Dexmethylphenidate ER 5mg Capsules

Manufacturer LANNETT Active Ingredient Dexmethylphenidate Extended- Release Capsules(dex meth il FEN i date) Pronunciation dex 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 also 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
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
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Pregnancy Category
Category C
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FDA Approved
May 2005
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Dexmethylphenidate ER is a stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting certain natural chemicals in the brain that are involved in impulse control and hyperactivity. The 'ER' means extended-release, so it works throughout the day with a single morning dose.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Note that taking it with food may delay its effects. To minimize sleep disturbances, take your medication early in the day. Swallow the tablet whole; do not chew or crush it. If you have difficulty swallowing the tablet whole, you can sprinkle its contents onto applesauce, but be sure to swallow the mixture immediately without chewing.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, avoiding storage in a bathroom. To ensure safety, store your medication in a secure location where children and pets cannot access it, and consider using a locked box or area. Keep all medications out of reach of pets.

Missing a Dose

If you miss a dose, skip it and resume your regular 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 exactly as prescribed, usually once daily in the morning.
  • Do not crush, chew, or open the capsules; swallow them whole. If unable to swallow, the capsule may be opened and the contents sprinkled on a small amount of applesauce and consumed immediately.
  • Avoid alcohol, as it can affect the release of the medication.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Regularly monitor blood pressure and heart rate as advised by your doctor.
  • Maintain a healthy diet and regular sleep schedule.
  • For children, monitor growth and weight regularly.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial 10 mg once daily in the morning; may increase by 10 mg weekly. Max 40 mg/day.
Dose Range: 10 - 40 mg

Condition-Specific Dosing:

ADHD: Initial 10 mg once daily in the morning; may increase by 10 mg weekly. Max 40 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 6-12 years: Initial 5 mg once daily in the morning; may increase by 5 mg weekly. Max 30 mg/day.
Adolescent: For adolescents 13-17 years: Initial 10 mg once daily in the morning; may increase by 10 mg weekly. Max 40 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended; use with caution.
Moderate: No specific adjustment recommended; use with caution.
Severe: No specific adjustment recommended; use with caution; monitor for adverse effects.
Dialysis: Not well studied; consider lower doses and monitor for adverse effects.

Hepatic Impairment:

Mild: No specific adjustment recommended; use with caution.
Moderate: No specific adjustment recommended; use with caution.
Severe: No specific adjustment recommended; use with caution; monitor for adverse effects.

Pharmacology

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Mechanism of Action

Dexmethylphenidate is the d-threo-enantiomer of methylphenidate. It is a central nervous system (CNS) stimulant. Its therapeutic effect in Attention-Deficit/Hyperactivity Disorder (ADHD) is thought to be due 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: Not explicitly quantified for oral, but well absorbed.
Tmax: Biphasic: approximately 1.5 hours and 4.5 hours (for ER formulation).
FoodEffect: High-fat meal may delay Tmax by approximately 1 hour and decrease Cmax by 25%, but overall exposure (AUC) is not significantly affected.

Distribution:

Vd: Not explicitly reported for dexmethylphenidate, but methylphenidate has a Vd of 2.65 L/kg.
ProteinBinding: Approximately 15% (for methylphenidate).
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 2.2 hours (for ER formulation).
Clearance: Not explicitly reported for dexmethylphenidate, but methylphenidate clearance is high.
ExcretionRoute: Primarily renal (urine), as ritalinic acid.
Unchanged: <1% (as unchanged drug in urine).
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Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes (for ER formulation).
PeakEffect: Approximately 1.5 hours and 4.5 hours (biphasic for ER formulation).
DurationOfAction: Approximately 8-12 hours (for ER formulation).

