Mirtazapine Tablets 15 mg (Mirtazapine)

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 administered. The initial dose of mirtazapine is 15mg daily, and the dose may need to be increased until an appropriate clinical effect is achieved. The usual effective daily dose is 15~45 mg of this medicine. 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. 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 this group has not been studied. The recommended dose is the same as for adults. When increasing the dose, careful monitoring is necessary to achieve a satisfactory and safe effect. When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, at least 14 days must elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of psychiatric disorders. Treatment with this medicine should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization and other interventions, consider administering this medicine. 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 the benefits of treatment with linezolid or intravenous methylene blue are considered to outweigh the risk of serotonin syndrome in a particular patient, 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 comes first. Treatment with this medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this medicine at doses of 1mg/kg or less, are unclear. Nevertheless, clinicians should be aware of the potential for emergency symptoms of serotonin syndrome with these uses. Since 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 evaluate the therapeutic response to the dose of this medicine, do not change the dose at intervals of less than 1～2 weeks. Treatment at an appropriate dose usually produces a therapeutic effect within 2～4 weeks. If the therapeutic effect is insufficient, the dose may be increased up to the maximum dose. If there is no effect after continuing treatment for a further 2～4 weeks, discontinue treatment. Treatment should be continued for at least 4∼6 months until the patient's symptoms have completely resolved. Thereafter, gradual discontinuation is recommended to avoid withdrawal symptoms. Take this medicine orally with water. Swallow without chewing.

Children's dosage

Do not use this medicine in children or adolescents younger than 18 years.

This drug is primarily used as an antidepressant to treat symptoms associated with depression. The risk of suicidal thoughts or behaviors may increase during the use of this medication, particularly in young adults aged 18 to 24, adolescents, and children. Therefore, the physician should carefully evaluate the benefits and risks of this drug. During treatment, it is important to closely monitor for worsening depression symptoms or abnormal behavior changes such as suicidal tendencies, aggression, or anger, and family members or guardians should be vigilant about the patient’s condition and consult a doctor if any abnormal symptoms occur. This medication can cause a rare blood disorder called agranulocytosis, and if symptoms like sore throat, fever, or infection occur with decreased white blood cells especially within 4 to 6 weeks after administration, the medication should be discontinued immediately and a blood test should be conducted. If liver function is impaired or jaundice occurs, the use of this medication should be stopped, and patients with liver or kidney disorders require dosage adjustments and caution. This medication contains the artificial sweetener aspartame, so patients with certain genetic disorders such as phenylketonuria should not take it. Use is contraindicated in patients who are taking MAO inhibitors or have recently taken them, and patients with other specific genetic disorders should also avoid this medication. Drowsiness and dizziness may commonly occur at the beginning of treatment, so it is advisable to avoid activities that require alertness, such as driving or operating machinery, until the drug's effects stabilize. This medication may increase appetite and cause weight gain, so diabetic patients should closely monitor their blood sugar control. Serotonin syndrome, a serious side effect, can occur; thus, caution is needed when taken with serotonergic agents. Women who are pregnant or planning to become pregnant, as well as nursing mothers, should consult a physician before taking this drug. Furthermore, sudden cessation of this medication may cause withdrawal symptoms such as dizziness, anxiety, headaches, and nausea, so the dosages should be gradually reduced under the doctor’s guidance. In cases of overdose, symptoms such as loss of sensory perception, drowsiness, memory impairment, and rapid heart rate may occur. Immediate medical attention is required, and specific antidotes are not available; treatment should be symptomatic. This medication should be kept out of the reach of children and should not be transferred to other containers as it may affect the quality.

• Drowsiness
• nausea
• increased appetite
• weight gain
• dizziness
• asthenia
• flu syndrome
• lower back pain
• dry mouth
• constipation

This medication is sensitive to light, so it should be stored in a tightly closed container that blocks light. Additionally, avoid humid environments and store it in a cool place at a temperature between 2°C and 30°C.

Appearance

Yellowish oval film-coated tablets

Package unit

100 tablets/bottle, 30 tablets/bottle