Medication info
Oxitin Capsule (Fluoxetine Hydrochloride)

Oxitin Capsule (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›22.4mg / 1 capsule
Manufacturer / importer
Joah Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a green upper part and a yellowish lower part filled with a light gray powder
Packaging
30 caps/bottle, 500 caps/bottle
Approval status
Active

MFDS item code 200608206 · Notified 2006.10.31

Summary

Main use
Treatment of psychiatric disorders (depression and obsessive-compulsive disorder), bulimia nervosa, and premenstrual dysphoric disorder
Who uses it
Adults
Adult dosage
1. Depression 1) Initial treatment: The initial dose is 20mg 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 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 the duration of treatment with this medicine; however, psychopharmacology experts recognize that acute episodes of depression require several months or more of drug therapy. 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 60mg of this medicine daily. Do not exceed 80mg per day. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine daily. Do not exceed 80mg per day. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine daily. 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: Use a lower dose or reduce the frequency of administration. Adjust the dose appropriately according to age and symptoms. Switching from an MAO inhibitor used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, 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 requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, consider treatment. If linezolid or intravenous methylene blue must be urgently administered to a patient already receiving this medicine, and there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue are considered 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 comes 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 non-intravenous routes (oral tablets or local injection) or intravenous administration of this medicine 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 psychiatric disorders (depression and 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 or decreased sexual desire
  • increased fatigue
  • feelings of guilt or worthlessness
  • slowing of thought or decreased concentration
  • suicidal thoughts or attempts
  • binge eating
  • laxative behaviors
  • obsessive thoughts
View approved original text

This medication is used to treat depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. Symptoms improvement may occur within 5-6 weeks during depression treatment, alleviating persistent depressive feelings and various symptoms that interfere with daily life. In bulimia nervosa, it helps reduce binge eating and bowel problems, while in obsessive-compulsive disorder, it alleviates distress and social difficulties caused by repetitive thoughts and behaviors. In premenstrual dysphoric disorder, it reduces depression, anxiety, and physical symptoms, improving difficulties in daily life. However, regular evaluation according to individual patient conditions is necessary for long-term use. This medication is used for symptom improvement and treatment of the aforementioned disorders.

Dosage and Administration

Adult dosage

1. Depression 1) Initial treatment: The initial dose is 20mg 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 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 the duration of treatment with this medicine; however, psychopharmacology experts recognize that acute episodes of depression require several months or more of drug therapy. 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 60mg of this medicine daily. Do not exceed 80mg per day. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine daily. Do not exceed 80mg per day. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine daily. 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: Use a lower dose or reduce the frequency of administration. Adjust the dose appropriately according to age and symptoms. Switching from an MAO inhibitor used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, 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 requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, consider treatment. If linezolid or intravenous methylene blue must be urgently administered to a patient already receiving this medicine, and there is no alternative to linezolid or intravenous methylene blue and the benefits of treatment with linezolid or intravenous methylene blue are considered 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 comes 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 non-intravenous routes (oral tablets or local injection) or intravenous administration of this medicine 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 used to treat depression and psychiatric disorders and should be used with caution, especially in children, adolescents, and young adults due to an increased risk of suicidal thoughts or behavior. This drug should not be used if there is hypersensitivity or severe renal impairment or if certain types of other medications (particularly MAO inhibitors) are being taken. Patients with a history of seizures or suicidal risk, a history of mania, or heart-related diseases should use this medication with extra caution, and changes in symptoms or side effects should be closely monitored during treatment. Patients with liver or kidney problems may require dosage adjustments, and patients with diabetes should be cautious as it may affect blood sugar control. This medication may have common side effects such as headache, nausea, insomnia, fatigue, and diarrhea, and serious side effects such as allergic reactions or cardiac arrhythmias may occur infrequently. Especially at the beginning of treatment or when changing the dosage, psychiatric symptoms such as suicidal thoughts or behavior changes, anxiety, and aggression may appear, so patients and caregivers should monitor them closely and consult a healthcare professional immediately. This medication may interact with other drugs, so inform your doctor or pharmacist if you are taking other medications, and it is advisable to avoid alcohol consumption. During pregnancy, the risks to the fetus and the benefits of this medication should be carefully considered, and if breastfeeding, it should be discussed with a healthcare professional as the medication can be transmitted through breast milk. Safety in children and adolescents has not been established, so it is recommended to avoid using this medication. Abruptly stopping this medication can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so dosage should be gradually reduced according to a doctor's instructions. In case of overdose, cardiac problems or central nervous system abnormalities may occur, requiring immediate emergency treatment. This medication should be stored out of reach of children, and transferring to other containers should be avoided.

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 disturbances, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, benign fasciculation syndrome, convulsions, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, dilated pupils, palpitations, ventricular arrhythmia, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency for bruising, cold sweat, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, myoclonus, myalgia, frequent urination, dysuria, urinary retention, voiding dysfunction, 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 disorders, asthenia, agitation, anxiety, tremors, headache, anaphylactoid reaction, progressive systemic reactions, severe reactions related to skin, kidneys, liver, or lungs, suicidal ideation, suicidal behavior, mania, hypomania, Stevens-Johnson syndrome, thrombocytopenia, thrombocytopenic purpura, aggressive behavior, 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, hypoglycemia, immune-related hemolytic anemia, renal failure, worsening of movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, ventricular tachycardia, vaginal bleeding

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a room temperature between 1 and 30 degrees Celsius. This helps to prolong the effectiveness and safety of the medication.

Appearance and packaging

Appearance

A hard capsule with a green upper part and a yellowish lower part filled with a light gray powder

Package unit

30 caps/bottle, 500 caps/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.