Teva Mirtazapine ODT 15 mg

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. The initial dose of mirtazapine is 15 mg 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. Clearance of this medicine may be reduced in patients with moderate to severe renal impairment (creatinine clearance<40 mL/min); use caution when prescribing. Clearance of this medicine may be reduced in patients with hepatic impairment; use caution when prescribing. In particular, use caution when prescribing to patients with severe hepatic impairment, as this population 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 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. Patients receiving linezolid or intravenous methylene blue must not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients who require more urgent treatment of a psychiatric condition, including hospitalization or other interventional procedures, 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, 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 resumed 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 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. Because the half-life of this medicine is 20∼40 hours, once-daily dosing is sufficient; take it at a consistent time in the evening before bedtime whenever possible. 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. With an appropriate dose, a therapeutic effect appears within 2～4 weeks. If the effect is insufficient, the dose may be increased up to the maximum dose. Discontinue treatment if there is no effect after continuing treatment for another 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. Remove this medicine and place it on the tongue. It dissolves quickly on the tongue and can be swallowed without water. To prevent this medicine from breaking, do not press the tablet through the packaging (Figure 1). Each package contains 6 tablets, separated by perforations. Bend the package along the perforations as shown in Figures 2 and 3 to separate one tablet. Hold the marked area on the back and carefully peel off the backing in the direction of the arrow, as shown in Figures 4 and 5. With dry hands, remove the tablet and place it on the tongue (for Remeron SolTab tablets only).

Children's dosage

Do not use this medicine in children or adolescents under 18 years of age.

This drug may increase the risk of suicidal thoughts or behaviors in young patients with major depression or psychiatric disorders; therefore, the physician should carefully evaluate the benefits and risks of treatment. During treatment with this drug, agranulocytosis with decreased white blood cell count may rarely occur. If symptoms of throat pain, fever, or infection appear, consult a doctor immediately. There is insufficient experience using this drug in conjunction with electroconvulsive therapy, so caution is advised. If symptoms of jaundice occur, discontinue this medication. The artificial sweetener aspartame contained in this drug should not be administered to patients with certain genetic disorders. Patients who are allergic to this medication or its components or are taking MAO inhibitors should not use this medication. Special caution is required for patients with impaired liver or kidney function, epilepsy, diabetes, cardiovascular diseases, or hypotension when using this drug. Common side effects include drowsiness, dizziness, increased appetite, and weight gain; caution is required when driving or operating machinery. This medication may affect liver function, so patients with liver disorders should undergo regular check-ups. Suicidal tendencies or abnormal behavioral changes may occur at the beginning of treatment or when the dosage is altered, so patients and guardians should monitor this closely. This medication may interact with other drugs, so inform your doctor about any other medications you are taking. Pregnant or nursing women should consult their doctor before using this medication. It is generally recommended to avoid administering this drug to children and adolescents due to concerns over safety and efficacy. Elderly patients may be more sensitive to medication, so dosage adjustments and monitoring are necessary. In the event of an overdose, seek medical attention immediately since there is no antidote for this medication. Keep this medication out of the reach of children and do not transfer it to another container to maintain its quality.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. Additionally, it is advisable to keep it in a cool place below 30 degrees Celsius to preserve its effectiveness.

Appearance

White round orodispersible tablet that dissolves in the mouth without water, imprinted with '93' on one side and '7303' on the other side.

Package unit

30 tablets (6 tablets/PTP x 5)