Medication info

Bispentyn Controlled Release Capsule 30mg (Methylphenidate Hydrochloride)

Prescription medicationApproval withdrawn
Ingredient · strength
Methylphenidate Hydrochloride›Strength being verified
Manufacturer / importer
Mundipharma Korea Ltd.,
Appearance
A hard capsule with a white spherical particle inside, purple on the upper part and white on the lower part.
Packaging
30 capsules
Approval status
Approval withdrawn

MFDS item code 201503881 · Approved 2015.06.15

This product's status changed to Approval withdrawn on 2023.05.19.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.

Summary

Main use
Treatment of attention-deficit/hyperactivity disorder in children and adolescents aged 6 years and older
Who uses it
Adults
Adult dosage
Start this medicine at the lowest possible dose and adjust the dose individually according to the patient's response and tolerability. This medicine or its contents should be taken intact 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 longer 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, periodically reevaluate its long-term efficacy by temporarily interrupting drug treatment 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 after adjustment to an appropriate dose, discontinue this medicine.

Ingredients

Importer
Mundipharma Korea Ltd.,

Efficacy & effects

Treatment of attention-deficit/hyperactivity disorder in children and adolescents aged 6 years and older

  • Lack of attention
  • hyperactivity
  • restlessness
  • fidgeting
  • inability to remain seated
  • inappropriate running
  • climbing
  • difficulty with quiet activities
  • constant activity
  • excessive talking
  • delayed responses
  • inability to wait for turns
View approved original text

This medication is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents over the age of 6. ADHD is a condition characterized by symptoms such as lack of concentration, hyperactivity, and impulsivity that appear before the age of 7 and persist to the extent that they interfere with daily life in various environments such as school and home. This medication is used as an essential component of a comprehensive treatment program along with psychological, educational, and social therapeutic methods. Not all ADHD patients require pharmacological treatment, and the physician makes a prescription decision considering the degree and chronicity of the patient's symptoms. Moreover, this medication is not suitable for symptoms accompanying other psychiatric disorders, making accurate diagnosis and comprehensive evaluation important. Therefore, this medication is used effectively to improve ADHD symptoms.

Dosage and Administration

Adult dosage

Start this medicine at the lowest possible dose and adjust the dose individually according to the patient's response and tolerability. This medicine or its contents should be taken intact 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 longer 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, periodically reevaluate its long-term efficacy by temporarily interrupting drug treatment 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 after adjustment to an appropriate dose, discontinue this medicine.

Precautions

This medication should not be used in children, adolescents, or adults with significant heart disease. In particular, it should not be administered to those with pre-existing cardiac abnormalities or arrhythmias, coronary artery disease, etc. Caution is necessary for patients with hypertension, and blood pressure and pulse should be monitored regularly. If heart disease is suspected, a cardiac examination should be performed before deciding on administration. Patients with psychosis or bipolar disorder may experience worsening symptoms when using this medication, so caution is required. If new psychotic symptoms or manic symptoms occur, immediate consultation with healthcare professionals is necessary. There is a risk of aggression or suicidal tendencies, and evaluation is needed if such symptoms arise during treatment. Long-term use may result in growth suppression, so growth should be periodically monitored, and administration should be discontinued if necessary. Patients with a history of seizures may have an increased risk of convulsions, and administration should be stopped in case of a seizure. Visual disturbances or problems with eye adjustment may rarely occur. This medication should not be used in children under the age of 5, as its safety and efficacy have not been established. Patients with a history of substance dependence or alcohol addiction should be cautious about dosing adjustments and abuse. There may be persistent painful erections, so immediate medical attention is needed if such symptoms occur. Symptoms of peripheral vascular disease (such as Raynaud's phenomenon) may appear, and changes in the hands and feet should be well monitored during treatment. Patients with severe anxiety, tension, excitement, glaucoma, Tourette's syndrome, or those taking MAO inhibitors should not use this medication. Blood pressure, pulse, heart condition, and psychiatric history should be thoroughly evaluated before administration and monitored regularly during treatment. There may be interactions with other medications, so it is essential to inform healthcare professionals about any medications being taken. Pregnant or nursing women should be cautious when using this medication and consult professionals if necessary. This medication can be taken whole or sprinkled into applesauce and taken immediately, but should not be mixed and stored in advance. Caution is advised as dizziness may occur when driving or operating machinery. This medication should be stored out of reach of children and kept in its original container.

Side effects

  • Headache
  • abdominal pain
  • influenza-like syndrome
  • pain
  • infection
  • weakness
  • lethargy
  • photophobia
  • chills
  • fever
Show 67 more
  • allergic reactions
  • hypertension
  • vasodilation
  • insomnia
  • drowsiness
  • irritability
  • depression
  • apathy
  • emotional instability
  • compulsive behavior
  • verbal tics
  • speech disorders
  • motor tics
  • rebound
  • sleep disorders
  • dizziness
  • anxiety
  • euphoric mood
  • stereotypy
  • visual disturbances
  • conjunctivitis
  • corneal lesions
  • otitis media
  • palpitations
  • hypersensitivity
  • loss of appetite
  • nausea
  • increased appetite
  • vomiting
  • diarrhea
  • pharyngitis
  • asthma
  • increased cough
  • rash
  • eczema
  • skin discoloration
  • itching
  • dysmenorrhea
  • hallucinations
  • tremors
  • seizures
  • agitation
  • tremor
  • rebound hypersensitivity
  • muscle spasms
  • euphoria
  • confusion
  • delirium
  • sweating
  • flushing
  • hyperthermia
  • palpitations
  • deep vein thrombosis
  • pupil dilation
  • mucosal dryness
  • serotonin syndrome
  • hepatic coma
  • cerebral vascular arteritis
  • occlusion
  • anemia
  • transient depression
  • hair loss
  • malignant neuroleptic syndrome
  • persistent painful erection
  • Raynaud's phenomenon
  • distal ulcers
  • soft tissue damage

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is recommended to maintain a storage temperature between 1 and 25 degrees Celsius at room temperature. This will help maintain the medication's efficacy and safety.

Appearance and packaging

Appearance

A hard capsule with a white spherical particle inside, purple on the upper part and white on the lower part.

Package unit

30 capsules

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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.

Questions about this medicine

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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.