Medication info
Sultarin Tablet 100mg (Sertaline Hydrochloride)

Sultarin Tablet 100mg (Sertaline Hydrochloride)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Sertraline Hydrochloride›111.92mg / 1 tablet
Manufacturer / importer
현대약품(주)
Appearance
White rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202303462 · Approved 2023.12.29 · Insurance code 642005150

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: Initial dose is 50 mg taken orally once daily. Maintenance dose is 50-100 mg daily, and can be increased by 50 mg up to a maximum of 200 mg daily. Panic disorder, post-traumatic stress disorder, and social anxiety disorder: Start with 25 mg once daily, increasing to 50 mg after one week. A maximum of 200 mg per day can be administered. Premenstrual dysphoric disorder:
Children's dosage
Obsessive-compulsive disorder (ages 6-12): Start with 25 mg once daily. Ages 13-17: Start with 50 mg once daily. If there is no response, the dose can be increased up to 200 mg per day.

Ingredients

Manufacturer
현대약품(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
View approved original text

This medication is used to treat depression, including obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, social anxiety disorder, and premenstrual dysphoric disorder in adults and children.

Dosage and Administration

Adult dosage

Depression and obsessive-compulsive disorder: Initial dose is 50 mg taken orally once daily. Maintenance dose is 50-100 mg daily, and can be increased by 50 mg up to a maximum of 200 mg daily. Panic disorder, post-traumatic stress disorder, and social anxiety disorder: Start with 25 mg once daily, increasing to 50 mg after one week. A maximum of 200 mg per day can be administered. Premenstrual dysphoric disorder:

Children's dosage

Obsessive-compulsive disorder (ages 6-12): Start with 25 mg once daily. Ages 13-17: Start with 50 mg once daily. If there is no response, the dose can be increased up to 200 mg per day.

Precautions

This medication is primarily used as an antidepressant for the treatment of psychiatric disorders like depression and obsessive-compulsive disorder. During treatment, there may be an increase in suicidal thoughts or behaviors, especially in young patients aged 18 to 24, who require close monitoring and management by a physician. There is a risk of a severe side effect known as serotonin syndrome, which necessitates caution when taken with other serotonergic drugs. It should never be taken together with MAO inhibitors, as this can lead to life-threatening side effects. Patients with moderate to severe liver impairment should not use this medication. Patients with epilepsy or mild liver impairment should use this medication cautiously due to the risk of seizures. Patients with closed-angle glaucoma or a history of glaucoma should be cautious as this medication may cause pupil dilation, potentially increasing intraocular pressure. This medication may cause various side effects, including drowsiness, dizziness, headache, and insomnia, and in rare cases, severe skin reactions or liver damage have been reported. Patients should be careful when performing hazardous tasks such as driving or operating machinery after taking this medication, especially in conjunction with other sedatives. In the initial phase of treatment, depressive symptoms may worsen or suicidal tendencies may appear, so patients and their families should observe this and consult a doctor immediately if any abnormalities arise. Pregnant women or those who may become pregnant should consult a doctor before taking this medication as it may affect the fetus. Women who are breastfeeding should also make careful decisions as this medication may affect the infant. This medication has many drug interactions, particularly with drugs that affect the heart or blood coagulation, so professional guidance is necessary when taken in combination. Severe side effects may occur in case of overdose, so the prescribed dosage and administration must be followed rigorously. Keep out of reach of children and ensure not to transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, sweating, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome), shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), severe lethargy, liver abnormalities (liver damage)

Mild side effects

  • Headache
  • drowsiness
  • dizziness
  • loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • insomnia
  • agitation
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  • anxiety
  • hallucinations
  • confusion
  • nightmares
  • palpitations
  • flushing
  • fatigue
  • weakness
  • excessive sweating
  • mydriasis
  • visual disturbances
  • tinnitus
  • joint pain
  • muscle cramps
  • sexual dysfunction
  • irregular menstruation
  • dry mouth
  • weight gain
  • weight loss
  • increase in blood cholesterol
  • abnormal platelet function test
  • gait disturbance
  • enuresis
  • lethargy
  • urinary incontinence
  • blood

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. It is important to maintain the storage temperature between 1 and 30 degrees Celsius. This will help preserve the efficacy and safety of the medication.

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.