Medication info
Wellfit Capsule 10mg (Fluoxetine Hydrochloride)

Wellfit Capsule 10mg (Fluoxetine Hydrochloride)

Prescription medicationHard capsule
Ingredient · strength
Fluoxetine Hydrochloride›11.2mg / 1 capsule
Manufacturer / importer
Pharmgen Science Co., Ltd.
Appearance
A hard capsule with green upper and lower parts filled with white or grayish powder.
Packaging
(Bottle) 500 capsules, 30 capsules
Approval status
Active

MFDS item code 201309539 · Approved 2013.10.01 · Insurance code 670103450

Summary

Main use
Treatment of mood disorders (depression and premenstrual dysphoric disorder), obsessive-compulsive disorder, and bulimia nervosa
Who uses it
Adults
Adult dosage
1. Depression 1) Initial treatment: The initial dose is fluoxetine hydrochloride 20mg 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 starting treatment. 2) Maintenance/continuation/extended 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 medication 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 improvement. 2. Bulimia nervosa Administer 60mg per day. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg per day. After 6 months of treatment, reassess whether continued treatment is necessary. - Patients with renal and/or hepatic impairment, patients taking multiple drugs, older adults, and patients with comorbid conditions: Administer a lower dose or reduce the frequency of administration. Adjust the dose appropriately according to age and symptoms. - Switching from MAO inhibitors used to treat psychiatric disorders Allow an interval of at least 14 days after stopping an MAO inhibitor used to treat psychiatric disorders before initiating treatment with this drug. Conversely, allow at least 5 weeks after stopping this drug before initiating an MAO inhibitor to treat psychiatric disorders. - Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not be started on this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventional procedures, consider treatment. If linezolid or intravenous methylene blue must be administered urgently to a patient already receiving this drug, and 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 in a specific patient, discontinue this drug 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 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 methylene blue administered by nonintravenous routes (oral tablets or local injection), or with intravenous administration of this drug 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
Pharmgen Science Co., Ltd.

Efficacy & effects

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

  • Depression
  • changes in appetite
  • changes in sleep
  • agitation or lethargy in psychomotor activity
  • lack of interest in daily life or decreased sexual desire
  • increased fatigue
  • feelings of guilt or worthlessness
  • slowed thinking or decreased concentration
  • suicidal attempts or thoughts about suicide
  • binge eating
  • purging behaviors
  • obsessions
View approved original text

This medication is used for the treatment of depression and typically shows effects within 5 to 6 weeks. Depression can be accompanied by persistent low mood, changes in appetite or sleep, decreased concentration, feelings of guilt, and other symptoms. It also helps alleviate bulimia and reduces binge eating and purging behaviors. It is effective for obsessive-compulsive disorder, significantly reducing obsessions and compulsions, thereby mitigating their impact on social life. It is also used for the improvement of premenstrual dysphoric disorder symptoms, relieving premenstrual depression, anxiety, and physical symptoms. However, the efficacy should be regularly evaluated if taken for a long period. This medication is used to improve various mental and physical symptoms.

Dosage and Administration

Adult dosage

1. Depression 1) Initial treatment: The initial dose is fluoxetine hydrochloride 20mg 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 starting treatment. 2) Maintenance/continuation/extended 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 medication 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 improvement. 2. Bulimia nervosa Administer 60mg per day. The daily dose should not exceed 80mg. Measure electrolyte levels before starting treatment. 3. Obsessive-compulsive disorder Administer 20~60mg per day. The daily dose should not exceed 80mg. 4. Premenstrual dysphoric disorder Administer 20mg per day. After 6 months of treatment, reassess whether continued treatment is necessary. - Patients with renal and/or hepatic impairment, patients taking multiple drugs, older adults, and patients with comorbid conditions: Administer a lower dose or reduce the frequency of administration. Adjust the dose appropriately according to age and symptoms. - Switching from MAO inhibitors used to treat psychiatric disorders Allow an interval of at least 14 days after stopping an MAO inhibitor used to treat psychiatric disorders before initiating treatment with this drug. Conversely, allow at least 5 weeks after stopping this drug before initiating an MAO inhibitor to treat psychiatric disorders. - Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not be started on this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization or other interventional procedures, consider treatment. If linezolid or intravenous methylene blue must be administered urgently to a patient already receiving this drug, and 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 in a specific patient, discontinue this drug 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 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 methylene blue administered by nonintravenous routes (oral tablets or local injection), or with intravenous administration of this drug 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 medication is used for the treatment of depression and psychiatric disorders, and caution should be taken particularly in children, adolescents, and young adults due to an increased risk of suicidal thoughts and behaviors. Do not use this medication if you have an allergy to this drug or its additives, severe kidney dysfunction, or if you are taking certain drugs such as MAO inhibitors. Patients with a history of seizures, high risk of suicide, history of mania, heart disease, or with poor liver and kidney function need to use this medication with special caution. Common side effects such as headache, nausea, insomnia, fatigue, and diarrhea may occur during the use of this medication, and in rare cases, serious side effects such as allergic reactions, cardiac arrhythmias, and bleeding may also occur. This medication may interact with other drugs, so consult with your doctor or pharmacist if you are taking any other medications or plan to consume alcohol. Pregnant or nursing women should consult their doctor carefully as the use of this medication may affect the fetus or baby. The safety and efficacy of this medication have not been adequately established in children and adolescents, and it is not recommended for them. No special adverse reactions have been reported in the elderly, but caution is necessary depending on the presence of other diseases or medication use. Abrupt discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced as directed by your doctor. This medication should be kept out of reach of children, and transferring it to another container 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 disturbances, abnormal dreams, depersonalization, elevated mood, feeling happy, thought disorders, abnormal libido, bruxism, hypomania, mania, hallucinations, agitation, panic attacks, suicidal thoughts and behaviors, confusion, attention deficit, dizziness, taste disturbances, somnolence, drowsiness, tremors, psychomotor agitation, movement disorders, ataxia, balance disorders, tonic-clonic spasms, cramps, inability to sit still, Buccoglosso-pharyngeal syndrome, serotonin syndrome, memory impairment, blurred vision, mydriasis, palpitations, ventricular arrhythmias, QT prolongation, flushing, hypotension, vasculitis, vasodilation, yawning, dyspnea, pharyngitis, pulmonary-related events, epistaxis, vomiting, dyspepsia, dry mouth, dysphagia, esophageal pain, gastrointestinal bleeding, specific hepatitis, rash, urticaria, pruritus, hyperhidrosis, increased tendency for bruising, sweating, angioedema, petechiae, photosensitivity reactions, purpura, erythema multiforme, arthralgia, 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, fractures, withdrawal symptoms, dizziness, sensory disturbances, sleep disorders, asthenia, agitation, anxiety, tremors, headache, aplastic anemia, atrial fibrillation, cataract, cerebrovascular accident, cholestatic jaundice, movement dysregulation, eosinophilic pneumonia, epithelial necrosis, erythema multiforme, 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 medication should be stored in a tightly closed container to prevent air or moisture from entering. Also, avoid storing in places that are too hot or too cold, and it is best to store at a normal room temperature between 1 to 30 degrees.

Appearance and packaging

Appearance

A hard capsule with green upper and lower parts filled with white or grayish powder.

Package unit

(Bottle) 500 capsules, 30 capsules

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.