Medication info
Depmax Capsule 10 mg (Fluoxetine Hydrochloride)

Depmax Capsule 10 mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
Light Pharmtech 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 202105363 · Approved 2021.07.14

Summary

Main use
Treatment of depression, obsessive-compulsive disorder, bulimia nervosa, and premenstrual dysphoric disorder
Who uses it
Adults
Adult dosage
Adults 1. Depression 1) Initial treatment: The initial dose is 20mg of fluoxetine hydrochloride, taken 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 dose may be considered after several weeks. Doses exceeding 20mg per day should be administered in 2 divided doses (morning and noon), and the maximum dose of 80mg per day should not be exceeded. The onset of 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 generally agree that acute episodes of depression require several months or longer of drug treatment. It is not known whether the dose of antidepressant needed to relieve symptoms is the same as the dose needed to maintain or sustain stability. 2. Bulimia nervosa Administer 60mg of this medicine per day. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine per day. 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 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 for treatment of 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 treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a 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 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, this medicine may be stopped immediately and linezolid or intravenous methylene blue administered. Monitor the patient for symptoms of serotonin syndrome for 5 weeks after administration of linezolid or intravenous methylene blue, or for 24 hours after the last dose, whichever occurs first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by nonintravenous routes (oral tablets or local injection) or intravenous administration of this medicine 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
Light Pharmtech Co., Ltd.

Efficacy & effects

Treatment of depression, obsessive-compulsive disorder, bulimia nervosa, and premenstrual dysphoric disorder

  • Depression
  • changes in appetite
  • changes in sleep
  • agitation or retardation of psychomotor activity
  • lack of interest in daily life
  • decreased sexual desire
  • increased fatigue
  • feelings of guilt
  • feelings of worthlessness
  • slowing of thought
  • decreased concentration
  • suicide attempts
View approved original text

This medication shows effect within 5 to 6 weeks in treating patients with depression, helping to alleviate major symptoms such as depressed mood, changes in appetite and sleep, and decreased concentration. It also reduces binge eating and bowel-related behaviors in patients with bulimia nervosa. In obsessive-compulsive disorders, it has shown significant efficacy in reducing difficulties in social and work life caused by obsessive thoughts and compulsive behaviors. For patients with premenstrual dysphoric disorder, it is used to alleviate discomfort caused by periodic depressed mood, anxiety, and physical symptoms. However, the long-term effects of this medication can vary among patients, so it is important to regularly evaluate its efficacy in consultation with healthcare providers during long-term use. In summary, this medication is effective for the treatment of depression, bulimia nervosa, obsessive-compulsive disorders, and premenstrual dysphoric disorder.

Dosage and Administration

Adult dosage

Adults 1. Depression 1) Initial treatment: The initial dose is 20mg of fluoxetine hydrochloride, taken 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 dose may be considered after several weeks. Doses exceeding 20mg per day should be administered in 2 divided doses (morning and noon), and the maximum dose of 80mg per day should not be exceeded. The onset of 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 generally agree that acute episodes of depression require several months or longer of drug treatment. It is not known whether the dose of antidepressant needed to relieve symptoms is the same as the dose needed to maintain or sustain stability. 2. Bulimia nervosa Administer 60mg of this medicine per day. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine per day. 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 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 for treatment of 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 treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a 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 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, this medicine may be stopped immediately and linezolid or intravenous methylene blue administered. Monitor the patient for symptoms of serotonin syndrome for 5 weeks after administration of linezolid or intravenous methylene blue, or for 24 hours after the last dose, whichever occurs first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by nonintravenous routes (oral tablets or local injection) or intravenous administration of this medicine 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 medication is primarily used as an antidepressant for the treatment of psychiatric disorders such as depression. Particular caution is required when administering this medication to children, adolescents, and young adults, as it can increase the risk of suicidal impulses or behaviors in this age group. Patients with hypersensitivity, severe renal impairment, or those on certain medications called MAO inhibitors should not use this drug. Patients with a history of seizures or those at high risk of suicide require special attention when using this drug, and if symptoms worsen or unusual behavior occurs during treatment, they should consult a physician immediately. Patients with cardiac diseases or impaired liver or kidney function should also exercise caution when using this medication, and diabetics requiring blood sugar control should closely monitor blood glucose levels. Various side effects, such as headaches, nausea, insomnia, fatigue, and diarrhea, may occur while taking this medication, and in rare cases, serious allergic reactions, bleeding, or cardiac arrhythmias may occur. Stopping this medication suddenly can lead to withdrawal symptoms such as dizziness, sensory disturbances, and sleep disorders, so dosages should be gradually reduced according to a doctor's instructions. This medicine may interact with other drugs, particularly MAO inhibitors, anticoagulants, and certain antidepressants, so it is important to consult with a physician before taking them together. Pregnant or breastfeeding women should consult a doctor before using this medication, considering possible effects on the fetus or newborn. Its safety and efficacy have not been sufficiently established for children and adolescents, and its use is not recommended. Elderly patients should be cautious as the risk of side effects may increase depending on other diseases or medications they are taking. This medication should be taken strictly according to a doctor's prescription and instructions, and should be kept out of reach of children in a safe place.

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 disorder, abnormal dreams, derealization, elevated mood, happy mood, thought disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disorder, drowsiness, tremor, psychomotor agitation, movement disorders, ataxia, balance disorder, tics, cramps, inability to sit still, BuccoGlossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, 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, alopecia, tendency to bruise easily, cold sweat, angioedema, petechiae, phototoxicity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, increased urinary frequency, dysuria, urinary retention, urination disorders, 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, weakness, anxiety, tremors, headache, anaphylactoid reaction, gradual systemic response, severe skin, renal, hepatic, or pulmonary-related reactions, suicidal-related behaviors, growth delay, decreased alkaline phosphatase levels, 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, hepatic failure, 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

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is recommended to maintain room temperature between 1 degree and 30 degrees Celsius to preserve its effectiveness.

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.

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.