Rotin Capsule 10mg (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, an increase in dose may be considered after several weeks. Doses exceeding 20mg daily should be administered twice daily (morning and noon), and the maximum dose of 80mg daily should not be exceeded. The onset of an adequate 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 recognize that acute episodes of depression require drug treatment 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 stability. 2. Bulimia nervosa Administer 60mg of this medicine daily. The daily dose should not exceed 80mg. Measure electrolyte concentrations 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 whether continued treatment is necessary after 6 months of treatment. Patients with renal and/or hepatic impairment, patients taking multiple medicines, older adults, and patients with comorbid diseases: Administer a lower dose or reduce the frequency of administration. Adjust the dose as appropriate according to age and symptoms. Switching from MAO inhibitors 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 since 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 treatment for a more urgent psychiatric condition, including hospitalization and other interventions, consider administration. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If there is no alternative to linezolid or intravenous methylene blue and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient for symptoms of serotonin syndrome until 5 weeks after administration of linezolid or intravenous methylene blue or 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 risks associated with administration of methylene blue by a nonintravenous route (oral tablets or local injection) or intravenous administration of this medicine at doses of 1mg/kg or less are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

This medication is primarily used as an antidepressant for the treatment of depression and psychiatric disorders. This medication may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults, so when administering to patients in this age group, careful evaluation of risks and benefits by a physician is required. This medication should not be used in patients who are allergic to this medication or its additives, have severe renal impairment, or are taking certain medications known as MAO inhibitors. Caution is required in patients with a history of seizures or those at risk for seizures, and treatment should be immediately discontinued if seizures occur or worsen. Changes in mental health states, such as suicidal thoughts, may occur when taking this medication, so patients and caregivers should closely monitor these changes during the initial phases of treatment and consult a physician. For patients with heart disease or those at risk of cardiac rhythm abnormalities, such as QT prolongation, consideration of an electrocardiogram is advised, and treatment should be discontinued if any signs appear. Patients with impaired liver and kidney functions should adjust the dosage of this medication, and diabetic patients should closely monitor their blood sugar control. This medication can cause dilation of pupils. Therefore, patients with elevated intraocular pressure or at risk for glaucoma should take caution. Common side effects after taking this medication may include headaches, nausea, insomnia, fatigue, diarrhea, etc. Stopping this medication abruptly can lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, anxiety, nausea, tremors, and headaches, so it is crucial to taper down as directed by a physician. This medication can interact with other drugs, so patients must inform their physician or pharmacist about any current medications, especially not to use it with MAO inhibitors or serotonin-active medications. In case of pregnancy or breastfeeding, the use of this medication can affect the fetus or newborn, so careful decisions should be made in consultation with a physician. The safety and efficacy of this medication have not been established in children or adolescents; therefore, it is advised to avoid administering it to them if possible. Elderly patients may have an increased risk of side effects depending on other underlying conditions or medications, so caution is advised. In cases of overdose, symptoms such as nausea, vomiting, seizures, and cardiac rhythm abnormalities may occur, and immediate medical attention should be sought for appropriate treatment. This medication may affect judgment and motor functions, so it is safer to avoid driving or operating dangerous machinery while taking it. This medication should be kept out of the reach of children, and transferring it to another container is not advisable as it can affect its quality.

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attack, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, abnormal taste, hypersomnia, drowsiness, tremor, psychomotor agitation, movement disorders, ataxia, balance disorders, tics, seizures, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, dilated pupils, 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 for bruising, diaphoresis, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, voiding dysfunction, gynecological bleeding, erectile dysfunction, ejaculation disorder, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, malaise, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disturbances, weakness, restlessness, anxiety, tremor, headache, anaphylactoid reaction, gradual systemic reaction, severe skin, kidney, liver or pulmonary reactions, hyponatremia, changes in platelet function, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, worsening 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 closed container to protect it from air or moisture. It is important to maintain a room temperature between 1 to 30 degrees Celsius. This will help to preserve the efficacy of the medication.

Appearance

Hard capsules with a green upper and lower part filled with white to grayish-white powder

Package unit

30 capsules/bottle, 300 capsules/bottle