Medication info
Dae Hwa Hydrochloride Fluoxetine Capsule

Dae Hwa Hydrochloride Fluoxetine Capsule

Prescription medicationHard capsule
Ingredient · strength
Fluoxetine Hydrochloride›22.4mg / 1 capsule
Manufacturer / importer
Dae Hwa Pharmaceutical Co., Ltd.
Appearance
Capsules with a green top and a pale yellow bottom filled with powder that is white to grayish-white.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 200402134 · Notified 2004.09.30 · Insurance code 645600370

Summary

Main use
Treatment of mood disorders (depression, premenstrual dysphoric disorder), obsessive-compulsive disorder, and bulimia nervosa
Who uses it
Adults
Adult dosage
1. Depression 1) Initial treatment: Administer fluoxetine hydrochloride 20 mg orally once daily in the morning as the initial dose. In controlled clinical trials, doses of 20–80 mg per day were administered. If no improvement is observed, an increase in the dose may be considered after several weeks. Doses exceeding 20 mg per day should be administered 2 times daily (morning and noon), and the maximum dose of 80 mg per day must not be exceeded. The onset of a sufficient 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 medicine; however, psychopharmacologists recognize that acute symptoms 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 60 mg per day of this medicine. Do not exceed 80 mg per day. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20–60 mg per day of this medicine. Do not exceed 80 mg per day. 4. Premenstrual dysphoric disorder Administer 20 mg per day of this medicine. 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 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 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 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 requiring treatment of a more urgent psychiatric condition, including hospitalization, other interventions should be considered. If linezolid or intravenous methylene blue must be urgently administered 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, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient for symptoms of serotonin syndrome for 5 weeks after linezolid or intravenous methylene blue is administered, 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
Dae Hwa Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Depression
  • changes in appetite
  • changes in sleep
  • restlessness or retardation of mental and motor activity
  • lack of interest in daily life or reduced sexual desire
  • increased fatigue
  • feelings of guilt or worthlessness
  • slowed thinking or decreased concentration
  • suicidal thoughts or attempts
  • binge eating
  • laxative behavior
  • obsessions
View approved original text

This medication is effective in improving the depressed mood and various symptoms of patients with depression. Depression is accompanied by symptoms such as changes in appetite and sleep, fatigue, and decreased concentration, and this medication alleviates these symptoms within 5-6 weeks. It also helps control appetite by reducing binge eating and laxative behavior associated with bulimia nervosa. It reduces obsessions and compulsions in obsessive-compulsive disorders, relieving the discomfort in the patient's social and work life. It is also used to relieve depression, anxiety, and physical symptoms caused by premenstrual dysphoric disorder. However, when taken long-term, regular assessment of the treatment effect is necessary. This medication is used to improve depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder.

Dosage and Administration

Adult dosage

1. Depression 1) Initial treatment: Administer fluoxetine hydrochloride 20 mg orally once daily in the morning as the initial dose. In controlled clinical trials, doses of 20–80 mg per day were administered. If no improvement is observed, an increase in the dose may be considered after several weeks. Doses exceeding 20 mg per day should be administered 2 times daily (morning and noon), and the maximum dose of 80 mg per day must not be exceeded. The onset of a sufficient 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 medicine; however, psychopharmacologists recognize that acute symptoms 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 60 mg per day of this medicine. Do not exceed 80 mg per day. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20–60 mg per day of this medicine. Do not exceed 80 mg per day. 4. Premenstrual dysphoric disorder Administer 20 mg per day of this medicine. 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 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 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 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 requiring treatment of a more urgent psychiatric condition, including hospitalization, other interventions should be considered. If linezolid or intravenous methylene blue must be urgently administered 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, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient for symptoms of serotonin syndrome for 5 weeks after linezolid or intravenous methylene blue is administered, 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 primarily used to treat depression or psychiatric disorders. However, careful consideration by a physician is necessary before administering it to children, adolescents, and young adults (ages 18-24) due to an increased risk of suicidal thoughts and behaviors. This medication should not be administered to patients with known allergic reactions, significant renal impairment, or those taking certain types of medications (MAO inhibitors). It should be used cautiously in patients with a history of seizures and those at risk for suicide or with a history of mania should be closely monitored. Patients with heart disease or liver, and kidney dysfunction should also exercise caution when taking this medication. Diabetic patients might experience impacts on blood sugar control, thus their blood sugar levels should be carefully monitored. This medication can dilate the pupils, therefore caution is needed for patients at risk for increased intraocular pressure. Side effects such as headaches, nausea, insomnia, fatigue, and diarrhea may occur during treatment with this medication. Particularly, if there are any changes in mental symptoms such as suicidal thoughts or behaviors, anxiety, aggression, or hallucinations, immediate consultation with healthcare professionals is required. If this medication is abruptly discontinued, withdrawal symptoms such as dizziness, sensitivity disturbances, anxiety, vomiting, and tremors may appear, so it should be gradually tapered off under a doctor's guidance. Additionally, if an allergic reaction or rash occurs during medication usage, it should be immediately discontinued, and medical advice should be sought. This medication has many drug interactions, so if other medications are being taken, it is essential to inform the physician or pharmacist. Caution is especially needed when taken with MAO inhibitors, other antidepressants, medications affecting blood coagulation, or those influencing heart function. Pregnant individuals should carefully consider the risks to the fetus and the benefits of this medication, and nursing mothers should consult with professionals, as the medication can be passed into breast milk. The safety and efficacy of this medication have not been established in pediatrics and adolescents, thus its use is not recommended. Elderly patients have not reported specific unusual reactions, but caution is required based on other conditions or medications being taken. In cases of overdose, symptoms such as nausea, vomiting, seizures, and arrhythmias may occur, necessitating an immediate visit to a medical institution, with management based on symptoms. Finally, this medication should be kept out of reach of children, and caution should be taken as transferring it to another container could affect its quality.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, euphoric mood, altered thought processes, abnormal sexual desire, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, somnolence, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tonic-clonic seizures, spasms, inability to sit still, buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, 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, increased tendency for bruising, diaphoresis, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, myotonia, myalgia, increased frequency of urination, dysuria, urinary retention, voiding disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, lethargy, abnormal mood, sensation of cold, sensation of heat, mucosal bleeding, weight loss, abnormal liver function tests, suicidal ideation, suicidal behavior, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reactions, severe dermatological, renal, hepatic, or pulmonary-related reactions, weight loss, growth delay, delayed puberty, hyponatremia, changes in platelet function, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, 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, exacerbated 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 medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. The recommended storage temperature is between 1 degree and 30 degrees Celsius. Doing so will help maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Capsules with a green top and a pale yellow bottom filled with powder that is white to grayish-white.

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.

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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.