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Methylphenidate 10mg/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 patches are used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). They work by helping to balance certain natural chemicals in the brain, which can improve focus, attention, and control over impulsive behavior. The patch is applied to the hip once a day and delivers the medicine through the skin 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's essential to follow the instructions carefully to ensure safe and effective use.

Do not cut or divide the patches, and avoid using patches that are damaged.
 Before and after handling the patch, wash your hands thoroughly.
Apply the patch to clean, dry, and healthy skin on your hip, avoiding the waistline. Do not apply the patch to skin with cuts, scrapes, eczema, or other damage.
 Typically, you will apply 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 can apply the patch later in the day. Then, remove the patch at your usual time. Remember to:

 Avoid applying two doses at the same time.
* Never apply extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Apply the patch to a clean, dry area of the hip in the morning. Alternate hips daily.
  • Press firmly for 30 seconds to ensure good adhesion.
  • Remove the patch after 9 hours. Do not wear it longer than 9 hours to avoid sleep problems.
  • Dispose of the used patch by folding it in half so the adhesive side sticks to itself, then flushing it down the toilet or placing it in a lidded container out of reach of children and pets.
  • Avoid exposing the patch to external heat sources (e.g., heating pads, hot baths, saunas) as this can increase drug absorption and lead to overdose.
  • Inform healthcare providers about all medications, supplements, and medical conditions.
  • Maintain regular follow-up appointments for monitoring of blood pressure, heart rate, and growth (for children).
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Not FDA-approved for adult use. Off-label use may occur, but specific dosing guidelines are not established for the transdermal patch in adults.

Condition-Specific Dosing:

ADHD: Not FDA-approved for adult ADHD with transdermal patch.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial dose: 10 mg/9 hr patch applied once daily in the morning. Titrate weekly by 5 mg/9 hr or 10 mg/9 hr increments to a maximum of 30 mg/9 hr. Patch should be removed after 9 hours.
Adolescent: Initial dose: 10 mg/9 hr patch applied once daily in the morning. Titrate weekly by 5 mg/9 hr or 10 mg/9 hr increments to a maximum of 30 mg/9 hr. Patch should be removed after 9 hours.
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Dose Adjustments

Renal Impairment:

Mild: No specific dosage adjustment recommended.
Moderate: No specific dosage adjustment recommended.
Severe: Use with caution; consider lower doses and monitor for adverse effects. Data are limited.
Dialysis: Not available

Hepatic Impairment:

Mild: No specific dosage adjustment recommended.
Moderate: No specific dosage adjustment recommended.
Severe: Use with caution; consider lower doses and monitor for adverse effects. Data are limited.
Confidence: Medium

Pharmacology

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Mechanism of Action

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

Absorption:

Bioavailability: Not directly quantifiable as a percentage due to transdermal delivery; plasma concentrations increase gradually over the 9-hour application period.
Tmax: Approximately 7.5 to 10.5 hours after patch application.
FoodEffect: Not applicable for transdermal patch.

Distribution:

Vd: Approximately 2.65 L/kg (for oral methylphenidate, similar for transdermal)
ProteinBinding: Approximately 15% (primarily to alpha-1 acid glycoprotein)
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 5 to 7 hours (after patch removal, reflecting the elimination of absorbed drug).
Clearance: Approximately 0.53 L/hr/kg (for oral methylphenidate, similar for transdermal)
ExcretionRoute: Primarily renal (90% as ritalinic acid).
Unchanged: Less than 1% of the dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Approximately 2 hours after patch application.
PeakEffect: Corresponds to Tmax, approximately 7.5 to 10.5 hours after patch application.
DurationOfAction: Up to 3 hours after patch removal (total duration of effect up to 12 hours from application).
Confidence: High

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. Serious cardiovascular events, including sudden death, have been reported in association with CNS stimulant treatment of ADHD in pediatric patients with structural cardiac abnormalities or other serious heart problems. Serious psychiatric adverse reactions, including psychotic or manic symptoms, have been reported in patients with and without a history of psychiatric illness.
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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 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, including pale, blue, gray, purple, or red discoloration
 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 difficulty urinating
Changes in skin color
 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 heart problem or defect, inform your doctor. Additionally, if a family member has an abnormal heartbeat or died suddenly, notify your doctor. Seek immediate medical attention 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 immediate medical attention 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 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

Other Possible Side Effects

While many people may not experience any side effects or only minor side effects, it is essential to be aware of the following potential side effects:

 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
* Skin irritation

If any of these side effects or other side effects bother you or do not go away, contact your doctor or seek medical attention.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions about side effects, contact your doctor for medical advice.
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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 aggressive behavior, hostility, or agitation.
  • Seeing or hearing things that are not real (hallucinations).
  • Believing things that are not true (delusions).
  • New or worsening tics (uncontrolled movements or sounds).
  • Numbness, tingling, or color changes in fingers or toes (Raynaud's phenomenon).
  • Severe skin irritation, blistering, or swelling at the patch site, or a rash that spreads beyond the patch area.
  • Unexplained wounds on the skin.
  • Significant weight loss or lack of growth in children.
  • Difficulty sleeping.
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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)
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
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 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 and pharmacist need 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

Important Warnings and 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, 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 questions, consult 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 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 experience decreased efficacy, contact your doctor; do not take more than the prescribed dose.

This medication may increase the risk of seizures, particularly in individuals 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 left untreated.

