Dexmethylphenidate 35mg 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 or seek immediate 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Fast heartbeat
Joint pain
Purple patches on the skin or mouth
Changes in eyesight or eye pain, swelling, or redness
Seizures
Shakiness
Trouble controlling body movements
Difficulty 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
Urination problems, such as inability to pass urine 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 or an erection that lasts longer than 4 hours, seek medical attention immediately. This can occur even when you are not having sex. If left untreated, it may lead to permanent sexual dysfunction.

Cardiovascular Warning

Sudden deaths have occurred in people with pre-existing heart problems or defects. Inform your doctor if you have any heart condition or defect. If a family member has an abnormal heartbeat or has died suddenly, notify your doctor. 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 or mood problems, 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 severe and 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
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, 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 notify your doctor if you experience any of the following:

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

This is not an exhaustive list of possible side effects. If you have 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, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
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 (if you or a family member has been diagnosed)
The presence of any of the following health conditions:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
If you have ever had a stroke
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, 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 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.

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.

Until you know how this medication affects you, avoid driving and engaging in activities that require your full attention. If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means it may not work as well as it initially did. In this case, you may need higher doses to achieve the same effect. If you notice that the medication is no longer effective, contact your doctor. Do not take more than the prescribed dose.

Before starting this medication, your doctor may recommend some heart tests to ensure your safety. If you have any questions or concerns, be sure to discuss them with your doctor.

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

Additionally, this medication may cause high blood pressure. 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 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. It is also recommended that you avoid drinking alcohol while taking this medication.

If you have high blood pressure, consult with 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.

In some cases, this medication may cause changes in behavior and mood, including hallucinations, anger, and altered thinking. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, 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, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or a lack of interest in life.

This medication may affect growth in children and teenagers. Regular growth checks may be necessary, so be sure to discuss this with your doctor.

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 taking this medication to ensure the best possible outcome for you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis.
• Known hypersensitivity to methylphenidate or dexmethylphenidate.

• 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.
• Antihypertensive drugs: May reduce the effectiveness of drugs used to treat hypertension.

• Anticoagulants (e.g., warfarin): May prolong prothrombin time; monitor coagulation parameters.
• Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit metabolism of these drugs, increasing plasma concentrations.
• Tricyclic Antidepressants (TCAs): May inhibit metabolism of TCAs, increasing plasma concentrations and risk of adverse effects.

• Alcohol: May alter the release profile of the extended-release formulation, leading to a more rapid release of dexmethylphenidate.

• Cardiovascular symptoms (chest pain, shortness of breath, syncope)
• Psychiatric symptoms (hallucinations, delusions, mania, aggression, anxiety, depression)
• Growth trajectory (in children)
• Motor or verbal tics
• Peripheral vasculopathy (e.g., Raynaud's phenomenon)
• Priapism (rare)

Limited data on dexmethylphenidate use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with untreated ADHD in pregnancy. Use only if the potential benefit justifies the potential risk to the fetus.

Dexmethylphenidate is present in human milk. There are no data on the effects of dexmethylphenidate on the breastfed infant or on milk production. Monitor breastfed infants for agitation, insomnia, anorexia, and reduced weight gain. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for dexmethylphenidate and any potential adverse effects on the breastfed infant.

Safety and efficacy established in pediatric patients 6 to 17 years of age. Monitor growth (height and weight) regularly, as long-term stimulant use has been associated with growth suppression. Monitor for emergence or worsening of psychiatric symptoms.

Safety and efficacy have not been established in geriatric patients. Use with caution in elderly patients due to potential for increased sensitivity to stimulant effects and higher prevalence of cardiovascular disease.

• Dexmethylphenidate ER is the d-isomer of methylphenidate, often allowing for a lower dose compared to racemic methylphenidate.
• The extended-release formulation provides a biphasic release, mimicking a morning and early afternoon dose of immediate-release medication, offering up to 12 hours of effect.
• Counsel patients not to crush, chew, or open the capsules, as this will lead to immediate release of the entire dose and potential for adverse effects.
• Regularly assess for cardiovascular changes (BP, HR) and psychiatric symptoms, especially in patients with pre-existing conditions.
• Consider drug holidays (e.g., weekends or school breaks) for pediatric patients to assess continued need for medication and to mitigate potential growth suppression, if clinically appropriate and discussed with the prescriber.

• Other methylphenidate formulations (e.g., methylphenidate ER, methylphenidate IR, transdermal patch)
• Amphetamine-based stimulants (e.g., mixed amphetamine salts, lisdexamfetamine)
• Non-stimulants (e.g., atomoxetine, guanfacine ER, clonidine ER)
• 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, 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 amount, and the time it occurred.