Medication info
Ultra Newsemi Tablet

Ultra Newsemi Tablet

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

MFDS item code 202004095 · Approved 2020.05.29 · Insurance code 689001350

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
Children and adults aged 12 years and older: The dosage should be adjusted based on the severity of pain and therapeutic response. The initial recommended dose is 4 tablets, and subsequent doses should be taken at intervals of at least 6 hours, not exceeding 16 tablets in a day. The lowest effective dose should be administered for the shortest time possible. Avoid administering this medication for an extended period unnecessarily; depending on the characteristics and severity of the disease requiring long-term use, regular monitoring should be conducted to determine the continuation of this medication. Elderly patients: Administer the usual adult dosage. However, for elderly patients over 75 years, oral administration of tramadol has shown a 17% increase in the elimination half-life; therefore, administer this medication at intervals of at least 6 hours. Renal impairment: In moderate renal impairment patients (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. In severe renal impairment patients (creatinine clearance less than 10 mL/min), administration is not recommended. Since tramadol is eliminated very slowly during dialysis and filtration, there is no need to re-administer this medication post-dialysis to maintain analgesic effect. Hepatic impairment: In moderate hepatic impairment patients, carefully consider extending the dosing interval. Administration in severe hepatic impairment patients is not advised.

Ingredients

Manufacturer
(주)시어스제약

Efficacy & effects

Relief of moderate to severe acute and chronic pain

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

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

How to take

Adult dose

Children and adults aged 12 years and older: The dosage should be adjusted based on the severity of pain and therapeutic response. The initial recommended dose is 4 tablets, and subsequent doses should be taken at intervals of at least 6 hours, not exceeding 16 tablets in a day. The lowest effective dose should be administered for the shortest time possible. Avoid administering this medication for an extended period unnecessarily; depending on the characteristics and severity of the disease requiring long-term use, regular monitoring should be conducted to determine the continuation of this medication. Elderly patients: Administer the usual adult dosage. However, for elderly patients over 75 years, oral administration of tramadol has shown a 17% increase in the elimination half-life; therefore, administer this medication at intervals of at least 6 hours. Renal impairment: In moderate renal impairment patients (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. In severe renal impairment patients (creatinine clearance less than 10 mL/min), administration is not recommended. Since tramadol is eliminated very slowly during dialysis and filtration, there is no need to re-administer this medication post-dialysis to maintain analgesic effect. Hepatic impairment: In moderate hepatic impairment patients, carefully consider extending the dosing interval. Administration in severe hepatic impairment patients is not advised.

Precautions

This medication may burden the liver, so individuals who consume a significant amount of alcohol daily should consult a physician or pharmacist before use. If a rash or allergic reaction occurs during treatment, discontinue use immediately and consult a healthcare professional. Caution is required in patients with a history of seizures or those taking medications that can induce seizures, as there is a risk of seizures. Serious allergic reactions can occur occasionally; immediate emergency treatment is necessary for symptoms such as difficulty breathing or severe rash. Patients with severe respiratory conditions may experience difficulty breathing when taking this medication and should do so under medical supervision. Concurrent use with alcohol or central nervous system depressants may result in severe drowsiness or respiratory suppression; therefore, coadministration should be avoided or approached with caution. If there is a history of head injury or brain disease, there is a risk of increased intracranial pressure when taking this medication, so caution is advised. This medication may cause physical and psychological dependence; therefore, dependency should be monitored with long-term use. Patients with impaired liver function must consult a physician before taking this medication and should be careful not to exceed the recommended dosage. Patients with certain genetic metabolic characteristics may experience excessive effects of this medication, leading to risks of respiratory suppression, so they should consult a healthcare professional. This medication should not be used in children under 12 years of age or in certain pediatric patients following specific surgeries; it should also be avoided in adolescents over 12 years of age if special risk factors are present. Patients with sleep apnea or hypoxemia should be closely monitored as this medication may worsen symptoms. Elderly patients or patients at risk of hyponatremia should monitor for the occurrence of hyponatremia while taking this medication. Individuals allergic to the ingredients of this medication, those in severe respiratory suppression, those with head trauma, or those taking specific medications should not take this medication. Sudden discontinuation during treatment may cause withdrawal symptoms; therefore, dosage should be gradually reduced according to a physician's instructions. This medication may cause drowsiness or dizziness when driving or operating machinery, so caution is needed. In the event of an overdose, serious respiratory suppression, seizures, and liver damage may occur; therefore, adherence to the prescribed dosage is crucial, and in case of overdose, medical attention should be sought immediately. Keep this medication out of reach of children, and limit access to prevent misuse or abuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, paleness, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylactic reaction, seizures, asthmatic attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, disorientation, visual disturbances, paralysis, coma

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
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • sense of direction disorder
  • excitement
  • abnormal dreams
  • drug dependence
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremors
  • sensory abnormalities
  • attention

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

Storage

Store this medication in a sealed container to prevent exposure to air or moisture and keep it at room temperature between 1°C and 30°C. This way of storage will help maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pale yellow oblong film-coated tablets

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.