Medication info
Ultrafin Semi Tablets

Ultrafin Semi Tablets

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›18.75mg / 1 tablet
Manufacturer / importer
에스피씨(주)
Appearance
Light yellow oblong film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201503182 · Approved 2015.05.27 · Insurance code 669700200

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children 12 years and older and adults, the dosage should be adjusted according to the degree of pain and therapeutic response. A loading dose of 4 tablets is recommended, and subsequent doses should be spaced at least 6 hours apart, not exceeding 16 tablets in a day. Administer the lowest effective dose for the shortest duration possible. Avoid prolonged use beyond necessity, and if long-term administration is required due to the disease's characteristics and severity, regular monitoring of the medication's continuation should be conducted. Elderly Patients: Typically administer the usual adult dosage. However, in patients over 75 years of age, tramadol's elimination half-life increases by 17% when taken orally, so administer this medication at intervals of at least 6 hours. Renal Impairment: For moderate renal impairment (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. For severe renal impairment (creatinine clearance of less than 10 ml/min), administration is not recommended. Tramadol is removed very slowly during hemodialysis and filtration, so it is unnecessary to re-administer this medication after dialysis to maintain analgesic effect. Hepatic Impairment: For moderate hepatic impairment, carefully consider extending the dosing interval. Avoid administering this medication to severe hepatic impairment.
Child dose
For children 12 years of age and older, the dosage is adjusted to match that of adults.

Ingredients

Manufacturer
에스피씨(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

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

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

How to take

Adult dose

For children 12 years and older and adults, the dosage should be adjusted according to the degree of pain and therapeutic response. A loading dose of 4 tablets is recommended, and subsequent doses should be spaced at least 6 hours apart, not exceeding 16 tablets in a day. Administer the lowest effective dose for the shortest duration possible. Avoid prolonged use beyond necessity, and if long-term administration is required due to the disease's characteristics and severity, regular monitoring of the medication's continuation should be conducted. Elderly Patients: Typically administer the usual adult dosage. However, in patients over 75 years of age, tramadol's elimination half-life increases by 17% when taken orally, so administer this medication at intervals of at least 6 hours. Renal Impairment: For moderate renal impairment (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. For severe renal impairment (creatinine clearance of less than 10 ml/min), administration is not recommended. Tramadol is removed very slowly during hemodialysis and filtration, so it is unnecessary to re-administer this medication after dialysis to maintain analgesic effect. Hepatic Impairment: For moderate hepatic impairment, carefully consider extending the dosing interval. Avoid administering this medication to severe hepatic impairment.

Child dose

For children 12 years of age and older, the dosage is adjusted to match that of adults.

Precautions

This medication may place a burden on the liver, so those who regularly consume more than three glasses of alcohol daily should consult a doctor or pharmacist before taking it. This medication can rarely cause severe skin allergic reactions, so if skin rash or hypersensitivity symptoms occur, stop taking it immediately and seek medical attention. One of the active ingredients, tramadol, may increase the risk of seizures, and the risk may be heightened if taken with certain antidepressants or opioid analgesics, so caution is required. In patients with serious respiratory diseases, this medication may pose a risk of respiratory depression, so it should be administered in places equipped with cardiopulmonary resuscitation equipment. Taking this medication with alcohol or central nervous system depressants may lead to severe drowsiness, respiratory depression, or even coma, so co-administration should be avoided unless directed by a healthcare professional. Patients with head injuries or brain diseases should use this medication cautiously, as it may exacerbate symptoms of increased intracranial pressure or respiratory depression. This medication may lead to psychological and physical dependence, so long-term use requires careful observation of potential dependence and abuse risks. Patients with diminished liver function or liver disease should consult with a doctor before taking this medication, and dosage adjustments may be necessary. The metabolism of this medication may vary based on the activity of the enzyme CYP2D6, with some individuals metabolizing it quickly, thereby heightening the risk of respiratory depression and other side effects, necessitating caution. This medication should not be administered to children under 12 years of age or teenagers under 18 years of age following certain surgeries, and even for those 12 years and older with respiratory issues or risk factors, administration should be avoided. This medication may worsen symptoms of sleep apnea or hypoxemia, so patients with these symptoms should periodically monitor their condition while taking it. Symptoms of hyponatremia, or decreased sodium concentration in the blood, may occur, especially in elderly patients or those with relevant risk factors, thus monitoring for symptoms is necessary. In case of overdose, severe respiratory depression, seizures, or liver damage may occur; therefore, adherence to recommended dosage is essential, and if dosage is unclear or overdose is suspected, immediate emergency treatment should be sought. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, particularly nursing mothers, as it may be transmitted through breast milk and pose risks to the infant, making avoidance preferable. This medication may cause drowsiness or dizziness, so caution is advised when driving or operating machinery, and these symptoms may be aggravated if taken with alcohol or other central nervous system depressants. During treatment with this medication, care should be taken to avoid overlapping use with other analgesics or medications containing acetaminophen, and possible drug interactions should be discussed with a doctor or pharmacist regarding other medications being taken. This medication should be kept out of reach of children and managed carefully to prevent misuse and accidental ingestion.

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, peeling skin, pain in the oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, and urinary retention.

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
  • neuroexcitability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremors
  • paresthesia
  • and attention issues.

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

Storage

This medication should be stored in a sealed container to prevent air or moisture ingress. Additionally, it is recommended to store it at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Light yellow oblong 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.