Jornay PM 40mg 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 Stimulant
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Pharmacologic Class
Dopamine and Norepinephrine Reuptake Inhibitor
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Pregnancy Category
Not available
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FDA Approved
Aug 2018
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Jornay PM is a stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). Unlike most ADHD medications taken in the morning, Jornay PM is taken in the evening, usually around 8 PM. It's designed to release the medication slowly overnight so that it starts working when you wake up in the morning and lasts 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 be consistent in how you take it each time. If you choose to take it with food, always take it with food. If you choose to take it on an empty stomach, 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. Do not prepare a dose ahead of time or store it for later use.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom. Keep this medication out of the reach of children and pets, and consider storing it in a locked box or secure area to prevent accidental ingestion or misuse. When you no longer need this medication or it has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of unused or expired medication, as there may be drug take-back programs available in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember if it is still the same evening. If you do not remember until the next morning, skip the missed dose and resume your regular evening dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take Jornay PM exactly as prescribed, typically at 8 PM, or between 6:30 PM and 9:30 PM, to ensure it works when you wake up.
  • Do not chew, crush, or divide the capsule. Swallow it whole. If unable to swallow whole, the capsule may be opened and the entire contents sprinkled over applesauce. Consume immediately without chewing.
  • Avoid alcohol, as it can affect the release of the medication.
  • Maintain regular sleep patterns and a healthy diet.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Do not stop taking Jornay PM suddenly without consulting your doctor, as this can lead to withdrawal symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose: 40 mg orally once daily in the evening. Titrate weekly in 20 mg increments. Max: 100 mg/day.
Dose Range: 40 - 100 mg

Condition-Specific Dosing:

ADHD: Initial dose: 40 mg orally once daily in the evening. Titrate weekly in 20 mg increments. Max: 100 mg/day. Administer at 8 PM, or between 6:30 PM and 9:30 PM, to ensure effect the next morning.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Initial dose (6-12 years): 20 mg orally once daily in the evening. Titrate weekly in 20 mg increments. Max: 100 mg/day. Administer at 8 PM, or between 6:30 PM and 9:30 PM.
Adolescent: Initial dose (13-17 years): 40 mg orally once daily in the evening. Titrate weekly in 20 mg increments. Max: 100 mg/day. Administer at 8 PM, or between 6:30 PM and 9:30 PM.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended.
Dialysis: Not available. Methylphenidate is not significantly dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended.

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 transporters in the presynaptic neuron, thereby increasing the extracellular concentrations of these monoamines in the striatum and prefrontal cortex.
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Pharmacokinetics

Absorption:

Bioavailability: Not directly reported for Jornay PM, but generally high for methylphenidate (22-89% due to first-pass metabolism).
Tmax: Delayed release. Initial absorption is minimal for several hours. Mean Tmax for methylphenidate is approximately 14 hours (range 10-17 hours) after evening administration.
FoodEffect: Administration with a high-fat meal can delay Tmax by approximately 2.5 hours and increase Cmax by approximately 25% and AUC by approximately 16% compared to administration in a fasted state. Administer consistently with or without food.

Distribution:

Vd: Approximately 2.65 L/kg (for d-methylphenidate).
ProteinBinding: Approximately 15% (for d-methylphenidate).
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 5-7 hours (for d-methylphenidate, after the delayed release).
Clearance: Approximately 0.53 L/hr/kg (for d-methylphenidate).
ExcretionRoute: Primarily renal (90% as ritalinic acid).
Unchanged: <1% (as unchanged methylphenidate).
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Pharmacodynamics

OnsetOfAction: Due to the delayed-release mechanism, the therapeutic effect is designed to begin approximately 8-12 hours after evening administration, coinciding with waking hours.
PeakEffect: Approximately 14 hours post-dose (Tmax).
DurationOfAction: Approximately 10-12 hours of therapeutic effect after the delayed release.

Safety & Warnings

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BLACK BOX WARNING

CNS stimulants, including Jornay PM, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor patients for signs of abuse and dependence while on therapy.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: 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
Difficulty 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 a family history of abnormal heartbeat or sudden death, inform your doctor

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

Additional Urgent Side Effects

Painful erection (hard penis) or an erection lasting longer than 4 hours (even when not having sex); if left untreated, this may lead to lasting sexual problems
New or worsening behavior and mood changes, such as changes in thinking, anger, or hallucinations; if you or a family member have a history of mental or mood problems (e.g., depression, bipolar illness), or if a family member has committed suicide, inform your doctor
Serotonin syndrome, a potentially life-threatening condition, may occur when taking this medication with certain other drugs; seek medical help immediately if you experience agitation, balance problems, confusion, hallucinations, fever, fast or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:

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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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, or irritability.
  • New or worsening psychotic symptoms (e.g., hearing voices, believing things that are not true).
  • Manic symptoms (e.g., feeling unusually excited, restless, or having racing thoughts).
  • Numbness, coolness, or pain in fingers or toes (Raynaud's phenomenon).
  • Unexplained weight loss or significant decrease in growth (in children).
  • Blurred vision or other eye problems.
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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)
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 this medication with these drugs 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 needs to be aware of all your medications and health conditions to ensure it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without consulting your doctor first.
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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, have 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 any questions or concerns, 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 this 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, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you notice this medication is not working as well as it previously did, contact your doctor. Do not exceed the prescribed dose.

