Medication info
PMS Fluoxetine Capsule 20 mg (Fluoxetine Hydrochloride)

PMS Fluoxetine Capsule 20 mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsule
Ingredient · strength
Fluoxetine Hydrochloride›22.36mg / 1 capsule
Manufacturer / importer
Pharmascience Korea
Appearance
A hard capsule with a green upper part and a yellowish lower part filled with a white powder.
Packaging
Bottle - 30 capsules/bottle
Approval status
Active

MFDS item code 201405195 · Approved 2014.11.06 · Insurance code 627600060

Summary

Main use
Treatment of mood disorders (depression and 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 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, an increase in dose 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 the start of treatment. 2) Maintenance/continuation/long-term treatment: There are no definitive data on how long patients should be treated with this drug; however, psychopharmacologists agree that acute episodes of depression require drug treatment for several months or longer. It is not known whether the dose of antidepressant needed to relieve symptoms is the same as the dose needed to maintain or sustain remission. 2. Bulimia nervosa Administer 60mg of this drug per day. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this drug per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug per day. After 6 months of treatment, reassess whether continued treatment is needed. Patients with renal and/or hepatic impairment, patients taking multiple medications, older adults, and patients with comorbid diseases: Use 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, at least 5 weeks must elapse after discontinuing this drug 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 this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, treatment may be considered. 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are considered to outweigh the risk of serotonin syndrome, this drug may be stopped immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 5 weeks after receiving 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 administration of methylene blue by a nonintravenous route (oral tablets or local injection), or with 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

Importer
Pharmascience Korea

Efficacy & effects

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

  • Depression
  • changes in appetite
  • changes in sleep patterns
  • agitation or retardation of psychomotor activity
  • loss of interest in daily life
  • decreased sexual desire
  • increased fatigue
  • feelings of guilt
  • sense of worthlessness
  • slowed thought process
  • decreased concentration
  • suicidal attempts
View approved original text

This medication is used for the treatment of depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. It helps alleviate the persistent depressive state significantly impacting everyday functioning, reduces binge eating and purging behaviors in bulimia nervosa, and substantially lowers the symptoms of obsessive-compulsive disorder, thus easing difficulties in social and occupational functioning. It also aids in improving emotional instability and physical symptoms associated with premenstrual dysphoric disorder. The effectiveness should be regularly reevaluated for long-term use in each condition, and this medication effectively treats the symptoms of these conditions.

Dosage and Administration

Adult dosage

Adults 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, an increase in dose 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 the start of treatment. 2) Maintenance/continuation/long-term treatment: There are no definitive data on how long patients should be treated with this drug; however, psychopharmacologists agree that acute episodes of depression require drug treatment for several months or longer. It is not known whether the dose of antidepressant needed to relieve symptoms is the same as the dose needed to maintain or sustain remission. 2. Bulimia nervosa Administer 60mg of this drug per day. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this drug per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this drug per day. After 6 months of treatment, reassess whether continued treatment is needed. Patients with renal and/or hepatic impairment, patients taking multiple medications, older adults, and patients with comorbid diseases: Use 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, at least 5 weeks must elapse after discontinuing this drug 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 this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventions, treatment may be considered. 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are considered to outweigh the risk of serotonin syndrome, this drug may be stopped immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 5 weeks after receiving 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 administration of methylene blue by a nonintravenous route (oral tablets or local injection), or with 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 primarily an antidepressant used for the treatment of psychiatric disorders related to depression. It may increase the risk of suicidal thoughts and behaviors, especially in children, adolescents, and young adults. Therefore, when administering to patients in these age groups, physicians should carefully assess the risks and benefits. This medication should not be administered to patients with significantly impaired renal function, those with allergies to this medication or its additives, and those currently taking MAO inhibitors. Care should be taken when using this medication in patients with a history of seizures or mania, and treatment should be discontinued immediately if seizures or manic symptoms occur. Patients with cardiac conditions or cardiac-related risk factors, such as long QT syndrome, should undergo an ECG before administration and be closely monitored during treatment. Dose adjustments may be necessary for patients with impaired liver or kidney function, and diabetic patients should frequently monitor their blood glucose levels as it may affect blood sugar control. Patients at risk of increased intraocular pressure or glaucoma should be cautious due to the possibility of increased eye pressure from pupil dilation. This medication contains a dye called Yellow No. 5, so patients with hypersensitivity to this component should be administered with caution. While taking this medication, side effects such as headaches, nausea, insomnia, fatigue, or diarrhea are common, and rare cases of allergic reactions or severe skin reactions may occur. Behavioral changes such as suicidal thoughts, aggression, anxiety, or agitation may occur at the initiation of therapy or with dosage adjustments; therefore, patients and caregivers should monitor closely and inform the physician immediately if abnormalities occur. Abrupt discontinuation of this medication may cause withdrawal symptoms, including dizziness, sensory disturbances, sleep disorders, anxiety, nausea, tremors, headaches, and should be tapered off gradually according to the physician's instructions. This medication may interact with other drugs, particularly with MAO inhibitors, other antidepressants, anticoagulants, and central nervous system medications; therefore, it is crucial to consult a physician when taken together. During pregnancy, the risks and benefits to the fetus must be closely considered before use, and during breastfeeding, as this medication is excreted in breast milk, it is recommended to either discontinue breastfeeding or administer the lowest effective dose. It is not recommended for use in children and adolescents due to established safety and efficacy, and seniors should be monitored closely. In cases of overdose, severe symptoms, including nausea, vomiting, seizures, and arrhythmias, may occur, requiring immediate emergency treatment. This medication should be kept out of reach of children, and care should be taken not to transfer to other containers, as this can adversely affect quality.

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 disorders, libido disorders, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behavior, confusion, attention deficit, dizziness, taste disorders, hypersomnia, drowsiness, tremors, psychomotor agitation, abnormal movements, ataxia, balance disorders, tonic-clonic seizures, convulsions, akathisia, buccoglossal syndrome, serotonin syndrome, memory disorders, blurred vision, dilated pupils, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, events related to the lungs, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, alopecia, tendency for bruising, sweating, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, muscle spasms, 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, weakness, anxiety, nausea, vomiting, tremors, headache), anaphylactoid reactions, progressive systemic reactions, severe reactions related to skin, kidneys, liver, or lungs, hypoglycemia, immune-related hemolytic anemia, renal failure, movement disorders and worsening of existing movement disorders, optic neuritis, pancreatitis, pancytopenia, pulmonary embolism, pulmonary hypertension, thrombocytopenia, thrombocytopenic purpura, ventricular tachycardia, vaginal bleeding, aggressive behavior, akathisia, psychomotor restlessness

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 and 30 degrees Celsius; doing so helps preserve the medication's effectiveness.

Appearance and packaging

Appearance

A hard capsule with a green upper part and a yellowish lower part filled with a white powder.

Package unit

Bottle - 30 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.