Bispentum Extended Release Capsule 50mg (Methylphenidate Hydrochloride)
Methylphenidate Hydrochloride
Prescription medication
Korea Mundi Pharma Co., Ltd.
MFDS item code 201504504 · Approved 2015.07.03
This product's status changed to Approval withdrawn on 2023.05.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.
Treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 years and older
This medication is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 years and older. ADHD is a condition characterized by persistent symptoms of inattention, hyperactivity, and impulsivity for more than 6 months, resulting in impairment in social and academic functioning. Diagnosis is made according to the DSM-IV criteria or the ICD-10 guidelines, and requires psychological, educational, and social assessments. This medication is one of several treatment options and is administered in conjunction with psychotherapy and educational support, proving to be more effective as part of a comprehensive treatment program than as monotherapy. Medication treatment is not necessary for all patients; the doctor determines the prescription considering the degree of symptoms and environmental factors. This medication helps improve symptoms of ADHD.
Administer this medicine starting at the lowest possible dose, and adjust the dose individually according to the patient's response and tolerability. Take this medicine or its contents whole with water. Do not chew or crush the contents of this medicine. Administer this medicine once daily in the morning. The initial dose is 10 - 20mg once daily. Increase the daily dose by 10mg each week according to the patient's response to treatment and tolerability. The maximum daily dose of this medicine is 60mg. The efficacy of this medicine for treatment lasting more than 4 weeks has not been systematically evaluated in placebo-controlled clinical trials. When prescribing this medicine for long-term use in patients with ADHD, regularly reevaluate its efficacy for long-term use by temporarily discontinuing medication and assessing 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 even after adjusting to an appropriate dose, discontinue this medicine.
This medication should not be used by individuals with heart problems or those at risk of cardiovascular disease. Caution is especially needed among children and adolescents with structural heart abnormalities or arrhythmias due to the risk of sudden death. Adults with heart disease should also avoid using this medication. Patients with high blood pressure should frequently monitor their blood pressure and heart rate when using this medication, as there is a risk for rapid increases in blood pressure. Individuals with a family history of heart disease or those who have previously had heart problems should undergo cardiac evaluation before taking this medication. Patients with psychiatric disorders or a history of psychosis may experience exacerbation of symptoms with this medication, so careful usage is necessary. In patients with bipolar disorder, this medication may trigger manic or psychotic symptoms, and mental state should be thoroughly assessed before administration. This medication can cause new psychotic symptoms or manic symptoms; if such symptoms arise, immediate consultation with a physician is needed. Aggressiveness or hostility may develop, so careful observation for behavioral changes is essential. Sudden thoughts or behaviors of suicide may occur, thus any changes in mental state necessitate immediate evaluation. In children, long-term use has been reported to cause growth delays, so their growth status must be regularly monitored. Patients with a history of seizures or abnormal EEG results may have increased seizure risks with this medication. Visual disturbances may occur rarely, so patients should notify their physician if they experience changes in vision. The safety and efficacy of this medication in children under 5 years of age have not been established, so its use is not recommended. Due to the potential risk of drug abuse, patients with a history of substance dependence or alcohol addiction should take particular caution when using this medication. Persistent and painful erections may occur, so patients must notify healthcare professionals immediately if they experience such symptoms. Peripheral vascular effects may lead to color changes or pain in fingers or toes, necessitating consultation with a physician. This medication should not be used in patients with severe anxiety, tension, or agitation, and individuals with glaucoma or certain neurological disorders should also avoid administration. Patients using or who have recently discontinued MAO inhibitors are at risk of hypertension and should not use this medication. Pregnant or breastfeeding women should exercise caution when using this medication; during breastfeeding, they may consider discontinuing the medication or stopping breastfeeding. Dizziness and related symptoms may occur while driving or operating machinery, so caution is advised. This medication must be taken whole or sprinkled on a small amount of applesauce for immediate consumption, as it should not be prepared in advance. Regular blood tests and evaluations of growth, cardiovascular, and mental states should be performed when using this medication long-term. There may be drug interactions with other medicines, so it is essential to consult with a physician or pharmacist regarding concurrent medications.
Not everyone experiences these, and they can vary from person to person.
This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 to 25 degrees Celsius (room temperature).
A hard capsule with a clear green upper part and a white lower part containing white spherical particles.
30 capsules
Even with the same ingredient, strength, dosage form and how it is taken can differ.
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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.
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For anything that needs medical judgment, consult a doctor or pharmacist.
This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.