Dexmethylphenidate ER 5mg Capsules
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
- Dexmethylphenidate 10mg Tablets
- Dexmethylphenidate 2.5mg Tablets
- Dexmethylphenidate 5mg Tablets
- Dexmethylphenidate 25mg ER Capsules
- Dexmethylphenidate ER 5mg Capsules
- Dexmethylphenidate ER 20mg Capsules
- Dexmethylphenidate ER 10mg Capsules
- Dexmethylphenidate 15mg ER Capsules
- Dexmethylphenidate 30mg ER Capsules
- Dexmethylphenidate 35mg ER Capsules
- Dexmethylphenidate 40mg ER Capsules
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of discontinuing an MAOI due to risk of hypertensive crisis.
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.
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).
Minor Interactions
- Alcohol: May alter the release rate of dexmethylphenidate from the extended-release formulation.
Monitoring
Baseline Monitoring
Rationale: Stimulants can cause increases in BP and HR.
Timing: Prior to initiation of treatment.
Rationale: Stimulants have been associated with growth suppression.
Timing: Prior to initiation of treatment.
Rationale: To identify patients at risk for serious cardiovascular events.
Timing: Prior to initiation of treatment.
Rationale: Stimulants can exacerbate or unmask psychiatric symptoms.
Timing: Prior to initiation of treatment.
Routine Monitoring
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.
Frequency: Every 3-6 months.
Target: Normal growth trajectory.
Action Threshold: Significant growth deceleration; consider drug holiday or alternative treatment.
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.
Frequency: Regularly (e.g., at each visit).
Target: Absence of new or worsening symptoms.
Action Threshold: New onset or worsening of symptoms; consider discontinuation.
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
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:
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 motherβs clinical need for the drug and any potential adverse effects on the breastfed infant.
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.
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
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.
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
Cost & Coverage
General Drug Facts
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.