Safety & Warnings

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BLACK BOX WARNING

ABUSE, MISUSE, AND ADDICTION: Dexmethylphenidate Extended-Release Capsules has a high potential for abuse and misuse, which can lead to a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Dexmethylphenidate Extended-Release Capsules, can result in overdose and death, and serious cardiovascular adverse events. Before prescribing Dexmethylphenidate Extended-Release Capsules, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout Dexmethylphenidate Extended-Release Capsules treatment, regularly assess the risks of abuse, misuse, and addiction and monitor for the development of these behaviors or conditions.
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Side Effects

WHAT ARE SOME SIDE EFFECTS THAT I NEED TO CALL MY DOCTOR ABOUT RIGHT AWAY? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:Signs of an allergic reaction, like 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; or swelling of the mouth, face, lips, tongue, or throat.Signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.A fast heartbeat.Joint pain. Purple patches on the skin or mouth.Change in eyesight or eye pain, swelling, or redness.Seizures. Shakiness.Trouble controlling body movements. Trouble controlling sounds, like humming, throat clearing, yelling, or making loud noises.Sweating a lot.Restlessness.Change in color of hands, feet, or other areas. Skin may turn pale, blue, gray, purple, or red.Numbness, pain, tingling, or cold feeling of the hands or feet.Any sores or wounds on the fingers or toes.Not able to pass urine or change in how much urine is passed.Muscle pain or weakness, dark urine, or trouble passing urine.Change in sex interest.Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.Sudden deaths have happened in people with some heart problems or heart defects. Tell your doctor if you have any heart problem or defect. Tell your doctor if a family member has an abnormal heartbeat or died suddenly. Get medical help right away if you have any signs of heart problems like chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or passing out.New or worse behavior and mood changes like change in thinking, anger, and hallucinations have happened with this drug. Tell your doctor if you or a family member have any mental or mood problems like depression or bipolar illness, or if a family member has committed suicide. Call your doctor right away if you have hallucinations; change in the way you act; or signs of mood changes like depression, thoughts of suicide, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.A severe and sometimes deadly problem called serotonin syndrome may happen if you take this drug with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache. WHAT ARE SOME OTHER SIDE EFFECTS OF THIS DRUG? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:Dizziness or headache.Feeling sleepy.Feeling nervous and excitable.Stomach pain or heartburn. Weight loss.Decreased appetite.Trouble sleeping.Dry mouth.Upset stomach or throwing up.Throat pain. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.You may report side effects to the FDA at 1-800-332-1088. You may also report side effects 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., unusually elevated mood, decreased need for sleep, racing thoughts).
  • Unexplained numbness, pain, skin color change, or sensitivity to temperature in fingers or toes (Raynaud's phenomenon).
  • 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 conditions to ensure safe treatment:

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.
A family history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics
Your medical history, particularly if you have:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
+ A history of stroke
Recent use of certain 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)
* Current use of certain medications, including:
+ 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 you 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 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 engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Long-term use or high doses of this medication may lead to tolerance, where the drug becomes less effective, and higher doses may be necessary to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.

Before starting this medication, your doctor may recommend heart tests. If you have any questions or concerns, discuss them with your doctor.

This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.

There is a potential risk of high blood pressure associated with this medication. Monitor your blood pressure and heart rate as directed by your doctor, and seek immediate medical attention if you experience severe headache, dizziness, fainting, or changes in vision.

To minimize potential interactions, limit your consumption of caffeine (found in tea, coffee, cola) and chocolate, as combining these substances with this medication may cause nervousness, shakiness, and rapid heartbeat. Additionally, avoid consuming alcohol while taking this medication.

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.

This medication may cause changes in behavior and mood, including altered thinking, anger, and hallucinations. 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, including depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.

In some cases, this medication may affect growth in children and adolescents, and regular growth checks may be necessary. Discuss this with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to weigh 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
  • Dry mouth

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes supportive care, maintaining circulation and respiration, and external cooling for hyperpyrexia. Gastric lavage and activated charcoal may be considered.

