Jornay PM 100mg 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 and Dopamine Reuptake Inhibitor (NDRI)
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Pregnancy Category
Category C
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FDA Approved
Feb 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's taken in the evening, between 6:30 PM and 9:30 PM. This allows the medication to start working in the morning when you wake up and last throughout the day, helping with focus, attention, and impulse control.
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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 in a dry place. Avoid storing it in a bathroom. Keep your medication in a safe and secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to store your medication. Also, keep all medications away from pets.

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

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 every evening at the same time, between 6:30 PM and 9:30 PM, to ensure it works effectively in the morning.
  • Do not crush, chew, or divide the capsule. Swallow it whole. If swallowing is difficult, the capsule can be opened and the entire contents sprinkled over applesauce or yogurt and consumed immediately.
  • Avoid alcohol, as it can cause the medication to be released too quickly.
  • Maintain regular sleep patterns, as stimulants can sometimes affect sleep, even with evening dosing.
  • Eat a balanced diet and monitor growth, especially in children and adolescents.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial 20 mg orally once daily in the evening (between 6:30 PM and 9:30 PM), titrate weekly by 20 mg increments. Max 100 mg/day.
Dose Range: 20 - 100 mg

Condition-Specific Dosing:

ADHD: Initial 20 mg once daily in the evening, titrate weekly by 20 mg increments based on clinical response and tolerability. Maximum 100 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 6 years and older: Initial 20 mg orally once daily in the evening (between 6:30 PM and 9:30 PM), titrate weekly by 20 mg increments. Max 100 mg/day.
Adolescent: Initial 20 mg orally once daily in the evening (between 6:30 PM and 9:30 PM), 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. Use with caution and monitor closely.

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 mediated through the blockade of dopamine and norepinephrine reuptake into the presynaptic neuron and the inhibition of monoamine oxidase, thereby increasing the extracellular levels of these monoamines in the striatum and prefrontal cortex.
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Pharmacokinetics

Absorption:

Bioavailability: Not explicitly stated for Jornay PM, but generally high for methylphenidate (22-65% due to first-pass metabolism). Jornay PM is designed for delayed and extended release.
Tmax: Approximately 10-12 hours post-dose (when taken in the evening, peak occurs in the morning).
FoodEffect: A high-fat meal can delay Tmax by approximately 2.5 hours, but does not significantly affect Cmax or AUC.

Distribution:

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

Elimination:

HalfLife: Approximately 3.5 hours (for methylphenidate, after peak absorption)
Clearance: Approximately 0.53 L/hr/kg
ExcretionRoute: Primarily renal (90% as ritalinic acid, 1% as unchanged drug)
Unchanged: Less than 1%
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Pharmacodynamics

OnsetOfAction: Due to the delayed-release formulation, the therapeutic effect typically begins in the morning after an evening dose, approximately 8-12 hours post-dose.
PeakEffect: Corresponds to Tmax, approximately 10-12 hours post-dose.
DurationOfAction: Up to 12 hours (providing effect throughout the school/work day).
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including Jornay PM, 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 immediately or seek emergency 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
Uncontrollable 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 a family history of abnormal heart rhythms or sudden death, inform your doctor

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

Additional Urgent Side Effects:

Prolonged or painful erections (lasting more than 4 hours); if not treated promptly, this can lead to permanent sexual dysfunction
New or worsening behavioral and mood changes, such as altered thinking, anger, or hallucinations; if you or a family member have a history of mental health conditions, such as depression or bipolar disorder, inform your doctor
Serotonin syndrome, a potentially life-threatening condition, can occur if you take this medication with certain other drugs; seek medical help immediately if you experience agitation, balance problems, confusion, hallucinations, fever, rapid or irregular heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache

Common Side Effects:

While many people may not experience side effects or may only have mild side effects, it is essential to inform your doctor if you notice any of the following:

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:

If you experience any side effects that bother you or do not go away, contact your doctor for medical 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)
  • New or worsening aggression, hostility, or irritability
  • New psychotic symptoms (e.g., hearing voices, believing things that are not true)
  • New manic symptoms (e.g., extreme high mood, increased energy, racing thoughts)
  • Unexplained wounds on fingers or toes (Raynaud's phenomenon)
  • Prolonged or painful erections (priapism)
  • Blurred vision or other vision changes
  • Uncontrolled movements or tics
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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 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 or concerns, consult your doctor.

