Medication info
Sandoz Sertraline Tablets 100 Milligrams (Sertraline Hydrochloride)

Sandoz Sertraline Tablets 100 Milligrams (Sertraline Hydrochloride)

Prescription medicationTablet
Ingredient · strength
Sertraline Hydrochloride›111.9mg / 1 tablet
Manufacturer / importer
삼일제약(주)
Appearance
White, oblong film-coated tablet with a scoring line on one side
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201206823 · Approved 2012.09.17 · Insurance code 668101160

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: For the initial dose, administer 50 mg of sertraline orally once daily. The maintenance dose is 50-100 mg once daily; if the effect is insufficient, it may be increased by 50 mg, up to a maximum of 200 mg daily. Panic Disorder, Post-Traumatic Stress Disorder, and Social Anxiety Disorder: Start with 25 mg once daily and increase to 50 mg once daily after 1 week. Therapeutic effect
Children's dosage
Obsessive-Compulsive Disorder (6-17 years): For ages 6-12, start with 25 mg once daily, and for ages 13-17, start with 50 mg once daily. If there is no response, the dose may be increased up to a maximum of 200 mg daily. Pediatric

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
View approved original text

This medication is effective for the treatment of depression and is used to improve obsessive-compulsive disorder in both adults and children. It also alleviates symptoms of panic disorder and post-traumatic stress disorder, and is beneficial for treating social anxiety disorder or social phobia. It helps improve symptoms of premenstrual dysphoric disorder. It is widely used to improve various mental health issues.

Dosage and Administration

Adult dosage

Depression and Obsessive-Compulsive Disorder: For the initial dose, administer 50 mg of sertraline orally once daily. The maintenance dose is 50-100 mg once daily; if the effect is insufficient, it may be increased by 50 mg, up to a maximum of 200 mg daily. Panic Disorder, Post-Traumatic Stress Disorder, and Social Anxiety Disorder: Start with 25 mg once daily and increase to 50 mg once daily after 1 week. Therapeutic effect

Children's dosage

Obsessive-Compulsive Disorder (6-17 years): For ages 6-12, start with 25 mg once daily, and for ages 13-17, start with 50 mg once daily. If there is no response, the dose may be increased up to a maximum of 200 mg daily. Pediatric

Precautions

This medication may increase the risk of suicidal thoughts or behaviors when used in children, adolescents, or young adults with depression or psychiatric disorders; therefore, careful monitoring is required. Serotonin syndrome, a serious side effect, may occur during treatment with this medication, so if any changes in mental status, high fever, tremors, vomiting, or similar symptoms occur, consult a doctor immediately. Co-administration with MAO inhibitors can lead to dangerous side effects, so MAO inhibitors should not be used during treatment or within 14 days after discontinuing this medication. When used with other serotonergic medications, there is an increased risk of side effects, thus following medical advice is essential. Patients with moderate to severe liver dysfunction, a history of hypersensitivity to this medication, or those taking certain medications should not use this medication. Patients with epilepsy or slightly impaired liver function should be closely monitored as there is a risk of seizures when using this medication. Caution is needed when driving or operating hazardous machinery, particularly avoiding co-administration with sedatives. This medication may lead to suicidal tendencies or worsening of psychiatric symptoms with prolonged use, so a careful observation is particularly important during the initial weeks. Women who are pregnant or may become pregnant should be careful with this medication as it may affect the fetus, and should decide with medical consultation. If breastfeeding, it's important to consult a healthcare professional as this medication may be present in breast milk. Serious side effects may occur in case of overdose, so the dosing regimen must be strictly observed, and any decision to discontinue use should be discussed with a physician. This medication should be stored out of reach of children, and it's best not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), serotonin syndrome, neuroleptic malignant syndrome, hyponatremia, coma, seizures, fainting, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, rhabdomyolysis, urinary retention, hematuria, nocturnal enuresis, gynecomastia, postpartum hemorrhage, thrombocytopenia, hypersensitivity, anaphylaxis-like reactions, hypothyroidism, inappropriate antidiuretic hormone secretion, hyperprolactinemia, hypoglycemia, severe rash with fever, blisters

Mild side effects

  • Decreased appetite
  • increased appetite
  • hypoglycemia
  • hyperglycemia
  • insomnia
  • depressive symptoms
  • decreased libido
  • restlessness
  • anxiety
  • hallucinations
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  • aggression
  • euphoria
  • confusion
  • bruxism
  • psychotic disorders
  • nightmares
  • drowsiness
  • dizziness
  • headache
  • sensory disturbances
  • muscle rigidity
  • tremors
  • involuntary muscle contractions
  • convulsions
  • fainting
  • hyperactivity
  • migraines
  • sensory loss
  • abnormal muscle tone
  • visual disturbances
  • mydriasis
  • periorbital edema
  • tinnitus
  • palpitations
  • tachycardia
  • facial flushing
  • bleeding
  • hyperhidrosis

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

Storage

This medication should be stored in a tightly sealed container, protected from air and moisture. It is advisable to keep it at room temperature between 1 to 30 degrees Celsius. By doing so, the medication's effectiveness can be maintained for a longer period.

Appearance and packaging

Appearance

White, oblong film-coated tablet with a scoring line 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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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.