Jornay PM 60mg ER Capsules

Manufacturer IRONSHORE PHARMACEUTICALS Active Ingredient Methylphenidate Extended- Release Capsules (Evening Formulation)(meth il FEN i date) Pronunciation JOR-nay P.M. (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
Mar 2019
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Jornay PM is an extended-release capsule used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). Unlike most ADHD medications, it is taken in the evening, usually around 8 PM, so that the medication starts working the next morning when you wake up and continues throughout the day.
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How to Use This Medicine

Taking Your Medication

To take this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose in the evening, as taking it in the morning is not recommended. You can take this medication with or without food, but it's essential to take it the same way each time. This means you should either always take it with food or always take it on an empty stomach.

If you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce. However, do not chew the mixture. After mixing, take your dose immediately, and do not store it for later use.

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 crucial to store your medication in a safe location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to keep your medication secure. Keep all medications out of reach of 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 local drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember, but only if it's still the same evening. If you don't remember until the next morning, skip the missed dose and resume your normal evening dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take Jornay PM consistently at the same time each evening, typically around 8 PM, regardless of when you wake up the next morning.
  • Do not chew, crush, or dissolve the capsule or its contents. Swallow the capsule whole. If unable to swallow whole, the capsule may be opened and the entire contents sprinkled onto a small amount of applesauce and consumed immediately.
  • Avoid alcohol, as it may cause the medication to be released too quickly.
  • Inform your doctor if you have a history of heart problems, high blood pressure, mental health conditions (like bipolar disorder or psychosis), or a history of drug abuse.
  • Regularly monitor height and weight in children, as this medication can sometimes slow growth.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 20 mg orally once daily in the evening. Titrate weekly by 20 mg increments. Max: 100 mg/day.
Dose Range: 20 - 100 mg

Condition-Specific Dosing:

ADHD: Taken once daily in the evening, approximately 8 PM, to provide effect the next morning and throughout the day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: Initial: 20 mg orally once daily in the evening. Titrate weekly by 20 mg increments. Max: 100 mg/day.
Adolescent: 13-17 years: Initial: 20 mg orally once daily in the evening. Titrate weekly by 20 mg increments. Max: 100 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 studied. Avoid or use with extreme caution due to lack of data and potential for accumulation of active drug or metabolites.

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. Its therapeutic efficacy in ADHD is thought to be related to its ability to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
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Pharmacokinetics

Absorption:

Bioavailability: 22-65% (variable)
Tmax: Approximately 8-10 hours post-dose (for Jornay PM, due to delayed-release mechanism)
FoodEffect: High-fat meals can delay Tmax and slightly increase Cmax and AUC, but overall absorption is not significantly affected to warrant dose adjustment.

Distribution:

Vd: 2.65 L/kg
ProteinBinding: Approximately 15%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 3.5 hours (for methylphenidate, but Jornay PM's release profile extends effective duration)
Clearance: Not readily available for methylphenidate, but rapid metabolism to inactive metabolite.
ExcretionRoute: Renal (urine)
Unchanged: Less than 1% of the dose is excreted in the urine as unchanged methylphenidate.
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Pharmacodynamics

OnsetOfAction: Delayed (next morning, typically within 1-2 hours of waking after evening dose)
PeakEffect: Approximately 8-10 hours post-dose (evening dose, peak effect occurs during the day)
DurationOfAction: Approximately 10-12 hours

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including Jornay PM, other methylphenidate products, and amphetamines, 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 immediate medical attention:

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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and 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.
Difficulty 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, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Sudden death has occurred in people with certain heart problems or defects. If you have a heart condition or defect, inform your doctor. Also, notify your doctor if a family member has an abnormal heartbeat or died suddenly. Seek immediate medical attention if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting.

Additional Warnings

If you experience a painful erection (hard penis) or an erection lasting longer than 4 hours, seek medical help right away. This can occur even when not having sex, and if left untreated, may lead to permanent sexual problems.
New or worsening behavioral and mood changes, such as altered thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood disorders, 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, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.
A 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, balance problems, confusion, hallucinations, fever, rapid or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache.

Common Side Effects

Most people do not experience severe side effects, but some may occur. If you notice 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 or excitable.
Difficulty sleeping.
* Nose or throat irritation.

Reporting Side Effects

This is not an exhaustive list of potential 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, anxiety, depression, or other unusual changes in mood or behavior
  • 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, coolness, or pain in fingers or toes (Raynaud's phenomenon)
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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. Be sure to describe the allergic reaction you experienced, including any 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 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. Do not start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before undergoing surgery, discuss this with your doctor.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. As directed by your doctor, undergo regular blood tests, blood pressure checks, and heart rate monitoring. 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 to avoid consuming alcohol. Additionally, limit your intake of caffeine (found in tea, coffee, cola) and chocolate, as combining these with the medication may cause nervousness, shakiness, and a rapid heartbeat.

