Medication info
Parmasertraline 100 mg Tablets (Sertraline Hydrochloride)

Parmasertraline 100 mg Tablets (Sertraline Hydrochloride)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Sertraline Hydrochloride›111.9mg / 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 202001212 · Approved 2020.02.20 · Insurance code 653006640

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: Start with an initial dose of 50 mg of sertraline taken orally once daily. The maintenance dose is 50-100 mg once daily. If the effect is insufficient, the dose may be increased by 50 mg increments up to a maximum of 200 mg daily, and dosage 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 with a dosage of 25 mg once daily; for patients aged 13-17 years, start with a dosage of 50 mg once daily. 6-17 year old pediatric patients with obsessive-compulsive disorder may receive a dosage of 25-200

Ingredients

Manufacturer
(주)한국파마

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 in the treatment of various mental health issues, 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: Start with an initial dose of 50 mg of sertraline taken orally once daily. The maintenance dose is 50-100 mg once daily. If the effect is insufficient, the dose may be increased by 50 mg increments up to a maximum of 200 mg daily, and dosage 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 with a dosage of 25 mg once daily; for patients aged 13-17 years, start with a dosage of 50 mg once daily. 6-17 year old pediatric patients with obsessive-compulsive disorder may receive a dosage of 25-200

Precautions

This medication may increase the risk of suicidal ideation or behavior in children, adolescents, and young adults with major depressive or psychiatric disorders; therefore, careful observation by a physician and guardian is advised during use. Serotonin syndrome and other serious side effects may occur, particularly when used in combination with serotonergic drugs; if abnormal symptoms occur, treatment should be discontinued immediately. This medication should not be used in conjunction with MAO inhibitors and should not be administered within 14 days after discontinuation. Patients with moderate to severe liver impairment or hypersensitivity to this medication should not take it. Patients with epilepsy are at risk of seizures and should be observed carefully; if seizures occur, treatment should be discontinued immediately. Patients with narrow-angle glaucoma may experience increased intraocular pressure due to the mydriatic effect of this medication and should be cautious. This medication may cause side effects such as drowsiness and dizziness; therefore, caution should be exercised when driving or operating machinery, and it is advisable to avoid taking it with alcohol. During the initial stages of treatment or when the dosage is changed, watch for behavioral changes such as suicidal tendencies, anxiety, agitation, or aggressiveness, and consult a physician if there are any abnormal symptoms. Pregnant women or women who may become pregnant should carefully consider the benefits and risks of this medication, as use may affect the fetus, and appropriate contraceptive methods should be used. If breastfeeding, it should be discussed with a physician whether to administer this medication, as it may be excreted in breast milk. This medication is only approved for use in children and adolescents for obsessive-compulsive disorder and should be regularly monitored for weight and growth status. In case of overdose, serious side effects may occur; therefore, dosages should be strictly adhered to, and immediate medical attention should be sought if overdose occurs. This medication may interact with other drugs, so patients must inform their physician or pharmacist about any other medications they are taking. Store this medication in a safe place out of reach of children, and avoid transferring it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweats, paleness, severe allergic reactions, high fever with severe rash, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, Stevens-Johnson syndrome, toxic epidermal necrolysis, desquamative rash, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanying cough and fever, respiratory problems, jaundice of skin or eyes

Mild side effects

  • Decreased appetite
  • increased appetite
  • hyponatremia
  • hypoglycemia
  • hyperglycemia
  • insomnia
  • depressive symptoms
  • decreased libido
  • restlessness
  • anxiety
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  • hallucinations
  • aggression
  • euphoria
  • confusion
  • bruxism
  • psychotic disorders
  • nightmares
  • drowsiness
  • dizziness
  • headache
  • sensory disturbances
  • muscle rigidity
  • tremor
  • involuntary muscle contractions
  • seizures
  • fainting
  • extrapyramidal symptoms
  • hyperactivity
  • restlessness
  • migraine
  • sensory loss
  • muscle rigidity abnormalities
  • mydriasis
  • periorbital edema
  • tinnitus
  • palpitations

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 tightly sealed container. It is best to maintain a storage temperature of between 1 and 30 degrees Celsius to help preserve the medication's effectiveness.

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.