Medication info
Stariset Tablet (Acetaminophen, Tramadol Hydrochloride)

Stariset Tablet (Acetaminophen, Tramadol Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
태극제약(주)
Appearance
Pale yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200804939 · Notified 2008.04.30 · Insurance code 644803360

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children aged 12 years and older and adults: The dosage should be adjusted based on the patient’s level of pain and therapeutic response. It is recommended to administer 2 tablets as the initial dose, after which the dosing interval should be at least 6 hours, but not to exceed 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Avoid prolonged administration beyond what is necessary, and in cases where long-term administration is needed due to the nature and severity of the illness, regular monitoring should be conducted to evaluate the necessity of continued treatment.
Child dose
Children aged 12 years and older and adults: The dosage should be adjusted based on the patient’s level of pain and therapeutic response. It is recommended to administer 2 tablets as the initial dose, after which the dosing interval should be at least 6 hours, but not to exceed 8 tablets per day.

Ingredients

Manufacturer
태극제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

This medication is used for the relief of acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

Children aged 12 years and older and adults: The dosage should be adjusted based on the patient’s level of pain and therapeutic response. It is recommended to administer 2 tablets as the initial dose, after which the dosing interval should be at least 6 hours, but not to exceed 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Avoid prolonged administration beyond what is necessary, and in cases where long-term administration is needed due to the nature and severity of the illness, regular monitoring should be conducted to evaluate the necessity of continued treatment.

Child dose

Children aged 12 years and older and adults: The dosage should be adjusted based on the patient’s level of pain and therapeutic response. It is recommended to administer 2 tablets as the initial dose, after which the dosing interval should be at least 6 hours, but not to exceed 8 tablets per day.

Precautions

This drug may stress the liver; individuals who regularly consume more than three drinks a day must consult a physician or pharmacist. Otherwise, liver damage may occur. While rare, acetaminophen can cause severe skin reactions; if rashes or allergic reactions occur, discontinue use immediately. Exceeding the recommended dose of tramadol may increase the risk of seizures, particularly when taken in combination with certain antidepressants or narcotics. There is a risk of respiratory depression while taking this medication, thus special caution is needed for patients with acute asthma or respiratory conditions, and it should be administered under medical supervision. Taking this drug with alcohol or sedatives may lead to severe drowsiness, respiratory depression, or coma, so co-administration should be avoided. Patients with elevated intracranial pressure or head injuries may experience worsening symptoms while using this medication. This medication may lead to physical and psychological dependence; therefore, close monitoring for dependency is necessary during long-term use. Individuals with impaired liver function must consult a physician before using this drug, as there is a risk of hepatotoxicity; care must be taken not to exceed the daily maximum dosage. Patients with certain genotypes may metabolize this drug rapidly, increasing the risk of respiratory depression, necessitating dosage adjustment and symptom monitoring. This drug should not be used in children under 12 years old or in adolescents under 18 years old who have undergone tonsillectomy or adenoidectomy. Patients with sleep apnea or hypoxemia may experience exacerbated symptoms while taking this drug and should be carefully monitored. Those at risk of hyponatremia should have their serum sodium levels checked regularly while taking this drug. Individuals allergic to any ingredient in this medication, those with central nervous system drug abuse, severe respiratory depression, head injuries, or taking MAO inhibitors should not take this drug. When using this medication, adhere strictly to the recommended dosages and avoid using other acetaminophen or tramadol products concurrently. Sudden discontinuation may lead to withdrawal symptoms; gradual tapering under medical guidance is necessary. There are many interactions with this drug and other medications so it's crucial to inform healthcare providers of any concomitant medications, especially when used with antidepressants, antibiotics, anticoagulants, or central nervous system depressants. Caution is advised when driving or operating machinery as drowsiness and dizziness may occur. In cases of overdose, serious side effects such as respiratory depression, seizures, or liver damage may occur; strict adherence to dosages is essential, and immediate medical attention should be sought in emergencies. Store in a safe place out of the reach of children to prevent misuse or abuse of the medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/nasal mucous membranes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormality accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urinary issues.

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • indigestion
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • reduced libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory disturbance
  • tremors
  • numbness.

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

Storage

Store this medication in a tightly sealed container to prevent air exposure, and it is best kept at room temperature, below 25 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 300 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.