If you have high blood pressure, consult your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Long-term use or high doses of this medication may lead to tolerance, reducing its effectiveness. If you find that the medication is no longer working as well, 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. In children and teenagers, this medication may affect growth in some cases, requiring regular growth checks; consult your doctor about this potential effect.

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

What to Do:

Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222. Seek immediate medical attention. Management includes supportive care, maintaining circulation and respiration, and controlling hyperpyrexia and convulsions.

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

  • Halogenated Anesthetics: Risk of sudden blood pressure and heart rate increases during surgery.
  • Vasopressors: May potentiate the pressor effect of vasopressors.
  • Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, Triptans, Fentanyl, Tramadol, Tryptophan): Increased risk of serotonin syndrome.
  • Antihypertensive Drugs: May reduce the effectiveness of drugs used to treat hypertension.
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Moderate Interactions

  • Coumarin Anticoagulants: May prolong prothrombin time.
  • Anticonvulsants (e.g., Phenobarbital, Phenytoin, Primidone): May inhibit their metabolism, increasing plasma concentrations.
  • Tricyclic Antidepressants (TCAs): May inhibit their metabolism, increasing plasma concentrations.
  • Dopaminergic Drugs (e.g., Bupropion, Levodopa): Potential for additive dopaminergic effects.
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Minor Interactions

  • Alcohol: May increase the rate of drug release from extended-release formulations.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia).

Timing: Prior to initiation of treatment.

Height and Weight

Rationale: Risk of growth suppression in pediatric patients.

Timing: Prior to initiation of treatment.

Psychiatric History (e.g., bipolar disorder, psychosis, tics)

Rationale: Risk of exacerbating pre-existing psychiatric conditions or inducing new psychotic/manic symptoms or tics.

Timing: Prior to initiation of treatment.

Cardiac History (e.g., structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia)

Rationale: Risk of sudden death in patients with pre-existing cardiac conditions.

Timing: Prior to initiation of treatment.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each dose adjustment and at least every 6 months.

Target: Within normal limits for age and clinical status.

Action Threshold: Significant or sustained increases warrant dose reduction or discontinuation.

Height and Weight

Frequency: Every 3 months for children and adolescents.

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration may warrant dose interruption or discontinuation.

ADHD Symptom Control

Frequency: Regularly, at each follow-up visit.

Target: Improved attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.

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

Frequency: Regularly, at each follow-up visit.

Target: Absence of new or worsening symptoms.

Action Threshold: Prompt evaluation and potential discontinuation.

Emergence/Worsening of Tics or Tourette's Syndrome

Frequency: Regularly, at each follow-up visit.

Target: Absence of new or worsening tics.

Action Threshold: Prompt evaluation and potential discontinuation.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • New or worsening anxiety
  • New or worsening agitation
  • Hallucinations
  • Delusions
  • Mania
  • New or worsening tics
  • Numbness, coolness, or pain in digits (Raynaud's phenomenon)

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.

Trimester-Specific Risks:

First Trimester: Limited data. Potential for increased risk of cardiac malformations based on some studies, though overall data are conflicting.
Second Trimester: Limited data. Monitor for fetal growth.
Third Trimester: Limited data. Potential for premature birth and low birth weight. Neonatal withdrawal symptoms (e.g., agitation, tremor, hypotonia) have been reported with stimulant use during pregnancy.
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Lactation

Methylphenidate is excreted into human milk. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother and the potential adverse effects on the breastfed infant.

Infant Risk: L3 (Moderate risk). Monitor breastfed infants for agitation, insomnia, decreased appetite, and reduced weight gain. Consider alternative agents or close monitoring.
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) regularly. Long-term effects on growth have been observed with stimulant use.

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Geriatric Use

Safety and effectiveness in patients over 65 years of age have not been established. Use with caution due to potential for increased sensitivity to adverse effects, particularly cardiovascular effects. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Jornay PM is unique among methylphenidate formulations as it is designed for evening administration to provide therapeutic effect the following morning and throughout the day, aligning with the natural wake cycle.
  • It uses a novel Delexisยฎ drug delivery system, which delays initial release for approximately 10 hours, followed by an extended-release profile.
  • Patients should be instructed to take Jornay PM consistently at the same time each evening (e.g., 8 PM), regardless of when they plan to wake up.
  • Not interchangeable with other methylphenidate products on a milligram-per-milligram basis due to its unique pharmacokinetic profile.
  • Counsel patients on the importance of swallowing the capsule whole or sprinkling the entire contents on applesauce, without chewing or crushing the beads.
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Alternative Therapies

  • Other Methylphenidate formulations (e.g., Concerta, Ritalin LA, Aptensio XR, Adhansia XR, Quillivant XR, Quillichew ER, Daytrana)
  • Amphetamine formulations (e.g., Adderall XR, Vyvanse, Dexedrine, Dyanavel XR, Adzenys XR-ODT)
  • Non-stimulants (e.g., Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay))
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Cost & Coverage

Average Cost: $300 - $450 per 30 capsules (approximate)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand-name, may require prior authorization)
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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 provides crucial information for patients. 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 reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.