Dexmethylphenidate 10mg Tablets

Dexmethylphenidate is the d-threo-enantiomer of methylphenidate. It is a central nervous system (CNS) stimulant. Its therapeutic efficacy in ADHD is thought to be related 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.

Serious 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 experience 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

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 having sex. If left untreated, it may lead to lasting sexual problems and impotence.

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 an abnormal heartbeat or died suddenly. Seek medical help immediately if you experience any signs of heart problems, such as:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting

Mental Health Warning

New or worsening behavioral and mood changes, including 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, thoughts of suicide, nervousness, emotional ups and downs, 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
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

Most people do not experience serious side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

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 questions or concerns about side effects, 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 conditions
+ 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 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: this may increase the risk of very high blood pressure)
Current use of certain medications, such as:
+ Linezolid
+ Methylene blue

This is not an exhaustive list of all potential interactions. Therefore, 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 will help you determine whether it is safe to take this medication with your existing medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.

Caution: Potential Effects on Alertness
Until you know how this medication affects you, avoid driving and engaging in other activities that require you to be alert. This will help prevent accidents and ensure your safety.

Tolerance and Dosage
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, which means that the medication may not work as well as it did initially. In this case, you may need to take higher doses to achieve the same effect. If you notice that the medication is not working as well as it used to, contact your doctor. Do not take more than the prescribed dose, as this can lead to adverse effects.

Pre-Treatment Heart Tests
Before starting this medication, your doctor may recommend that you undergo certain heart tests to ensure that it is safe for you to take this medication. If you have any questions or concerns, be sure to discuss them with your doctor.

Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those who have a history of seizures. Talk to your doctor about your risk of seizures while taking this medication.

Blood Pressure Monitoring
This medication may cause high blood pressure. Monitor your blood pressure and heart rate as directed by your doctor, and contact them immediately if you experience any symptoms of high blood pressure, such as severe headaches, dizziness, fainting, or changes in vision.

Interactions with Other Substances
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 a rapid heartbeat. Additionally, avoid drinking alcohol while taking this medication.

OTC Medications and High Blood Pressure
If you have high blood pressure and are taking this medication, 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.

Mental Health and Mood Changes
This medication may cause changes in behavior and mood, including hallucinations, anger, and changes in thinking. If you or a family member have a history of mental health problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Contact your doctor immediately if you experience any symptoms of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or a lack of interest in life.

Growth Effects in Children and Teens
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss any concerns with your doctor.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. They will help you weigh the benefits and risks of taking this medication to ensure the best possible outcome for 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.
• Antihypertensive drugs - may reduce the effectiveness of antihypertensives.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - theoretical risk of serotonin syndrome.

• Anticoagulants (e.g., warfarin) - may inhibit metabolism of coumarin anticoagulants, 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 and lead to increased adverse effects.

• Caffeine - additive stimulant effects, increased risk of nervousness, insomnia, and palpitations.

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening tics
• Hallucinations
• Delusions
• Mania
• Aggression
• Anxiety
• Insomnia
• Loss of appetite
• Weight loss

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Data from observational studies suggest a possible increased risk of cardiac malformations and other congenital malformations with methylphenidate exposure during the first trimester. Neonates exposed to amphetamines or methylphenidate during the third trimester have a risk of withdrawal symptoms.

Dexmethylphenidate and its metabolites are excreted in human milk. Monitor breastfed infants for adverse reactions such as agitation, insomnia, anorexia, and reduced weight gain. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother.

Safety and efficacy established in pediatric patients 6 to 17 years of age. Long-term effects on growth (height and weight) should be monitored. Risk of new or worsening psychiatric symptoms (e.g., psychosis, mania, aggression, tics) should be monitored.

Safety and efficacy have not been established in geriatric patients. Use with caution due to potential for increased sensitivity to stimulant effects, higher prevalence of cardiovascular disease, and polypharmacy. Start with lower doses and titrate slowly.

• Dexmethylphenidate is the more pharmacologically active d-isomer of methylphenidate, allowing for lower doses compared to racemic methylphenidate.
• Administer in divided doses, typically in the morning and early afternoon, to avoid interference with sleep.
• Patients should be screened for cardiac abnormalities and family history of sudden death before starting therapy.
• Monitor for signs of abuse and diversion, as it is a Schedule II controlled substance.
• Consider drug holidays in pediatric patients to assess continued need for medication and to mitigate potential growth suppression.

• Other methylphenidate formulations (e.g., methylphenidate IR, ER, transdermal patch)
• Amphetamine-based stimulants (e.g., mixed amphetamine salts, lisdexamfetamine)
• Non-stimulants (e.g., atomoxetine, guanfacine ER, clonidine ER)
• Behavioral therapy and psychotherapy

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe and effective use. It is essential to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care and treatment.