Medication info
Loran Capsule (Fluoxetine Hydrochloride)

Loran Capsule (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›22.4mg / 1 capsule
Manufacturer / importer
Seoul Pharmaceutical Co., Ltd.
Appearance
Hard capsule with green upper part and yellowish-brown lower part filled with white or gray-white powder
Packaging
30 capsules/bottle, 200 capsules/bottle
Approval status
Active

MFDS item code 200808211 · Notified 2008.07.29

Summary

Main use
Treatment of mental disorders (depression and obsessive-compulsive disorder), premenstrual dysphoric disorder, and bulimia nervosa
Who uses it
Adults
Adult dosage
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 (in the morning and at noon), and the maximum dose of 80mg per day should not be exceeded. The onset of an adequate antidepressant effect 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 drug, but psychopharmacologists agree that acute symptoms of depression require medication 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 per day of this drug. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg per day of this drug. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg per day of this drug. Reassess whether continued treatment is needed after 6 months of treatment. - Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid conditions: Administer a lower dose or reduce the dosing frequency. Adjust the dose appropriately according to age and symptoms. - Switching from MAO inhibitors used to treat psychiatric disorders Allow an interval of at least 14 days after discontinuing an MAO inhibitor used to treat psychiatric disorders before starting treatment with this drug. Conversely, at least 5 weeks must elapse after discontinuing this drug before starting an MAO inhibitor to treat psychiatric disorders. - Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this drug because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization, other interventions should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If 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, discontinue this drug 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 occurs first. Treatment with this drug may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this drug at doses of 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 mental disorders (depression and obsessive-compulsive disorder), premenstrual dysphoric disorder, and bulimia nervosa

  • Depression
  • changes in appetite
  • changes in sleep
  • agitation or lethargy in psychomotor activity
  • lack of interest in daily activities
  • decreased sexual desire
  • increased fatigue
  • feelings of guilt
  • feelings of worthlessness
  • slowed thought processes
  • decreased concentration
  • suicidal attempts
View approved original text

This drug is used for treating depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. The effect usually appears within 5 to 6 weeks in the treatment of depression, improving various symptoms such as changes in appetite, sleep disturbances, and decreased concentration. In the case of bulimia nervosa, it reduces binge eating and purging behaviors to alleviate symptoms, while in obsessive-compulsive disorder, it reduces obsessions and compulsions to assist the patient's social life. For premenstrual dysphoric disorder, it alleviates depression, anxiety, and physical symptoms, reducing discomfort in daily activities. Regular assessments of effectiveness are necessary with long-term use. This drug is effective in improving the symptoms of the aforementioned disorders.

Dosage and Administration

Adult dosage

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 (in the morning and at noon), and the maximum dose of 80mg per day should not be exceeded. The onset of an adequate antidepressant effect 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 drug, but psychopharmacologists agree that acute symptoms of depression require medication 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 per day of this drug. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg per day of this drug. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg per day of this drug. Reassess whether continued treatment is needed after 6 months of treatment. - Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbid conditions: Administer a lower dose or reduce the dosing frequency. Adjust the dose appropriately according to age and symptoms. - Switching from MAO inhibitors used to treat psychiatric disorders Allow an interval of at least 14 days after discontinuing an MAO inhibitor used to treat psychiatric disorders before starting treatment with this drug. Conversely, at least 5 weeks must elapse after discontinuing this drug before starting an MAO inhibitor to treat psychiatric disorders. - Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this drug because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization, other interventions should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If 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, discontinue this drug 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 occurs first. Treatment with this drug may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by non-intravenous routes (oral tablets or local injection), or with intravenous administration of this drug at doses of 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 drug may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric disorders; therefore, careful assessment of necessity and risk by a physician is required. This drug should not be used in certain patients, such as those allergic to this drug or its additives, patients with severe renal impairment, and those taking MAO inhibitors. Caution should be exercised when administering this drug to patients with a history of seizures or those at risk of suicide, and if there is worsening of symptoms or unusual behavioral changes, medical consultation should be sought immediately. Patients with heart disease or impaired liver or kidney function should also be careful when using this drug, and diabetic patients requiring blood sugar control should monitor changes in blood sugar. Common side effects of this drug include headache, nausea, insomnia, fatigue, diarrhea, and decreased appetite, while rare but serious side effects such as severe allergic reactions, bleeding, or liver function abnormalities have also been reported. Abrupt discontinuation of this drug may cause withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, and anxiety, so the dosage should be gradually reduced according to the physician's instructions. This drug may interact with other medications, and it is essential to inform your doctor or pharmacist of any ongoing medications, especially when taken with MAO inhibitors or medications affecting blood coagulation. Women who are pregnant or breastfeeding should consult a doctor before taking this drug, as it may affect the fetus or newborn, requiring careful judgment. It is recommended not to administer this drug to children or adolescents since its safety and efficacy have not been fully established in this population. Elderly patients should use this drug carefully, considering the potential for interactions with other diseases or medications. In case of overdose, serious symptoms such as nausea, vomiting, seizures, cardiac arrhythmias, etc. may occur, and immediate medical attention is necessary; treatment should be based on the symptoms. This drug should be kept out of reach of children and should not be transferred to other containers for safety.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, serum sickness, dysregulation of antidiuretic hormone secretion, decreased appetite, hyponatremia, anxiety, neuro irritability, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, feelings of happiness, thought disorder, sexual dysfunction, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, abnormal movements, ataxia, balance disorders, myoclonus, seizures, inability to sit still, Bucco-glossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary related events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency for bruising, sweating, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myalgia, frequent urination, dysuria, urinary retention, urination difficulties, 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, fractures, dizziness, sensory disturbances, sleep disorders, weakness, agitation, anxiety, tremors, headache, anaphylactoid reactions, progressive systemic reactions, behaviors associated with suicide, hostility, growth delay, decreased alkaline phosphatase levels, changes in platelet function, abnormal bleeding, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accident, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, 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

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

Storage

This drug should be stored in a tightly closed container to prevent exposure to air or moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Hard capsule with green upper part and yellowish-brown lower part filled with white or gray-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.