D-fren Capsule (Fluoxetine Hydrochloride)

Adult dosage

Adults 1. Depression 1) Initial treatment: Administer an initial dose of 20mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20～80mg per day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg per day should be administered in 2 divided doses (morning and noon); do not exceed the maximum dose of 80mg per day. The onset of an adequate antidepressant effect may be delayed until 4 weeks or more 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 recognize that acute episodes of depression require pharmacotherapy for several months or longer. It is not known whether the amount of antidepressant needed to relieve symptoms is the same as that needed to maintain or sustain remission. 2. Bulimia nervosa Administer 60mg of this medicine per day. Do not exceed 80mg per day. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20～60mg of this medicine per day. Do not exceed 80mg per day. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine per day. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients taking multiple medicines, older patients, and patients with comorbid conditions: Administer a low dose or reduce the frequency of administration. Adjust the dose appropriately according to age and symptoms. Switching from or to an MAO inhibitor used to treat psychiatric disorders 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, when starting an MAO inhibitor to treat psychiatric disorders, at least 5 weeks must have elapsed after discontinuing this medicine. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or an intravenous methylene blue product 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, other interventions should be considered. It may be necessary to urgently administer linezolid or an intravenous methylene blue product to a patient already receiving this medicine. If no alternative to linezolid or an intravenous methylene blue product is available and, for a particular patient, the benefits of treatment with linezolid or an intravenous methylene blue product are judged to outweigh the risk of serotonin syndrome, this medicine may be stopped immediately and linezolid or an intravenous methylene blue product may be administered. Monitor the patient for symptoms of serotonin syndrome for 5 weeks after administration of linezolid or an intravenous methylene blue product, or for 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 an intravenous methylene blue product. 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 emergency symptoms of serotonin syndrome with these uses.

This medication is used for the treatment of depression and psychiatric disorders; however, the risk of suicidal impulses or behaviors may increase, particularly in younger individuals aged 18 to 24, necessitating careful judgment and ongoing monitoring by a physician. This medication should not be administered to certain patients, such as those with allergies to the drug or excipients, patients with severe renal impairment, and patients currently taking MAO inhibitors. Caution should be exercised when used in patients with a history of seizures, as well as in patients at risk of suicide or experiencing manic symptoms. Patients with heart disease or liver and kidney function impairments should consult with a physician and undergo necessary tests before taking this medication. Diabetic patients must monitor their blood sugar levels closely as their blood sugar control may be affected. Patients at risk for glaucoma should be cautious, as this medication can dilate pupils and increase the risk of elevated intraocular pressure. During treatment, side effects such as headaches, nausea, insomnia, fatigue, and diarrhea may occur; if serious allergic reactions, bleeding, or changes in mental state arise, immediate consultation with healthcare professionals is required. Abrupt discontinuation of this medication can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; therefore, the dose should be gradually reduced under a physician's direction. Interactions may occur when taken with other medications, so all medications being taken should be disclosed to the physician, particularly MAO inhibitors or serotonergic agents should not be used concurrently. During pregnancy, the risks to the fetus may be present, hence should be used only when necessary, and caution is needed if breastfeeding, as the drug may pass into breast milk. Safety and efficacy have not been established in children and adolescents, therefore, it is preferable not to use it in this population. In elderly patients, the possibility of adverse reactions due to other illnesses or medications should be considered. In case of overdose, symptoms such as nausea, vomiting, seizures, and cardiac arrhythmias may occur, and immediate medical attention should be sought; there are no specific antidotes for this medication. This medication should be stored out of the reach of children and should not be transferred to other containers.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, happy mood, thought disturbances, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention disorders, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, myoclonic jerks, seizures, inability to remain seated, buccoglosssal syndrome, serotonin syndrome, memory impairment, blurred vision, dilated pupils, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency for bruising, diaphoresis, angioedema, petechiae, photosensitivity reactions, 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, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reactions, progressive systemic reactions, severe skin, kidney, liver or pulmonary-related reactions, behaviors related to suicide, hostility, growth delay, decreased alkaline phosphatase levels, changes in platelet function, abnormal bleeding, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, hepatic failure, 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

This medication should be stored in a tightly closed container, protected from air and moisture. It is recommended to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

A hard capsule with a green upper part and a yellowish lower part, filled with white to grayish white powder.

Package unit

30 capsules/bottle, 300 capsules/bottle