Medication info
Fluphenazine Capsules 10 mg (Fluoxetine Hydrochloride)

Fluphenazine Capsules 10 mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsule
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
Alvogend Korea Co., Ltd.
Appearance
Green capsule filled with white or gray-white powder
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 200502770 · Notified 2005.05.19 · Insurance code 652604750

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 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 in 2 divided doses (morning and noon), and the maximum dose of 80mg daily should not be exceeded. The onset of a sufficient 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 several months or longer of drug treatment. It is unknown whether the amount of antidepressant needed to relieve symptoms is the same as that needed to maintain or sustain improvement. 2. Bulimia nervosa Administer 60mg of this medicine daily. Do not exceed 80mg daily. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine daily. Do not exceed 80mg daily. 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 receiving multiple medicines, elderly patients, and patients with concomitant diseases: Administer a low 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 medicine, 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 medicine. 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 treatment of a more urgent psychiatric condition, including hospitalization and other interventional procedures, consider administering treatment. 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, 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 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with nonintravenous administration of methylene blue (oral tablets or local injection), or intravenous administration of this medicine at doses 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
Alvogend Korea Co., Ltd.

Efficacy & effects

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

  • Depression
  • bulimia nervosa
  • obsessive-compulsive disorder
  • premenstrual dysphoria symptoms
  • sadness
  • anxiety
  • emotional instability
  • breast pain
  • headache
  • joint pain
  • muscle pain
  • abdominal distension
View approved original text

This drug is effective in treating depression, particularly in outpatient antidepressant patients according to the DSM-III criteria, where effects may appear within 5 to 6 weeks. Depression refers to a state characterized by a persistently low mood that interferes with daily life along with various physical and mental symptoms. Additionally, this drug helps reduce binge eating behavior in patients with bulimia nervosa. It significantly alleviates symptoms in obsessive-compulsive disorder, reducing difficulties in social and work life. It is also used to alleviate symptoms of premenstrual dysphoric disorder, contributing to the improvement of periodic psychological and physical discomfort. However, regular evaluation of individual patient status is necessary for long-term use. This drug is used to treat depression, bulimia nervosa, obsessive-compulsive disorder, and premenstrual dysphoric disorder.

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 in 2 divided doses (morning and noon), and the maximum dose of 80mg daily should not be exceeded. The onset of a sufficient 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 several months or longer of drug treatment. It is unknown whether the amount of antidepressant needed to relieve symptoms is the same as that needed to maintain or sustain improvement. 2. Bulimia nervosa Administer 60mg of this medicine daily. Do not exceed 80mg daily. Measure electrolyte concentrations before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg of this medicine daily. Do not exceed 80mg daily. 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 receiving multiple medicines, elderly patients, and patients with concomitant diseases: Administer a low 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 medicine, 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 medicine. 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 treatment of a more urgent psychiatric condition, including hospitalization and other interventional procedures, consider administering treatment. 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, 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 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 medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with nonintravenous administration of methylene blue (oral tablets or local injection), or intravenous administration of this medicine at doses 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 drug is primarily used as an antidepressant for treating psychiatric disorders. During treatment, there may be an increase in suicidal impulses or behavior; therefore, young patients, particularly those aged 18 to 24, require careful monitoring by a physician. Patients with allergic reactions to this drug, severe renal impairment, or those taking certain types of medications known as MAO inhibitors should not use this drug. Patients with a history of seizures should use this drug with caution, and treatment should be discontinued immediately if seizures worsen. Patients with depression should be closely monitored for changes in suicidal thoughts or behaviors at the beginning of treatment and with dosage changes, and family members or caregivers should also observe the patient's condition closely. Patients exhibiting symptoms of mania should discontinue this drug. Patients with heart conditions or suspected arrhythmias are advised to undergo cardiac evaluation before using this drug, and treatment should be stopped immediately if arrhythmia symptoms occur. Patients with weakened liver or kidney function may require dosage adjustments. Patients with diabetes require periodic blood glucose monitoring as blood sugar control may fluctuate. Patients with high intraocular pressure or at risk of glaucoma should take caution when using this drug. This drug contains specific dyes, so patients allergic to them should use it with caution. Common side effects include headache, nausea, insomnia, fatigue, diarrhea, etc., and if serious allergic reactions or skin rashes occur, immediate consultation with medical personnel is necessary. Abrupt discontinuation of this drug can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so dosage should be gradually reduced following medical advice. This drug may interact with other medications, so if there are concurrent medications being taken, it is essential to inform medical personnel. Pregnant or breastfeeding women should carefully consider the risks and benefits of using this drug, especially in late pregnancy, as temporary symptoms may appear in newborns. Safety and efficacy in children and adolescents have not been sufficiently established, so use is not recommended. In the elderly, no specific adverse reactions have been reported; however, caution may be necessary based on other concurrent conditions or medications. In cases of overdose, serious symptoms such as vomiting, seizures, and cardiac abnormalities may occur, requiring immediate emergency treatment. This drug should be stored out of the reach of children and not transferred to other containers.

Side effects

Headache, nausea, insomnia, fatigue, diarrhea, anaphylactic reactions, serum sickness, abnormal secretion of antidiuretic hormone, decreased appetite, hyponatremia, anxiety, irritability, restlessness, tension, reduced libido, sleep disorders, abnormal dreams, depersonalization, elevated mood, happy mood, cognitive disturbances, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal impulses and behaviors, confusion, attention deficit, dizziness, taste disturbances, hypersomnia, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance issues, myoclonic jerks, seizures, inability to sit still, buccoglottal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, hair loss, increased tendency for bruising, cold sweats, angioedema, purpura, photosensitivity reactions, petechiae, erythema multiforme, arthralgia, myopathy, 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, dizziness, sensory disturbances, sleep disturbances, asthenia, agitation, anxiety, nausea, vomiting, tremors, headache, aplastic anemia, atrial fibrillation, cataracts, cerebrovascular accidents, cholestatic jaundice, movement disorders, eosinophilic pneumonia, epithelial necrosis, nodular erythema, 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 drug may be sensitive to air or moisture and should be stored in a tightly sealed container. It is advisable to maintain storage temperatures between 1°C and 30°C out of direct sunlight. Proper storage ensures the drug’s effectiveness and safety over time.

Appearance and packaging

Appearance

Green capsule filled with white or gray-white powder

Package unit

30 capsules/bottle, 100 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.