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

  • Vasopressor agents: May potentiate the pressor effect of vasopressor agents.
  • Halogenated Anesthetics: Risk of sudden blood pressure and heart rate increases during surgery.
  • Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort): Increased risk of serotonin syndrome.
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Moderate Interactions

  • Antihypertensive drugs: May reduce the effectiveness of antihypertensive drugs.
  • Antipsychotics: May exacerbate psychotic symptoms or interfere with antipsychotic effects.
  • Anticonvulsants: May alter plasma concentrations of certain anticonvulsants (e.g., phenobarbital, phenytoin, primidone).
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Minor Interactions

  • Alcohol: May alter the release rate of dexmethylphenidate from the extended-release formulation.

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.

Height and Weight (Pediatric Patients)

Rationale: Stimulants have been associated with growth suppression.

Timing: Prior to initiation of treatment.

Cardiac History and Family History of Sudden Death/Arrhythmias

Rationale: To identify patients at risk for serious cardiovascular events.

Timing: Prior to initiation of treatment.

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

Rationale: Stimulants can exacerbate or unmask psychiatric symptoms.

Timing: Prior to initiation of treatment.

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Regularly (e.g., at each visit or 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 (Pediatric Patients)

Frequency: Every 3-6 months.

Target: Normal growth trajectory.

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

ADHD Symptom Control

Frequency: Regularly (e.g., at each visit).

Target: Improved attention, reduced hyperactivity/impulsivity.

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

Emergence of Psychiatric Symptoms (e.g., psychosis, mania, aggression, tics)

Frequency: Regularly (e.g., at each visit).

Target: Absence of new or worsening symptoms.

Action Threshold: New onset or worsening of symptoms; consider discontinuation.

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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)
  • Motor or vocal tics
  • Unexplained weight loss
  • Blurred vision

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. Data from a pregnancy registry suggest no increased risk of major congenital malformations with methylphenidate exposure during the first trimester.

Trimester-Specific Risks:

First Trimester: Limited data, but some studies suggest no increased risk of major congenital malformations. However, potential for cardiovascular effects in the fetus cannot be ruled out.
Second Trimester: Potential for cardiovascular effects (e.g., tachycardia, hypertension) in the fetus.
Third Trimester: Potential for cardiovascular effects in the fetus; withdrawal symptoms in neonates if exposed late in pregnancy.
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Lactation

L3 (Moderate Risk). Dexmethylphenidate and/or its metabolites are excreted in human milk. Monitor breastfed infants for agitation, insomnia, anorexia, or poor weight gain. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant.

Infant Risk: Agitation, insomnia, anorexia, poor weight gain. Low levels in milk, but caution advised.
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Pediatric Use

Approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly due to potential for growth suppression. Monitor for emergence or worsening of psychiatric symptoms and tics.

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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, potential for cardiovascular events, and comorbidities. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Dexmethylphenidate ER is the d-isomer of methylphenidate, offering similar efficacy at approximately half the dose of racemic methylphenidate.
  • Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing, but the beads should not be chewed.
  • Patients should be screened for cardiac abnormalities and psychiatric conditions prior to initiation.
  • Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
  • Educate patients and caregivers about the potential for abuse, misuse, and diversion, and the importance of secure storage.
  • Consider drug holidays if growth suppression or significant adverse effects occur, under medical supervision.
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Alternative Therapies

  • Methylphenidate (e.g., Ritalin, Concerta, Daytrana)
  • Amphetamine/Dextroamphetamine (e.g., Adderall)
  • Lisdexamfetamine (Vyvanse)
  • Atomoxetine (Strattera) - non-stimulant
  • Guanfacine ER (Intuniv) - non-stimulant
  • Clonidine ER (Kapvay) - non-stimulant
  • Behavioral therapy
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Cost & Coverage

Average Cost: Varies widely, typically $100-$400+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for generic); Tier 3 or Tier 4 (for 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 is a valuable resource that provides important information about its safe and effective use. It is crucial 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. This information will help healthcare professionals provide you with the most appropriate care and treatment.