Concerta OROS Extended-Release Tablets 54 mg (Methylphenidate Hydrochloride)

Adult dose

Administer orally once daily in the morning. This medicine should be taken whole with water. Do not chew, cut, or crush the tablet. This medicine may be taken with or without food. Adults (18-65 years): Recommended initial dose: 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 a dose or regimen other than those listed above, determine the initial dose based on clinical judgment. The dose should be individualized according to the patient's symptoms and response to the medication. Based on evaluation 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 low dose. Adults (18-65 years): Maximum dose: 72mg/day A 27mg dose may be used when prescribing a dose between 18mg and 36mg of methylphenidate. No controlled clinical trials have established how long patients with ADHD can use this medicine. However, it is generally recognized that pharmacological treatment of ADHD may be needed over the long term. No controlled clinical trials have evaluated the efficacy of this medicine for long-term use beyond 7 weeks. When prescribing this medicine for long-term use in patients with ADHD, periodically reassess its efficacy through a trial period of temporarily discontinuing treatment and evaluating the patient's social functioning. If symptoms worsen or other adverse reactions occur, reduce the dose and, if necessary, discontinue this medicine. If symptoms do not improve within one month after adjusting to an appropriate dose, discontinue this medicine.

Child dose

Children (6-12 years): Recommended initial dose: 18mg/day; maximum dose: 54mg/day Adolescents (13-17 years): Recommended initial dose: 18mg/day; maximum dose: 72mg/day, not to exceed 2mg/kg/day.

This medication should not be used in individuals with heart problems, especially in children or adolescents with structural heart abnormalities or rhythm disorders, and in adults with potential heart disease. Patients with high blood pressure should use this medication cautiously; blood pressure and heart rate must be monitored regularly during treatment. Before using this medication, check for a family history or symptoms of heart disease; if necessary, undergo cardiac testing. Patients with psychosis or bipolar disorder need special caution as symptoms may worsen with this medication. New-onset psychotic or manic symptoms may occur; if such symptoms appear, consult a doctor immediately. Aggressive behaviors or hostility may occur in children and adolescents, so changes in behavior should be observed closely. Long-term use may lead to growth delays; growth should be monitored periodically and the medication should be temporarily discontinued if necessary. Patients with a history of seizures or abnormal EEG findings should be cautious, as this medication may induce seizures; discontinuation is necessary if seizures occur. Visual disturbances or eye accommodation issues may arise rarely, and consultation with a healthcare provider is advised if vision changes occur. This medication should be swallowed whole and not chewed, crushed, or divided, and should not be administered to patients who have difficulty swallowing. The safety and efficacy of this medication have not been established in children younger than 5 years old. There is a risk of drug abuse, so take the correct dosage as prescribed by a physician and do not alter the dosage on your own. Priapism may occur; if this happens, notify a healthcare provider immediately. Peripheral vascular problems, such as coldness or color changes in the hands and feet, may occur rarely; these symptoms should also be observed closely. This medication may interact with certain other drugs, so make sure to inform your doctor if you are taking other medications. If you are pregnant or breastfeeding, consult your doctor before using this medication. Caution is needed as dizziness may occur while driving or operating machinery. Store this medication out of reach of children and keep it in its original container.

Depression, headache, insomnia, irritability, psychomotor hyperactivity, tics, anxiety, hypertension, nervousness, decreased appetite, anorexia, restlessness, agitation, bruxism, depression, affective instability, reduced libido, panic attacks, tension, aggression, confusion, dizziness, cough, oropharyngeal pain, upper abdominal pain, vomiting, fever, upper respiratory infection, sinusitis, drowsiness, diarrhea, abdominal discomfort, abdominal pain, rash, irritability, leukopenia, anger, sleep disorders, excessive vigilance, increased tear production, mood changes, psychomotor agitation, sedation, hypersomnia, dry eyes, maculopapular rash, pancytopenia, thrombocytopenia, thrombocytopenic purpura, angioedema, anaphylactic reaction, auricular swelling, blisters, exfoliative dermatitis, urticaria, pruritus, rash and lesions not elsewhere classified, spatial disorientation, hallucinations, auditory hallucinations, visual hallucinations, mania, polyuria, sexual dysfunction, obsessive-compulsive disorder and symptoms, convulsions, generalized tonic-clonic seizures, cerebral vasculitis, intracerebral hemorrhage, cerebral arteritis, cerebral vascular occlusion, movement disorders, motor tics and vocal tics, diplopia, mydriasis, vision impairment, angina, bradycardia, premature ventricular contractions, supraventricular tachycardia, ventricular ectopic beats, Raynaud's phenomenon, epistaxis, hair loss, erythema, arthralgia, myalgia, muscle cramps, priapism, gynecomastia in men, reduced treatment response, chest pain, chest discomfort, reduced efficacy, hyperthermia, decreased platelet count, abnormal white blood cell count, increased serum alkaline phosphatase, increased serum bilirubin, elevated liver enzymes, hepatocellular damage, acute liver failure, vomiting, agitation, muscle spasms, convulsions, confusion, hallucination, hyperhidrosis, headache, fever, tachycardia, palpitations, increased heart rate, venous occlusion, hypertension, mydriasis, dry mouth

This medication should be stored at a temperature between 15 to 30 degrees Celsius in a tightly closed container that is not exposed to moisture. Avoid storing in areas with high humidity to maintain the medication's effectiveness.

Appearance

Brownish-red oval film-coated tablets

Package unit

30 tablets/bottle