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

The use of this medication may cause skin discoloration at or around the patch application site, and in some cases, at other areas. This effect may persist even after discontinuing 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 adolescents, this medication may affect growth; regular growth checks may be necessary. Consult your doctor to discuss this potential risk.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks of this medication to 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

What to Do:

Call 911 or Poison Control (1-800-222-1222) immediately. Remove the patch. Provide supportive care, including maintaining a clear airway, monitoring vital signs, and managing agitation or seizures.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOIs (risk of hypertensive crisis).
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Major Interactions

  • Vasopressor agents (e.g., phenylephrine, pseudoephedrine): May potentiate pressor effects.
  • Halogenated anesthetics (e.g., halothane, isoflurane): Risk of sudden blood pressure and heart rate increases during surgery.
  • Antihypertensive drugs: May reduce the effectiveness of antihypertensives.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort): Risk of serotonin syndrome (though less common with methylphenidate than other stimulants).
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Moderate Interactions

  • Coumarin anticoagulants (e.g., warfarin): May increase prothrombin time; monitor INR.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit metabolism, increasing plasma levels of anticonvulsants.
  • Tricyclic antidepressants (TCAs): May inhibit metabolism, increasing plasma levels of TCAs.
  • Dopaminergic drugs (e.g., antipsychotics, dopamine agonists): Potential for additive or antagonistic effects.
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Minor Interactions

  • Alcohol: May increase plasma levels of methylphenidate and lead to dose dumping with extended-release formulations (less relevant for patch, but still caution).

Monitoring

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Baseline Monitoring

Cardiovascular assessment (BP, HR, ECG)

Rationale: To identify pre-existing cardiac conditions that may contraindicate stimulant use or require close monitoring due to risk of sudden death or serious cardiovascular events.

Timing: Prior to initiation of therapy.

Psychiatric history (personal and family)

Rationale: To screen for bipolar disorder, psychosis, or other psychiatric conditions that may be exacerbated by stimulants.

Timing: Prior to initiation of therapy.

Height and weight

Rationale: To establish baseline for growth monitoring, especially in pediatric patients.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At least every 6 months, or more frequently if clinically indicated.

Target: Within normal limits for age; avoid sustained elevations.

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

Height and Weight

Frequency: Every 3-6 months in pediatric patients.

Target: Consistent growth along percentile curves.

Action Threshold: Significant growth deceleration or weight loss warrants evaluation of dose, drug holiday, or alternative therapy.

ADHD symptom control and adverse effects

Frequency: Regularly, at each follow-up visit.

Target: Improved ADHD symptoms with tolerable side effects.

Action Threshold: Inadequate symptom control, emergence of new or worsening psychiatric symptoms (e.g., psychosis, mania, aggression), or intolerable side effects.

Skin at application site

Frequency: Daily by patient/caregiver, and at each follow-up visit.

Target: Minimal to no irritation.

Action Threshold: Significant erythema, edema, blistering, or signs of contact sensitization (e.g., spreading rash beyond patch site) warrant discontinuation and evaluation.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hallucinations
  • Delusions
  • Mania
  • Anxiety
  • Depression
  • Tics
  • Numbness or tingling in extremities (Raynaud's phenomenon)
  • Unexplained wounds or skin changes at patch site
  • Sleep disturbances
  • Appetite suppression
  • Weight loss
  • Growth deceleration

Special Patient Groups

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Pregnancy

Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown some evidence of developmental toxicity at doses higher than typical human doses.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cardiac malformations (based on some observational studies, though data are conflicting and limited).
Second Trimester: Not specifically studied, but continued exposure may carry risks.
Third Trimester: Not specifically studied, but continued exposure may carry risks. Neonatal withdrawal symptoms (e.g., agitation, tremor, poor feeding) have been reported in infants exposed to stimulants in utero.
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Lactation

L3 (Moderate risk). Methylphenidate is excreted into human milk. Monitor breastfed infants for agitation, insomnia, decreased weight gain, or other adverse effects. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for methylphenidate and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

Infant Risk: Low to moderate risk of adverse effects. Monitor for irritability, poor feeding, and sleep disturbances.
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Pediatric Use

FDA-approved for children and adolescents 6 to 17 years of age. Close monitoring of growth (height and weight) is essential due to potential for growth suppression. Cardiovascular and psychiatric monitoring are also critical.

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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 and potential for underlying cardiovascular conditions.

Clinical Information

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Clinical Pearls

  • The transdermal patch offers a non-oral administration route, which can be beneficial for patients with dysphagia or those who prefer not to take pills.
  • The 9-hour wear time allows for flexible removal to manage evening appetite suppression or insomnia, offering more control over duration of effect compared to some oral extended-release formulations.
  • Proper patch application and disposal are crucial to ensure efficacy and prevent accidental exposure to others (especially children and pets).
  • Skin irritation at the application site is a common side effect. Rotating the application site daily and ensuring the skin is clean and dry can help minimize this. If severe irritation occurs, discontinue use and consult a healthcare provider.
  • Patients and caregivers should be educated on the signs of contact sensitization (e.g., rash spreading beyond the patch site, severe itching) which would necessitate discontinuation.
  • Avoid external heat sources (e.g., heating pads, hot baths, saunas) over the patch, as this can significantly increase drug absorption and lead to overdose symptoms.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., Concerta, Ritalin LA, Quillivant XR, Adhansia XR, Jornay PM)
  • Amphetamine-based stimulants (e.g., Adderall, Vyvanse, Dexedrine)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy
  • Cognitive behavioral therapy (CBT)
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Cost & Coverage

Average Cost: Varies widely, typically $300-$600+ per 30 patches
Insurance Coverage: Tier 2 or Tier 3 (Specialty drug)
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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, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call the poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.