Medication info
Oveflu Capsule (Fluoxetine Hydrochloride)

Oveflu Capsule (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›22.4mg / 1 capsule
Manufacturer / importer
Huons Meditec Co., Ltd.
Appearance
A hard capsule with a green upper part and a light yellow lower part containing a white to light gray powder.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201404233 · Approved 2014.09.16

Summary

Main use
Treatment of mental disorders (depression and obsessive-compulsive disorder), nervous bulimia, and premenstrual dysphoric disorder
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 20~80 mg per day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg per day should be administered twice daily (morning and noon), and the maximum dose of 80 mg per day 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 agree 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 60 mg of this medicine per day. The daily dose should not exceed 80 mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60 mg of this medicine per day. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg of this medicine per day. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with comorbid conditions: Use a lower dose or reduce the frequency of administration. Adjust the dose appropriately according to age and symptoms. Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, 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 who require treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, consider administering it. 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 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 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 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 methylene blue administered by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1 mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Huons Meditec Co., Ltd.

Efficacy & effects

Treatment of mental disorders (depression and obsessive-compulsive disorder), nervous bulimia, and premenstrual dysphoric disorder

  • Depression
  • changes in appetite
  • changes in sleep
  • agitation or psychomotor retardation
  • lack of interest in daily activities or decreased sexual desire
  • increased fatigue
  • feelings of guilt or worthlessness
  • slowing of thought or decreased concentration
  • suicidal ideation or attempts
  • binge eating
  • purging behaviors
  • obsessions
View approved original text

This medicine is used for various mental health-related disorders such as depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. It typically shows effects within 5-6 weeks when used for treating depression and helps alleviate functional impairments in daily life. For bulimia nervosa, it reduces binge eating and purging behaviors, and for obsessive-compulsive disorder, it diminishes obsessive thoughts and behaviors, improving patients' social and work life. It is also used to relieve symptoms of premenstrual dysphoric disorder, including depression, anxiety, breast pain, and headaches. However, during long-term use, it is crucial to regularly monitor the patient's condition and evaluate the drug's utility. This medication is effective for 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 20~80 mg per day were administered. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20 mg per day should be administered twice daily (morning and noon), and the maximum dose of 80 mg per day 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 agree 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 60 mg of this medicine per day. The daily dose should not exceed 80 mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60 mg of this medicine per day. The daily dose should not exceed 80 mg. 4. Premenstrual dysphoric disorder Administer 20 mg of this medicine per day. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, older adults, and patients with comorbid conditions: Use a lower dose or reduce the frequency of administration. Adjust the dose appropriately according to age and symptoms. Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, 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 who require treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, consider administering it. 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 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 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 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 methylene blue administered by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1 mg/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 an antidepressant used to treat psychiatric disorders such as depression. There is an increased risk of suicidal thoughts or behaviors, particularly in young people aged 18 to 24 while taking this medication. This medication should not be used in patients with a known allergy to it or its additives, severe renal impairment, or those currently taking MAO inhibitors. Caution is advised for patients with a history of seizures, those at high risk for suicide, patients exhibiting manic symptoms, those with heart disease, diminished liver or renal function, and diabetics. Various side effects such as headaches, nausea, insomnia, fatigue, and diarrhea may occur during treatment; in rare cases, severe allergic reactions or cardiac arrhythmias may happen, and any unusual symptoms should be consulted with a healthcare professional immediately. If this medication is suddenly discontinued, withdrawal symptoms such as dizziness, anxiety, and sleep disturbances may arise, and doses should be gradually reduced as directed by a physician. Since this medication may interact with others, inform your doctor or pharmacist of any other medications you are taking, and it is advisable to avoid alcohol consumption. Women who are pregnant or breastfeeding should consult their physician adequately after considering the potential effects on the fetus or newborn. Safety in children and adolescents has not been established; therefore, its use is not recommended, and elderly patients should also be treated with caution. Overdosage may lead to severe adverse effects, so it's essential to adhere to the prescribed dosage and regimen. This medication should be stored out of the reach of children, and it is safer not to transfer 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 disorders, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorders, sexual desire disorders, bruxism, hypomania, mania, hallucination, agitation, panic attacks, suicidal impulses and behaviors, confusion, attention deficit, dizziness, taste disorders, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tonic-clonic cramps, spasms, akathisia, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, shortness of breath, pharyngitis, pulmonary-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increased tendency for bruising, cold sweats, 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, fatigue, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, dizziness, sensory disturbances, sleep disorders, weakness, restlessness, anxiety, tremors, headache, anaphylactoid reactions, progressive systemic reactions, severe skin, kidney, liver or pulmonary-related reactions, suicidal ideation, suicidal behavior, 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, necrosis, hyperprolactinemia, hypoglycemia, immune-mediated hemolytic anemia, renal failure, movement disorders, exacerbation of pre-existing movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, akathisia

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

Storage

This medicine should be stored in a tightly sealed container to protect it from air and moisture. It's important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

A hard capsule with a green upper part and a light yellow lower part containing a white to light gray powder.

Package unit

30 capsules/bottle, 300 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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.