Medication info
Loran Capsule 10mg (Fluoxetine Hydrochloride)

Loran Capsule 10mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
Seoul Pharmaceutical Co., Ltd.
Appearance
Green capsule filled with white or grayish-white powder.
Packaging
30 capsules/bottle, 200 capsules/bottle
Approval status
Active

MFDS item code 200700022 · Notified 2006.12.29

Summary

Main use
Treatment of psychiatric disorders (depression and obsessive-compulsive disorder), bulimia nervosa, and premenstrual dysphoric disorder
Who uses it
Adults
Adult dosage
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 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, but psychopharmacologists recognize that acute symptoms of depression require medication for several months or longer. It is unknown whether the amount of antidepressant needed to relieve symptoms is the same as the amount needed to maintain or sustain remission. 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 treatment. Patients with renal and/or hepatic impairment, patients taking multiple medicines, older adults, and patients with comorbid conditions: Administer a low dose or reduce the frequency of administration. Adjust the dose according to age and symptoms. Switching from 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 should elapse after discontinuing 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 who require more urgent treatment of a psychiatric condition, including hospitalization or other interventions, consider treatment. 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, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. 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 comes first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a non-intravenous route (oral tablet or local injection) or with intravenous administration of this medicine at 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Seoul Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of psychiatric disorders (depression and obsessive-compulsive disorder), bulimia nervosa, and premenstrual dysphoric disorder

  • Depression
  • bulimia nervosa
  • obsessive-compulsive disorder
  • symptoms of premenstrual dysphoric disorder
  • depression
  • anxiety
  • emotional instability
  • breast pain
  • headache
  • joint pain
  • muscle pain
  • abdominal bloating
View approved original text

This medication is used for the treatment of depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. In the case of depression, the effect usually appears within 5 to 6 weeks and helps alleviate persistent sadness and various symptoms. In bulimia nervosa, it is effective in appetite control by reducing binge eating and purging behaviors. For patients with obsessive-compulsive disorder, it contributes to alleviating obsessive symptoms and eases difficulties in social and work life. It is also used for premenstrual dysphoric disorder to help improve emotional symptoms like depression and anxiety, as well as physical discomfort. In all cases, it is important to periodically reassess the efficacy for each patient during long-term administration.

Dosage and Administration

Adult dosage

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 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, but psychopharmacologists recognize that acute symptoms of depression require medication for several months or longer. It is unknown whether the amount of antidepressant needed to relieve symptoms is the same as the amount needed to maintain or sustain remission. 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 treatment. Patients with renal and/or hepatic impairment, patients taking multiple medicines, older adults, and patients with comorbid conditions: Administer a low dose or reduce the frequency of administration. Adjust the dose according to age and symptoms. Switching from 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 should elapse after discontinuing 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 who require more urgent treatment of a psychiatric condition, including hospitalization or other interventions, consider treatment. 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, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. 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 comes first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a non-intravenous route (oral tablet or local injection) or with intravenous administration of this medicine at 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Precautions

This medication is primarily used to alleviate symptoms related to depression. During the course of taking this medication, there may be an increased risk of suicidal thoughts or behaviors; therefore, special attention should be given to young patients aged 18 to 24. The use of this medication is not approved for children and adolescents, and it is advisable not to administer it. Patients who are allergic to this medication, have severe renal impairment, or are currently taking certain medications (MAO inhibitors) should not use this medication. It must be administered cautiously to patients with a history of seizures, and treatment should be immediately discontinued if seizures occur or increase in frequency. Patients with severe depression or suicidal tendencies should be closely monitored during the initial treatment phase for worsening symptoms or abnormal behavior changes, and family members or caregivers should also keep a close watch on the patient. Patients with heart diseases, liver dysfunction, and diabetes should be particularly careful when taking this medication. Common side effects include drowsiness, dizziness, headache, nausea, insomnia, fatigue, diarrhea, etc., and there is also a rare risk of serious allergic reactions or arrhythmias. Withdrawal symptoms may occur upon discontinuation of treatment, so the dosage should be gradually reduced according to the doctor's instructions. Drug interactions may occur if this medication is taken with other drugs or alcohol, so be sure to consult with a doctor or pharmacist. Pregnant or nursing women should consult with healthcare professionals before taking this medication, as it may affect the fetus or newborn. When performing activities requiring attention, such as driving or operating hazardous machinery, caution is advised as this medication may impair judgment or motor function. This medication should be stored out of reach of children, and it is advisable to avoid transferring it to another container.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disturbance, abnormal dreams, depersonalization, elevated mood, feeling happy, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbance, somnolence, drowsiness, trembling, psychomotor agitation, movement disorders, ataxia, balance disorders, tics, seizures, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, shortness of breath, 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, phototoxic reactions, purpura, erythema multiforme, arthralgia, muscle stiffness, myalgia, frequent urination, dysuria, urinary retention, micturition 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 disturbance, sleep disorders, weakness, agitation, anxiety, nausea, vomiting, trembling, headache, anaphylactic reactions, gradual systemic reactions, severe skin, renal, hepatic, or pulmonary reactions, behavior related to suicide, hostility, growth retardation, decreased levels of alkaline phosphatase, changes in platelet function, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, cholestatic jaundice, dyskinesia, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hypoglycemia, immune-mediated hemolytic anemia, renal failure, worsening movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, at room temperature between 1°C and 30°C. This will help maintain the effectiveness and ensure safe use of the medication.

Appearance and packaging

Appearance

Green capsule filled with white or grayish-white powder.

Package unit

30 capsules/bottle, 200 capsules/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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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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.