Medication info
Craset Tablet (Tramadol, Acetaminophen)

Craset Tablet (Tramadol, Acetaminophen)

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
지엘파마(주)
Appearance
Light yellow oblong film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201901925 · Approved 2019.03.29 · Insurance code 649702040

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children over 12 years and adults: Dosage should be adjusted according to the severity of pain and therapeutic response. An initial dose of 2 tablets is recommended, and the interval between doses should be a minimum of 6 hours, not exceeding 8 tablets per day. Administer the lowest effective dosage for the shortest duration necessary. Avoid prolonged administration of this drug beyond what is necessary, and if long-term administration is required due to disease characteristics and severity, regular monitoring should be conducted to ascertain the need for continued use of this drug. Elderly Patients Administer the typical adult dose. However, in elderly patients over 75 years, the elimination half-life of tramadol is increased by 17% when administered orally; thus, doses should be administered at intervals of at least 6 hours. Renal Impairment In patients with moderate renal impairment (creatinine clearance 10-30 ml/min), extend the dosing interval to 12 hours. In severe renal impairment (creatinine clearance less than 10 ml/min), administration is not recommended. As tramadol is very slowly removed during dialysis, there is no need to re-administer this drug after dialysis to maintain analgesic efficacy. Hepatic Impairment For patients with moderate hepatic impairment, carefully consider extending the dosing interval. This drug should not be administered to patients with severe hepatic impairment.
Child dose
Children over 12 years and adults: Dosage should be adjusted according to the severity of pain and therapeutic response. An initial dose of 2 tablets is recommended, and the interval between doses should be a minimum of 6 hours, not exceeding 8 tablets per day.

Ingredients

Manufacturer
지엘파마(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

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

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

How to take

Adult dose

Children over 12 years and adults: Dosage should be adjusted according to the severity of pain and therapeutic response. An initial dose of 2 tablets is recommended, and the interval between doses should be a minimum of 6 hours, not exceeding 8 tablets per day. Administer the lowest effective dosage for the shortest duration necessary. Avoid prolonged administration of this drug beyond what is necessary, and if long-term administration is required due to disease characteristics and severity, regular monitoring should be conducted to ascertain the need for continued use of this drug. Elderly Patients Administer the typical adult dose. However, in elderly patients over 75 years, the elimination half-life of tramadol is increased by 17% when administered orally; thus, doses should be administered at intervals of at least 6 hours. Renal Impairment In patients with moderate renal impairment (creatinine clearance 10-30 ml/min), extend the dosing interval to 12 hours. In severe renal impairment (creatinine clearance less than 10 ml/min), administration is not recommended. As tramadol is very slowly removed during dialysis, there is no need to re-administer this drug after dialysis to maintain analgesic efficacy. Hepatic Impairment For patients with moderate hepatic impairment, carefully consider extending the dosing interval. This drug should not be administered to patients with severe hepatic impairment.

Child dose

Children over 12 years and adults: Dosage should be adjusted according to the severity of pain and therapeutic response. An initial dose of 2 tablets is recommended, and the interval between doses should be a minimum of 6 hours, not exceeding 8 tablets per day.

Precautions

This drug may burden the liver, so individuals who consume a lot of alcohol daily must consult a doctor or pharmacist before taking it. If any abnormal symptoms such as skin rash or blisters occur during the administration of this drug, stop taking it immediately and seek medical attention. The ingredients in this drug may induce seizures; thus, individuals with a history of seizures or at high risk of seizures should exercise caution, especially when taken in combination with certain antidepressants or other medications. Severe allergic reactions may occur rarely; thus, immediate treatment is necessary if allergic symptoms appear. Individuals with severe respiratory diseases may experience difficulty breathing when taking this drug, so it should be taken in a medical facility equipped with the necessary equipment. Taking this drug with alcohol or central nervous system depressants, such as sedatives, can cause severe drowsiness or respiratory depression. Therefore, strict adherence to the doctor's instructions is required when combining them. Individuals with head injuries or increased intracranial pressure may experience worsening symptoms when taking this drug, so caution is advised. This drug may cause dependency, so dosage should be adjusted per the doctor's instructions during long-term use, and it should not be suddenly discontinued. Individuals with impaired liver function must consult a doctor before taking this drug and should avoid taking other acetaminophen products. Those with certain genotypes may metabolize this drug rapidly, increasing the risk of respiratory suppression; thus, doctors may consider dose adjustments or alternative medications in such cases. It is safer not to use this drug in children under 12 years of age and in adolescents under 18 years after certain surgeries. This drug can worsen sleep apnea or hypoxia; therefore, it should be continuously monitored for symptoms or exacerbation. Elderly individuals or patients at risk of hyponatremia should closely monitor for symptoms of hyponatremia while taking this drug. Before taking this drug, individuals with allergies to it or who are taking certain medications, those with severe respiratory depression, head trauma, severe liver or kidney disease, or those who are pregnant or breastfeeding should not take this drug. Caution is needed as drowsiness or dizziness may occur when driving or operating machinery. In the case of overdose, severe respiratory depression, seizures, liver damage, etc. may occur; therefore, it is important to adhere to the prescribed dosage and contact a medical institution immediately if in doubt. As there are many interactions with other medications, it is essential to inform the doctor or pharmacist of all medications being taken, especially when combining with antidepressants, antibiotics, sedatives, and anticoagulants. This drug should be kept out of the reach of children and managed safely to prevent drug abuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash accompanied by fever, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache.

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
  • hypoglycemia
  • anxiety
  • irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbance
  • confusion
  • sense of direction impairment
  • excitability
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremors
  • and sensations.

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

Storage

This drug should be stored in a tightly sealed container to prevent air and moisture from entering. Additionally, it is advisable to store the medicine at room temperature between 1°C and 30°C. Proper storage will safely maintain the drug's efficacy.

Appearance and packaging

Appearance

Light 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.