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Dexmethylphenidate Safety and Warning Information

Dexmethylphenidate is a medication with important safety considerations. Please review the following information carefully and consult your healthcare provider if you have any questions or concerns.

• Risk of Misuse and Dependence: This medication may be habit-forming and may lead to misuse or dependence, especially in individuals with a history of substance use disorders. Misuse can cause serious side effects, such as an increased heart rate, high blood pressure, anxiety, aggressive behavior, and even harmful thoughts. Taking more than prescribed can also lead to physical dependence and withdrawal symptoms if stopped abruptly. Always follow the prescribed dosage and schedule.

• Serious Heart Problems: There have been reports of sudden death, stroke, and heart attack in individuals taking stimulant medications, including dexmethylphenidate, even at recommended doses. This medication can elevate blood pressure and heart rate. Inform your healthcare provider of any heart problems before starting treatment, and seek medical attention if you experience symptoms like fainting, chest pain during physical activity, or an irregular heartbeat.

• Behavioral and Mental Health Changes: Stimulant medications like dexmethylphenidate can cause mental health issues, including hallucinations, unclear thinking, and mania. These effects can worsen existing mood disorders or occur in individuals without a prior history. Contact your healthcare provider if you notice any changes in mood or behavior.

• Prolonged and Painful Erection: Rare cases of prolonged and painful erections have been reported. If an erection lasts longer than 4 hours, discontinue the medication and seek immediate medical assistance.

• Circulation Problems (Raynaud's Phenomenon): Some individuals may experience poor blood circulation in the fingers and toes, leading to numbness, pain, or skin changes. Inform your healthcare provider if these symptoms occur.

• Growth Impact in Children: Long-term use may temporarily slow growth in children. Healthcare providers should monitor growth closely and may adjust treatment if necessary.

• Serotonin Syndrome: A rare but serious condition that can occur when dexmethylphenidate is taken with other medications affecting serotonin levels. Symptoms include confusion, hallucination, seizure, extreme changes in blood pressure, fever, and fast heart rate. Consult your healthcare provider if you take other medications that affect serotonin.

• Drug Interactions: Dexmethylphenidate can interact with various medications, including blood pressure medications and monoamine oxidase inhibitors (MAOIs). Discuss all medications, including over-the-counter drugs and supplements, with your provider to avoid potential interactions.

Contraindications: Do not use dexmethylphenidate if you have a severe allergy to methylphenidate-containing products, or if you are currently taking or have recently taken MAOIs within the last 14 days.

Always consult your healthcare provider for personalized advice and follow their guidance for safe and effective use of this medication.

Common side effects:

• Trouble sleeping
• Headaches
• Nausea
• Stomach pain
• Dry mouth
• Low appetite
• Nervousness
• Dizziness
• Heartburn
• Weight loss

Less common but important to monitor:

• Changes in blood pressure
• Coldness or numbness in extremities
• Unusual wounds
• Irregular or pounding heartbeat
• Mood changes
• Uncontrolled muscle movements or vocal outbursts
• Blurred vision
• Skin color changes in fingers or toes

Serious side effects:

• Fainting
• Seizures
• Heart attack symptoms
• Stroke symptoms
• Prolonged erection lasting four or more hours
• Rare but severe allergic reactions

Interactions with high risk of serious adverse effects and should be avoided:

• MAO inhibitors (isocarboxazid, Linezolid, methylene blue, moclobemide, phenelzine, procarbazine, Rasagiline, safinamide, Selegiline, Tranylcypromine)
• methylphenidate-containing drugs

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Desflurane
• Enflurane
• Halothane
• Risperidone
• Sevoflurane