Medication info
Sandoz Sertraline Tablets (Sertraline Hydrochloride)

Sandoz Sertraline Tablets (Sertraline Hydrochloride)

Prescription medicationTablet
Ingredient · strength
Sertraline Hydrochloride›55.95mg
Manufacturer / importer
삼일제약(주)
Appearance
White rectangular film-coated tablet imprinted with a break line and SE 50 on one side
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200410506 · Notified 2004.05.27 · Insurance code 668100100

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: Start with 50 mg of sertraline taken orally once daily. The maintenance dose is 50-100 mg once daily, and if effect is insufficient, it can be increased by 50 mg up to a maximum of 200 mg. Dosing adjustments should be made at intervals of at least one week. Panic Disorder and Post-Traumatic Stress Disorder and Social Anxiety Disorder: Start at 25 mg once daily and increase to 50 mg once daily after one week.
Children's dosage
Obsessive-Compulsive Disorder: For patients aged 6-12 years, start with 25 mg once daily, and for patients aged 13-17 years, start with 50 mg once daily. The dosage for pediatric patients aged 6-17 years ranges from 25-200 mg/day.

Ingredients

Importer
삼일제약(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 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: Start with 50 mg of sertraline taken orally once daily. The maintenance dose is 50-100 mg once daily, and if effect is insufficient, it can be increased by 50 mg up to a maximum of 200 mg. Dosing adjustments should be made at intervals of at least one week. Panic Disorder and Post-Traumatic Stress Disorder and Social Anxiety Disorder: Start at 25 mg once daily and increase to 50 mg once daily after one week.

Children's dosage

Obsessive-Compulsive Disorder: For patients aged 6-12 years, start with 25 mg once daily, and for patients aged 13-17 years, start with 50 mg once daily. The dosage for pediatric patients aged 6-17 years ranges from 25-200 mg/day.

Precautions

This drug is primarily used to treat psychiatric disorders such as depression and obsessive-compulsive disorder. During treatment with this medication, potentially dangerous changes in mental state, such as suicidal thoughts or behaviors, may occur, particularly in young patients aged between 18 and 24, requiring careful judgment and strict monitoring by a physician. Additionally, this drug increases the action of serotonin, a neurotransmitter, which can rarely lead to life-threatening serotonin syndrome or neuroleptic malignant syndrome. Symptoms should be closely monitored. This medication should not be taken with certain types of drugs known as MAO inhibitors, as this combination significantly increases the risk of serious side effects. Caution is also required when used in combination with other serotonergic medications, and consult a physician when combining this medication. Patients with moderate to severe liver dysfunction or hypersensitivity to this drug should refrain from use. Patients with a history of seizures, slight liver dysfunction, and those with glaucoma should be monitored more closely when using this drug. This medication may cause various side effects such as drowsiness, dizziness, headache, insomnia, appetite changes, and decreased libido, and in severe cases, seizures or heart rhythm disturbances may occur. When taking this drug, caution should be exercised when driving or operating machinery, and it is advisable not to use it in combination with other sedatives. Pregnant or breastfeeding women should consult with a physician before using this drug, as it may affect the fetus or newborn. The safety and efficacy of this drug for indications other than obsessive-compulsive disorder in children and adolescents have not been established, so its use is limited. Abruptly stopping this medication may result in withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced according to the physician's instructions. In case of overdose, serious side effects can occur; immediate medical attention is necessary. Finally, this medication should be kept out of reach of children and it is advisable to avoid transferring it to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, hypersensitivity, anaphylactoid reactions, serotonin syndrome, coma, seizures, fainting, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, rhabdomyolysis, neurological symptoms (severe headache, confusion, visual disturbances, paralysis), liver damage, liver abnormalities (jaundice), urinary retention, prolonged QT interval on ECG, Torsades de Pointes

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
  • paresthesia
  • muscle rigidity
  • tremors
  • involuntary muscle contractions
  • seizures
  • fainting
  • hyperactivity
  • restlessness
  • migraine
  • sensory loss
  • muscle tone disorders
  • visual impairment
  • mydriasis
  • periorbital edema
  • tinnitus
  • palpitations
  • tachycardia
  • facial flushing
  • bleeding
  • hypertension
  • yawning
  • bronchospasm
  • rhinitis

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. Additionally, it should be kept at room temperature, ideally between 1 degree and 30 degrees Celsius, away from extremes of temperature.

Appearance and packaging

Appearance

White rectangular film-coated tablet imprinted with a break line and SE 50 on one side

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.