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Methylphenidate 15mg/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 a type of medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). The patch is applied to the skin, usually on the hip, and releases the medicine slowly over several hours. It helps improve focus, attention, and control over impulsive behaviors by affecting certain chemicals in the brain.
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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 patches, 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 the patch on 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. However, remove the patch at your usual time to maintain your regular schedule. Do not apply two patches 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, alternating sides daily.
  • Apply 2 hours before the desired effect and remove 9 hours later. Do not wear for more than 9 hours.
  • Avoid exposing the patch site to external heat sources (e.g., heating pads, electric blankets, hot tubs, prolonged sun exposure) as this can increase drug absorption and lead to overdose.
  • Do not cut the patch.
  • Wash hands thoroughly after applying or removing the patch.
  • Fold the used patch in half with the adhesive sides together and dispose of it safely, out of reach of children and pets.
  • Maintain a healthy diet and regular sleep schedule.
  • Engage in regular physical activity.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Not FDA approved for adults; off-label use may follow pediatric titration, typically starting at 10 mg/9hr patch and titrating based on response and tolerability. The 15mg/9hr patch delivers 15mg of methylphenidate over 9 hours.
Dose Range: 10 - 30 mg

Condition-Specific Dosing:

ADHD: Apply patch to hip area 2 hours before desired effect, remove 9 hours after application. Max 30 mg/9hr patch.
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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 to the hip 2 hours before desired effect, removed 9 hours after application. Dose may be titrated weekly in 5 mg/9hr increments to a maximum of 30 mg/9hr. The 15mg/9hr patch is a common titrated dose.
Adolescent: For adolescents 13-17 years: Initial dose is 10 mg/9hr patch applied to the hip 2 hours before desired effect, removed 9 hours after application. Dose may be titrated weekly in 5 mg/9hr increments to a maximum of 30 mg/9hr. The 15mg/9hr patch is a common titrated dose.
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Dose Adjustments

Renal Impairment:

Mild: No specific dosage adjustment recommended, but use with caution.
Moderate: No specific dosage adjustment recommended, but use with caution.
Severe: No specific dosage adjustment recommended, but use with caution. Monitor for adverse effects.
Dialysis: Not well studied. Methylphenidate is not significantly dialyzable. Use with caution and monitor.

Hepatic Impairment:

Mild: No specific dosage adjustment recommended, but use with caution.
Moderate: No specific dosage adjustment recommended, but use with caution.
Severe: No specific dosage adjustment recommended, but 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 effect in ADHD is believed to be related to increased dopamine and norepinephrine activity in the prefrontal cortex.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90% (transdermal absorption, relative to oral)
Tmax: Approximately 9 hours (after patch application)
FoodEffect: Not applicable for transdermal patch

Distribution:

Vd: 2.65 L/kg (for d-methylphenidate)
ProteinBinding: 10-33%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3.5 hours (after patch removal)
Clearance: Not available (variable)
ExcretionRoute: Renal (primarily as ritalinic acid)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Approximately 2 hours after patch application
PeakEffect: Approximately 9 hours after patch application (corresponds to Tmax)
DurationOfAction: Up to 3 hours after patch removal (total effect duration up to 12 hours from application)

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

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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 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

Heart Problems:

If you have a heart condition or defect, inform your doctor. Sudden deaths have occurred in people with certain heart problems. Seek medical help immediately if you experience:

 Chest pain
Abnormal heartbeat
 Shortness of breath
Severe dizziness or fainting

Mental Health:

New or worsening behavior 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 or mood problems, such as depression or bipolar disorder, 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:

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 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
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

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 agitation
  • Seeing or hearing things that are not real (hallucinations)
  • Believing things that are not true (delusions)
  • Unusual changes in mood or behavior, such as extreme happiness or irritability
  • Unexplained wounds or skin irritation at the patch site
  • Numbness, tingling, or coldness in fingers or toes
  • Uncontrolled muscle movements or tics
  • Blurred vision
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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)
A family history of:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
 If you have ever experienced a stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications can lead to very high blood pressure)
 Current use of:
+ Linezolid
+ Methylene blue

This list is not exhaustive, and it is crucial 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 existing treatments and health status. Never start, stop, or adjust the dosage 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 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, 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 and requiring higher doses to achieve the same effect. 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, particularly in individuals with a history of seizures. Discuss your risk with your doctor. If you experience a painful erection (priapism) or an erection lasting longer than 4 hours, seek medical attention immediately, as delayed treatment may result in lasting sexual dysfunction.

