Medication info
Goodtraset Semitab

Goodtraset Semitab

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›18.75mg / 1 tablet
Manufacturer / importer
(주)다산제약
Appearance
Pale yellow rectangular film-coated tablet
Packaging
Bottle packaging - 30 tablets/bottle, Bottle packaging - 300 tablets/bottle
Approval status
Active

MFDS item code 201906521 · Approved 2019.09.18 · Insurance code 678601500

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children 12 years and older and adults: Dosage should be adjusted according to the patient's level of pain and therapeutic response. A recommended initial dose is 4 tablets, after which intervals should be at least 6 hours apart, with a maximum of 16 tablets per day. Administer the effective minimum dosage for the shortest duration necessary. Avoid prolonged administration of this medication beyond what is required, and for cases necessitating prolonged treatment due to the nature and severity of the condition, regular monitoring should be conducted to verify the continuation of this medication. Elderly: Administer the standard adult dosage; however, for elderly patients over 75 years, the elimination half-life of tramadol may increase by 17%, thus intervals of at least 6 hours between doses should be maintained. Renal impairment patients: For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. For patients with severe renal impairment (creatinine clearance less than 10 mL/min), administration is not recommended. Tramadol is eliminated very slowly by hemodialysis and filtration; hence, re-administration after dialysis for pain relief is unnecessary. Hepatic impairment patients: For patients with moderate hepatic impairment, consider extending the dosing interval carefully. Do not administer this medication to patients with severe hepatic impairment.
Child dose
Children 12 years and older and adults: Dosage should be adjusted according to the patient's level of pain and therapeutic response. A recommended initial dose is 4 tablets, after which intervals should be at least 6 hours apart, with a maximum of 16 tablets per day.

Ingredients

Manufacturer
(주)다산제약

Efficacy & effects

Relief of moderate to severe acute and chronic 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

Children 12 years and older and adults: Dosage should be adjusted according to the patient's level of pain and therapeutic response. A recommended initial dose is 4 tablets, after which intervals should be at least 6 hours apart, with a maximum of 16 tablets per day. Administer the effective minimum dosage for the shortest duration necessary. Avoid prolonged administration of this medication beyond what is required, and for cases necessitating prolonged treatment due to the nature and severity of the condition, regular monitoring should be conducted to verify the continuation of this medication. Elderly: Administer the standard adult dosage; however, for elderly patients over 75 years, the elimination half-life of tramadol may increase by 17%, thus intervals of at least 6 hours between doses should be maintained. Renal impairment patients: For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. For patients with severe renal impairment (creatinine clearance less than 10 mL/min), administration is not recommended. Tramadol is eliminated very slowly by hemodialysis and filtration; hence, re-administration after dialysis for pain relief is unnecessary. Hepatic impairment patients: For patients with moderate hepatic impairment, consider extending the dosing interval carefully. Do not administer this medication to patients with severe hepatic impairment.

Child dose

Children 12 years and older and adults: Dosage should be adjusted according to the patient's level of pain and therapeutic response. A recommended initial dose is 4 tablets, after which intervals should be at least 6 hours apart, with a maximum of 16 tablets per day.

Precautions

This medication may pose a risk of liver damage, so individuals who consume large amounts of alcohol daily should consult with a doctor or pharmacist before taking it. If abnormal reactions such as skin rashes or itching occur while taking this medication, stop taking it immediately and consult healthcare professionals. Due to the risk of seizures, individuals with a history of seizures or risk factors for seizures should use this medication cautiously, as the risk may increase when used in combination with certain antidepressants or other medications. Rarely, severe allergic reactions can occur; if symptoms such as hives or breathing difficulties appear, seek medical attention immediately. In patients with acute and severe bronchial asthma, there is a risk of respiratory depression when administering this medication, so it should only be given in the presence of medical professionals. Taking this medication with alcohol or central nervous system depressants may cause severe drowsiness or respiratory depression, so use caution or avoid combination. Patients with head injuries or increased intracranial pressure should be cautious, as this medication may worsen symptoms due to respiratory depression and increased brain pressure. This medication may cause psychological and physical dependence, so long-term use requires caution regarding the risk of dependence. Patients with poor liver function should consult a doctor before taking this medication and should take care not to exceed the recommended daily dosage. Patients with certain genotypes may experience accelerated metabolism of this medication, increasing the risk of respiratory depression; dose adjustment and symptom monitoring may be necessary in such cases. This medication is not to be administered to children under 12 years of age and adolescents under 18 years of age who have undergone tonsillectomy or adenoidectomy. This medication can cause sleep apnea or hypoxemia, so patients should be monitored continuously for symptoms or worsening conditions. Elderly patients or patients at risk of hyponatremia should be carefully monitored for the occurrence of hyponatremia during treatment with this medication. This medication has many interactions with specific drugs; patients currently taking other medications should inform their healthcare provider, especially regarding combinations with antidepressants, anticonvulsants, or narcotic analgesics. Women who are pregnant or may become pregnant should consult a physician before taking this medication, and nursing mothers should either stop breastfeeding or consult with a doctor while taking this medication. Caution is needed while driving or operating machinery as drowsiness or dizziness may occur. In case of overdose, severe respiratory depression, seizures, and liver damage may occur, requiring immediate emergency treatment. This medication should be stored safely out of reach of children and managed carefully to prevent drug misuse.

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 high fever, blisters, peeling skin, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough + fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

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 disturbances
  • confusion
  • disturbed perception
  • excitement
  • abnormal dreams
  • drug misuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory loss
  • tremor
  • sensation

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

Storage

Store this medication in a sealed container to prevent air from entering, and it is recommended to keep it at room temperature between 1°C and 30°C. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 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

No questions yet.

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.