Medication info
Ultrasce Semi Tablet

Ultrasce Semi Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›18.75mg / 1 tablet
Manufacturer / importer
에스케이케미칼(주)
Appearance
Pale yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 200804918 · Notified 2008.04.29

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children and adults over 12 years: The dosage should be adjusted based on the patient's pain level and therapeutic response. It is recommended to administer 4 tablets as the initial dose, with subsequent doses spaced at least 6 hours apart, not exceeding 16 tablets in one day. Administer the effective minimum dosage for the shortest duration possible. Do not use this medication for longer than necessary, and if prolonged use is required due to the nature and severity of the disease, regular monitoring should confirm the continuation of this medication. Elderly Administer the usual adult dosage. However, in elderly patients over 75 years, the elimination half-life of tramadol has been increased by 17%, so the medication should be administered at least 6 hours apart. Renal Impairment For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), the dosing interval should be extended to 12 hours. For patients with severe renal impairment (creatinine clearance of less than 10 mL/min), this medication is not recommended. Tramadol is removed very slowly during hemodialysis and filtration, so there is no need to readminister this medication after dialysis to maintain analgesic effect. Hepatic Impairment For patients with moderate hepatic impairment, careful consideration should be given to extend the dosing interval. This medication should not be administered to patients with severe hepatic impairment.
Child dose
Children and adults over 12 years: The dosage should be adjusted based on the patient's pain level and therapeutic response. It is recommended to administer 4 tablets as the initial dose, with subsequent doses spaced at least 6 hours apart, not exceeding 16 tablets in one day.

Ingredients

Manufacturer
에스케이케미칼(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute and chronic pain
View approved original text

This medication is used to effectively alleviate moderate to severe acute and chronic pain.

How to take

Adult dose

Children and adults over 12 years: The dosage should be adjusted based on the patient's pain level and therapeutic response. It is recommended to administer 4 tablets as the initial dose, with subsequent doses spaced at least 6 hours apart, not exceeding 16 tablets in one day. Administer the effective minimum dosage for the shortest duration possible. Do not use this medication for longer than necessary, and if prolonged use is required due to the nature and severity of the disease, regular monitoring should confirm the continuation of this medication. Elderly Administer the usual adult dosage. However, in elderly patients over 75 years, the elimination half-life of tramadol has been increased by 17%, so the medication should be administered at least 6 hours apart. Renal Impairment For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), the dosing interval should be extended to 12 hours. For patients with severe renal impairment (creatinine clearance of less than 10 mL/min), this medication is not recommended. Tramadol is removed very slowly during hemodialysis and filtration, so there is no need to readminister this medication after dialysis to maintain analgesic effect. Hepatic Impairment For patients with moderate hepatic impairment, careful consideration should be given to extend the dosing interval. This medication should not be administered to patients with severe hepatic impairment.

Child dose

Children and adults over 12 years: The dosage should be adjusted based on the patient's pain level and therapeutic response. It is recommended to administer 4 tablets as the initial dose, with subsequent doses spaced at least 6 hours apart, not exceeding 16 tablets in one day.

Precautions

This medication may put stress on the liver, so individuals who frequently consume alcohol above a certain amount daily should consult a doctor or pharmacist before taking it. During the use of this medication, serious skin rashes or allergic reactions may occur; therefore, if skin rashes or hypersensitivity reactions are observed, discontinue use immediately and consult a professional. The ingredients in this medication may trigger seizures, so patients with a history of seizures or those at high risk for seizures should take it with caution. For patients with severe respiratory diseases, this medication may suppress breathing, which can be life-threatening, so it should be taken under medical supervision. Taking this medication with alcohol or central nervous system depressants such as sleep aids can cause severe sedation or respiratory depression, so caution or avoidance is required. Patients with increased intracranial pressure or head injuries should be cautious when taking this medication, as respiratory suppression may worsen symptoms. This medication can cause physical and psychological dependence; therefore, it should be taken under the guidance of a physician when used for long periods, as abrupt cessation may lead to withdrawal symptoms. Patients with liver dysfunction must consult a doctor before taking this medication, and should not take other acetaminophen products to reduce the risk of liver damage. Especially in individuals with rapid metabolism of this medication's ingredients, the risk of serious side effects such as respiratory depression is high, requiring dosage adjustments and careful monitoring. This medication should not be administered to children under 12 years old or adolescents under 18 years old post-surgery, and special caution is needed for adolescents aged 12 to 18. This medication may cause sleep apnea or hypoxia; therefore, it is important to regularly check for these symptoms or worsening conditions and adjust the dosage or discontinue use if necessary. During the use of this medication, drowsiness or dizziness may occur, so it is advisable to avoid dangerous activities such as driving or operating machinery. In the case of overdose, serious side effects such as respiratory depression, seizures, or liver damage may occur; therefore, the prescribed dosage must be strictly adhered to, and if suspected, consult a healthcare facility immediately. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, as it may be transmitted through breast milk and pose risks to the baby, thus avoidance is advised. This medication can interact with various drugs; therefore, if taking other medications, it is crucial to inform the healthcare provider, with particular caution when taken in conjunction with antidepressants, anticonvulsants, narcotic analgesics, and antibiotics.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, mucosal pain in mouth/eyes, difficulty or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, significantly decreased urination

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • dyspepsia
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • spatial disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • narcolepsy
  • sensory impairment
  • tremor
  • sensory disturbances

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 or moisture from entering. Additionally, it is best to store it at room temperature between 1°C and 30°C. Proper storage will help maintain the efficacy of the medication for an extended period.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 500 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.