Medication info
Zoloft 50 mg Tablet (Sertraline Hydrochloride)

Zoloft 50 mg Tablet (Sertraline Hydrochloride)

Prescription medicationTablet
Ingredient · strength
Sertraline Hydrochloride›55.95mg / 1 tablet
Manufacturer / importer
비아트리스코리아(주)
Appearance
White film-coated tablet in capsule shape with a score line
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200511068 · Approved 2005.05.10 · Insurance code 073400310

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: the starting dose of sertraline is 50 mg, administered orally once daily. The maintenance dose is 50-100 mg daily. If the effect is insufficient, the dose can be increased by 50 mg, with a maximum of 200 mg per day, and dose adjustments should be made with a minimum interval of one week. Panic disorder, post-traumatic stress disorder, and social anxiety disorder: start at a dose of 25 mg once daily.
Children's dosage
Patients aged 6-12 are started on a dosage of 25 mg once daily, while those aged 13-17 are started on a dosage of 50 mg once daily. For pediatric patients aged 6-17 with obsessive-compulsive disorder, a dosage of 25-200 mg/day has been administered.

Ingredients

Importer
비아트리스코리아(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 for the treatment of depression, obsessive-compulsive disorder in adults and children, panic disorder, post-traumatic stress disorder, social anxiety disorder, and premenstrual dysphoric disorder.

Dosage and Administration

Adult dosage

Depression and obsessive-compulsive disorder: the starting dose of sertraline is 50 mg, administered orally once daily. The maintenance dose is 50-100 mg daily. If the effect is insufficient, the dose can be increased by 50 mg, with a maximum of 200 mg per day, and dose adjustments should be made with a minimum interval of one week. Panic disorder, post-traumatic stress disorder, and social anxiety disorder: start at a dose of 25 mg once daily.

Children's dosage

Patients aged 6-12 are started on a dosage of 25 mg once daily, while those aged 13-17 are started on a dosage of 50 mg once daily. For pediatric patients aged 6-17 with obsessive-compulsive disorder, a dosage of 25-200 mg/day has been administered.

Precautions

This medication may increase the risk of suicidal thoughts and behaviors in children and young adults with depression or psychiatric disorders, therefore the physician should carefully evaluate before prescribing. During treatment with this medication, if any changes in mental state, suicidal tendencies, aggressiveness, or other abnormal behaviors appear, family members or guardians should observe closely and consult a physician immediately. This medication can cause a serious side effect known as serotonin syndrome; caution should be exercised when combined with other medications that affect serotonin. It is extremely dangerous to take this medication in conjunction with certain antidepressants known as MAO inhibitors, or to switch to them within a certain period, and it must not be done under any circumstances. This medication is not to be administered to patients with moderate to severe liver dysfunction, patients with allergies to this medication, or patients currently taking specific medications. Patients with epilepsy or slightly impaired liver function and those with glaucoma require careful observation and adjustments while using this medication. Side effects such as drowsiness, dizziness, and headaches may occur; if they are severe, the physician should be informed immediately. Caution should be taken when driving or operating dangerous machinery as this medication may affect mental or physical abilities, and it is advisable not to take it with other sedatives. Abrupt discontinuation of this medication can lead to withdrawal symptoms; therefore, dosages should be reduced gradually as directed by a physician. Women who are pregnant or may become pregnant should carefully consider the risks to the fetus and the benefits of treatment before taking this medication, and appropriate contraception is recommended. Breastfeeding women should consult with their physician regarding whether to take this medication due to the possibility of some transfer to breast milk. This medication has many drug interactions, so it is important to inform the physician or pharmacist of all medications being taken and monitor closely. In cases of overdose, serious side effects may occur; the prescribed dosage must be strictly followed, and if an overdose occurs, immediate medical attention should be sought. This medication should be kept out of reach of children, and care should be taken not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rashes with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe headaches, lightning-like pain.

Mild side effects

  • Decreased appetite
  • increased appetite
  • hyponatremia
  • hypoglycemia
  • hyperglycemia
  • insomnia
  • depressive symptoms
  • decreased libido
  • agitation
  • anxiety
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  • hallucinations
  • aggression
  • euphoria
  • confusion
  • bruxism
  • psychotic disorders
  • nightmares
  • drowsiness
  • dizziness
  • headaches
  • paresthesia
  • muscle rigidity
  • tremors
  • involuntary muscle contractions
  • restlessness
  • migraines
  • sensory loss
  • muscle tone abnormalities
  • mydriasis
  • periorbital edema
  • tinnitus
  • palpitations
  • tachycardia
  • facial flushing
  • bleeding
  • hypertension
  • yawning

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 best stored at room temperature, ideally between 1°C and 30°C.

Appearance and packaging

Appearance

White film-coated tablet in capsule shape with a score line

Package unit

30 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.