This medication may increase the risk of seizures in 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, and regular growth checks may be necessary. Consult your doctor to discuss this further.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial 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
  • Tachycardia
  • Palpitations
  • Cardiac arrhythmias
  • Hypertension
  • Mydriasis
  • Dry mouth and mucous membranes

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and may include gastric lavage, activated charcoal, and management of symptoms.

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).
  • Known hypersensitivity to methylphenidate or other components of Jornay PM.
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Major Interactions

  • Vasopressor agents (e.g., pressor amines, clonidine): Risk of increased blood pressure.
  • Halogenated anesthetics: Risk of sudden blood pressure and heart rate increases during surgery.
  • Antihypertensive drugs: Methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
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Moderate Interactions

  • Anticoagulants (e.g., warfarin): May inhibit metabolism, requiring dose adjustment.
  • Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit metabolism, requiring dose adjustment.
  • Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine): May inhibit metabolism, requiring dose adjustment.
  • Selective Serotonin Reuptake Inhibitors (SSRIs): Potential for serotonin syndrome, though less common than with other stimulants.
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Minor Interactions

  • Alcohol: May increase plasma levels of methylphenidate and lead to dose dumping of immediate-release component.

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Stimulants can cause increases in BP and HR.

Timing: Prior to initiation of treatment.

Cardiac History and Physical Exam

Rationale: To screen for pre-existing cardiac conditions that may contraindicate stimulant use.

Timing: Prior to initiation of treatment.

Mental Status Exam/Psychiatric History

Rationale: To screen for bipolar disorder, psychosis, or other psychiatric comorbidities.

Timing: Prior to initiation of treatment.

Height and Weight

Rationale: Stimulants can cause growth suppression.

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 3-6 months.

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 children and adolescents.

Target: Normal growth trajectory.

Action Threshold: Significant growth deceleration; consider drug holiday or alternative treatment.

ADHD Symptom Control

Frequency: Regularly, especially during titration and long-term treatment.

Target: Improved attention, reduced hyperactivity/impulsivity.

Action Threshold: Lack of efficacy or worsening symptoms; consider dose adjustment or alternative.

Emergence of Psychiatric Symptoms

Frequency: Regularly.

Target: Absence of new or worsening psychosis, mania, aggression, or suicidal ideation.

Action Threshold: New or worsening symptoms; discontinue treatment.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope
  • Palpitations
  • New or worsening aggression
  • New or worsening psychotic symptoms (e.g., hallucinations, delusions)
  • Manic symptoms (e.g., elevated mood, decreased need for sleep, racing thoughts)
  • Suicidal ideation
  • Unexplained weight loss
  • Growth deceleration (in children)
  • Peripheral vasculopathy (e.g., Raynaud's phenomenon)

Special Patient Groups

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Pregnancy

Limited data on methylphenidate use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. There are published studies and postmarketing reports of adverse pregnancy outcomes with maternal use of methylphenidate; however, these studies cannot definitively establish a risk.

Trimester-Specific Risks:

First Trimester: Some studies suggest a possible small increase in risk for cardiac malformations, but data are conflicting and insufficient to establish causality.
Second Trimester: Not specifically studied for trimester-specific risks.
Third Trimester: Not specifically studied for trimester-specific risks. Neonatal withdrawal symptoms (e.g., feeding difficulties, irritability, poor tone) have been reported in infants exposed to CNS stimulants during pregnancy.
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Lactation

Methylphenidate is present in human milk. There are no data on the effects of methylphenidate on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Jornay PM and any potential adverse effects on the breastfed infant from Jornay PM or from the underlying maternal condition. Monitor breastfed infants for agitation, insomnia, anorexia, and reduced weight gain.

Infant Risk: L3 (Moderate risk)
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Pediatric Use

Approved for children 6 years and older. Safety and effectiveness in pediatric patients under 6 years of age have not been established. Monitor growth (height and weight) in children and adolescents during treatment.

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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 stimulant effects and higher prevalence of cardiovascular disease.

Clinical Information

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Clinical Pearls

  • Jornay PM is unique among methylphenidate formulations as it is dosed in the evening (6:30 PM to 9:30 PM) to provide a delayed release of medication, ensuring effect upon waking and throughout the school/work day.
  • The delayed-release mechanism means patients will not feel the effects immediately after taking the dose; the onset is typically 8-12 hours later.
  • Consistency in administration time is crucial for optimal effect. Advise patients to take it at the same time each evening.
  • Patients should be advised not to take Jornay PM in the morning, as this would lead to a delayed effect later in the day/evening.
  • Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing whole capsules. The entire contents must be consumed immediately without chewing.
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Alternative Therapies

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

Average Cost: Check current pricing per 30 capsules
Insurance Coverage: Tier 2 or 3 (Specialty/Non-preferred Brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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. Please read this guide 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 your local poison control center or seek emergency medical attention. Be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.