Mirtazapine 15 mg Tablet

Adult dosage

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition, and the lowest effective dose should be used whenever possible. 1. Adults The initial dose of mirtazapine is 15mg once daily, and the dose may need to be increased until an adequate clinical response is achieved. The usual effective daily dose is 15~45 mg of this medicine. 2. Administration in special populations 1) Patients with renal impairment Clearance of this medicine may be reduced in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min); use caution when prescribing. 2) Patients with hepatic impairment Clearance of this medicine may be reduced in patients with hepatic impairment; use caution when prescribing. In particular, as patients with severe hepatic impairment have not been studied, use caution when prescribing. 3) Elderly patients The recommended dose is the same as that for adults. When increasing the dose, careful monitoring is required to achieve a satisfactory and safe effect. 3. Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuing this medicine. 4. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients who require more urgent treatment for a psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If no alternative to linezolid or intravenous methylene blue is available and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. Monitor the patient for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever comes first. Treatment with this medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or intravenous administration of this medicine at 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses. As the half-life of this medicine is 20∼40 hours, once-daily dosing is sufficient; if possible, take it at a regular time in the evening before bedtime. The daily dose of this medicine may also be divided into equal doses taken once in the morning and once in the evening. Do not change the dose at intervals of less than 1∼2 weeks, to allow sufficient time to assess the therapeutic response to the dose. At an appropriate dose, a therapeutic effect is observed within 2∼4 weeks. If the therapeutic effect is insufficient, the dose may be increased to the maximum dose. If there is no effect after continuing treatment for another 2∼4 weeks, discontinue treatment. Treatment should continue for at least 4∼6 months, until the patient's symptoms have completely resolved. Thereafter, gradual discontinuation is recommended to avoid withdrawal symptoms. This medicine is taken orally. Swallow it whole with water without chewing.

Children's dosage

Children and adolescents under 18 years: Do not use this medicine.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric conditions, so the physician must carefully consider the benefits and risks of treatment. This medication can rarely cause a serious side effect called agranulocytosis, which is a rapid decrease in white blood cell count; therefore, if the patient experiences a sore throat, fever, or signs of infection during treatment, they should seek medical attention immediately. This medication can increase blood levels in patients with certain liver or kidney disorders; therefore, careful monitoring and dosage adjustments are required for these patients. This medication can cause a serious side effect called serotonin syndrome when taken with other antidepressants or certain medications; therefore, it should not be taken together with MAO inhibitors at all. Drowsiness or dizziness may frequently occur during the use of this medication, so caution is needed during activities requiring concentration, like driving or operating machinery. The medication may increase appetite and lead to weight gain; therefore, regular monitoring of weight changes and consultation with a doctor if necessary is advised. Women who are pregnant or breastfeeding should definitely consult their doctor before taking this medication, and it should be used cautiously during pregnancy only if necessary. This medication is not recommended for children and adolescents under 18 years of age, and if administration is required, symptoms related to suicide-related behaviors or aggression should be closely monitored. Caution is needed when administering to elderly patients, as physical function decline or other diseases may influence their response. Abrupt discontinuation of the medication can result in withdrawal symptoms such as dizziness, anxiety, headache, and nausea; therefore, the dosage should be gradually reduced according to a doctor's instructions. Taking this medication with alcohol may enhance central nervous system depressant effects, so it is advisable to avoid alcohol during treatment. In cases of overdose, symptoms such as loss of directional sense, drowsiness, memory impairment, and tachycardia may occur, so individuals should visit a medical facility immediately if suspected. This medication should be kept out of reach of children and should not be transferred to another container for safety.

• drowsiness
• nausea
• increased appetite
• weight gain
• dizziness
• weakness
• flu-like syndrome
• low back pain
• dry mouth
• constipation

This medication should be stored in a container that protects it from light and air, and kept in a temperature range of 2 to 30 degrees Celsius while avoiding moisture. Storing it this way preserves the medication's effectiveness and prevents deterioration.

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle