Ostedo Tablet 6 mg (Dutetrabenazine)

Adult dose

The dose of this drug should be determined individually for each patient based on the reduction in symptoms of chorea or tardive dyskinesia and tolerability. For patients who are not switching from tetrabenazine (a VMAT2 inhibitor related to this drug), the recommended starting dose when initiating this drug is 12mg per day (6mg twice daily). Increase the dose of this drug by 6 mg per day at 1-week intervals; the maximum recommended dose is 48 mg per day. If the total daily dose is 12 mg or more, administer it in 2 divided doses. Administer this drug with food. Swallow this drug whole. Do not chew, crush, or split the tablets. Discontinue tetrabenazine and start this drug the following day. Current daily dose of tetrabenazine 12.5 mg: 6 mg, once daily Current daily dose of tetrabenazine 25 mg: 6 mg, twice daily Current daily dose of tetrabenazine 37.5 mg: 9 mg, twice daily Current daily dose of tetrabenazine 50 mg: 12 mg, twice daily Current daily dose of tetrabenazine 62.5 mg: 15 mg, twice daily Current daily dose of tetrabenazine 75 mg: 18 mg, twice daily Current daily dose of tetrabenazine 87.5 mg: 21 mg, twice daily Current daily dose of tetrabenazine 100 mg: 24 mg, twice daily After switching to this drug, the dose may be adjusted at 1-week intervals. For patients taking strong CYP2D6 inhibitors (e.g., antidepressants such as paroxetine, fluoxetine, and bupropion, or quinidine), the total daily dose of this drug must not exceed 36 mg (maximum single dose 18 mg) [see Precautions for Use 5. Drug Interactions, item 1)]. Treatment with this drug may be discontinued without tapering. If treatment with this drug is resumed after an interruption of more than 1 week, the dose must be titrated again. If treatment has been interrupted for less than 1 week, treatment may be resumed at the previous maintenance dose without dose titration.

This medication may increase the risk of depression and suicidal thoughts or behaviors in patients with Huntington's disease, so a careful assessment of the patient's mental state should be done before use. Patients and caregivers should be adequately informed about the risks of depression and suicide, and any unusual behavior should be reported to a doctor immediately. Do not administer this medication to patients with suicidal impulses or untreated depression, patients with liver dysfunction, or patients taking certain medications. This medication may commonly cause side effects such as drowsiness, diarrhea, dry mouth, and fatigue, so if any unusual symptoms occur during administration, consult with healthcare professionals. Changes in mood, insomnia, anxiety, constipation, and urinary tract infections have also been reported, so caution is needed. This medication can affect heart rhythm, so patients with a history of heart disease should use it with caution. Rare but serious side effects may include neuroleptic malignant syndrome; if symptoms like high fever, muscle rigidity, or changes in consciousness appear, notify healthcare professionals immediately. Symptoms such as akathisia, restlessness, and agitation may occur during administration, so consider dose adjustment or discontinuation if these symptoms appear. Symptoms of Parkinsonism may also be induced, so if tremors or slowed movements occur, consult with healthcare professionals. This medication can cause drowsiness and sedation, so avoid driving or operating hazardous machinery after taking it. Prolactin levels may rise, leading to amenorrhea and galactorrhea in women, and erectile dysfunction in men. Long-term use may also pose risks of eye-related side effects, so regular ophthalmological examinations may be necessary. This medication is contraindicated in patients with impaired liver function, and dose adjustment is needed for patients with reduced CYP2D6 metabolism. There are many drug interactions, so particularly avoid concomitant use with strong CYP2D6 inhibitors, reserpine, MAO inhibitors, antipsychotics, and alcohol. There is insufficient data on safety during pregnancy, so use during pregnancy should be approached cautiously, and consultation with a professional is needed if breastfeeding. Safety and efficacy in pediatric patients have not been established, so it is advisable not to use in children. In elderly patients, a lower starting dose should be used, and caution should be exercised, and it should not be used in liver failure patients. In case of overdose, symptoms affecting the central nervous system and lowering blood pressure may occur, requiring immediate medical attention. This medication should be stored out of reach of children and should not be transferred to other containers.

• depression
• suicidal thoughts
• drowsiness
• diarrhea
• dry mouth
• fatigue
• urinary tract infection
• insomnia
• anxiety
• constipation

This medication is sensitive to air and moisture and should be stored in a tightly closed container. The storage temperature should be maintained between 1 to 30 degrees Celsius, and direct sunlight and humid places should be avoided.

Appearance

Purple round film-coated tablet

Package unit

60 tablets/bottle [60 tablets/bottle X 1]