Medication info
Fricdin Capsule 10 mg (Fluoxetine Hydrochloride)

Fricdin Capsule 10 mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
Aprogen BioLogic Co., Ltd.
Appearance
A capsule with a green upper and lower part filled with white or grayish-white powder
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201802271 · Approved 2018.05.31

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 20mg of fluoxetine hydrochloride orally once daily in the morning. In controlled clinical trials, doses of 20~80mg daily were administered. 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; however, 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. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine daily. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine daily. Reassess whether continued treatment is necessary after 6 months of treatment. Patients with renal and/or hepatic impairment, patients taking multiple medicines, older adults, and patients with comorbid diseases: 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 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 since 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 treatment for a more urgent psychiatric condition, including hospitalization and other interventions, consider administration. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If there is no alternative to linezolid or intravenous methylene blue and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient for symptoms of serotonin syndrome until 5 weeks after administration of linezolid or intravenous methylene blue or 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 risks associated with administration of methylene blue by a nonintravenous route (oral tablets or local injection) or intravenous administration of this medicine at doses of 1mg/kg or less are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Aprogen BioLogic Co., 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
  • lack of interest in daily life
  • decreased sexual desire
  • increased fatigue
  • feelings of guilt
  • feelings of worthlessness
  • slowed thinking
  • decreased concentration
  • suicide attempts
View approved original text

This medication is effective for various psychiatric symptoms, such as depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder. In the case of depression, symptom improvement is usually observed within 5 to 6 weeks, helping to alleviate various symptoms including changes in appetite and sleep, and decreased concentration. In bulimia nervosa, it effectively reduces binge eating and excessive purging symptoms. In obsessive-compulsive disorder, it decreases obsessions and compulsions, mitigating their negative impact on the patient’s social and work life. In premenstrual dysphoric disorder, it is used to alleviate premenstrual depression, anxiety, and physical symptoms, thereby reducing discomfort in daily life. It is important to regularly assess the effectiveness of this medication in individual patients during long-term use, and there are expectations for therapeutic effects on these various symptoms.

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 daily were administered. 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; however, 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. The daily dose should not exceed 80mg. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine daily. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg of this medicine daily. Reassess whether continued treatment is necessary after 6 months of treatment. Patients with renal and/or hepatic impairment, patients taking multiple medicines, older adults, and patients with comorbid diseases: 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 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 since 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 treatment for a more urgent psychiatric condition, including hospitalization and other interventions, consider administration. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If there is no alternative to linezolid or intravenous methylene blue and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient for symptoms of serotonin syndrome until 5 weeks after administration of linezolid or intravenous methylene blue or 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 risks associated with administration of methylene blue by a nonintravenous route (oral tablets or local injection) or intravenous administration of this medicine at doses of 1mg/kg or less are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Precautions

This medication is mainly used as an antidepressant for treating psychiatric disorders such as depression. When taking this medication, the risk of suicidal thoughts or behaviors may particularly increase in children, adolescents, and young adults, so careful judgment and ongoing monitoring by a physician are necessary. This medication should not be administered to patients with an allergy to it or severe renal dysfunction, or those taking certain other medications known as MAO inhibitors. Patients with a history of seizures should use this medication cautiously, and it should be discontinued immediately if seizures occur or increase in frequency. Patients with heart disease or those at risk of cardiac arrhythmias such as QT prolongation should also exercise caution when using this medication. Since this medication is metabolized and excreted by the liver and kidneys, dosage adjustments may be necessary for patients with impaired liver or kidney function. Patients with diabetes should closely monitor their blood sugar levels, as this medication may cause fluctuations in blood glucose levels. Patients at risk of increased intraocular pressure or acute glaucoma should be cautious when using this medication. This medication contains lactose and Tartrazine (Yellow No. 5), so patients with certain genetic lactose intolerance or allergies to this dye should use it cautiously. Common side effects may include headaches, nausea, insomnia, fatigue, and diarrhea; rarely, serious allergic reactions or liver dysfunction may occur. Withdrawal symptoms such as dizziness, sensory disturbances, anxiety, and vomiting may appear upon discontinuation, so the dosage should be gradually reduced according to a physician’s instructions. This medication may interact with other drugs, so if you are taking or planning to take other medications, you must consult a physician or pharmacist. During pregnancy, use only when necessary due to potential risks to the fetus, and during breastfeeding, consideration should be given to discontinuing breastfeeding as this medication may be excreted in breast milk and affect the infant. Safety and efficacy in children and adolescents have not been established, so use is not recommended. Elderly patients should also use this medication with caution, and dosage adjustments and side effect monitoring are necessary. In the event of overdose, serious symptoms such as nausea, vomiting, seizures, and arrhythmias may occur, requiring immediate medical attention. This medication should be stored out of reach of children and not transferred to another container for safety reasons.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reaction, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, irritability, restlessness, tension, decreased libido, sleep disturbances, abnormal dreams, depersonalization, elevated mood, happy mood, thought disorder, sexual dysfunction, 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, myoclonus, seizures, inability to sit still, Buccoglossal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, lung-related events, nosebleeds, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, hives, pruritus, hyperhidrosis, increased tendency for bruising, sweating, angioedema, petechiae, photosensitivity, purpura, erythema multiforme, arthralgia, muscle spasms, myalgia, polyuria, dysuria, urinary retention, urination disorders, gynecological bleeding, erectile dysfunction, ejaculation disorder, sexual dysfunction, galactorrhea, hyperprolactinemia, priapism, anxious mood, chills, fatigue, abnormal mood, feeling cold, feeling hot, mucosal bleeding, weight loss, abnormal liver function tests, dizziness, sensory disturbances, sleep disturbances, weakness, agitation, anxiety, nausea, vomiting, tremors, headache, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, erythema nodosum, exfoliative dermatitis, gynecomastia, cardiac arrest, liver failure, necrosis, hyperprolactinemia, hypoglycemia, immune-related hemolytic anemia, renal failure, 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 avoid exposure to air or moisture. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

A capsule with a green upper and lower part filled with white or grayish-white powder

Package unit

30 capsules/bottle, 300 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.