Agotin Tablet 25 mg (Agomelatine)

Adult dose

The recommended dose of this medicine is 25 mg, administered once daily at bedtime. If symptoms do not improve within the following periods, the dose may be increased to 50 mg (2 tablets of 25mg) once daily. - 2 weeks after starting treatment in patients with major depressive disorder - 4 weeks after starting treatment in patients with generalized anxiety disorder Do not exceed the maximum recommended dose. The decision to increase the dose should be made by weighing it against the risk of elevated transaminases. An increase to 50mg should be made based on the benefit-risk profile for each patient and under strict monitoring of liver function tests (LFTs). Liver function tests should be performed in all patients before starting treatment. Treatment should not be initiated if transaminase levels exceed 3 times the upper limit of normal. During treatment, transaminase levels should also be monitored at approximately 3 weeks, 6 weeks (end of the acute phase), 12 weeks, and 24 weeks (end of the maintenance phase), and as clinically indicated. Treatment should be discontinued if transaminase levels exceed 3 times the upper limit of normal. (See “Precautions for Use, 2. Do not administer to the following patients,” and “4. General Precautions.”) When the dose is increased, liver function tests should be repeated at the same frequency as when treatment was initiated. Patients with depression and generalized anxiety disorder should be treated for a sufficient period of at least 6 months to achieve resolution of symptoms. Patients may experience withdrawal symptoms when discontinuing antidepressants in the SSRI (selective serotonin reuptake inhibitor)/SNRI (serotonin-norepinephrine reuptake inhibitor) class. To prevent these withdrawal symptoms, refer to the prescribing information for the relevant product regarding discontinuation of SSRI/SNRI treatment. Agomelatine may be started immediately while the dose of an SSRI or SNRI is being gradually reduced (tapered). The safety and efficacy of this medicine (25 ~ 50mg/day) have been established in elderly patients with depression (under 75 years of age). Its effects in patients aged 75 years and older have not been demonstrated. Therefore, this medicine should not be administered to patients in this age group. No dose adjustment is required based on age. As experience with this medicine (25~50mg/day) in elderly patients with generalized anxiety disorder is limited, its use is not recommended for the treatment of generalized anxiety disorder in patients aged 65 years and older. Pharmacokinetic parameters of this medicine are not significantly altered in patients with severe renal impairment. However, clinical data in patients with severe or moderate renal impairment are limited, so caution should be exercised when administering this medicine. This medicine should not be administered to patients with hepatic impairment (see “Precautions for Use, 2. Do not administer to the following patients” and “4. General Precautions”). There is no need to gradually reduce the dose when discontinuing treatment. This medicine may be taken with or without food.

Child dose

The safety and efficacy of this medicine have not been established in children and adolescents under 18 years of age (see “Precautions for Use, 4. General Precautions”).

This medication is used for the treatment of depression or generalized anxiety disorder, and the risk of suicidal thoughts or self-harm may increase during the first few weeks of treatment, so patients should be monitored carefully. This medication may affect liver function, so it should not be administered to patients with liver impairment or high liver enzyme levels, and liver function tests should be regularly performed during treatment. Additionally, co-administration of this medication with strong CYP1A2 inhibitors may significantly increase drug concentrations, so combination should be avoided. The safety and efficacy of this medication have not been established in children and adolescents under 18 years of age, elderly patients over 75 years, and patients with dementia, so it is recommended not to be used in these populations. Mild side effects such as headache, nausea, dizziness, and insomnia may occur during treatment, and if symptoms are severe or persistent, consultation with a medical professional is required. Use in pregnant or nursing women is not recommended; if necessary, consult a specialist. In case of overdose, symptoms such as drowsiness, dizziness, and anxiety may occur, so it is essential to adhere to the prescribed dosage and seek immediate medical attention for any unusual symptoms. Caution is needed when driving or operating machinery as dizziness or drowsiness may occur. Keep out of reach of children, and do not transfer the medication to other containers.

Suicidal thoughts or behavior, anxiety, abnormal dreams, restlessness and related symptoms, aggression, nightmares, mania/hypomania, confusion, hallucinations, headaches, dizziness, drowsiness, insomnia, sensory disturbances, restless legs syndrome, migraines, akathisia, blurred vision, tinnitus, nausea, diarrhea, constipation, abdominal pain, vomiting, elevated ALT and/or AST, increased GGT, hepatitis, elevated alkaline phosphatase, liver failure, jaundice, sweating, eczema, itching, hives, erythematous rash, facial swelling and angioedema, low back pain, myalgia, urinary retention, fatigue, weight gain, weight loss, dyspepsia, edema, asthenia, strange sensations, sedation, flexibility, movement disorders, confusion, atrial fibrillation, bipolar disorder, daydreaming, social anxiety disorder, dry mouth, shingles, concussion, complications of tranquilizer administration, decreased appetite, hyponatremia, increased appetite, musculoskeletal rigidity, dry eyes, benign prostatic hyperplasia, upper abdominal pain, drowsiness, fatigue, restlessness, anxiety, tension, dizziness, cyanosis, malaise

This medication should be stored in a sealed container to prevent air from entering, preferably at room temperature between 1 degree and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness.

Appearance

Yellow, rectangular film-coated tablets with a blue company logo printed on one side (refer to company logo in physical properties).

Package unit

28 tablets (14 tablets/PTP X 2)