Smootherpin Tablet 100 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia Adults: This medicine is taken twice daily, regardless of meals. The total daily dose for the first 4 days is 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3, and 300 mg on Day 4. From Day 4 onward, the dose should be adjusted to the usual effective daily dose of 300～400 mg. Depending on the clinical response and tolerability of each patient, the dose may be adjusted within the range of 150～750 mg/day. Acute treatment of manic episodes associated with bipolar I disorder Adults: This medicine is taken twice daily, regardless of meals. As monotherapy or as adjunctive therapy to a mood stabilizer (lithium or valproate), the total daily dose for the first 4 days is 100 mg on Day 1, 200 mg on Day 2, 300 mg on Day 3, and 400 mg on Day 4. The total daily dose may be increased to 800 mg by Day 6, in increments of no more than 200mg per day. Depending on the clinical response and tolerability of each patient, the dose may be adjusted within the range of 200～800 mg/day, and the usual effective daily dose is 400～800 mg. Treatment of depression associated with bipolar disorder Adults: This medicine is taken once daily at bedtime, regardless of meals. The total daily dose for the first 4 days should reach 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3, and 300 mg on Day 4. In pivotal clinical trials of this medicine, doses of 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3, 300 mg on Day 4, 400 mg on Day 5, and up to 600 mg on Day 8 were administered. The recommended daily dose is 300 mg . Antidepressant effects were observed with both 300 mg and 600 mg, but there was no additional benefit with 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, clinical trials indicate that the dose may be reduced to a minimum of 200 mg. Prevention of recurrence of bipolar disorder Adults: To prevent recurrence of manic, mixed, or depressive episodes associated with bipolar disorder, patients who responded to quetiapine for acute treatment of bipolar disorder should be maintained on the same dose. Depending on the clinical response and tolerability of each patient, the dose administered twice daily may be adjusted within the range of 300～800 mg/day. It is important to use the lowest effective dose for maintenance therapy. Older adults Older patients should start treatment with this medicine at 25 mg/day, with gradual increases of 25～50 mg per day. The effective dose in older adults may be lower than that in younger patients. Patients with renal or hepatic impairment Patients with renal or hepatic impairment should start treatment with this medicine at 25 mg/day, with gradual increases of 25～50 mg per day until the effective dose is reached.

Child dose

Children and adolescents: Safety and efficacy have not been established.

This medication is primarily used for treating psychiatric disorders, particularly for alleviating symptoms of depression, mania, and schizophrenia. While taking this drug, changes in mental state such as suicidal thoughts or behaviors may occur, so careful monitoring is required especially for younger patients aged 18 to 24 after the initiation of treatment. It can increase blood sugar levels, so diabetic patients or those at risk for diabetes should regularly check their blood sugar and be vigilant for symptoms of hyperglycemia such as thirst, frequent urination, and fatigue. In severe cases, a rare side effect known as Neuroleptic Malignant Syndrome may occur, characterized by high fever, muscle rigidity, and altered consciousness, requiring immediate notification to medical personnel. With long-term use, extrapyramidal symptoms or tardive dyskinesia may develop, and if abnormal movements occur, dose adjustment or discontinuation should be considered. Elderly patients with dementia have an increased risk of death, so use of this medication is generally not recommended. Severe neutropenia can rarely occur, leading to a rapid decrease in the white blood cell count, so immediate medical attention should be sought if symptoms of infection emerge. Patients with cardiovascular disease or those at risk for hypotension should be cautious of dizziness or fainting due to orthostatic hypotension when taking this medication, especially during initial dose adjustments. There is a risk of severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, so if symptoms like skin rash or fever occur, the medication should be stopped immediately and a doctor consulted. This medication should not be administered to patients with hypersensitivity to specific components, those in a coma, those undergoing barbiturate treatment, individuals receiving epinephrine, or diabetic patients. Patients with impaired liver function may experience increased drug levels, so treatment should begin with a low dose and increase while monitoring the patient's condition. Women who are pregnant or breastfeeding should consult a doctor before taking this medication as it may affect the fetus or newborn. During treatment, symptoms such as drowsiness or dizziness may occur, so it is advisable to avoid driving or operating hazardous machinery. Discontinuation of this medication should not be abrupt, as withdrawal symptoms such as nausea, vomiting, and insomnia may arise; gradual dose reduction is recommended. Additionally, interactions with other medications may occur, so it is essential to inform medical personnel of any other medications being taken, particularly when combined with strong liver enzyme inhibitors or inducers. In case of overdose, symptoms such as drowsiness, hypotension, and increased heart rate may present, and since there is no specific antidote, immediate emergency treatment is required. This medication is not recommended for children and adolescents as its safety and effectiveness have not been established. Elderly patients may experience increased blood levels, so it is advisable to start at a low dose and administer it cautiously.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglycerides
• increased total cholesterol
• decreased HDL cholesterol
• weight gain
• decreased hemoglobin
• extrapyramidal symptoms

Store this medication in a tightly closed container to protect it from air and moisture, and keep it in a cool place below 30 degrees Celsius.

Appearance

Yellow, round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTPX3], 100 tablets/bottle