Concerta OROS Extended-Release Tablet 27mg (Methylphenidate Hydrochloride)

Adult dose

Administer orally once daily in the morning. This medicine should be swallowed whole with water. Do not chew, cut, or crush the tablet. This medicine may be taken with or without food. Adults (18-65 years) 18mg or 36mg/day The recommended doses for patients receiving immediate-release methylphenidate 2 or 3 times daily, or extended-release methylphenidate (8-hour duration) at 10-60mg/day, are shown in the table below. 5mg methylphenidate 2 or 3 times daily, 20mg extended-release methylphenidate (8-hour duration) 18mg once daily 10mg methylphenidate 2 or 3 times daily, 40mg extended-release methylphenidate (8-hour duration) 36mg once daily 15mg methylphenidate 2 or 3 times daily, 60mg extended-release methylphenidate (8-hour duration) 54mg once daily 20mg methylphenidate 2 or 3 times daily 72mg once daily For patients receiving methylphenidate at doses or dosing regimens other than those described above, the initial dose should be determined based on clinical judgment. The dose should be individualized according to the patient's symptoms and response to the medication. Based on assessments of clinical benefit and tolerability, the dose may be increased by 18mg at 1-week intervals in patients who do not achieve an optimal response at a lower dose. Adults (18-65 years) 72mg/day When prescribing a dose between 18mg and 36mg of methylphenidate, 27mg may be used. No controlled clinical trials have established how long patients with ADHD can use this medicine. However, it is generally accepted that pharmacological treatment of ADHD is needed over the long term. No controlled clinical trials have been conducted to evaluate the efficacy of this medicine with long-term use of more than 7 weeks. When prescribing this medicine to patients with ADHD for long-term use, periodically reassess its efficacy by temporarily discontinuing drug treatment and evaluating the patient's social functioning. If symptoms worsen or other adverse reactions occur, the dose should be reduced and, if necessary, treatment with this medicine should be discontinued. If symptoms do not improve within one month after adjusting to an appropriate dose, discontinue treatment with this medicine.

Child dose

Children (6-12 years): 18mg/day Children (6-12 years): 54mg/day Adolescents (13-17 years): 18mg/day Adolescents (13-17 years): 72mg/day, provided that it does not exceed 2mg/kg/day.

This medication should be used with caution in patients with heart problems or high blood pressure. In particular, children or adolescents with heart abnormalities or arrhythmias, as well as adult patients, may experience sudden death or heart-related issues, so administration should be avoided or managed carefully. During treatment, blood pressure and heart rate should be monitored periodically, with extra caution for patients who have high blood pressure or conditions that may strain the heart. Patients with psychiatric issues, such as psychosis or bipolar disorder, may have exacerbated symptoms, so a psychiatric evaluation is necessary before administration, and symptoms should be closely monitored during treatment. This medication has a risk of growth suppression, so the growth status of children should be continuously observed, and temporary discontinuation of use may be necessary if needed. Patients with a history of seizures or abnormal EEG may experience seizures from this medication, which should be used with caution. Ocular side effects may include visual disturbances or difficulties in eye accommodation; if abnormal symptoms occur, consult a doctor immediately. This medication cannot be administered to patients who have difficulty swallowing or those with gastrointestinal stenosis and must be swallowed whole. It should not be used in children under 5 years of age, as its safety and efficacy have not been established. Caution is required for patients with a history of drug dependence or alcohol addiction, as there is a risk of increasing the dosage on their own judgment. Serious side effects such as prolonged erections may occur during medication use, and if this symptom arises, immediate medical assistance should be sought. Peripheral vascular diseases, especially symptoms such as Raynaud's phenomenon, may rarely occur; if there are color changes or pain in the hands and feet, inform a doctor. This medication may interact with certain drugs, so if other medications are being taken, definitely inform healthcare providers. Pregnant or breastfeeding women should only take this medication if necessary, as its safety has not been established, and caution should be exercised to avoid effects on the baby while breastfeeding. Dizziness may occur while driving or operating machinery, so care is needed. This medication should be kept out of the reach of children and stored in its original container safely. In case of overdose, symptoms such as central nervous system overactivity, irregular heartbeats, and high blood pressure may occur, and immediate emergency treatment is required.

• Depression
• headache
• insomnia
• irritability
• psychomotor hyperactivity
• tic
• anxiety
• elevated blood pressure
• nervousness
• rhinitis

This medication should be stored at temperatures between 15 and 30 degrees Celsius, and kept in an airtight container to prevent air exposure. It should also be stored in a dry place to maintain its effectiveness.

Appearance

Gray rectangular film-coated tablet

Package unit

30 tablets/bottle