Dexmethylphenidate 30mg ER Capsules

Dexmethylphenidate is the d-threo enantiomer of methylphenidate. It is believed 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 Attention Immediately

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 medical help right away:

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
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 feeling 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 trouble passing urine
Changes in sex interest

Erectile Dysfunction Warning

If you experience a painful erection (hard penis) 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 lasting sexual problems and impotence.

Cardiovascular Warning

Sudden deaths have occurred in people with certain heart problems or defects. Inform your doctor if you have any heart condition or defect. If a family member has an abnormal heartbeat or 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 behavior 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 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, thoughts of suicide, nervousness, emotional ups and downs, 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 Possible Side Effects

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

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

If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help.

Reporting Side Effects

You can 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. 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 (you or a family member)
Presence of other health conditions, such as:
+ 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, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
Current use of certain medications, such as:
+ 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 you determine if it is safe to take this medication with your existing health conditions and medications. Never start, stop, or change the dose of any medication without consulting your doctor.

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 potential interactions with other treatments.

Before operating a vehicle or engaging in activities that require your full attention, make sure you understand how this medication affects you. Avoid driving or performing tasks that demand alertness until you have a clear understanding of its effects.

Long-term use or high doses of this medication may lead to tolerance, reducing its effectiveness. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose, as this can lead to adverse consequences.

Your doctor may recommend heart tests before starting this medication, especially if you have pre-existing heart conditions. If you have 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 assess your risk and discuss any necessary precautions.

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 interactions, 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 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 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, planning to become pregnant, or breastfeeding, consult your doctor to weigh the benefits and risks of this medication to both you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis)

• Vasopressor agents (risk of hypertensive crisis)
• Halogenated anesthetics (risk of sudden death)
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) (risk of serotonin syndrome)
• Antihypertensive drugs (may reduce the hypotensive effect of these drugs)

• Coumarin anticoagulants (may prolong prothrombin time)
• Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) (may alter plasma concentrations)
• Tricyclic antidepressants (TCAs) (e.g., imipramine, desipramine) (may inhibit metabolism and increase plasma concentrations)
• Dopaminergic drugs (e.g., antipsychotics, dopamine agonists) (potential for pharmacodynamic antagonism)

• Alcohol (may increase plasma levels of dexmethylphenidate)

• Chest pain
• Shortness of breath
• Syncope (fainting)
• Palpitations
• New or worsening aggression
• Hallucinations
• Delusions
• Mania
• Agitation
• Unexplained wounds or pain in fingers/toes (Raynaud's phenomenon)

Based on animal data, dexmethylphenidate may cause fetal harm. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Dexmethylphenidate and/or its metabolites are excreted into human milk. Monitor breastfed infants for agitation, insomnia, decreased weight gain, or other adverse reactions. Use with caution, and 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.

Approved for children 6 years and older. Monitor growth (height and weight) regularly due to potential for growth suppression. Monitor for emergence of new psychiatric symptoms.

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Use with caution, generally starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• Dexmethylphenidate ER capsules can be opened and the beads sprinkled onto a small amount of applesauce and consumed immediately for patients who have difficulty swallowing capsules whole.
• Take in the morning to avoid insomnia; avoid late afternoon or evening doses.
• Regularly monitor blood pressure, heart rate, and growth (in children) throughout treatment.
• Educate patients and caregivers about the high potential for abuse and dependence, and the importance of secure storage.
• Consider drug holidays (e.g., weekends or school breaks) in pediatric patients to mitigate growth suppression, if clinically appropriate and discussed with a healthcare provider.

• Other methylphenidate formulations (e.g., methylphenidate ER, transdermal patch, chewable tablets)
• Amphetamine-based stimulants (e.g., mixed amphetamine salts ER, 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 your safety, 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 seeking help, be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.