Dexmethylphenidate 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 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 attention 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 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 (priapism) or an erection that lasts longer than 4 hours, seek medical help immediately. If left untreated, this can lead to lasting sexual problems and impotence.
If you have a history of heart problems or heart defects, inform your doctor. Sudden deaths have occurred in people with certain heart conditions. Seek medical attention immediately if you experience chest pain, abnormal heartbeat, shortness of breath, or severe dizziness.
New or worsening behavioral and mood changes, such as changes in thinking, anger, and hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar illness, inform your doctor. Seek medical help immediately if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, thoughts of suicide, nervousness, emotional ups and downs, or lack of interest in life.
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, fast or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, upset stomach, or severe headache.

Other Possible Side Effects:

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

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 side effects that bother you or do not go away, contact your doctor or seek medical attention. 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 (you or a family member)
Presence 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:
+ 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 if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or modify 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 any potential interactions with other treatments.

Until you know how this medication affects you, avoid driving and other activities that require you to be alert. 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, discuss them with your doctor.

This medication may increase the risk of seizures, particularly in individuals who have a history of seizures. Consult your doctor to determine if you are at a higher risk of 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 medical attention immediately 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. Avoid drinking alcohol during treatment with this medication.

If you have high blood pressure, consult 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.

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 problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Seek medical attention immediately 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. 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 to you and your baby.

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

• Vasopressors (e.g., phenylephrine, epinephrine, dopamine) - risk of increased blood pressure.
• Halogenated Anesthetics (e.g., halothane, isoflurane) - risk of sudden blood pressure and heart rate increases during surgery.
• Antihypertensive drugs - may reduce the effectiveness of antihypertensive agents.
• 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, requiring dose adjustment.
• Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, requiring dose adjustment.
• Tricyclic Antidepressants (TCAs) - may inhibit metabolism, requiring dose adjustment.
• Alcohol - may increase plasma levels of dexmethylphenidate.

• Caffeine - additive stimulant effects.

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening aggression
• Hallucinations
• Delusions
• Mania
• Severe anxiety
• Numbness, coolness, or pain in digits (Raynaud's phenomenon)
• Unexplained wounds on fingers or toes

Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects at doses higher than human therapeutic doses.

Dexmethylphenidate and/or its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., agitation, insomnia, decreased appetite, weight loss), 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.

Approved for children 6 years and older. Monitor growth (height and weight) regularly, as long-term 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 due to increased sensitivity to stimulant effects and potential for cardiovascular events. Start with lower doses and titrate slowly.

• Dexmethylphenidate is the more potent d-isomer of methylphenidate, meaning lower doses are generally required compared to racemic methylphenidate.
• Immediate-release formulations are typically dosed twice daily to cover school/work hours, with the second dose given in the early afternoon to avoid interfering with sleep.
• Patients should be screened for cardiac abnormalities and psychiatric conditions (e.g., bipolar disorder, psychosis) before starting treatment.
• Regular monitoring of blood pressure, heart rate, and growth (in children) is crucial.
• Educate patients and caregivers about the potential for abuse and dependence, and the importance of secure storage.
• Consider drug holidays (e.g., weekends, school breaks) to assess the need for continued treatment and to potentially mitigate growth suppression in children, though this should be discussed with a healthcare provider.

• Methylphenidate (e.g., Ritalin, Concerta, Daytrana)
• Amphetamine/Dextroamphetamine (e.g., Adderall)
• Lisdexamfetamine (Vyvanse)
• Atomoxetine (Strattera) - non-stimulant
• Guanfacine (Intuniv) - non-stimulant
• Clonidine (Kapvay) - non-stimulant
• Behavioral therapy
• Cognitive behavioral therapy (CBT)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred, to facilitate prompt and appropriate treatment.