Medication info

Hanin Sertraline Tablets 100 mg (Sertraline Hydrochloride)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Sertraline Hydrochloride›111.9mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
White oval film-coated tablets
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 201507846 · Approved 2015.11.24 · Insurance code 657203280

Summary

Main use
Treatment of mental health disorders such as depression and obsessive-compulsive disorder
Who uses it
Adults · Children
Adult dosage
Depression and Obsessive-Compulsive Disorder: The initial dose of sertraline is 50 mg taken orally once daily. The maintenance dose is 50-100 mg per day. If the effect is insufficient, the dose may be increased by 50 mg, up to a maximum of 200 mg per day, and dosage adjustments should be made at intervals of at least 1 week. Panic Disorder, Post-Traumatic Stress Disorder, and Social Anxiety Disorder: Start with a dosage of 25 mg once daily.
Children's dosage
Obsessive-Compulsive Disorder: Patients aged 6-12 should start with a dosage of 25 mg once daily, and patients aged 13-17 should start with a dosage of 50 mg once daily. For pediatric patients aged 6-17 with obsessive-compulsive disorder,

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

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

  • 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 a range of mental health problems including depression, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, social anxiety disorder, and premenstrual dysphoric disorder.

Dosage and Administration

Adult dosage

Depression and Obsessive-Compulsive Disorder: The initial dose of sertraline is 50 mg taken orally once daily. The maintenance dose is 50-100 mg per day. If the effect is insufficient, the dose may be increased by 50 mg, up to a maximum of 200 mg per day, and dosage adjustments should be made at intervals of at least 1 week. Panic Disorder, Post-Traumatic Stress Disorder, and Social Anxiety Disorder: Start with a dosage of 25 mg once daily.

Children's dosage

Obsessive-Compulsive Disorder: Patients aged 6-12 should start with a dosage of 25 mg once daily, and patients aged 13-17 should start with a dosage of 50 mg once daily. For pediatric patients aged 6-17 with obsessive-compulsive disorder,

Precautions

This medication may increase the risk of suicidal thoughts or behavior in young patients with depression or psychiatric disorders; therefore, a doctor's careful assessment and close monitoring of the patient and guardian are required during treatment. Severe side effects such as serotonin syndrome may occur, and particular caution is needed when used in combination with other serotonergic medications. If unusual symptoms occur, discontinue use immediately and seek treatment. The combined use or cross-dosing of this medication with certain drugs such as MAO inhibitors is very dangerous and is prohibited. Patients with moderate to severe liver impairment or allergies to this medication, or those taking certain medications should not use this medication. Patients with epilepsy or mild liver impairment, glaucoma, etc., should use this medication with caution, and require a doctor's observation regarding the potential for side effects such as seizures or increased intraocular pressure. This medication may cause various side effects, including drowsiness, dizziness, headache, and especially serious symptoms such as irregular heartbeat, bleeding, or skin rash. Therefore, consult healthcare professionals immediately if any unusual symptoms occur. Caution is advised when performing dangerous tasks such as driving or operating machinery, as the effects of this medication may impair attention, and it is advisable to avoid taking it with other sedatives. Pregnant or nursing women should consult a doctor before using this medication, as it may affect the fetus or newborn. The safety and efficacy of this medication have not been sufficiently proven in pediatric and adolescent patients, except for those with obsessive-compulsive disorder, and its use is not recommended in these cases. Sudden discontinuation of this medication can result in withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; therefore, the dosage should be gradually reduced according to a doctor's instructions when discontinuing. Overdose may lead to severe cardiac abnormalities or coma, so it is important to avoid exceeding the prescribed dose, and in the case of an overdose, visit a hospital immediately. This medication should be kept out of reach of children, and transferring it to another container may cause accidents and deterioration of quality, so care should be taken.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe swelling, facial swelling, peripheral edema, severe allergic reactions, toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, photosensitive skin reactions, severe skin adverse reactions, serotonin syndrome, liver damage, yellowing of the skin or eyes (jaundice), liver abnormalities (jaundice), seizures, coma, serious neurological symptoms, urinary retention, significantly reduced urine output, severe body swelling accompanied by increased blood pressure, severe adverse effects

Mild side effects

  • Insomnia
  • depressive symptoms
  • decreased libido
  • restlessness
  • anxiety
  • hallucinations
  • aggression
  • euphoria
  • confusion
  • bruxism
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  • psychotic disorders
  • nightmares
  • drowsiness
  • dizziness
  • headache
  • sensory disturbances
  • muscle tension
  • tremors
  • involuntary muscle contractions
  • migraines
  • sensory loss
  • muscle rigidity
  • mydriasis
  • periorbital edema
  • tinnitus
  • palpitations
  • tachycardia
  • flushing
  • bleeding
  • hypertension
  • yawning
  • bronchospasm
  • epistaxis
  • diarrhea
  • dry mouth
  • nausea
  • vomiting
  • abdominal pain
  • constipation

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius to safely preserve the medication's efficacy.

Appearance and packaging

Appearance

White oval film-coated tablets

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.