Dexmethylphenidate 25mg ER Capsules

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.

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, such as:
+ Rash or 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Rapid heartbeat
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, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Difficulty urinating or changes in urine output
Muscle pain or weakness, dark urine, or difficulty passing urine
Changes in sex drive

Erectile Dysfunction Warning

If you experience a painful erection (priapism) or an erection that lasts longer than 4 hours, seek medical attention immediately. This can occur even when you are not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction.

Cardiovascular Warning

Sudden deaths have occurred in people with pre-existing heart problems or heart defects. Inform your doctor if you have any heart condition or defect. If a family member has a history of abnormal heartbeat or sudden death, notify your doctor. Seek emergency medical help if you experience:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting

Mental Health Warning

New or worsening behavioral and mood changes, such as changes in thinking, anger, and hallucinations, have been reported with this medication. Inform your doctor 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. Seek medical help immediately if you experience:

Hallucinations
Changes in behavior
Signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life

Serotonin Syndrome Warning

A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek medical help immediately if you experience:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache

Other Possible Side Effects

While many people may not experience side effects or may only have mild side effects, it is essential to monitor your body's response to this medication. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Dizziness or headache
Drowsiness
Feeling nervous or excitable
Stomach pain or heartburn
Weight loss
Decreased appetite
Difficulty sleeping
Dry mouth
Upset stomach or vomiting
Throat pain

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.

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. Be sure to describe the allergic reaction and its symptoms.
A 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 (you or a family member)
Presence of other health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have ever experienced a stroke
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: this may increase the risk of very high blood pressure)
Current use of certain medications, such as:
+ 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) medications
Natural products
* Vitamins

Your doctor and pharmacist will help determine whether it is safe to take this medication with your existing medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor first.

Important Information to Share with Your Healthcare Providers

Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.

Precautions to Take When Starting This Medication

Until you know how this medication affects you, avoid driving and other activities that require you to be alert. This will help prevent accidents and ensure your safety.

Long-Term Use and Tolerance

If you have been taking this medication for a long time or at high doses, you may develop tolerance, which means that the medication may not work as well as it did initially. In this case, you may need to take higher doses to achieve the same effect. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose, as this can lead to serious side effects.

Heart Tests and Monitoring

Before starting this medication, you may need to undergo some heart tests to ensure that it is safe for you to take. If you have any questions or concerns, discuss them with your doctor. Additionally, you will need to monitor your blood pressure and heart rate as directed by your doctor.

Seizure Risk

This medication may increase the risk of seizures in some individuals, particularly those who have a history of seizures. Talk to your doctor to determine if you are at a higher risk of seizures while taking this medication.

Blood Pressure Monitoring

This medication may cause high blood pressure, which can lead to serious health problems. Monitor your blood pressure regularly and contact your doctor immediately if you experience any symptoms of high blood pressure, such as severe headache, dizziness, fainting, or changes in vision.

Interactions with Other Substances

To minimize potential side effects, limit your consumption of caffeine (found in tea, coffee, cola, and chocolate) while taking this medication, as it may cause nervousness, shakiness, and a rapid heartbeat. Avoid drinking alcohol while taking this medication, as it can increase the risk of side effects. If you have high blood pressure, talk to your doctor before taking any 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.

Mental Health and Mood Changes

This medication may cause changes in behavior and mood, including hallucinations, anger, and changes in thinking. If you or a family member have a history of mental health problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Contact your doctor immediately if you experience any symptoms of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.

Growth and Development in Children and Teens

This medication may affect growth in children and teens. If you are a parent or guardian, talk to your doctor about the potential risks and benefits of this medication. Regular growth checks may be necessary to monitor the effects of this medication.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation)

• Vasopressors (e.g., phenylephrine, epinephrine, norepinephrine) - risk of hypertensive crisis
• Halogenated Anesthetics (e.g., halothane, isoflurane) - risk of sudden blood pressure and heart rate increases during surgery
• Antihypertensive drugs (may reduce effectiveness of antihypertensives)
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome

• Coumarin anticoagulants (e.g., warfarin) - may inhibit metabolism, increasing anticoagulant effect
• Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, increasing anticonvulsant levels
• Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine) - may inhibit metabolism, increasing TCA levels
• Dopaminergic drugs (e.g., antipsychotics, dopamine agonists) - may antagonize effects

• Alcohol (may alter release rate of drug from ER formulation)

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening aggression
• Hallucinations
• Delusions
• Mania
• Severe anxiety
• Numbness, coolness, or pain in fingers/toes
• Unexplained wounds on fingers/toes
• Blurred vision
• Persistent headache
• Insomnia
• Loss of appetite
• Weight loss

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 suggest no increased risk of major congenital malformations with methylphenidate exposure during the first trimester.

Dexmethylphenidate and/or its metabolites are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, anorexia, reduced weight gain), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and efficacy established in pediatric patients 6 to 17 years of age. Long-term effects on growth (weight and height) should be monitored. Psychiatric adverse events (e.g., psychosis, mania) can occur.

Safety and efficacy have not been established in geriatric patients (over 65 years of age). Use with caution due to potential for increased sensitivity to adverse effects, particularly cardiovascular effects.

• Dexmethylphenidate is the more potent d-isomer of methylphenidate, typically requiring half the dose of racemic methylphenidate.
• ER formulation provides a biphasic release, mimicking twice-daily dosing of immediate-release formulations.
• Patients should be screened for cardiac abnormalities and psychiatric conditions prior to initiation.
• Growth suppression is a concern in pediatric patients; consider drug holidays or alternative treatments if significant growth deceleration occurs.
• Abuse potential is high; store securely and monitor for signs of diversion or misuse.
• Advise patients to avoid abrupt discontinuation after prolonged high-dose therapy to prevent withdrawal symptoms.

• Methylphenidate (e.g., Ritalin, Concerta, Daytrana, Quillivant XR)
• Amphetamine/Dextroamphetamine (e.g., Adderall, Vyvanse, Dexedrine)
• Lisdexamfetamine (Vyvanse)
• Atomoxetine (Strattera)
• Guanfacine ER (Intuniv)
• Clonidine ER (Kapvay)
• Non-pharmacological interventions (e.g., behavioral therapy, cognitive behavioral therapy)

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, we encourage you to discuss them with 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 incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.