Viewing nowPronin Capsule 10 mg (Fluoxetine Hydrochloride)
Fluoxetine Hydrochloride 11.2mg
Hard capsule · Prescription medication
CMG Pharmaceutical Co., Ltd.

MFDS item code 201903548 · Approved 2019.05.29
Treatment of mood disorders (depression and premenstrual dysphoric disorder), obsessive-compulsive disorder, and bulimia nervosa
This medicine is primarily used for the treatment of depression, and improvement in depressive symptoms is typically observed within 5 to 6 weeks. Depression includes various symptoms such as changes in appetite and sleep, psychomotor agitation or retardation, loss of interest and libido, fatigue, guilt, decreased concentration, and suicidal thoughts, and this medication helps alleviate these symptoms. Additionally, it reduces binge eating and bowel disturbances in patients with bulimia nervosa. It is also effective for obsessive-compulsive disorder, reducing obsessive thoughts and compulsive behaviors, thereby improving social and occupational functioning. In patients with premenstrual dysphoric disorder, it is used to relieve depression, anxiety, and physical symptoms. However, when taken long-term, continuous efficacy and safety should be regularly assessed for each patient. This medication is used for the treatment of depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder.
Adults 1. Depression 1) Initial treatment: The initial dose is 20 mg 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 the dose may be considered after several weeks. Doses exceeding 20mg per day should be administered twice daily (morning and noon), and the maximum dose of 80mg per day should not be exceeded. The onset of adequate antidepressant effects may be delayed until 4 weeks or longer after the start of 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 episodes of depression require several months or more of drug therapy. It is not known 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 per day. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine per day. Reassess whether continued treatment is necessary after 6 months of treatment. Patients with renal and/or hepatic impairment, patients taking multiple medications, elderly patients, and patients with concurrent illnesses: 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 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 intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. For patients requiring other interventional procedures, including hospitalization, or more urgent treatment of a psychiatric condition, consider administration. If linezolid or intravenous methylene blue must be administered urgently to a patient already receiving this medicine, and 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 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 administration of methylene blue by non-intravenous routes (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 mainly used for the treatment of depression or other psychiatric disorders, and special caution is needed as it may increase the risk of suicidal impulses or behaviors, especially in children, adolescents, and young adults. This medication should not be administered to patients with hypersensitivity, severe renal impairment, or those taking MAO inhibitors. Special precautions are required for patients with a seizure history, high suicide risk, manic symptoms, heart disease, reduced liver or renal function, and diabetes. Common side effects such as headache, nausea, insomnia, fatigue, and diarrhea may occur during treatment, and rare but serious allergic reactions, cardiac arrhythmias, or bleeding may occur. When discontinuing treatment, it is important to gradually reduce the dosage rather than stopping abruptly, as withdrawal symptoms like dizziness, anxiety, and nausea may occur. This medication may interact with other medications, so it is essential to consult a physician if taking alcohol or other drugs. Women who are pregnant or breastfeeding should cautiously use this medication considering its effects on the fetus or newborn, especially in late pregnancy where abnormal symptoms may appear in the newborn. For children and adolescents, safety and efficacy have not been sufficiently established, and it is advisable to avoid administration if possible. Elderly patients also require special caution, and in case of overdose, immediate medical attention should be sought. This medication should be kept out of reach of children, and care should be taken not to transfer it to different containers.
Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, irritability, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, euphoric mood, thought disturbances, abnormal libido, bruxism, hypomania, mania, hallucination, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste abnormalities, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tonic-clonic seizures, spasms, akathisia, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, tendency to bruising, diaphoresis, angioedema, petechial hemorrhage, photosensitivity, purpura, erythema multiforme, arthralgia, myalgia, frequent urination, dysuria, urinary retention, voiding dysfunction, gynecological bleeding, erectile dysfunction, ejaculation disorder, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, suicidal ideation, suicidal behavior, fractures, dizziness, sensory disturbances, sleep disturbances, weakness, agitation, anxiety, tremors, headache, anaphylactoid reaction, gradual systemic response, severe reactions related to skin, kidney, liver, or lungs, weight loss, growth delay, hyponatremia, changes in platelet function, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, 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, agitation, hallucinations, delirium, coma, tachycardia, unstable blood pressure, sweating, fever, hypertension, tonic-clonic seizures, petechial hemorrhage, coordination disorders, seizures, vomiting, gastrointestinal bleeding, abnormal bleeding of the skin, postpartum hemorrhage, petechial hemorrhage, vaginal bleeding, gastrointestinal bleeding, bleeding of the skin or mucous membranes, anxiety, agitation, panic disorder, excitement, hostility, aggression, impulsiveness, akathisia, hypomania, mania
Not everyone experiences these, and they can vary from person to person.
This medication should be stored in a tightly closed container to prevent air exposure, and it is recommended to keep it at room temperature between 1°C to 30°C. Storing it this way will help maintain its effectiveness.
Green hard capsule filled with white or grayish-white powder
30 capsules/bottle, 500 capsules/bottle
Even with the same ingredient, strength, dosage form and how it is taken can differ.
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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.
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For anything that needs medical judgment, consult a doctor or pharmacist.
This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.