Medication info
Oxtin Capsule 10mg (Fluoxetine Hydrochloride)

Oxtin Capsule 10mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
Joah Pharmaceutical Co., Ltd.
Appearance
Green hard capsule filled with white or grayish-white powder, top and bottom.
Packaging
30 capsules/bottle, 500 capsules/bottle
Approval status
Active

MFDS item code 201112304 · Approved 2011.12.29

Summary

Main use
Treatment of mood disorders (depression and premenstrual dysphoric disorder), obsessive-compulsive disorder, and bulimia nervosa
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 per day were administered. If no improvement is observed, a dose increase may be considered after several weeks. Doses exceeding 20mg per day should be administered twice daily (morning and noon), and the maximum dose of 80mg per day must not be exceeded. 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 drug, but psychopharmacologists recognize that acute symptoms of depression require drug treatment for several months or longer. It is unknown whether the amount of antidepressant needed to relieve symptoms is the same as that needed to maintain or continue stability. 2. Bulimia nervosa Administer 60mg of this drug per day. The daily dose must not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this drug per day. The daily dose must not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug per day. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbidities: 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 drug, 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 drug. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue must not start this drug because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, consider treatment. 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 for 24 hours after the last dose, whichever occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with nonintravenous administration (oral tablets or local injection) of methylene blue or intravenous administration of this drug at a dose 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
Joah Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Depression
  • changes in appetite
  • changes in sleep
  • psychomotor agitation or retardation
  • lack of interest in daily life
  • decreased libido
  • increased fatigue
  • feelings of guilt or worthlessness
  • slowed thinking
  • decreased concentration
  • suicidal attempts
  • thoughts of suicide
View approved original text

This medication helps improve the symptoms of patients with depression within 5 to 6 weeks. Depression can be accompanied by various symptoms such as persistent sadness, changes in appetite, sleep, psychomotor agitation or retardation, and loss of interest in daily activities. This medication is effective in alleviating these symptoms. It also reduces binging and constipation issues in patients with bulimia nervosa and significantly decreases obsessive symptoms in obsessive-compulsive disorders. Additionally, it is used to alleviate emotional instability and physical discomfort caused by premenstrual dysphoric disorder. It is important to regularly assess the condition of individual patients during long-term use for all disorders. In summary, this medication is used to improve symptoms of depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder.

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 per day were administered. If no improvement is observed, a dose increase may be considered after several weeks. Doses exceeding 20mg per day should be administered twice daily (morning and noon), and the maximum dose of 80mg per day must not be exceeded. 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 drug, but psychopharmacologists recognize that acute symptoms of depression require drug treatment for several months or longer. It is unknown whether the amount of antidepressant needed to relieve symptoms is the same as that needed to maintain or continue stability. 2. Bulimia nervosa Administer 60mg of this drug per day. The daily dose must not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this drug per day. The daily dose must not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug per day. After 6 months of treatment, reassess whether continued treatment is necessary. Patients with renal and/or hepatic impairment, patients receiving multiple medications, elderly patients, and patients with comorbidities: 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 drug, 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 drug. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue must not start this drug because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, consider treatment. 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 for 24 hours after the last dose, whichever occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with nonintravenous administration (oral tablets or local injection) of methylene blue or intravenous administration of this drug at a dose 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 an antidepressant primarily used to treat depression and other psychiatric disorders. This medication may increase the risk of suicidal thoughts or behavior, especially in young adults aged 18 to 24, and should be administered with caution in this age group. This medication should not be used in patients with hypersensitivity, severe renal impairment, or those taking certain drugs known as MAO inhibitors. Patients with a history of seizures, who are at high risk of suicidality, experiencing manic symptoms, and those with heart disease should use this medication with special caution. Additionally, patients with reduced liver or kidney function, diabetics, and those at risk of elevated intraocular pressure should exercise caution when taking this medication. Common side effects may include headaches, nausea, insomnia, fatigue, diarrhea, and decreased appetite; rare occurrences of allergic reactions, severe skin reactions, and bleeding can occur. Behavioral changes such as suicidal thoughts, aggression, and anxiety may occur during initial treatment or dosage changes, so patients and caregivers should carefully observe these changes. During pregnancy, there may be risks to the fetus, so it should only be used when necessary, and during breastfeeding, careful consideration must be made as the medication can be passed into breast milk. This medication may interact with other drugs, so patients should consult their doctor if they are taking or planning to take other medications. It is advisable to avoid alcohol intake while taking this medication, and sudden discontinuation may cause withdrawal symptoms, so the dosage should be gradually reduced according to the doctor's instructions. This medication is not recommended for use in children or adolescents as its safety and efficacy have not been established. In case of overdose, symptoms such as nausea, vomiting, seizures, and cardiac irregularities may appear, prompting immediate medical attention. This medication should be stored out of reach of children and should not be transferred to another container for safety. Finally, caution should be exercised during activities requiring alertness, such as driving or operating machinery, while taking this medication.

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 disorder, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tics, convulsions, akathisia, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, pupil dilation, palpitations, ventricular arrhythmia, prolonged QT interval, flushing, hypotension, vasculitis, vasodilation, yawning, respiratory distress, pharyngitis, pulmonary-related events, nosebleed, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticarial, itching, hyperhidrosis, hair loss, tendency for increased bruising, sweating, angioedema, petechiae, photophobia, 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, lethargy, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, fractures, withdrawal symptoms (dizziness, sensory disturbances, sleep disturbances, weakness, agitation, anxiety, nausea, vomiting, tremors, headache), anaphylactoid reactions, progressive systemic reactions, suicidal behaviors, hostility, growth retardation, death, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, cholestatic jaundice, hyperkinetic syndrome, eosinophilic pneumonia, epithelial necrosis, nodular erythema, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, hyperprolactinemia, 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 medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it is best stored at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication for a prolonged period.

Appearance and packaging

Appearance

Green hard capsule filled with white or grayish-white powder, top and bottom.

Package unit

30 capsules/bottle, 500 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.