Medication info
Ultrone Semi Sustained-Release Tablets

Ultrone Semi Sustained-Release Tablets

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
익수제약(주)
Appearance
Pale yellow round sustained-release film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201905270 · Approved 2019.07.24 · Insurance code 658502210

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
It is recommended to take 2 tablets as the initial dose, with subsequent doses spaced at least 12 hours apart. Do not exceed a total of 8 tablets per day. For the elderly, particularly those aged 75 and over, administration should be spaced at least 12 hours apart.

Ingredients

Manufacturer
익수제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

Used to relieve acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

It is recommended to take 2 tablets as the initial dose, with subsequent doses spaced at least 12 hours apart. Do not exceed a total of 8 tablets per day. For the elderly, particularly those aged 75 and over, administration should be spaced at least 12 hours apart.

Precautions

This medication can be burdensome to the liver; therefore, individuals who consume more than three alcoholic drinks daily should consult a doctor or pharmacist before taking this medication or other antipyretic analgesics. Serious skin reactions such as rash or pus-filled lesions may occur while taking this medication; if such symptoms appear, the medication should be stopped immediately and medical attention should be sought. One of the components of this medication, tramadol, may increase the risk of seizures; therefore, patients with a history of seizures or at high risk for seizures should exercise particular caution. Additionally, tramadol may increase the risk of seizures when taken with certain antidepressants or other central nervous system depressants; thus, when used together, consultation with a healthcare professional is necessary. This medication can rarely cause life-threatening allergic reactions; therefore, in case of difficulty breathing or severe allergic symptoms, immediate medical attention should be sought. For patients with acute asthma, this medication may make breathing more difficult; if necessary, it should be administered in a medical facility equipped with necessary equipment. Caution should also be exercised when taking this medication with alcohol, sleep aids, or other central nervous system depressants, as severe drowsiness, respiratory depression, or coma may result. Patients with elevated intracranial pressure or head injuries may experience worsening symptoms while using this medication. This medication can cause both psychological and physical dependence; therefore, long-term use should be monitored closely for signs of dependency. Sudden cessation of use can trigger withdrawal symptoms, and doses should be tapered gradually. Patients with impaired liver function should consult a doctor before using this medication, and caution should be exercised to ensure that the total daily dose does not exceed 4,000mg due to potential hepatotoxicity. Additionally, patients with certain genetic traits may metabolize this medication more rapidly, increasing the risk of respiratory depression; hence, dosage adjustment and monitoring may be necessary. This medication should not be administered to children under 12 years of age or adolescents under 18 years of age who have undergone tonsillectomy and adenoidectomy. Adolescents aged 12 to 18 should also avoid use if there are specific risk factors. During treatment with this medication, there is a rare possibility of developing hyponatremia; therefore, elderly patients or those at risk for hyponatremia should be monitored closely for symptoms. This medication should not be administered to individuals with allergies to certain ingredients or those in severe respiratory depression, severe liver, kidney, or cardiac dysfunction, brain injuries, or those taking certain medications, as well as nursing mothers. Drowsiness or dizziness may occur during treatment, so caution is advised when driving or operating machinery. In cases of overdose, there is a risk of severe respiratory depression and liver damage; thus, immediate contact with a medical institution is necessary for appropriate emergency treatment.

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, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme sleepiness, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • rigidity
  • fainting
  • withdrawal symptoms
  • hypertension
  • exacerbation of hypertension
  • hypotension
  • arrhythmia
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  • palpitations
  • tachycardia
  • dizziness
  • headache
  • tremors
  • ataxia
  • increased tension
  • migraine
  • exacerbation of migraine
  • involuntary muscle contractions
  • sensory disturbances
  • confusion
  • dizziness
  • abdominal pain
  • constipation
  • diarrhea
  • indigestion
  • flatulence
  • dry mouth
  • nausea
  • vomiting
  • dysphagia
  • bloody stools
  • tongue swelling
  • decreased appetite
  • anxiety
  • confusion
  • euphoria
  • insomnia
  • nervosity

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

Storage

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. Additionally, it is recommended to store it at room temperature between 1 degrees Celsius and 30 degrees Celsius, away from extreme heat or cold.

Appearance and packaging

Appearance

Pale yellow round sustained-release film-coated tablet

Package unit

30 tablets/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.

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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.