Mirtazapine 30 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 possible should be used. 1. Adults The initial dose of mirtazapine is 15mg once daily, and 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 medicine. 2. Dosage in special populations 1) Patients with renal impairment Use caution when prescribing this medicine to patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min), as its clearance may be reduced. 2) Patients with hepatic impairment Use caution when prescribing this medicine to patients with hepatic impairment, as its clearance may be reduced. In particular, use caution when prescribing to patients with severe hepatic impairment, as these patients have not been studied. 3) Elderly patients The recommended dose is the same as for adults. When increasing the dose, careful monitoring is necessary to achieve a satisfactory and safe effect. 3. Switching from an MAO inhibitor used to treat psychiatric disorders Allow an interval of at least 14 days between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine. Conversely, at least 14 days must elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of psychiatric disorders. 4. Other MAO inhibitors such as linezolid or methylene blue Do not initiate this medicine in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment for a psychiatric condition, including hospitalization and other interventions, consider administration. Linezolid or intravenous methylene blue may need to be administered urgently to a patient already receiving this medicine. 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, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. 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 occurs first. Treatment with this medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses. Because the half-life of this medicine is 20∼40 hours, once-daily dosing is sufficient; if possible, take it at a consistent time in the evening before bedtime. The daily dose may also be divided into equal doses taken once in the morning and once in the evening. To allow sufficient time to assess the therapeutic response to the dose, do not change the dose at intervals of less than 1～2 weeks. At an appropriate dose, a therapeutic response occurs within 2～4 weeks. If the response is inadequate, the dose may be increased up to the maximum dose. Discontinue treatment if there is no response after continuing treatment for an additional 2～4 weeks. 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 for oral use. Swallow it with water without chewing.

Children's dosage

4) Children and adolescents under 18 years of age Do not use this medicine in children and adolescents under 18 years of age because its efficacy has not been demonstrated in two short-term clinical trials and there are safety concerns (see sections 4. Adverse Reactions and 8. Use in Children and Adolescents under Precautions for Use).

This medication should be used with great caution in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders, as the risk of suicidal thoughts or behaviors may increase. A rare blood disorder called agranulocytosis may occur during treatment, so if symptoms of infection such as sore throat or fever occur, consult a doctor immediately. There is not enough experience using this medication in combination with electroconvulsive therapy, so caution is required when co-administered. If jaundice symptoms appear, discontinue this medication immediately. This drug contains aspartame, an artificial sweetener, and should not be taken by patients with phenylketonuria, a specific genetic disorder. Patients with allergies to this drug or its components, or those taking MAO inhibitors should not use this medication. Patients with impaired liver or kidney function, epilepsy, diabetes, heart disease, or low blood pressure should use this medication with caution. Common side effects such as drowsiness, dizziness, increased appetite, and weight gain may occur, so caution is advised when driving or operating machinery. This medication may affect liver function, so patients with liver dysfunction should consult a physician before use. Mental changes such as anxiety, agitation, insomnia, and aggression may occur in the early stages of treatment, so it is essential for patients and caregivers to observe carefully. This medication may interact with other drugs, so all medications being taken should be disclosed to the doctor, and especially MAO inhibitors should not be used concurrently. Pregnant or breastfeeding women should always consult a doctor before taking this medication. It is generally not recommended to use this medication in children and adolescents, as its safety and efficacy have not been proven. Elderly patients may have decreased drug elimination, so careful monitoring and dosage adjustment are necessary. In case of overdose, immediate medical attention should be sought, and there is no specific antidote for this medication. Keep out of reach of children, and do not transfer it to other containers for safety.

• Drowsiness
• nausea
• increased appetite
• weight gain
• dizziness
• weakness
• flu-like syndrome
• lumbar pain
• dry mouth
• constipation

This medication should be stored in a tightly sealed container that blocks light, in a cool, dry place at a temperature between 2°C and 30°C. Storing it this way helps maintain its effectiveness and safety.

Appearance

Reddish-brown oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle