Medication info
Paroxetine Hydrochloride Tablets 50 mg (Sertraline Hydrochloride)

Paroxetine Hydrochloride Tablets 50 mg (Sertraline Hydrochloride)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Sertraline Hydrochloride›55.95mg / 1 tablet
Manufacturer / importer
(주)한국파마
Appearance
White rectangular film-coated tablets
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 201908216 · Approved 2019.12.03 · Insurance code 653006560

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 an initial dose of 50 mg of sertraline, taken orally once daily. The maintenance dose is 50-100 mg per day. If the effect is insufficient, the dosage can be increased by 50 mg up to a maximum of 200 mg per day, and dose adjustments should be made at intervals of at least one week. Panic disorder, post-traumatic stress disorder and social anxiety disorder: Start with a dose of 25 mg once daily.
Children's dosage
Obsessive-compulsive disorder: For patients aged 6-12 years, start at 25 mg once daily; for patients aged 13-17 years, start at 50 mg once daily. For child patients with obsessive-compulsive disorder aged 6-17 years regarding 2

Ingredients

Manufacturer
(주)한국파마

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 various mental health issues including depression, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, social anxiety disorder, and premenstrual dysphoric disorder. It helps alleviate symptoms tailored to each condition and aids in the mental stability of patients. This is effective in improving the quality of life and enhancing mental health.

Dosage and Administration

Adult dosage

Depression and obsessive-compulsive disorder: Start with an initial dose of 50 mg of sertraline, taken orally once daily. The maintenance dose is 50-100 mg per day. If the effect is insufficient, the dosage can be increased by 50 mg up to a maximum of 200 mg per day, and dose adjustments should be made at intervals of at least one week. Panic disorder, post-traumatic stress disorder and social anxiety disorder: Start with a dose of 25 mg once daily.

Children's dosage

Obsessive-compulsive disorder: For patients aged 6-12 years, start at 25 mg once daily; for patients aged 13-17 years, start at 50 mg once daily. For child patients with obsessive-compulsive disorder aged 6-17 years regarding 2

Precautions

This medication may increase the risk of suicidal thoughts or behaviors in young people with depression or psychiatric disorders, so these patients should be observed closely after starting treatment. While taking this medication, serious side effects such as serotonin syndrome or neuroleptic malignant syndrome may occur, so if related symptoms appear, immediate consultation with a physician is required. It is hazardous to take this medication in conjunction with MAO inhibitors, which inhibit certain enzymes, so patients on these medications should not use it. Additionally, the risk of side effects may increase when combined with other serotonergic drugs, so it should only be taken after consulting a physician. Patients with specific conditions such as liver disease or seizures should use this medication cautiously, and if symptoms such as seizures appear, they should stop taking the medication immediately and inform their healthcare provider. This medication can cause various side effects, so if unusual symptoms like insomnia, anxiety, headache, indigestion, skin rash, palpitations occur, immediate medical attention is necessary. It can affect psychomotor abilities, so caution is needed when driving or operating dangerous machinery, especially when taken with other sedatives. To ensure therapeutic efficacy, it is important to continue taking the medication as directed by a physician even if symptoms improve; sudden discontinuation may cause withdrawal symptoms, so the dosage should be tapered gradually. Women who are pregnant or may become pregnant should carefully consider the potential impact on the fetus when taking this medication, weighing the benefits and risks of treatment and using appropriate contraception. Nursing mothers should consult a physician before determining whether to take this medication, considering the possible effects on infants due to its excretion in breast milk. Children and adolescents have not had their safety and efficacy fully verified except for certain indications, so caution is needed for use. Overdose may lead to severe side effects, so adherence to prescribed dosages is crucial, and patients should not discontinue or change the dosage without a doctor's guidance. This medication can interact with other drugs, so if taking other medications, inform the healthcare provider, especially when using heart medications or medications affecting blood coagulation.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (angioedema)
  • chest tightness
  • difficulty breathing
  • sweating
  • pallor
  • hypersensitivity
  • anaphylactoid reactions
  • severe rashes with fever
  • blisters
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  • skin peeling
  • pain in mucous membranes of mouth/eyes
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • angioedema
  • exfoliative dermatitis
  • photosensitive skin reactions
  • severe skin reactions
  • serotonin syndrome
  • altered consciousness
  • seizures
  • coma
  • changes in consciousness state
  • neuroleptic malignant syndrome

Mild side effects

  • Decreased appetite
  • increased appetite
  • insomnia
  • depressive symptoms
  • decreased libido
  • agitation
  • anxiety
  • aggression
  • euphoria
  • confusion
Show 28 more
  • bruxism
  • nightmares
  • drowsiness
  • dizziness
  • headache
  • sensory disturbances
  • muscle tension
  • tremors
  • involuntary muscle contractions
  • convulsions
  • fainting
  • hyperactivity
  • migraines
  • sensory reduction
  • abnormal muscle tension
  • visual disturbances
  • mydriasis
  • periorbital swelling
  • tinnitus
  • palpitations
  • tachycardia
  • flushing
  • bleeding
  • hypertension
  • yawning
  • bronchospasm
  • epistaxis
  • diarrhea

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It should be kept at room temperature, between 1 degree and 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance and packaging

Appearance

White rectangular film-coated tablets

Package unit

30 tablets/bottle, 200 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.