Medication info
Ultraset ER Extended Release Tablet

Ultraset ER Extended Release Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›390mg / 1 tabletTramadol Hydrochloride›58mg / 1 tablet
Manufacturer / importer
(주)한국얀센
Appearance
Yellow oblong film-coated sustained-release tablet
Packaging
1 - 50 tablets/box [10 tablets/PTP x 5], 1 - 100 tablets/bottle
Approval status
Active

MFDS item code 202201173 · Approved 2022.03.24 · Insurance code 646902650

Summary

Main use
Relief of moderate to severe chronic pain
Who takes it
Adults
Adult dose
The dosage for adults should be adjusted based on the level of pain and therapeutic response. It is recommended to administer an initial dose of 1 tablet, and subsequent doses should be spaced at least 12 hours apart, not exceeding 4 tablets in one day. The lowest effective dose should be administered for the shortest duration necessary. This medication should not be taken longer than necessary, and if long-term use is required due to the characteristics of the condition and its severity, regular monitoring should be conducted.

Ingredients

Manufacturer
(주)한국얀센

Efficacy & effects

Relief of moderate to severe chronic pain

  • Chronic pain
View approved original text

This medication is used for the treatment of moderate to severe chronic pain.

How to take

Adult dose

The dosage for adults should be adjusted based on the level of pain and therapeutic response. It is recommended to administer an initial dose of 1 tablet, and subsequent doses should be spaced at least 12 hours apart, not exceeding 4 tablets in one day. The lowest effective dose should be administered for the shortest duration necessary. This medication should not be taken longer than necessary, and if long-term use is required due to the characteristics of the condition and its severity, regular monitoring should be conducted.

Precautions

This medication may strain the liver, so individuals who regularly consume more than three alcoholic drinks per day must consult a doctor or pharmacist. During the use of this medication, serious skin reactions such as rashes or blisters may develop; if such symptoms occur, the treatment should be stopped immediately, and medical advice should be sought. One of the components of this medication may increase the risk of seizures, so individuals with a history of seizures or those at risk should be cautious when taking it, especially when combined with certain antidepressants or other medications. Rarely, during treatment, severe allergic reactions may occur; if symptoms such as difficulty breathing or hives appear, medical personnel should be notified immediately. Patients with acute bronchial asthma are at risk of severe respiratory suppression while taking this medication, so it should be administered carefully in a medically equipped setting. Co-administration with alcohol or certain sedatives can cause severe drowsiness or respiratory suppression leading to coma, so concurrent use should be avoided or done under medical supervision. Patients with head injuries or increased intracranial pressure need to be cautious as respiratory suppression caused by this medication may worsen symptoms. This medication has the potential to cause psychological or physical dependence, so the risk of dependence should be regularly assessed during long-term use. Patients with impaired liver function should consult a doctor before taking this medication, as its components may cause liver damage, and it should not be taken with other acetaminophen products. Patients with specific genetic profiles may have faster metabolism of this medication, resulting in higher blood concentrations and serious respiratory suppression; dose adjustment or alternative medications may be necessary in such cases. This medication is not to be administered to children under 12 years or adolescents under 18 years who have undergone tonsillectomy or adenoidectomy. Patients with sleep apnea or hypoxia should be closely monitored for worsening symptoms during treatment, and dosage may need to be reduced or discontinued if necessary. Elderly patients or those with specific diseases may experience electrolyte imbalances like hyponatremia and require regular monitoring. Patients with biliary tract disease or a history of gallbladder surgery should be cautious about the possibility of acute pancreatitis. This medication should not be given to individuals allergic to its components, those with central nervous system drug intoxication, severe respiratory suppression, head injuries, or those currently taking MAO inhibitors. Patients taking narcotic analgesics or central nervous system depressants should be careful with this medication due to interaction risks that heighten side effect risks. During the use of this medication, patients should be cautious when driving or operating dangerous machinery as drowsiness or dizziness may occur. In case of overdose, serious respiratory suppression, seizures, or liver damage may occur; therefore, prescribed dosages must be adhered to, and emergency medical assistance should be contacted immediately.

Side effects and when to seek care immediately

Serious side effects

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

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
  • itching
  • sweating
  • rash
  • fatigue
  • flushing
  • excessive sweating
  • urinary disorders
  • thirst
  • chest discomfort
  • facial swelling
  • chills
  • fever
  • peripheral edema
  • weakness
  • blood pressure fluctuations
  • cough
  • runny nose
  • erectile dysfunction
  • weakness
  • chest pain
  • abnormal emotions
  • chills
  • chest discomfort
  • lethargy
  • irritability
  • physical fatigue.

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees at room temperature to preserve the effectiveness of the medication.

Appearance and packaging

Appearance

Yellow oblong film-coated sustained-release tablet

Package unit

1 - 50 tablets/box [10 tablets/PTP x 5], 1 - 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

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.