Dexmethylphenidate 15mg ER Capsules

Dexmethylphenidate is the d-threo enantiomer of methylphenidate. It is a central nervous system (CNS) stimulant. Its therapeutic effect in 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
+ 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 (hands, feet, or other areas), which may turn pale, blue, gray, purple, or red
Numbness, pain, tingling, or cold sensation in the hands or feet
Sores or wounds on the 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, or if a family member has a history of abnormal heart rhythms or sudden death. Seek medical help immediately 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 health conditions, such as depression or bipolar disorder, 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 Side Effects

While many people may not experience side effects or may only have mild side effects, it is essential to be aware of the following:

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 potential side effects. If you have concerns or questions, 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, 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
+ A history of stroke
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: combining these medications 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 problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.

Before operating a vehicle or engaging in activities that require your full attention, wait until you understand how this medication affects you. This is crucial to prevent accidents and ensure your safety.

Long-term use or high doses of this medication may lead to tolerance, reducing its effectiveness. If you notice that the medication is no longer working as well as it should, contact your doctor. Do not exceed the prescribed dose, as this can lead to adverse effects.

Your doctor may recommend heart tests before starting this medication, especially if you have pre-existing heart conditions. 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 seizure disorders. 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 headaches, dizziness, fainting, or changes in vision.

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 rapid heartbeat. Additionally, avoid consuming alcohol during treatment.

If you have high blood pressure, consult your doctor before using over-the-counter (OTC) products that may exacerbate the condition, such as cough and 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 health issues, such as depression or bipolar disorder, or if a family member has attempted 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. Regular growth checks may be necessary, so 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 for both you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing an MAOI (risk of hypertensive crisis).

• Vasopressor agents (e.g., phenylephrine, epinephrine): May potentiate pressor effects.
• Halogenated Anesthetics: Risk of sudden blood pressure and heart rate increases during surgery.
• Anticoagulants (e.g., coumarin): May decrease their metabolism, increasing bleeding risk.
• Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit their metabolism, increasing plasma concentrations.
• Antidepressants (e.g., tricyclic antidepressants, SSRIs): May inhibit their metabolism, increasing plasma concentrations.

• Alcohol: May lead to dose dumping of extended-release formulations.
• Antihypertensive drugs: May reduce the effectiveness of these drugs.

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening aggression
• Hallucinations
• Delusional thinking
• Mania
• Agitation
• Anxiety
• Depression
• Motor tics
• Verbal tics
• Unexplained weight loss
• Growth deceleration

There are no adequate and well-controlled studies of dexmethylphenidate in pregnant women. Data from a pregnancy registry for methylphenidate (the racemic mixture) did not show an increased risk of major congenital malformations. However, there are risks to the mother and fetus associated with untreated ADHD in pregnancy. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.

Dexmethylphenidate and/or its metabolites are excreted into human milk. There are no data on the effects of dexmethylphenidate 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 dexmethylphenidate and any potential adverse effects on the breastfed infant from dexmethylphenidate or from the underlying maternal condition. Monitor breastfed infants for agitation, insomnia, anorexia, or reduced weight gain.

Safety and efficacy have been 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, aggression) can occur. Risk of tics or exacerbation of pre-existing tics.

Safety and efficacy have not been established in geriatric patients. Use with caution in elderly patients, generally starting with lower doses and titrating slowly, due to potential for increased sensitivity to adverse effects, especially cardiovascular effects.

• Dexmethylphenidate ER provides a biphasic release, designed to provide an initial effect followed by a sustained effect throughout the day, typically lasting 8-10 hours.
• It is the d-isomer of methylphenidate, which is considered the more pharmacologically active enantiomer, allowing for lower doses compared to racemic methylphenidate.
• Capsules can be opened and sprinkled on applesauce for patients who have difficulty swallowing whole capsules, but the entire contents must be consumed immediately.
• Patients should be advised to avoid taking the medication in the late afternoon or evening to prevent sleep disturbances.
• Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial during therapy.

• Other methylphenidate formulations (e.g., methylphenidate ER, methylphenidate IR, methylphenidate transdermal system)
• Amphetamine-based stimulants (e.g., mixed amphetamine salts, lisdexamfetamine)
• Non-stimulant medications (e.g., atomoxetine, guanfacine extended-release, clonidine extended-release)
• Behavioral therapy and psychotherapy for ADHD

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, consult 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.