Medication info
Ultracet Tablets

Ultracet Tablets

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
(주)한국얀센
Appearance
Light yellow, oval-shaped film-coated tablets
Packaging
PTP - 50 tablets/box [50 tablets (10 tablets x 5 PTP)/box], Bottle - 100 tablets/bottle
Approval status
Active

MFDS item code 202003694 · Approved 2020.05.21 · Insurance code 646902330

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children over 12 years and adults, adjust the dosage based on the patient's level of pain and therapeutic response. Administer an initial dose of 2 tablets, with subsequent dosing intervals of at least 6 hours, not to exceed 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Elderly patients generally receive the standard adult dosage, but those over 75 years should take intervals of at least 6 hours.
Child dose
For children over 12 years, adjust the dosage based on the patient's level of pain and therapeutic response. Administer an initial dose of 2 tablets, with subsequent dosing intervals of at least 6 hours, not to exceed 8 tablets per day.

Ingredients

Importer
(주)한국얀센

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate pain
  • severe pain
View approved original text

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

How to take

Adult dose

For children over 12 years and adults, adjust the dosage based on the patient's level of pain and therapeutic response. Administer an initial dose of 2 tablets, with subsequent dosing intervals of at least 6 hours, not to exceed 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Elderly patients generally receive the standard adult dosage, but those over 75 years should take intervals of at least 6 hours.

Child dose

For children over 12 years, adjust the dosage based on the patient's level of pain and therapeutic response. Administer an initial dose of 2 tablets, with subsequent dosing intervals of at least 6 hours, not to exceed 8 tablets per day.

Precautions

This medication may pose a risk of liver damage in individuals who regularly consume more than three drinks a day, so it is essential to consult a doctor or pharmacist. Due to the acetaminophen component, severe skin reactions may rarely occur, so discontinue use immediately if skin rash or hypersensitivity occurs. Exceeding the recommended dose of tramadol increases the risk of seizures, and combined use with certain antidepressants or narcotic analgesics can further elevate the risk of seizures. Severe allergic reactions such as fatal anaphylaxis may rarely occur during treatment, requiring caution. Patients with acute and severe bronchial asthma may have an increased risk of respiratory depression when taking this medication, so it should be administered in an environment where specialized monitoring is possible. The combined use of this medication with central nervous system depressants or alcohol may lead to severe sedation, respiratory depression, coma, and potentially death, necessitating avoidance of such combinations. Patients with elevated intracranial pressure or head injury may experience worsened symptoms due to respiratory depression from this medication, requiring careful attention. The tramadol component may lead to psychological and physical dependence, so the risk of dependency must be considered with long-term use. Acetaminophen can cause severe liver damage in overdose situations, so do not use this medication with other acetaminophen products. Patients with decreased liver function must consult a doctor before taking this medication. Certain patients, including ultra-rapid metabolizers of CYP2D6, may generate excessive active metabolites, heightening the risk of respiratory depression, requiring attention. This medication should not be administered to children under 12 years or to certain post-surgical children, and adolescents with risk factors should also avoid administration. Patients with sleep apnea or hypoxemia may experience worsened symptoms after taking this medication, necessitating ongoing evaluation and dosage adjustment if needed. Elderly patients or those at risk of hyponatremia should be carefully observed for the potential occurrence of hyponatremia. Patients with biliary abnormalities or a history of gallbladder surgery may require monitoring for the risk of acute pancreatitis. This medication should not be administered to patients with hypersensitivity to its components, patients with severe respiratory depression, patients with head injury, patients taking MAO inhibitors, patients with severe liver, kidney, or heart dysfunction, nursing mothers, or children under 12 years. Caution is warranted for patients taking narcotic analgesics or central nervous system depressants, patients with biliary disease, patients with liver or kidney dysfunction, patients who consume alcohol, and those at risk for seizures. During treatment, do not exceed the recommended dosage, and sudden discontinuation may cause withdrawal symptoms, including anxiety, insomnia, and nausea, so gradual reduction is necessary. This medication may cause drowsiness or dizziness, so caution is required when driving or operating machinery. In cases of overdose, severe symptoms such as respiratory depression, seizures, and liver failure may occur, necessitating an immediate visit to a medical institution for appropriate treatment. Due to numerous interactions with other medications taken alongside this medication, it is imperative to consult a doctor or pharmacist about any concurrent medications. Store in a secure place out of reach of children to prevent accidental ingestion or 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 high fever, blisters, skin peeling, pain in the oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme drowsiness, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizure

Mild side effects

  • Loss of appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
Show 29 more
  • diarrhea
  • indigestion
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • agitation
  • abnormal dreams
  • drug misuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory loss
  • tremors
  • sensory disturbance

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

Storage

Store this medication in a tightly sealed container to prevent the ingress of air or moisture. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Light yellow, oval-shaped film-coated tablets

Package unit

PTP - 50 tablets/box [50 tablets (10 tablets x 5 PTP)/box], Bottle - 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.

Related searches

Search tags

Suggested searches

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.