Mirtazapine 15 mg Tablets

Adult dosage

The therapeutic dose of this medication should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. Adults: The initial dose of mirtazapine is 15 mg once daily. The dose may need to be increased until an appropriate clinical response is achieved. The usual effective daily dose is 15~45 mg of this medication. Since the clearance of this medication may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min), caution should be exercised when prescribing it. Since the clearance of this medication may be decreased in patients with hepatic impairment, caution should be exercised when prescribing it. In particular, this medication has not been studied in patients with severe hepatic impairment; therefore, caution should be exercised when prescribing it. Elderly patients: The recommended dose is the same as for adults. When increasing the dose, careful monitoring is required to obtain a satisfactory and safe response. When discontinuing treatment with an MAO inhibitor for a psychiatric disorder and starting treatment with this medication, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor for a psychiatric disorder, at least 14 days must have elapsed after discontinuing this medication. Patients receiving linezolid or intravenous methylene blue must not start treatment with this medication because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization and other interventional procedures, treatment may be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. If there is no alternative to linezolid or intravenous methylene blue 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 medication may be stopped immediately and linezolid or intravenous methylene blue administered. Patients must be monitored for symptoms of serotonin syndrome for 2 weeks after receiving linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever occurs first. Treatment with this medication 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 with intravenous administration of this medication at doses of 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 medication is 20∼40 hours, once-daily dosing is sufficient, and, if possible, it should be taken at a consistent time in the evening before bedtime. The daily dose of this medication may also be divided into equal doses taken once in the morning and once in the evening. To allow sufficient time to evaluate the therapeutic response to the dose of this medication, the dose should not be changed at intervals shorter than 1～2 weeks. With an appropriate dose, a therapeutic response occurs within 2～4 weeks. If the response is insufficient, the dose may be increased up to the maximum dose. If there is no response after continuing treatment for an additional 2～4 weeks, treatment should be discontinued. 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 medication is taken orally. Swallow it with water without chewing.

Children's dosage

Pediatric patients and adolescents under 18 years: The efficacy of this drug was not established in two short-term clinical trials, and due to safety concerns, this drug should not be used in pediatric patients or adolescents under 18 years of age.

This medication is an antidepressant used for the treatment of depression. Its safety and efficacy have not been established for children and adolescents under 18 years, and its use is not recommended. Patients and caregivers should closely monitor for abnormal behavioral changes such as suicidal thoughts or actions, aggression, and anger while taking this medication. Particular caution is necessary at the beginning of treatment or when changing doses, and immediate consultation with a healthcare provider is required if symptoms worsen or new symptoms appear. This medication can rarely cause agranulocytosis, a severe decrease in white blood cells. If fever, sore throat, or infection symptoms occur, stop taking the medication and visit a hospital immediately. Patients with liver or kidney impairment may experience slowed metabolism of this medication, so they should consult with healthcare providers before taking it. This medication may cause drowsiness and dizziness, so it is advisable to avoid activities that require alertness, such as driving or operating machinery, until symptoms have completely resolved. Weight gain and increased appetite can commonly occur during treatment, so care should be taken regarding weight management and dietary habits. Additionally, this medication may affect liver function, so caution should be exercised if there is existing liver disease or abnormal liver function test results. Serious side effects can occur if this medication is taken in conjunction with other antidepressants or certain medications, so patients should inform their healthcare provider about any other medications they are currently taking. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, and it is important for women of childbearing potential to confirm whether they are pregnant while taking this medication. In case of overdose, serious side effects can occur, so it is crucial to adhere strictly to the prescribed dosage, and if overdose is suspected, seek emergency treatment immediately. This medication should be kept out of reach of children and should not be transferred to other containers during storage.

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

This medication should be stored in a container that protects it from light and air and in a cool place between 2°C and 30°C, avoiding humid areas. Proper storage will help maintain the effectiveness of the medication over time.

Appearance

Pale yellow oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle