.g., 10mg/9hr patch) would be necessary, with careful monitoring. Max dose for oral methylphenidate is often 60mg/day.

Condition-Specific Dosing:

ADHD: Individualized titration based on response and tolerability. The 30mg/9hr patch delivers 30mg of methylphenidate over 9 hours.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 6-12 years: Initial dose is 10 mg/9hr patch applied once daily in the morning. Dose may be titrated weekly in 5 mg or 10 mg increments to a maximum of 30 mg/9hr patch, based on clinical response and tolerability. The 30mg/9hr patch delivers 30mg over 9 hours.
Adolescent: For adolescents 13-17 years: Initial dose is 10 mg/9hr patch applied once daily in the morning. Dose may be titrated weekly in 5 mg or 10 mg increments to a maximum of 30 mg/9hr patch, based on clinical response and tolerability. The 30mg/9hr patch delivers 30mg over 9 hours.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: No specific dose adjustment recommended, but use with caution.
Severe: No specific dose adjustment recommended, but use with caution. Monitor for adverse effects.
Dialysis: Not available

Hepatic Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: No specific dose adjustment recommended, but use with caution.
Severe: No specific dose adjustment recommended, but use with caution. Monitor for adverse effects.
Confidence: Medium

Pharmacology

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Mechanism of Action

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic effects in Attention-Deficit/Hyperactivity Disorder (ADHD) are thought to be mediated through the blockade of dopamine and norepinephrine reuptake transporters in the presynaptic neuron, thereby increasing the extracellular levels of these monoamines in the striatum and prefrontal cortex.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 20-30% (relative to oral methylphenidate, transdermal delivery bypasses first-pass metabolism, but overall bioavailability can vary)
Tmax: Approximately 7.5-10.5 hours after patch application
FoodEffect: Not applicable for transdermal patch

Distribution:

Vd: Approximately 2.65 L/kg
ProteinBinding: Approximately 15% (to plasma proteins)
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 2-3 hours (for methylphenidate itself, but the patch provides sustained release)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Primarily renal (90% as ritalinic acid)
Unchanged: Less than 1% (excreted unchanged in urine)
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Pharmacodynamics

OnsetOfAction: Approximately 2 hours after patch application
PeakEffect: Approximately 7.5-10.5 hours after patch application
DurationOfAction: Up to 3 hours after patch removal (total duration of effect is related to patch wear time plus residual effect, typically 12-15 hours for a 9-hour wear time)
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 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
 Numbness, pain, tingling, or cold sensation in the hands or feet
Sores or wounds on the fingers or toes
 Muscle pain or weakness, dark urine, or difficulty passing urine
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

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 medical help immediately if you experience any signs of heart problems, such as:

Chest pain
 Abnormal heartbeat
Shortness of breath
 Severe dizziness or fainting

Mental Health and Mood Changes

New or worsening behavior and mood changes, including changes in thinking, anger, and hallucinations, have been reported with this medication. 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 Warning

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

Other Possible Side Effects

While many people may not experience any side effects or only minor side effects, some individuals may encounter the following:

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
 Skin irritation

If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor for advice. 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)
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon)
  • New or worsening aggressive behavior, hostility, or agitation
  • Seeing, hearing, or feeling things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • Unusual changes in mood or behavior, including mania or severe anxiety
  • Unexplained wounds, blisters, or severe irritation at the patch application site
  • Unexplained fever or muscle stiffness (possible serotonin syndrome, especially if combined with other serotonergic drugs)
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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. Describe the allergic reaction you experienced, including the 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 (within the last 14 days) of certain medications for depression or Parkinson's disease, 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 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.
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Precautions & Cautions

Important Warnings and Cautions

Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. If you are scheduled to have surgery, 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 advised by your doctor. You may need to undergo certain heart tests before starting this medication; if you have questions, consult your doctor.

It is recommended that you avoid consuming alcohol while taking this medication. Limit your intake of caffeine (found in tea, coffee, cola) and chocolate, as combining these with this drug 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 or high-dose use of this medication may lead to tolerance, reducing its effectiveness. If you notice this drug 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 some individuals, particularly those with a history of seizures. Discuss your risk with your doctor.

Seek immediate medical attention if you experience a painful erection or an erection lasting longer than 4 hours, as this can lead to lasting sexual problems if not treated promptly.

Avoid exposure to heat sources, such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated waterbeds. Refrain from taking long, hot baths or sunbathing, as your body temperature may rise and cause excessive absorption of the medication.

Using this medication may cause skin discoloration at or around the application site, and in some cases, at other areas. This effect may persist even after stopping the medication. If you or a family member has a history of vitiligo, a skin condition, discuss this with your doctor.

This medication can be harmful if chewed or swallowed, including used patches. If the medication is ingested, contact a doctor or poison control center immediately.

In children and teenagers, this medication may affect growth. Regular growth checks may be necessary; consult your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best outcome for 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
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis
  • Dry mouth

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and may include 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): Concomitant use or within 14 days of discontinuing an MAOI due to risk of hypertensive crisis.
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Major Interactions

  • Vasopressor agents (e.g., pressor amines): May potentiate the pressor effect.
  • Halogenated anesthetics: Risk of sudden blood pressure and heart rate increases during surgery.
  • Antipsychotics: May antagonize the effects of methylphenidate or exacerbate psychotic symptoms.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort): Increased risk of serotonin syndrome.
  • Antihypertensive drugs: May reduce the effectiveness of antihypertensive agents.
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Moderate Interactions

  • Coumarin anticoagulants: May decrease metabolism of anticoagulants, increasing bleeding risk.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit their metabolism, increasing serum levels.
  • Tricyclic antidepressants (TCAs): May inhibit their metabolism, increasing serum levels and potential for adverse effects.
  • Alcohol: May increase plasma levels of methylphenidate and lead to increased adverse effects.
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Minor Interactions

  • Caffeine: Additive stimulant effects.

Monitoring

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Baseline Monitoring

Cardiovascular assessment (BP, HR, ECG)

Rationale: To identify pre-existing cardiac conditions or risk factors for sudden cardiac death or other serious cardiovascular events.

Timing: Prior to initiation of therapy

Psychiatric history and family history of psychiatric disorders

Rationale: To assess risk for new or exacerbated psychiatric symptoms (e.g., psychosis, mania, aggression).

Timing: Prior to initiation of therapy

Height and Weight (pediatric patients)

Rationale: To establish baseline for growth monitoring.

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

Action Threshold: Persistent elevation (e.g., >95th percentile for age/sex/height or significant increase from baseline) warrants investigation and potential dose adjustment or discontinuation.

Height and Weight (pediatric patients)

Frequency: Every 3-6 months

Target: Consistent growth along established growth curves

Action Threshold: Significant growth deceleration or weight loss warrants investigation and potential dose adjustment or drug holiday.

Psychiatric symptoms (e.g., agitation, aggression, hallucinations, mania)

Frequency: At each visit

Target: Absence of new or exacerbated symptoms

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

ADHD symptom control and functional improvement

Frequency: At each visit

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

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

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations (visual, tactile, auditory)
  • Delusional thinking
  • Mania or hypomania
  • Severe anxiety or agitation
  • Unexplained wounds or skin irritation at patch site
  • Numbness, coolness, or pain in fingers/toes (Raynaud's phenomenon)

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Data from observational studies on methylphenidate use during pregnancy are inconclusive regarding major birth defects. Animal studies have shown some evidence of developmental toxicity at maternally toxic doses.

Trimester-Specific Risks:

First Trimester: Limited human data; some studies suggest a possible, but not definitive, association with cardiac malformations. Overall risk appears low.
Second Trimester: No specific data indicating increased risk.
Third Trimester: No specific data indicating increased risk; potential for withdrawal symptoms in neonate if exposed near term.
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Lactation

Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding. However, monitor breastfed infants for agitation, insomnia, or decreased weight gain. Use with caution, especially in preterm or unstable infants.

Infant Risk: L3 (Moderate risk - There are no controlled studies in breastfeeding women. The risk of adverse effects to a breastfed infant cannot be ruled out. Weigh the potential benefits of treatment against the potential risks.)
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Pediatric Use

Methylphenidate transdermal system is approved for children 6-17 years of age. Growth (height and weight) should be monitored regularly, as long-term use of stimulants has been associated with modest growth suppression. Cardiovascular and psychiatric monitoring are also crucial.

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Geriatric Use

Safety and efficacy have not been established in geriatric patients. Use with caution due to increased sensitivity to stimulant effects, potential for cardiovascular events, and polypharmacy. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • The 30mg/9hr patch delivers 30mg of methylphenidate over a 9-hour wear period, not that the patch contains 30mg total.
  • Proper patch application and removal technique is crucial for efficacy and to minimize skin irritation. Rotate application sites daily.
  • Educate patients and caregivers on proper disposal of used patches (folding adhesive sides together and flushing or placing in a lidded trash can) to prevent accidental exposure to children or pets.
  • Warn patients about external heat sources (e.g., hot baths, heating pads) as they can increase drug absorption and lead to overdose.
  • Monitor for skin sensitization or allergic contact dermatitis at the application site, which may necessitate discontinuation.
  • Consider drug holidays (e.g., weekends, school breaks) to assess the need for continued therapy and to potentially mitigate growth suppression, though this should be discussed with a healthcare provider.
  • The onset of action is slower than oral immediate-release formulations, but the duration of effect is extended due to sustained release.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., immediate-release, extended-release oral tablets/capsules, chewable tablets, liquid solutions)
  • Amphetamine-based stimulants (e.g., Adderall, Vyvanse, Dexedrine)
  • Non-stimulant medications (e.g., Atomoxetine, Guanfacine extended-release, Clonidine extended-release)
  • Behavioral therapy and psychotherapy
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Cost & Coverage

Average Cost: Varies widely, typically $300-$600+ per 30 patches
Insurance Coverage: Tier 2 or 3 (Brand-name prescription, may require prior authorization)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about its safe and effective use. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, it is vital to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide critical information, including the name of the medication taken, the amount consumed, and the time it happened, to ensure you receive the most appropriate care.