Medication info
Prozac Capsule 20 mg (Fluoxetine Hydrochloride)

Prozac Capsule 20 mg (Fluoxetine Hydrochloride)

Prescription medication
Ingredient · strength
Fluoxetine Hydrochloride›22.36mg / 1 capsule
Manufacturer / importer
Lilly Korea Ltd.
Appearance
Capsules with a green upper part and a yellowish lower part filled with white or grayish powder
Packaging
100 capsules (10 capsules/PTPX10)/carton, 28 capsules (14 capsules/PTPX2)/carton
Approval status
Active

MFDS item code 200409973 · Approved 2004.01.12 · Insurance code 670800310

Summary

Main use
Treatment of mood disorders (depression, premenstrual dysphoric disorder), obsessive-compulsive disorder, and bulimia nervosa
Who uses it
Adults
Adult dosage
Adults 1. Depression 1) Initial treatment: The initial dose is fluoxetine hydrochloride 20mg orally once daily in the morning. Doses of 20~80mg daily were used in controlled clinical trials. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg daily should be administered twice daily (morning and noon), and the maximum dose of 80mg daily 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, but psychopharmacologists recognize that acute episodes 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 60mg of this medicine daily. Do not exceed 80mg per day. Measure electrolyte levels 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 needed. - 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 frequency of administration. Adjust the dose as appropriate according to age and symptoms. - Switching from MAO inhibitors used to treat psychiatric disorders When stopping an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, at least 5 weeks must elapse after stopping this medicine before starting an MAO inhibitor to treat a psychiatric disorder. - 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 or other interventional procedures, treatment 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome for a particular patient, this medicine may be stopped immediately and linezolid or intravenous methylene blue administered. Monitor the patient for symptoms of serotonin syndrome for 5 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, 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 methylene blue administered by a non-intravenous route (oral tablets or local injection), or with intravenous doses of 1mg/kg or less of this medicine, is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Ingredients

Importer
Lilly Korea Ltd.

Efficacy & effects

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

  • Depression
  • changes in appetite
  • changes in sleep
  • agitation or lethargy of psychomotor activity
  • lack of interest in daily life
  • decreased sexual desire
  • increased fatigue
  • feelings of guilt
  • feeling worthless
  • slowed thinking
  • decreased concentration
  • suicidal attempts
View approved original text

This medication is effective in improving the depressive state and related symptoms in patients with depression, usually showing symptom relief within 5-6 weeks. It also helps reduce binge eating and purging behaviors in patients with bulimia nervosa. For patients with obsessive-compulsive disorders, it reduces obsessive thoughts and compulsive behaviors, alleviating distress in daily life. Patients with premenstrual dysphoric disorder can expect relief from periodic emotional instability and bodily symptoms. This medication contributes to symptom improvement for each condition, and regular evaluation of individual patient status is important during long-term treatment. Overall, it is used for 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 fluoxetine hydrochloride 20mg orally once daily in the morning. Doses of 20~80mg daily were used in controlled clinical trials. If no improvement is observed, an increase in dose may be considered after several weeks. Doses exceeding 20mg daily should be administered twice daily (morning and noon), and the maximum dose of 80mg daily 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, but psychopharmacologists recognize that acute episodes 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 60mg of this medicine daily. Do not exceed 80mg per day. Measure electrolyte levels 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 needed. - 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 frequency of administration. Adjust the dose as appropriate according to age and symptoms. - Switching from MAO inhibitors used to treat psychiatric disorders When stopping an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, at least 5 weeks must elapse after stopping this medicine before starting an MAO inhibitor to treat a psychiatric disorder. - 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 or other interventional procedures, treatment 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome for a particular patient, this medicine may be stopped immediately and linezolid or intravenous methylene blue administered. Monitor the patient for symptoms of serotonin syndrome for 5 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, 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 methylene blue administered by a non-intravenous route (oral tablets or local injection), or with intravenous doses of 1mg/kg or less of this medicine, 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 psychiatric disorders such as depression, and its use is not approved in children and adolescents, so it should be avoided in these populations. During treatment with this medicine, there may be an increased risk of suicidal thoughts or behavior, particularly in young adults aged 18 to 24 and children and adolescents requiring careful judgment and continuous observation by a physician. Patients with an allergy to this medication or its additives, severe renal impairment, or who are taking certain medications (MAO inhibitors) should not use this medication. Patients with a history of seizures should be particularly cautious while using this medication, and treatment must be stopped immediately if seizures occur or the frequency increases. This medication can affect heart rhythms, so patients with heart disease or abnormal EKG findings should consult a physician before taking it. Patients with impaired liver or kidney function may require dosage adjustments, and diabetic patients should closely monitor their blood glucose levels. This medication can dilate pupils, so caution is needed in patients at risk for increased intraocular pressure or glaucoma. Common side effects during treatment may include headache, nausea, insomnia, fatigue, and diarrhea, while serious allergic reactions, bleeding, or changes in mental state may occur infrequently. Abrupt discontinuation of this medication can lead to withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and nausea, so dosages should be gradually reduced under a physician's direction. This medication may interact with other medications, so it is essential to inform the physician or pharmacist of any other drugs being taken, especially regarding the combination with antidepressants, anticoagulants, and central nervous system drugs. Women who are pregnant or breastfeeding should consult a physician before use, as this medication may affect the fetus or newborn. It is advisable to avoid alcohol while taking this medication, and caution is warranted when driving or operating hazardous machinery. Keep this medication out of reach of children and do not transfer it to another container.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, thrombocytopenia, neutropenia, leukopenia, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, nervousness, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, euphoric mood, thought disorder, abnormal libido, bruxism, suicidal impulses and behaviors, hypomania, mania, hallucinations, agitation, panic attacks, confusion, stuttering, aggression, attention deficit disorder, dizziness, taste abnormalities, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, myoclonus, memory impairment, seizures, akathisia, buccoglossal syndrome, serotonin syndrome, blurred vision, pupil dilation, tinnitus, palpitations, prolonged QT interval on ECG, ventricular arrhythmia, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, epistaxis, pharyngitis, pulmonary-related incidents, vomiting, dyspepsia, dry mouth, dysphagia, gastrointestinal bleeding, esophageal pain, specific hepatitis, rash, urticaria, itching, sweating, increased tendency for bruising, cold sweat, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, arthralgia, myalgia, urinary frequency, dysuria, urinary retention, urination disorders, gynecological bleeding, erectile dysfunction, ejaculation disorders, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, postpartum hemorrhage, anxious mood, chills, lethargy, abnormal mood, sensation of cold, sensation of heat, mucosal bleeding, weight loss, transaminase increase, gamma-glutamyl transferase increase, suicidal ideation, suicidal behavior, suicide attempt, pathological thoughts, self-harming behavior, fractures, dizziness, sensory disturbances, sleep disorders, weakness, agitation, anxiety, nausea, vomiting, tremors, headache, anaphylactic-like reaction, progressive systemic reaction, weight loss, hyponatremia, changes in platelet function, 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-related hemolytic anemia, renal failure, motor disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, akathisia, psychomotor agitation, serotonin syndrome, persistent sexual dysfunction

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

Storage

Store this medication at room temperature between 1 and 30 degrees Celsius, and it is important to keep it sealed in an airtight container to maintain its efficacy and prevent degradation.

Appearance and packaging

Appearance

Capsules with a green upper part and a yellowish lower part filled with white or grayish powder

Package unit

100 capsules (10 capsules/PTPX10)/carton, 28 capsules (14 capsules/PTPX2)/carton

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.