Medication info
Han-in Sertraline Tablets 50 mg (Sertraline Hydrochloride)

Han-in Sertraline Tablets 50 mg (Sertraline Hydrochloride)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Sertraline Hydrochloride›55.95mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
White, oblong film-coated tablet
Packaging
For domestic use - 30 tablets/bottle, for domestic use - 100 tablets/bottle, for export - 30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 201507070 · Approved 2015.10.08 · Insurance code 657203270

Summary

Main use
Treatment of depression and obsessive-compulsive disorder (adults and children)
Who uses it
Adults · Children
Adult dosage
Depression and obsessive-compulsive disorder: Administer 50 mg orally once daily as the initial dose. The maintenance dose is 50-100 mg daily, and if the effect is insufficient, it can be increased by 50 mg to a maximum of 200 mg daily. Panic disorder, post-traumatic stress disorder, and social anxiety disorder: Start with 25 mg once daily and increase to 50 mg after one week. Clinically, it can be administered within a range of 50-200 mg daily.
Children's dosage
Obsessive-compulsive disorder (ages 6-17): For children aged 6-12 years, start with 25 mg once daily; for those aged 13-17 years, start with 50 mg once daily. If there is no response, the dose can be increased up to a maximum of 200 mg daily.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Treatment of depression and obsessive-compulsive disorder (adults and children)

  • Depression
  • obsessive-compulsive disorder
  • panic disorder
  • post-traumatic stress disorder
  • social anxiety disorder
  • premenstrual dysphoric disorder
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This medication is used to treat various mental health issues such as depression, obsessive-compulsive disorder in adults and children, panic disorder, post-traumatic stress disorder, social anxiety disorder, and premenstrual dysphoric disorder. It helps alleviate symptoms of each condition, improving quality of life and supporting emotional stability. These disorders can all be caused primarily by mental stress and anxiety, and this medication effectively mitigates these issues. Therefore, this drug is used to enhance the symptoms mentioned above.

Dosage and Administration

Adult dosage

Depression and obsessive-compulsive disorder: Administer 50 mg orally once daily as the initial dose. The maintenance dose is 50-100 mg daily, and if the effect is insufficient, it can be increased by 50 mg to a maximum of 200 mg daily. Panic disorder, post-traumatic stress disorder, and social anxiety disorder: Start with 25 mg once daily and increase to 50 mg after one week. Clinically, it can be administered within a range of 50-200 mg daily.

Children's dosage

Obsessive-compulsive disorder (ages 6-17): For children aged 6-12 years, start with 25 mg once daily; for those aged 13-17 years, start with 50 mg once daily. If there is no response, the dose can be increased up to a maximum of 200 mg daily.

Precautions

This medication can increase the risk of suicidal thoughts or behaviors in young people with major depression or psychiatric disorders; therefore, it should be prescribed with caution by a physician. During treatment, patients or their guardians should monitor closely for signs of suicidal tendencies, aggression, or unstable behavior changes. There is a risk of a serious side effect known as serotonin syndrome, so caution must be exercised when taking this drug with other medications that affect serotonin. Particularly, it should not be taken with monoamine oxidase inhibitors (MAOIs) as this combination is dangerous. The drug should not be used in patients with severely impaired liver function, those who are hypersensitive to this medication, or patients taking certain medications. Patients with epilepsy may have a heightened risk of seizures, so caution is especially needed when administering this drug. Patients with mild liver impairment may require dosage adjustments or extended dosing intervals. This medication may affect mental and physical abilities, causing drowsiness or dizziness; therefore, caution should be exercised when driving or operating hazardous machinery. Pregnant women or those who may become pregnant should use this drug cautiously after consulting a physician as it may affect the fetus. Nursing mothers should also administer this drug under a physician's advice as it may partially pass into breast milk and affect the baby. If treatment is stopped abruptly, withdrawal symptoms such as dizziness, anxiety, and sleep disturbances may occur, so the dosage should be gradually reduced. There may be an increased risk of bleeding during treatment; therefore, caution is needed when taken with drugs that affect bleeding tendencies or blood coagulation. In cases of overdose, symptoms such as heart issues, drowsiness, vomiting, and tremors may appear, necessitating immediate medical attention. This medication should be kept out of the reach of children and not transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • purpura
  • rash
  • liver damage
  • leukopenia
  • thrombocytopenia
  • hyponatremia
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  • coma
  • seizures
  • syncope
  • severe swelling (edema)
  • QT prolongation in the electrocardiogram
  • Torsades de Pointes
  • serotonin syndrome
  • severe rash with fever
  • blisters
  • skin peeling
  • pain in oral/ocular mucosae
  • severe allergic reactions
  • dyspnea
  • breathing difficulties
  • asthma

Mild side effects

  • Decreased appetite
  • increased appetite
  • hypoglycemia
  • hyperglycemia
  • insomnia
  • depressive symptoms
  • decreased libido
  • agitation
  • anxiety
  • hallucinations
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  • aggression
  • euphoria
  • confusion
  • bruxism
  • drowsiness
  • dizziness
  • headache
  • sensory disturbances
  • muscle rigidity
  • tremors
  • involuntary muscle contractions
  • seizures
  • syncope
  • hyperactivity
  • restlessness
  • migraine
  • sensory losses
  • muscle tone abnormalities
  • mydriasis
  • periorbital edema
  • tinnitus
  • palpitations
  • tachycardia
  • facial flushing
  • bleeding
  • hypertension
  • yawning
  • bronchoconstriction

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 sealed container. Additionally, avoid storing it in extremely hot or cold places, and it is best to keep it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White, oblong film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, for domestic use - 100 tablets/bottle, for export - 30 tablets/box [(10 tablets/PTP x 3)]

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

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.