Medication info

Citracet Semi Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Tramadol Hydrochloride›18.75mg / 1 tabletAcetaminophen›162.5mg / 1 tablet
Manufacturer / importer
천우신약(주)
Appearance
Light yellow oval film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 202002793 · Approved 2020.04.21

This product's status changed to Expired on 2025.04.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children aged 12 and older and adults: The dosage should be adjusted according to the patient's pain level and therapeutic response. A starting dose of 4 tablets is recommended, and subsequent dosing intervals should be at least 6 hours apart, but not to exceed 16 tablets per day. The lowest effective dose should be administered for the shortest duration necessary. This medication should not be used longer than necessary, and if long-term use is required due to the nature of the disease and severity, regular monitoring should be conducted to assess the need for continued administration of this medication. Elderly patients Standard adult dosages should be administered; however, for elderly patients over 75 years of age, the elimination half-life of tramadol is increased by 17% when taken orally, so intervals of at least 6 hours should be maintained for administration of this medication. Patients with renal impairment For patients with moderate renal impairment (creatinine clearance of 10-30 ml/min), the dosing interval should be extended to 12 hours. Administration is not recommended for patients with severe renal impairment (creatinine clearance of less than 10 ml/min). Tramadol is eliminated very slowly during blood dialysis and filtration, so there is no need to re-administer this medication after dialysis for pain management. Patients with hepatic impairment Caution should be exercised in considering dosage adjustments for patients with moderate hepatic impairment, and this medication should not be administered to patients with severe hepatic impairment.
Child dose
For children aged 12 and older and adults: The dosage should be adjusted according to the patient's pain level and therapeutic response. A starting dose of 4 tablets is recommended, and subsequent dosing intervals should be at least 6 hours apart, with a maximum of

Ingredients

Manufacturer
천우신약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

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

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

How to take

Adult dose

For children aged 12 and older and adults: The dosage should be adjusted according to the patient's pain level and therapeutic response. A starting dose of 4 tablets is recommended, and subsequent dosing intervals should be at least 6 hours apart, but not to exceed 16 tablets per day. The lowest effective dose should be administered for the shortest duration necessary. This medication should not be used longer than necessary, and if long-term use is required due to the nature of the disease and severity, regular monitoring should be conducted to assess the need for continued administration of this medication. Elderly patients Standard adult dosages should be administered; however, for elderly patients over 75 years of age, the elimination half-life of tramadol is increased by 17% when taken orally, so intervals of at least 6 hours should be maintained for administration of this medication. Patients with renal impairment For patients with moderate renal impairment (creatinine clearance of 10-30 ml/min), the dosing interval should be extended to 12 hours. Administration is not recommended for patients with severe renal impairment (creatinine clearance of less than 10 ml/min). Tramadol is eliminated very slowly during blood dialysis and filtration, so there is no need to re-administer this medication after dialysis for pain management. Patients with hepatic impairment Caution should be exercised in considering dosage adjustments for patients with moderate hepatic impairment, and this medication should not be administered to patients with severe hepatic impairment.

Child dose

For children aged 12 and older and adults: The dosage should be adjusted according to the patient's pain level and therapeutic response. A starting dose of 4 tablets is recommended, and subsequent dosing intervals should be at least 6 hours apart, with a maximum of

Precautions

This medication may impose a burden on the liver, so individuals who consume alcohol regularly should consult their doctor or pharmacist before taking it. Serious allergic reactions may occur when taking this medication, so if a rash or hypersensitivity occurs, stop taking it immediately and inform a healthcare professional. The ingredients in this medication can cause seizures; therefore, patients with a history of seizures or at risk for seizures should be particularly cautious. Patients with compromised respiratory function or acute asthma may be at risk when using this medication, which should be administered in a place equipped for cardiopulmonary resuscitation. Taking this medication with central nervous system depressants like alcohol or sedatives can result in severe drowsiness or respiratory depression, so careful monitoring is required when using these medications together. Patients with head injuries or brain diseases should be cautious as this medication may exacerbate problems such as increased intracranial pressure. This medication can cause psychological and physical dependence, so long-term use should be closely monitored for signs of dependence. Patients with reduced liver function must consult their doctor before using this medication, and care must be taken not to take other acetaminophen products simultaneously. Patients with very high activity of the CYP2D6 enzyme may have faster metabolism of this medication's components, increasing the risk of respiratory depression, hence monitoring is needed. This medication should not be administered to children under 12 or pediatric patients under 18 who have undergone tonsillectomy or adenoidectomy. Patients with symptoms of sleep apnea or hypoxemia may find their symptoms worsen after taking this medication, so careful monitoring of symptom changes is essential. Hypo-sodium emia may occur while taking this drug; therefore, especially in elderly patients or those with risk factors, monitoring blood sodium levels is advisable. This medication can interact with certain drugs; therefore, if other medications are being taken, patients must inform their doctor or pharmacist, particularly when used in conjunction with antidepressants, anticonvulsants, or opioid analgesics. Women who are pregnant or breastfeeding should consult their doctor before using this medication; if breastfeeding, caution must be exercised as this medication can pass into breast milk and harm the infant. This medication may cause drowsiness or dizziness, making it advisable to avoid driving or operating hazardous machinery. In cases of overdose, severe side effects such as respiratory depression, seizures, and liver damage can occur, so prescribed dosages must be strictly followed, and immediate emergency measures should be taken if an overdose is suspected.

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, peeling of the skin, mouth/eye mucosal pain, severe skin adverse reactions, severe allergic reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, breathing issues, jaundice (yellowing of the skin or eyes), profound lethargy, liver abnormalities (jaundice), sudden and severe

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
  • pruritis
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • sense of direction disturbance
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sense of loss
  • tremor
  • sensory disturbance

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 infiltration and kept at a temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Light yellow oval 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.