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 medication absorption.

Prolonged use of this medication may cause skin discoloration at or around the patch application site, which may persist even after discontinuing the medication. This risk may be higher if you or a family member has a history of vitiligo; discuss this with your doctor.

If the medication is chewed or swallowed, including used patches, it may cause harm. If this occurs, 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 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
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis (dilated pupils)
  • Dry mouth

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes supportive care, gastric lavage (if oral ingestion), and symptomatic treatment for cardiovascular and CNS effects.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis.
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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.
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may inhibit metabolism, increasing antidepressant levels; risk of serotonin syndrome with serotonergic agents.
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Moderate Interactions

  • Alcohol - may increase plasma levels of methylphenidate and lead to more adverse effects.
  • Antihypertensive agents - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
  • Dopaminergic drugs (e.g., levodopa, bromocriptine) - theoretical risk of pharmacodynamic interaction.
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Minor Interactions

  • Caffeine - additive stimulant effects.

Monitoring

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Baseline Monitoring

Cardiovascular assessment (BP, HR, medical history)

Rationale: To identify pre-existing cardiac conditions or risk factors for 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

Action Threshold: Persistent elevation outside normal range; consider dose reduction 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; consider drug holiday or alternative treatment.

Psychiatric symptoms (e.g., agitation, aggression, new-onset psychosis, mania)

Frequency: Regularly, at each follow-up visit

Target: Absence of new or worsening symptoms

Action Threshold: Emergence or worsening of severe psychiatric symptoms; consider discontinuation.

ADHD symptom control and functional improvement

Frequency: Regularly, at each follow-up visit

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

Action Threshold: Lack of efficacy or intolerable side effects; consider dose adjustment or alternative.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • Hostility
  • Psychotic symptoms (e.g., hallucinations, delusions)
  • Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
  • Severe anxiety
  • Depression
  • Tics or abnormal movements
  • Skin irritation/reactions at patch site

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 adverse effects at doses higher than human therapeutic doses.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cardiac malformations (e.g., ventricular septal defects) based on some observational studies, though data are conflicting and overall risk appears low.
Second Trimester: No specific risks identified beyond general stimulant effects.
Third Trimester: Potential for premature birth and low birth weight. Neonatal withdrawal symptoms (e.g., agitation, tremors) have been reported with stimulant exposure late in pregnancy.
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Lactation

Methylphenidate is excreted into human milk. The American Academy of Pediatrics considers methylphenidate to be compatible with breastfeeding, but caution is advised. Monitor the infant for adverse effects such as irritability, poor feeding, or sleep disturbances.

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

Approved for children and adolescents aged 6 to 17 years. Monitor growth (height and weight) regularly, as long-term use has been associated with growth suppression. Cardiovascular and psychiatric monitoring is 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 and higher prevalence of cardiovascular conditions. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • The transdermal patch offers a once-daily dosing option that bypasses first-pass metabolism and provides a smoother drug delivery profile compared to immediate-release oral formulations.
  • Patch application site reactions (e.g., erythema, pruritus, edema) are common. Rotate application sites daily to minimize irritation.
  • Ensure patients understand the importance of removing the patch after 9 hours to prevent excessive drug exposure and potential sleep disturbances.
  • Educate patients and caregivers about the risk of increased absorption with external heat sources and the proper disposal of used patches.
  • Consider a drug holiday (e.g., weekends or school breaks) to assess the need for continued therapy, monitor growth, and potentially reduce side effects.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., Concerta, Ritalin LA, Focalin XR, Quillivant XR, Adhansia XR)
  • 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
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand name), Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, contact your doctor immediately. It is essential to use your prescribed medication responsibly: do not share it with others, and never take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, promptly call your local poison control center or seek immediate medical attention. Be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.