Medication info
Ultraset ER Semi-Extended Release Tablet

Ultraset ER Semi-Extended Release Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›195mg / 1 tabletTramadol Hydrochloride›29mg / 1 tablet
Manufacturer / importer
(주)한국얀센
Appearance
Yellow round film-coated sustained-release tablet
Packaging
50 tablets/box [10 tablets/PTP x 5], 100 tablets/bottle
Approval status
Active

MFDS item code 202201174 · Approved 2022.03.24 · Insurance code 646902660

Summary

Main use
Relief of moderate to severe chronic pain
Who takes it
Adults
Adult dose
Adjust the dosage based on the degree of pain and therapeutic response of the patient. Administer an initial dose of 2 tablets, ensuring that subsequent dosing intervals are at least 12 hours apart. Do not exceed 8 tablets per day. The lowest effective dose should be administered for the shortest duration possible. If prolonged administration is necessary, regular monitoring should be conducted. For the elderly, administer the usual adult dosage; however, for those over 75 years, ensure a minimum interval of 12 hours.

Ingredients

Manufacturer
(주)한국얀센

Efficacy & effects

Relief of moderate to severe chronic pain

  • Moderate to severe chronic pain
View approved original text

This medication is used for chronic pain ranging from moderate to severe.

How to take

Adult dose

Adjust the dosage based on the degree of pain and therapeutic response of the patient. Administer an initial dose of 2 tablets, ensuring that subsequent dosing intervals are at least 12 hours apart. Do not exceed 8 tablets per day. The lowest effective dose should be administered for the shortest duration possible. If prolonged administration is necessary, regular monitoring should be conducted. For the elderly, administer the usual adult dosage; however, for those over 75 years, ensure a minimum interval of 12 hours.

Precautions

This medication may put stress on the liver, so individuals who consume a lot of alcohol daily should consult a physician or pharmacist before taking it. This medication can occasionally cause serious skin allergic reactions, so if a rash or hypersensitivity occurs, discontinue use immediately and seek medical attention. The tramadol component of this medication may increase the risk of seizures, and the risk may rise further when taken with certain antidepressants or sedatives. Patients with acute bronchial asthma may experience severe respiratory suppression if this medication is administered, so it should only be given in a medical facility equipped with the necessary equipment. Taking this medication along with alcohol or CNS depressants may lead to severe drowsiness, respiratory depression, and coma, so caution is warranted. Patients with head injuries or brain diseases need to use this medication cautiously due to the risk of respiratory depression and increased intracranial pressure. This medication can cause psychological and physical dependence, so if used for long periods, the dosage and duration should be adjusted according to a physician's instructions. Patients with impaired liver function must consult a physician before taking this medication and should not exceed the recommended dosage due to the risk of hepatotoxicity. Patients with ultra-rapid metabolism may experience a rapid increase in active metabolites, elevating the risk of respiratory depression, so special precautions are needed. Children under 12 years of age and individuals under 18 years who have undergone tonsillectomy or adenoidectomy should not use this medication. Individuals with sleep apnea or hypoxia may experience worsening symptoms after taking this medication, so continuous monitoring is necessary. This medication may cause hyponatremia, so it is crucial for elderly patients or those with risk factors to monitor their sodium levels. Patients with biliary disease or a history of gallbladder surgery should carefully observe for potential gastrointestinal diseases such as acute pancreatitis. This medication has numerous drug interactions; therefore, inform the physician of any other medications being taken. Pregnant women or those who may become pregnant should carefully consider the risks and benefits of taking this medication, while nursing mothers should avoid it. This medication may induce drowsiness or dizziness, so caution is necessary while driving or operating machinery. In the case of an overdose, serious respiratory depression or liver damage may occur, so it is important to adhere to the prescribed dosage and seek immediate medical attention in emergencies. During treatment with this medication, dependence or withdrawal symptoms may occur, so dosage should be gradually reduced under a physician's direction if discontinuing use.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), cold sweat, pallor, severe allergic reaction, severe rash with high fever, blisters, pain in the mucous membranes of the mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, respiratory problems, jaundice (yellowing of the skin or eyes), profound lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache

Mild side effects

  • Loss of 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
  • hypersensitivity
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • direction sense disturbance
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremors

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

Storage

This medication should be stored in a tightly closed container to protect it from air or light. It should be kept at a normal room temperature between 1 and 30 degrees Celsius, avoiding extremely hot or cold places.

Appearance and packaging

Appearance

Yellow round film-coated sustained-release tablet

Package unit

50 tablets/box [10 tablets/PTP x 5], 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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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.