Medication info
Hanin Sertraline Tablet 25 mg (Sertraline Hydrochloride)

Hanin Sertraline Tablet 25 mg (Sertraline Hydrochloride)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Sertraline Hydrochloride›55.95mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
White rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202204286 · Approved 2022.11.29 · Insurance code 657204130

Summary

Main use
Treatment of mental disorders such as depression and obsessive-compulsive disorder
Who uses it
Adults · Children
Adult dosage
For depression and obsessive-compulsive disorder: Administer 50 mg of sertraline orally once daily as an initial dose; the maintenance dose is 50-100 mg per day. If the effect is insufficient, doses may be increased by 50 mg, up to a maximum of 200 mg per day, with dosage adjustments made at intervals of at least one week. For panic disorder, post-traumatic stress disorder, and social anxiety disorder: Start at 25 mg once daily, and after one week, increase to 50 mg once daily.
Children's dosage
For patients aged 6 to 12 with obsessive-compulsive disorder, start at 25 mg once daily, and for patients aged 13 to 17, start at 50 mg once daily. If there is no response, the dosage may be increased up to 200 mg daily.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Treatment of mental disorders such as depression and obsessive-compulsive disorder

  • 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 effectively alleviates these symptoms, helping patients’ daily lives and mental health. It aids in reducing symptoms through tailored treatment for each condition and improves the quality of life. Therefore, this medication is used for the treatment of multiple mental health concerns.

Dosage and Administration

Adult dosage

For depression and obsessive-compulsive disorder: Administer 50 mg of sertraline orally once daily as an initial dose; the maintenance dose is 50-100 mg per day. If the effect is insufficient, doses may be increased by 50 mg, up to a maximum of 200 mg per day, with dosage adjustments made at intervals of at least one week. For panic disorder, post-traumatic stress disorder, and social anxiety disorder: Start at 25 mg once daily, and after one week, increase to 50 mg once daily.

Children's dosage

For patients aged 6 to 12 with obsessive-compulsive disorder, start at 25 mg once daily, and for patients aged 13 to 17, start at 50 mg once daily. If there is no response, the dosage may be increased up to 200 mg daily.

Precautions

This medication may increase the risk of suicidal thoughts or behaviors in young patients aged 18 to 24 with major depressive disorder or psychiatric illnesses; therefore, physicians must carefully evaluate the need for treatment and its risks. All patients taking this medication should be monitored closely for unusual behavioral changes such as suicidal tendencies, aggression, or anger, and family members or guardians should also keep a close watch on the patients. This medication is approved for use only in patients aged 6 to 17 with obsessive-compulsive disorder, and its use in other children and adolescents is not recommended. Severe side effects such as serotonin syndrome and neuroleptic malignant syndrome may occur, so caution is advised when taking this medication with serotonin-acting drugs. This medication should not be taken in conjunction with MAO inhibitors, as co-administration may lead to life-threatening side effects—therefore, it must be avoided. Patients with moderate or severe liver impairment, hypersensitivity to this medication, or those taking certain medications (e.g., pimozide) should not use this medication. Patients with epilepsy, mild liver impairment, or angle-closure glaucoma should be closely monitored for the risk of side effects such as seizures or increased intraocular pressure when taking this medication. This medication may cause various side effects including drowsiness, headache, dizziness, anxiety, insomnia, dyspepsia, rash, etc.; if abnormal symptoms appear, consult a doctor immediately. Extra caution is needed when engaging in activities that require attention, such as driving a vehicle or operating machinery after taking this medication, and it is recommended not to take it with other sedatives. Abrupt discontinuation of this medication may result in withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, thus the dosage should be gradually reduced per the physician's instructions. Women who are pregnant or may become pregnant should carefully decide on taking this medication, as it may affect the fetus, and appropriate contraception should be used. Breastfeeding mothers should consult with their doctors regarding whether to take this medication, as some of it may be excreted in breast milk. This medication can interact with other drugs; inform your doctor or pharmacist of any medications you are currently taking. In case of overdose, symptoms such as heart abnormalities, drowsiness, nausea, and trembling may occur, and immediate medical treatment should be sought. This medication should be stored out of reach of children and it is important not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa, toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, photosensitivity skin reactions, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough + fever, breathing difficulties, skin reactions

Mild side effects

  • Decreased appetite
  • increased appetite
  • hypoglycemia
  • hyperglycemia
  • insomnia
  • depressive symptoms
  • decreased libido
  • restlessness
  • anxiety
  • hallucinations
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  • aggression
  • exhilaration
  • confusion
  • teeth grinding
  • nightmares
  • drowsiness
  • dizziness
  • headache
  • sensory abnormalities
  • muscle rigidity
  • tremors
  • involuntary muscle contractions
  • hyperactivity
  • restlessness
  • migraines
  • sensory loss
  • muscle tone abnormalities
  • visual impairment
  • pupil dilation
  • periorbital edema
  • tinnitus
  • palpitations
  • tachycardia
  • facial flushing
  • bleeding
  • hypertension
  • yawning
  • fatigue

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/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.

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.