Dexmethylphenidate 2.5mg Tablets

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
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 hands or feet
Sores or wounds on fingers or toes
Difficulty urinating or changes in urine output
Muscle pain or weakness, dark urine, or trouble passing urine
Changes in sex interest

Important Warnings

If you experience a painful erection (hard penis) or an erection that lasts longer than 4 hours, seek medical help immediately. This can occur even when you are not having sex, and if left untreated, may lead to lasting sexual problems.
If you have a heart problem or defect, inform your doctor. Sudden deaths have occurred in people with certain heart conditions. Seek medical help right away if you experience:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or passing out
New or worsening behavioral and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
+ Depression
+ Thoughts of suicide
+ Nervousness
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ Lack of interest in life
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 inform your doctor if you notice any 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

This is not an exhaustive list of possible side effects. If you have concerns or questions, contact 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 (if you or a family member has been diagnosed)
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: combining these medications 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 conditions with your doctor and pharmacist. They will help determine whether 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.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Long-term use or high doses of this medication may lead to tolerance, where the drug becomes less effective, and higher doses may be needed to achieve the same effect. If you experience a decrease in the drug'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 drug.

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 with this medication may cause nervousness, shakiness, and rapid heartbeat. 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 teenagers, 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.

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

• Vasopressor agents (e.g., phenylephrine, pseudoephedrine) - risk of increased blood pressure
• Halogenated anesthetics (e.g., halothane, isoflurane) - risk of sudden blood pressure and heart rate increases during surgery

• Anticoagulants (e.g., warfarin) - may inhibit metabolism, requiring dose adjustment
• Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, requiring dose adjustment
• Tricyclic antidepressants (TCAs) (e.g., imipramine, desipramine) - may inhibit metabolism, requiring dose adjustment
• Alcohol - may increase plasma levels of dexmethylphenidate

• Not many specific minor interactions are well-documented beyond general caution with other CNS stimulants.

• Chest pain
• Shortness of breath
• Syncope (fainting)
• New or worsening psychiatric symptoms (e.g., hallucinations, paranoia, mania, aggression)
• New or worsening tics or Tourette's syndrome symptoms
• Unexplained weight loss or growth deceleration (in children)
• Blurred vision or other visual disturbances

There are no adequate and well-controlled studies of dexmethylphenidate in pregnant women. Data from observational studies of methylphenidate (racemic mixture) use in pregnancy have not identified a clear drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Dexmethylphenidate and its metabolites are excreted in human milk. There are no data on the effects of dexmethylphenidate on the breastfed infant or on milk production. Monitor breastfed infants for adverse reactions such as agitation, insomnia, anorexia, or reduced weight gain. 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.

Dexmethylphenidate is approved for ADHD in children 6 years and older. Monitor growth (height and weight) regularly, as stimulants can cause growth suppression. Monitor for emergence or worsening of psychiatric symptoms (e.g., psychosis, mania, aggression, tics).

Safety and efficacy in patients over 65 years have not been established. Generally not recommended due to increased risk of cardiovascular events and other adverse effects in this population. If used, start with lower doses and titrate cautiously.

• Dexmethylphenidate is the more pharmacologically active d-isomer of methylphenidate, allowing for lower doses compared to racemic methylphenidate.
• Immediate-release tablets are typically dosed twice daily, with the second dose given in the early afternoon to avoid interference with sleep.
• Patients should be advised to take the medication consistently (e.g., with or without food) as food can affect Tmax.
• Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
• Educate patients and caregivers about the potential for abuse and diversion, and the importance of secure storage.
• Consider drug holidays (e.g., weekends or school breaks) for some patients to assess continued need for medication and to mitigate potential growth suppression, though this should be discussed with a healthcare provider.

• Other CNS Stimulants (e.g., methylphenidate, amphetamine salts, lisdexamfetamine)
• Non-stimulants (e.g., atomoxetine, guanfacine extended-release, clonidine extended-release)
• Antidepressants (e.g., bupropion - off-label for ADHD)

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 is a valuable resource that provides important information. 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 amount taken and the time it occurred.