Ovetin Capsule (Fluoxetine Hydrochloride)

Adult dosage

1. Depression 1) Initial treatment: The initial dose is 20mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20～80mg daily were administered. If no improvement is observed, a dose increase may be considered after several weeks. Doses exceeding 20mg daily should be administered in 2 divided doses (morning and noon), and the maximum dose of 80mg daily should not be exceeded. The onset of a sufficient antidepressant effect may be delayed until 4 weeks or longer after starting treatment. 2) Maintenance/continuation/extended treatment: There are no definitive data on how long patients should be treated with this medicine; however, psychopharmacologists agree that acute symptoms of depression require several months or more of drug treatment. It is unknown whether the amount of antidepressant needed to relieve symptoms is the same as that needed to maintain or sustain stability. 2. Bulimia nervosa Administer 60mg of this medicine daily. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this medicine daily. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine daily. Reassess the need for continued treatment after 6 months of therapy. Patients with renal and/or hepatic impairment, patients taking multiple medicines, older adults, and patients with comorbid conditions: Administer a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms. Switching from or to an MAO inhibitor used to treat psychiatric disorders When stopping an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor for treatment of a psychiatric disorder, at least 5 weeks must have elapsed after stopping this medicine. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine may be stopped immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 5 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 non-intravenous administration of methylene blue (oral tablets or local injection) or intravenous administration of this medicine at a dose of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of an acute onset of serotonin syndrome with these uses.

This medication is primarily used as an antidepressant for treating depression or psychiatric disorders. When taking this medication, the risk of suicidal impulses or behavior may particularly increase in young patients aged 18 to 24. Therefore, careful observation of the patient is required during the initial treatment phase and when changing dosage. This medication should not be used in specific patients, such as those allergic to this drug or its ingredients, patients with severe kidney dysfunction, and those taking MAO inhibitors. Patients with a history of seizures should use this medication cautiously; if seizures occur or increase in frequency, treatment should be stopped immediately. This medication may affect the heart, so patients with heart conditions or those at risk for QT interval prolongation should undergo an ECG before use. Patients with impaired liver or kidney function should have their dosages adjusted, and diabetic patients should be cautious as there may be fluctuations in blood sugar control. This medication can cause eye-related abnormalities such as pupil dilation; therefore, patients at risk for glaucoma should use it cautiously. Common side effects during treatment include headache, nausea, insomnia, fatigue, and diarrhea, while rare occurrences of allergic reactions or severe skin reactions have also been reported. Abrupt discontinuation of this medication may result in withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, anxiety, nausea, tremors, and headaches. Therefore, when stopping the medication, the dosage should be gradually reduced according to a doctor’s instructions. Also, this medication may interact with other drugs, so if the patient is taking other medications, they must consult with their doctor or pharmacist. If pregnant or breastfeeding, the use of this medication may affect the fetus or newborn, so it should only be taken after consulting a doctor. This medication is not recommended for children and adolescents as its safety and efficacy have not been sufficiently established. Elderly patients may be at increased risk of side effects depending on other health conditions or medications taken, thus requiring caution. Store this medication out of reach of children and ensure not to stop or change the dosage without consulting a healthcare professional.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, hyperexcitability, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, derealization, elevated mood, feelings of happiness, thought disorders, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, abnormal taste, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, focal muscle spasms, convulsions, akathisia, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, events related to the lungs, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, tendency for increased bruising, clammy sweat, angioedema, petechiae, phototoxic reaction, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, urinary disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, fatigue, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, suicidal ideation, suicidal behavior, fractures, withdrawal symptoms, dizziness, sensory disturbances, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reactions, severe reactions related to skin, kidneys, liver, or lungs, growth retardation, ejaculation failure, ejaculation disorder, premature ejaculation, delayed ejaculation, retrograde ejaculation, cervical bleeding, uterine dysfunction, uterine bleeding, genital bleeding, dysfunctional uterine bleeding, heavy menstrual bleeding, frequent menstruation, postmenopausal bleeding, vaginal bleeding, asthenia, Stevens-Johnson syndrome, toxic epidermal necrolysis, changes in platelet function, abnormal bleeding, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, hepatic necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, exacerbation of movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, akathisia

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius. This helps preserve the medication's efficacy and safety over time.

Appearance

A capsule with dark green upper and lower parts filled with white or grayish-white powder

Package unit

30 capsules/bottle, 200 capsules/bottle