Medication info
Parmasertraline Tablets 25 mg (Sertraline Hydrochloride)

Parmasertraline Tablets 25 mg (Sertraline Hydrochloride)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Sertraline Hydrochloride›27.975mg / 1 tablet
Manufacturer / importer
(주)한국파마
Appearance
White oblong film-coated tablets
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202001213 · Approved 2020.02.20 · Insurance code 653006630

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 sertraline at 50 mg 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, with a maximum of 200 mg per day; dose adjustments should occur at intervals of at least 1 week. Panic disorder, post-traumatic stress disorder, and social anxiety disorder: Begin with a dose of 25 mg once daily.
Children's dosage
For patients aged 6-12 years, the dosage starts at 25 mg once daily, and for patients aged 13-17 years, it starts at 50 mg once daily. For children aged 6-17 years with obsessive-compulsive disorder, the dosage ranges from 25-200 mg.

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 depression and helps relieve symptoms of obsessive-compulsive disorder in adults and children. It is also effective in alleviating symptoms of panic disorder and post-traumatic stress disorder. It is used for the treatment of social anxiety disorder, i.e., social phobia, and is utilized to improve symptoms of premenstrual dysphoric disorder. This medication aids in the management of various mental health-related conditions.

Dosage and Administration

Adult dosage

Depression and obsessive-compulsive disorder: Start with an initial dose of sertraline at 50 mg 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, with a maximum of 200 mg per day; dose adjustments should occur at intervals of at least 1 week. Panic disorder, post-traumatic stress disorder, and social anxiety disorder: Begin with a dose of 25 mg once daily.

Children's dosage

For patients aged 6-12 years, the dosage starts at 25 mg once daily, and for patients aged 13-17 years, it starts at 50 mg once daily. For children aged 6-17 years with obsessive-compulsive disorder, the dosage ranges from 25-200 mg.

Precautions

This medication may increase the risk of suicidal thoughts or behaviors in young people with depression or psychiatric disorders; therefore, the physician must carefully determine whether to prescribe it. Severe symptoms such as changes in mental state, high fever, tremors, or seizures may occur during treatment, necessitating careful observation. It is dangerous to take this medication with certain types of drugs, especially MAO inhibitors, and they must not be used together. Patients with severe liver function impairment or those allergic to this medication should not take it. Patients with epilepsy need to be cautious as there is a risk of seizures when taking this medication, and those with mild liver function impairment may require dosage adjustments. Patients with narrow-angle glaucoma or a history of glaucoma should be careful as this medication can dilate pupils and increase intraocular pressure. This medication may cause various side effects such as drowsiness, dizziness, headache, insomnia, anxiety, changes in appetite, and more. Caution is advised during potentially hazardous activities like driving or operating machinery while taking this medication, and it is recommended not to combine it with other sedatives. Abruptly stopping this medication may lead to withdrawal symptoms such as dizziness, anxiety, or sleep disturbances, so the dosage should be gradually reduced under a physician's guidance. Women who are pregnant or planning to become pregnant should consult with a physician before taking this medication as it may affect the fetus. Breastfeeding women should also consult a physician prior to taking this medication, as it could impact the baby. Children and adolescents have not established the safety and efficacy of this medication for certain indications, so it should be used with caution. Many drug interactions may occur; therefore, it is essential to inform the physician or pharmacist of any other medications currently being taken. Severe side effects may occur in case of overdose; thus, strict adherence to the prescribed dosage and administration is crucial. This medication must be stored out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe skin adverse reactions, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures, confusion of consciousness,

Mild side effects

  • Insomnia
  • depressive symptoms
  • decreased libido
  • agitation
  • anxiety
  • hallucinations
  • aggression
  • euphoria
  • confusion
  • bruxism
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  • psychotic disorders
  • nightmares
  • drowsiness
  • dizziness
  • headache
  • sensory abnormalities
  • increased muscle tension
  • tremors
  • involuntary muscle contractions
  • extrapyramidal symptoms
  • hyperactivity
  • restlessness
  • migraines
  • sensory loss
  • anomalous muscle tension
  • mydriasis
  • periorbital edema
  • tinnitus
  • palpitations
  • tachycardia
  • facial flushing
  • bleeding
  • hypertension
  • yawning
  • bronchospasm
  • epistaxis
  • diarrhea

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

Storage

This medication may be sensitive to air or moisture; therefore, it must be stored in a tightly sealed container. The recommended storage temperature is between 1 and 30 degrees Celsius at room temperature. Proper storage ensures the efficacy remains intact.

Appearance and packaging

Appearance

White oblong 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.