Medication info
Dolttramsetsimi Tablet

Dolttramsetsimi Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›18.75mg / 1 tabletAcetaminophen›162.5mg / 1 tablet
Manufacturer / importer
광동제약(주)
Appearance
Pale yellow oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200710638 · Notified 2007.09.19 · Insurance code 641801210

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Administer to children over 12 years and adults. An initial dose of 4 tablets is recommended, with a minimum dosing interval of 6 hours. Do not exceed 16 tablets per day, and administer the lowest effective dose for as short a time as possible. For elderly patients over 75 years, ensure a dosing interval of at least 6 hours. For moderate renal impairment (creatinine clearance 10-30 ml/min), extend the dosing interval to 12 hours.
Child dose
For children aged over 12, administer the same dosage as for adults.

Ingredients

Manufacturer
광동제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate pain
  • severe pain
  • acute pain
  • 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

Administer to children over 12 years and adults. An initial dose of 4 tablets is recommended, with a minimum dosing interval of 6 hours. Do not exceed 16 tablets per day, and administer the lowest effective dose for as short a time as possible. For elderly patients over 75 years, ensure a dosing interval of at least 6 hours. For moderate renal impairment (creatinine clearance 10-30 ml/min), extend the dosing interval to 12 hours.

Child dose

For children aged over 12, administer the same dosage as for adults.

Precautions

This medication may put strain on the liver, so individuals who consume large amounts of alcohol regularly should consult a doctor or pharmacist before taking it. Rarely, serious skin reactions may occur while taking this medication; therefore, if a rash or allergic symptoms appear, stop taking it immediately and consult medical personnel. One of the ingredients in this medication, tramadol, can trigger seizures; thus, patients with a history of seizures or those at risk for seizures should use caution when taking it. Taking tramadol in combination with certain antidepressants or other medications may increase the risk of seizures; hence it is essential to consult a doctor before concurrent use. This medication can rarely cause serious allergic reactions, so if symptoms like difficulty breathing or hives occur, immediate medical attention is required. In patients with acute bronchial asthma, administering this medication may risk respiratory suppression, so it should be given in a facility equipped with professional tools. Concurrent use with central nervous system depressants or alcohol may lead to extreme drowsiness, respiratory suppression, or coma; thus, combination should be avoided or used very cautiously. Patients with head injuries or brain diseases are at risk of respiratory suppression and elevated intracranial pressure when taking this medication, so they should proceed with caution. This medication may lead to psychological or physical dependence, so long-term use necessitates careful monitoring for dependence. Patients with poor liver function should consult a doctor before taking this medication, as there is a risk of hepatic toxicity and they should not exceed the recommended dosage. Patients with certain genetic profiles may have faster metabolism of this medication, increasing the risk for respiratory suppression, warranting special caution. This medication should not be administered to children under 12 years of age or adolescents under 18 who have undergone tonsillectomy or adenoidectomy. This medication can cause sleep apnea and hypoxia, necessitating continuous observation for symptom worsening and dosage adjustment if needed. Elderly patients or those at risk for hyponatremia should be closely monitored for symptoms of hyponatremia while taking this medication. This medication may interact with specific drugs, so if taking other medications, it is crucial to inform medical personnel, especially when combined with MAO inhibitors, antidepressants, central nervous system depressants, warfarin, etc. Women who are pregnant or may become pregnant should consult a doctor before taking this medication, and nursing mothers should either stop breastfeeding or consult medical personnel when taking this medication. This medication can cause drowsiness and dizziness, so caution is advised when driving or operating machinery. In cases of overdose, severe respiratory suppression, seizures, or liver damage may occur, so it is vital to strictly adhere to the recommended dosage, and if overdose is suspected, immediate emergency treatment should be sought. This medication should be kept out of reach of children and stored securely to prevent misuse.

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 high fever, blisters, peeling skin, pain in mouth/eyes mucosa, difficulty breathing or shortness of breath, asthma attack, cough+fever with breathing abnormalities, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urine retention

Mild side effects

  • Loss of 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 disturbances
  • confusion
  • disorientation
  • excitability
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremor
  • paresthesia

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering, away from direct sunlight, and at room temperature, specifically below 25 degrees Celsius. Storing it this way helps maintain the medication's efficacy over time.

Appearance and packaging

Appearance

Pale yellow oval 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.