Medication info
Wontrazet Tablets

Wontrazet Tablets

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
엔비케이제약(주)
Appearance
Pale yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201804528 · Approved 2018.11.15 · Insurance code 054800240

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
For children aged 12 and older and adults: The dose should be adjusted according to the patient's pain intensity and therapeutic response. It is recommended to administer an initial dose of 2 tablets, and thereafter the dosing interval should be at least 6 hours apart, not exceeding 8 tablets per day. The minimum effective dose should be administered for the shortest duration possible. Avoid excessive prolonged use of this medication, and in cases where long-term treatment is necessary due to the nature and severity of illness, regular monitoring should be conducted to verify the continuation of this medication. Elderly patients Typically, administer the standard adult dosage. However, in elderly patients over 75 years of age, the half-life of tramadol is increased by 17% when taken orally, so ensure dosing is at least 6 hours apart. Renal impairment In patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. In patients with severe renal impairment (creatinine clearance below 10 mL/min), administration is not recommended. Tramadol is eliminated very slowly during hemodialysis and filtration, so there is no need to redose this medication after dialysis for pain relief. Hepatic impairment In patients with moderate hepatic impairment, it should be carefully considered to extend the dosing interval. In patients with severe hepatic impairment, this medication should not be administered.

Ingredients

Manufacturer
엔비케이제약(주)

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 acute or chronic pain ranging from moderate to severe.

How to take

Adult dose

For children aged 12 and older and adults: The dose should be adjusted according to the patient's pain intensity and therapeutic response. It is recommended to administer an initial dose of 2 tablets, and thereafter the dosing interval should be at least 6 hours apart, not exceeding 8 tablets per day. The minimum effective dose should be administered for the shortest duration possible. Avoid excessive prolonged use of this medication, and in cases where long-term treatment is necessary due to the nature and severity of illness, regular monitoring should be conducted to verify the continuation of this medication. Elderly patients Typically, administer the standard adult dosage. However, in elderly patients over 75 years of age, the half-life of tramadol is increased by 17% when taken orally, so ensure dosing is at least 6 hours apart. Renal impairment In patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. In patients with severe renal impairment (creatinine clearance below 10 mL/min), administration is not recommended. Tramadol is eliminated very slowly during hemodialysis and filtration, so there is no need to redose this medication after dialysis for pain relief. Hepatic impairment In patients with moderate hepatic impairment, it should be carefully considered to extend the dosing interval. In patients with severe hepatic impairment, this medication should not be administered.

Precautions

This medication may put strain on the liver, so individuals who regularly consume more than three drinks per day should consult with a doctor or pharmacist before taking this medication. This medication can rarely cause serious skin reactions, so if a rash or allergic symptoms appear during use, stop taking it immediately and notify a healthcare professional. The ingredients in this medication may induce seizures, so people with a history of seizures or a high risk of seizures should take it with caution. This medication can rarely cause serious allergic reactions, so if symptoms such as difficulty breathing or hives occur, immediate emergency treatment is required. Patients with asthma or weakened respiratory function may find breathing more difficult when taking this medication, so it should be taken under the supervision of a healthcare provider. Taking this medication with alcohol or central nervous system depressants can cause severe drowsiness or respiratory depression and can even be fatal, so caution is advised. Patients with head injuries or increased intracranial pressure should use this medication cautiously, as symptoms may worsen. This medication may cause psychological or physical dependence, so if used for long periods, the dosage and duration should be strictly managed under a doctor's guidance. Patients with impaired liver function should consult with a physician before taking this medication and should avoid using other acetaminophen products concurrently. Patients with specific genotypes may metabolize this medication rapidly, leading to serious side effects, so it should be taken as directed by a physician. This medication is not to be administered to children under 12 years of age or adolescents under 18 after certain surgeries, and special attention is required for patients in this age group. Patients with sleep apnea or those at risk for hypoxia should continuously monitor for worsening of symptoms while taking this medication and may stop taking it if necessary. This medication can rarely lower blood sodium levels, so particularly the elderly and patients with risk factors should be monitored through blood tests. Patients with hypersensitivity to this medication or those taking specific medications, severe respiratory depression, head trauma, or severe liver, kidney, or heart function impairments should not take it. Side effects such as drowsiness, dizziness, nausea, constipation, and dry mouth may occur during treatment, so caution is advised while driving or operating machinery. In cases of overdose, severe side effects such as respiratory depression, seizures, or liver damage may occur, so the prescribed dosage must be strictly followed, and immediate medical attention is required in case of overdose. This medication may interact with various drugs, so if taking other medications, be sure to inform a healthcare provider, especially when combined with antidepressants, antibiotics, anticonvulsants, or central nervous system depressants. Pregnant or breastfeeding women should always consult with a physician before taking this medication, as it may be passed to the infant through breast milk and could pose risks. Elderly patients may have a higher risk of side effects due to impaired liver and kidney function, thus requiring closer monitoring during administration. Withdrawal symptoms may occur when taking this medication, so sudden discontinuation should be avoided, and the dosage should be gradually reduced as per doctor's instructions.

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, difficulty breathing or trouble breathing, asthma attack, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary retention

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • dyspepsia
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • restlessness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremors
  • sensation

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

Storage

This medication should be stored in a sealed container to prevent air and moisture from entering. It is also recommended to store it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablet

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.