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, limit your intake of caffeine (found in tea, coffee, cola) and 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 or high-dose use of this medication may lead to tolerance, reducing its effectiveness and potentially requiring higher doses to achieve the same effect. If you notice 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 certain individuals, including those with a history of seizures. Discuss your risk of seizures with your doctor. In some cases, this medication may affect growth in children and teenagers, necessitating 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 to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Vomiting
  • Agitation
  • Tremors
  • Hyperreflexia
  • Muscle twitching
  • Convulsions (may be followed by coma)
  • Euphoria
  • Confusion
  • Hallucinations
  • Delirium
  • Sweating
  • Flushing
  • Headache
  • Hyperpyrexia (very high fever)
  • Tachycardia (fast heart rate)
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension (high blood pressure)
  • Mydriasis (dilated pupils)
  • Dryness of mucous membranes

What to Do:

Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention.

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

  • Vasopressors: Methylphenidate may decrease the hypotensive effect of drugs used to treat hypertension. Use with caution.
  • Halogenated Anesthetics: Risk of sudden blood pressure and heart rate increases during surgery. Discontinue Jornay PM on the day of surgery.
  • Alcohol: May lead to a more rapid release of methylphenidate, increasing systemic exposure and risk of adverse effects.
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Moderate Interactions

  • Anticoagulants (e.g., coumarin): May prolong prothrombin time. Monitor coagulation parameters.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit metabolism of these drugs, increasing their plasma concentrations. Adjust dose of anticonvulsant.
  • Antidepressants (e.g., tricyclic antidepressants, SSRIs): May inhibit metabolism of these drugs, increasing their plasma concentrations. Monitor for increased adverse effects.
  • Antihypertensive drugs: May reduce the effectiveness of antihypertensive agents. Monitor blood pressure.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Cardiovascular assessment (BP, HR)

Rationale: To identify pre-existing cardiovascular conditions and establish baseline for monitoring stimulant-induced changes.

Timing: Prior to initiation of therapy.

Height and Weight

Rationale: To monitor for growth suppression, especially in pediatric patients.

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.

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Routine Monitoring

Blood Pressure and Heart Rate

Frequency: At each visit or at least every 3-6 months.

Target: Within normal limits for age/sex.

Action Threshold: Persistent elevation (e.g., >95th percentile for age/sex or significant increase from baseline) warrants dose reduction, discontinuation, or further cardiovascular evaluation.

Height and Weight

Frequency: Every 3-6 months in children and adolescents.

Target: Normal growth trajectory.

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

ADHD symptom control and functional improvement

Frequency: Regularly at follow-up visits.

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

Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or re-evaluation of diagnosis/treatment plan.

Emergence/worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, anxiety)

Frequency: At each visit.

Target: Absence of new or worsening symptoms.

Action Threshold: Any new or worsening psychiatric symptoms warrant immediate evaluation and potential discontinuation.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • Unexplained fainting
  • New or worsening aggression
  • Hallucinations
  • Delusional thinking
  • Mania
  • Severe anxiety
  • Depressed mood
  • Tics or abnormal movements
  • Blurred vision
  • Priapism (rare)

Special Patient Groups

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Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Data from a pregnancy registry did not show an increased risk of major congenital malformations with methylphenidate exposure.

Trimester-Specific Risks:

First Trimester: Limited data, but no clear evidence of increased major congenital malformations.
Second Trimester: Not available
Third Trimester: Not available
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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 for adverse reactions in the breastfed infant.

Infant Risk: L3 (Moderate risk - Monitor infant for agitation, insomnia, anorexia, and reduced weight gain. Consider alternative if infant is very young or has health issues.)
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Pediatric Use

Approved for children 6 years and older. Monitor growth (height and weight) carefully. Monitor for emergence or worsening of psychiatric symptoms. Cardiovascular monitoring is essential.

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Geriatric Use

Safety and efficacy have not been established in geriatric patients. Use with caution due to potential for increased sensitivity to adverse effects, especially cardiovascular effects.

Clinical Information

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Clinical Pearls

  • Jornay PM is unique among methylphenidate formulations as it is dosed in the evening (between 6:30 PM and 9:30 PM) to provide effect the following morning.
  • The delayed-release technology ensures that the medication is not released until approximately 10 hours after ingestion, allowing for morning onset of action without requiring a morning dose.
  • Crucial to educate patients and caregivers on the specific evening dosing window to ensure proper therapeutic effect.
  • Patients should be advised not to take Jornay PM too late in the evening, as it could interfere with sleep.
  • The capsule can be opened and sprinkled on applesauce or yogurt for patients who have difficulty swallowing whole capsules, but the entire contents must be consumed immediately.
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Alternative Therapies

  • Other methylphenidate formulations (e.g., Concerta, Ritalin LA, Quillivant XR, Adhansia XR, Aptensio XR, Cotempla XR-ODT)
  • Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Mydayis)
  • Non-stimulants (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
  • Behavioral therapy
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Cost & Coverage

Average Cost: $300 - $500+ per 30 capsules
Insurance Coverage: Tier 2 or Tier 3 (Specialty/Non-preferred Brand)
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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 provides crucial information about its safe and effective use. It is vital 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 consult with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred.