Medication info
Suprafen Tablet

Suprafen Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
안국약품(주)
Appearance
Pale yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200804810 · Notified 2008.04.28

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children aged 12 and older and adults: The dose should be adjusted according to the level of pain and therapeutic response. A starting dose of 2 tablets is recommended, thereafter the dosing interval should be at least 6 hours, but not exceeding 8 tablets per day. The effective lowest dose should be administered for the shortest duration possible. Avoid unnecessary prolonged use of this medication, and if long-term use is needed due to the nature and severity of the disease, regular monitoring should be conducted to confirm whether continued use of this medication is appropriate. Elderly Administer usual adult dosing; however, caution should be taken as the elimination half-life of tramadol may increase by 17% in elderly patients aged 75 years and older, thus administering this medication at intervals of at least 6 hours is advised. Patients with renal failure For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), the dosing interval should be extended to 12 hours. For patients with severe renal impairment (creatinine clearance below 10 mL/min), the use of this medication is not recommended. Tramadol is removed very slowly during blood dialysis and filtration, so there is no need to readminister this medication to maintain analgesic effect post-dialysis. Patients with hepatic impairment The dosing interval should be carefully considered for patients with moderate hepatic impairment, and this medication should not be administered to patients with severe hepatic impairment.
Child dose
Children aged 12 and older and adults: The dose should be adjusted according to the level of pain and therapeutic response. A starting dose of 2 tablets is recommended, thereafter the dosing interval should be at least 6 hours, but not exceeding 8 tablets per day.

Ingredients

Manufacturer
안국약품(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

This medication is used for the relief of acute and chronic pain that ranges from moderate to severe.

How to take

Adult dose

Children aged 12 and older and adults: The dose should be adjusted according to the level of pain and therapeutic response. A starting dose of 2 tablets is recommended, thereafter the dosing interval should be at least 6 hours, but not exceeding 8 tablets per day. The effective lowest dose should be administered for the shortest duration possible. Avoid unnecessary prolonged use of this medication, and if long-term use is needed due to the nature and severity of the disease, regular monitoring should be conducted to confirm whether continued use of this medication is appropriate. Elderly Administer usual adult dosing; however, caution should be taken as the elimination half-life of tramadol may increase by 17% in elderly patients aged 75 years and older, thus administering this medication at intervals of at least 6 hours is advised. Patients with renal failure For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), the dosing interval should be extended to 12 hours. For patients with severe renal impairment (creatinine clearance below 10 mL/min), the use of this medication is not recommended. Tramadol is removed very slowly during blood dialysis and filtration, so there is no need to readminister this medication to maintain analgesic effect post-dialysis. Patients with hepatic impairment The dosing interval should be carefully considered for patients with moderate hepatic impairment, and this medication should not be administered to patients with severe hepatic impairment.

Child dose

Children aged 12 and older and adults: The dose should be adjusted according to the level of pain and therapeutic response. A starting dose of 2 tablets is recommended, thereafter the dosing interval should be at least 6 hours, but not exceeding 8 tablets per day.

Precautions

This medication may burden the liver, so those who regularly consume more than three alcoholic drinks daily should consult a physician or pharmacist before taking it. During the use of this medication, severe skin reactions such as rashes or pus-filled blisters may occur; if such symptoms appear, immediately stop taking the medication and consult a professional. One of the ingredients in this medication may pose a risk of seizures; therefore, those with a history of seizures or those who are at high risk of seizures should use it with caution. Severe allergic reactions may occur rarely; symptoms such as difficulty breathing or hives necessitate an immediate visit to a medical institution. Patients with acute and severe asthma may experience difficulty breathing when taking this medication, so it should only be administered in an environment where medical personnel are present. Taking this medication with alcohol or central nervous system depressants may cause severe drowsiness or respiratory depression; thus, it should be avoided or taken only under the guidance of a professional. Patients with head injuries or brain diseases should take caution as this medication may increase intracranial pressure. This medication can cause physical and psychological dependence, so long-term use should be done under the supervision of a professional. Patients with impaired liver function should consult a physician before using this medication and should avoid taking other acetaminophen products concurrently. Patients with certain genetic traits may produce excessive amounts of the active metabolite of this medication, heightening the risk of respiratory depression, thus requiring dosage adjustment and monitoring. Children under the age of 12 or adolescents under 18 after certain surgeries should not be given this medication; furthermore, those aged 12 to 18 should avoid it if there are risk factors. This medication may cause sleep apnea or hypoxia; continuous monitoring of symptoms and potential dosage adjustments or discontinuation is advised. Elderly patients or those at risk of hyponatremia should be closely monitored for signs of hyponatremia while taking this medication. This medication interacts with certain other medications, increasing the risk of seizures and serious side effects; therefore, patients should disclose all medications they are taking. Women who are pregnant or may become pregnant should consult a physician about the potential effects on the fetus before using this medication, and nursing mothers are advised to avoid it. This medication may cause drowsiness or dizziness, necessitating caution when driving or operating machinery. In case of overdose, serious respiratory depression, seizures, liver damage, etc., may occur; thus, it is crucial to adhere to the prescribed dosage and contact a medical institution immediately in emergencies. This medication should be stored in a safe place out of reach of children to prevent accidental ingestion.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary issues

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
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory reduction
  • tremor
  • dysesthesia
  • inattention

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the medication's effectiveness for a longer time.

Appearance and packaging

Appearance

Pale yellow rectangular 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

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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.