Medication info
Astra Setsemi Tablet

Astra Setsemi Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›18.75mg / 1 tabletAcetaminophen›162.5mg / 1 tablet
Manufacturer / importer
(주)셀비온
Appearance
Pale yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201905262 · Approved 2019.07.24 · Insurance code 055800250

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
The recommended dosage for children aged 12 and older and adults should be adjusted based on the severity of the patient's pain and treatment response, starting with an initial dose of 4 tablets. Dosing intervals should be at least 6 hours apart, and should not exceed 16 tablets per day. Administer the effective minimum dosage for the shortest period possible, and do not use it for longer than necessary. In elderly patients, use the standard adult dose, but for those aged 75 and older, ensure at least
Child dose
For children aged 12 and older, the same dosage as for adults applies.

Ingredients

Manufacturer
(주)셀비온

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

This medication is used to relieve acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

The recommended dosage for children aged 12 and older and adults should be adjusted based on the severity of the patient's pain and treatment response, starting with an initial dose of 4 tablets. Dosing intervals should be at least 6 hours apart, and should not exceed 16 tablets per day. Administer the effective minimum dosage for the shortest period possible, and do not use it for longer than necessary. In elderly patients, use the standard adult dose, but for those aged 75 and older, ensure at least

Child dose

For children aged 12 and older, the same dosage as for adults applies.

Precautions

This medication may place a burden on the liver, so those who drink more than three glasses of alcohol daily should consult a doctor or pharmacist before use. This medication can rarely cause severe skin reactions, so if skin rashes or hypersensitivity occur, discontinue use immediately and consult healthcare personnel. One of the ingredients in this medication may increase the risk of seizures, so caution is necessary for those with a history of seizures or those taking certain antidepressants and other medications. Rarely, this medication can lead to severe allergic reactions, so if there is difficulty breathing or severe skin reactions, inform healthcare personnel immediately. This medication may suppress respiration in patients with severe respiratory conditions, so it should be administered in a setting equipped with special equipment. Taking this medication with alcohol or CNS depressants such as sedatives can cause severe drowsiness or respiratory depression, so extreme caution is advised when combining. Patients with head injuries or elevated intracranial pressure should be cautious as this medication may increase brain pressure due to respiratory depression. This medication can cause physical and psychological dependence, so long-term use should be monitored for signs of dependence. Patients with impaired liver function or liver disease should consult a doctor before use, as there is a heightened risk of hepatotoxicity. Patients with certain genetic traits may experience accelerated metabolism of this medication, increasing the risk of respiratory depression and other hazards; in such cases, dosage adjustment or alternative medications should be considered. Children under 12 years and some postoperative pediatric patients should not use this medication, and adolescents aged 12 to 18 should avoid use if there are special risk factors. This medication may cause sleep apnea or hypoxia, so symptoms should be continuously monitored, and dosage adjusted or discontinued if necessary. Elderly patients or those at risk of hyponatremia should be closely monitored for the occurrence of hyponatremia during use of this medication. This medication may interact with certain drugs, so if taking other medications, consult a doctor or pharmacist, particularly when combining with MAO inhibitors, antidepressants, antibiotics, or warfarin. Pregnant or breastfeeding women should consult a doctor before use, and nursing mothers may need to stop breastfeeding or need special monitoring while using this medication. This medication can cause drowsiness or dizziness, so caution is necessary when driving or operating machinery. Overdose can result in severe respiratory depression, seizures, liver damage, etc., so adhere to the prescribed dosage, and seek emergency help immediately in case of overdose. This medication should be stored out of the reach of children and managed carefully to prevent misuse.

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 fever, blisters, skin peeling, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attack, abnormal breathing with coughing and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, urination 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
  • anxiety
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbance
  • confusion
  • spatial disorientation
  • excitability
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremors
  • paresthesia
  • attention issues

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

Storage

This medication should be stored in a tightly sealed container to prevent air exposure and kept at room temperature between 1 to 30 degrees Celsius. Storing it this way can help maintain the medication's effectiveness for a long time.

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

No questions yet.

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.