Medication info
Tamitra Tablet

Tamitra Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
삼익제약(주)
Appearance
Light yellow, rectangular film-coated tablets
Packaging
(Domestic use) 30 tablets/bottle, 100 tablets/bottle (Export) 100 tablets (10 tablets/PTP*10)
Approval status
Active

MFDS item code 200804611 · Notified 2008.04.24 · Insurance code 644002040

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 based on the severity of pain and therapeutic response. Initial recommended dose is 2 tablets, and subsequent doses should be taken at intervals of at least 6 hours, not exceeding 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Avoid prolonged use of this medication unnecessarily, and if prolonged use is required due to the nature and severity of the illness, regular monitoring should be implemented to confirm the continued use of this medication. Elderly Administer the normal adult dose. However, in patients over 75 years of age, oral administration of tramadol has been shown to increase the elimination half-life by 17%, so it should be administered at intervals of at least 6 hours. Renal impairment In patients with moderate renal impairment (creatinine clearance 10-30 ml/min), increase the dosing interval to 12 hours. In patients with severe renal impairment (creatinine clearance less than 10 ml/min), administration is not recommended. Tramadol is very slowly eliminated during dialysis and filtration, hence there is no need to re-administer this medication after dialysis to maintain analgesic effects. Hepatic impairment For patients with moderate hepatic impairment, carefully consider extending the dosing intervals. For those with severe hepatic impairment, administration of this medication is not indicated.
Child dose
Children over 12 years and adults: dosage should be adjusted based on the severity of pain and therapeutic response. Initial recommended dose is 2 tablets, and subsequent doses should be taken at intervals of at least 6 hours, not exceeding 1 day

Ingredients

Manufacturer
삼익제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute and 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 over 12 years and adults: dosage should be adjusted based on the severity of pain and therapeutic response. Initial recommended dose is 2 tablets, and subsequent doses should be taken at intervals of at least 6 hours, not exceeding 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Avoid prolonged use of this medication unnecessarily, and if prolonged use is required due to the nature and severity of the illness, regular monitoring should be implemented to confirm the continued use of this medication. Elderly Administer the normal adult dose. However, in patients over 75 years of age, oral administration of tramadol has been shown to increase the elimination half-life by 17%, so it should be administered at intervals of at least 6 hours. Renal impairment In patients with moderate renal impairment (creatinine clearance 10-30 ml/min), increase the dosing interval to 12 hours. In patients with severe renal impairment (creatinine clearance less than 10 ml/min), administration is not recommended. Tramadol is very slowly eliminated during dialysis and filtration, hence there is no need to re-administer this medication after dialysis to maintain analgesic effects. Hepatic impairment For patients with moderate hepatic impairment, carefully consider extending the dosing intervals. For those with severe hepatic impairment, administration of this medication is not indicated.

Child dose

Children over 12 years and adults: dosage should be adjusted based on the severity of pain and therapeutic response. Initial recommended dose is 2 tablets, and subsequent doses should be taken at intervals of at least 6 hours, not exceeding 1 day

Precautions

This medication may burden the liver; therefore, individuals who regularly consume more than three glasses of alcohol daily should consult a doctor or pharmacist before using it. This medication can, though rarely, cause serious skin reactions; if a rash or hypersensitivity occurs, use should be discontinued immediately and medical advice sought. The ingredients in this medication may increase the risk of seizures; therefore, patients with a history of seizures or at risk for seizures should use it cautiously, and caution is required when taken with certain antidepressants or opioid pain relief medications. Serious allergic reactions, such as anaphylaxis, may rarely occur; if symptoms such as difficulty breathing or hives appear, immediate medical attention is required. Patients with acute bronchial asthma are at risk of severe respiratory depression when taking this medication; therefore, it should be administered in a medically equipped environment, and other analgesics are preferable. Using this medication alongside alcohol or benzodiazepine medications can lead to severe drowsiness, respiratory depression, or coma, so co-administration should be avoided or used for the shortest duration at minimum dosages. Patients with elevated intracranial pressure or head injuries should be cautious with this medication, as respiratory depression can further elevate brain pressure. This medication can lead to psychological and physical dependence; therefore, continuous monitoring for dependency is necessary when used for extended periods. Patients with liver dysfunction might experience liver damage due to the acetaminophen component of this medication and should consult with a physician before use. Those who metabolize this medication rapidly due to genetic factors are at risk for severe respiratory depression; thus, careful dose adjustment and monitoring are required. This medication should not be used by children under 12 or by adolescents under 18 who have undergone tonsillectomy or adenoidectomy, and it is advisable to avoid use in cases of sleep apnea. Patients with symptoms of sleep apnea or hypoxia may experience worsening of symptoms after taking this medication; therefore, symptom changes should be carefully monitored, and dosing may need to be reduced or stopped as needed. Hyponatremia can occur during use, so especially elderly patients and those with risk factors should be monitored closely for symptoms. This medication should not be administered to patients with certain conditions or diseases, such as severe respiratory depression, head injuries, those taking MAO inhibitors, or patients with severe liver or kidney impairment. When taking this, the recommended dosage should not be exceeded, and it should not be combined with other medications of similar ingredients. Abruptly stopping this medication may lead to withdrawal symptoms; therefore, doses should be gradually reduced according to a physician's instructions. This medication can cause allergic reactions or severe skin adverse reactions; if abnormal symptoms occur, immediately discontinue use and consult a medical professional. This medication may interact with various other medications; therefore, if you are taking other drugs, be sure to inform your doctor or pharmacist, particularly regarding antidepressants, antibiotics, antifungals, and central nervous system depressants. Elderly patients may be at increased risk of side effects due to declining liver, kidney, and heart function or accompanying diseases, requiring careful administration. Women who are pregnant or may become pregnant should consult a doctor regarding the effects on the fetus before taking this medication, and nursing mothers are advised to avoid breastfeeding while using this medication. This medication can cause drowsiness or dizziness; therefore, it is best to avoid dangerous activities such as driving or operating machinery after taking it. In cases of overdose, severe respiratory depression, seizures, liver damage, etc., can occur; thus, dosage must be strictly adhered to, and in case of overdose, emergency treatment should be sought immediately. Lastly, this medication should be stored in a safe place out of children's reach to prevent accidental ingestion or 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 fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attack, cough with fever accompanied by respiratory abnormalities, yellowing of the skin or eyes (jaundice), profound drowsiness, sudden and extremely severe headache, lightning headache, seizures, confusion, visual abnormalities, paralysis, urine

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
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • direction sense impairment
  • agitation
  • abnormal dreams
  • drug dependence
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory loss
  • tremors
  • sensory

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, ideally at a temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Light yellow, rectangular film-coated tablets

Package unit

(Domestic use) 30 tablets/bottle, 100 tablets/bottle (Export) 100 tablets (10 tablets/PTP*10)

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.