Medication info
Tamitrasemi Tablets

Tamitrasemi Tablets

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mg / 1 tabletTramadol Hydrochloride›18.75mg / 1 tablet
Manufacturer / importer
삼익제약(주)
Appearance
Light yellow, rectangular film-coated tablets
Packaging
Bottle packaging - 30 tablets/bottle, Bottle packaging - 100 tablets/bottle
Approval status
Active

MFDS item code 200805632 · Notified 2008.05.20 · Insurance code 644003090

Summary

Main use
Relief of moderate to severe acute/chronic pain
Who takes it
Adults · Children
Adult dose
For children over 12 years and adults: The dosage should be adjusted according to the severity of the patient's pain and the treatment response. An initial dose of 4 tablets is recommended, and the interval between doses thereafter should be at least 6 hours, but not exceeding 16 tablets per day. The lowest effective dose should be used for as short a duration as possible. Avoid prolonged use beyond what is necessary, and if long-term administration is required due to the disease's characteristics and severity, regular monitoring should be conducted to ensure the continued appropriateness of this medication. Elderly Administer the usual adult dose. However, for elderly patients over 75 years old, the elimination half-life of tramadol has increased by 17% when taken orally, so doses should be administered with an interval of at least 6 hours. Patients with renal impairment For moderate renal impairment patients (creatinine clearance between 10-30 mL/min), extend the interval between doses to 12 hours. For severe renal impairment patients (creatinine clearance below 10 mL/min), administration of this medication is not recommended. Tramadol is very slowly removed during blood dialysis and filtration, and re-administration of this medication after dialysis to maintain analgesic effects is not necessary. Patients with liver impairment For moderate liver impairment patients, careful consideration should be given to extending the dosing interval. For severe liver impairment patients, this medication should not be administered.
Child dose
For children over 12 years and adults: The dosage should be adjusted according to the severity of the patient's pain and the treatment response. An initial dose of 4 tablets is recommended, and the interval between doses thereafter should be at least 6 hours, but not exceeding 1 day.

Ingredients

Manufacturer
삼익제약(주)

Efficacy & effects

Relief of moderate to severe acute/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

For children over 12 years and adults: The dosage should be adjusted according to the severity of the patient's pain and the treatment response. An initial dose of 4 tablets is recommended, and the interval between doses thereafter should be at least 6 hours, but not exceeding 16 tablets per day. The lowest effective dose should be used for as short a duration as possible. Avoid prolonged use beyond what is necessary, and if long-term administration is required due to the disease's characteristics and severity, regular monitoring should be conducted to ensure the continued appropriateness of this medication. Elderly Administer the usual adult dose. However, for elderly patients over 75 years old, the elimination half-life of tramadol has increased by 17% when taken orally, so doses should be administered with an interval of at least 6 hours. Patients with renal impairment For moderate renal impairment patients (creatinine clearance between 10-30 mL/min), extend the interval between doses to 12 hours. For severe renal impairment patients (creatinine clearance below 10 mL/min), administration of this medication is not recommended. Tramadol is very slowly removed during blood dialysis and filtration, and re-administration of this medication after dialysis to maintain analgesic effects is not necessary. Patients with liver impairment For moderate liver impairment patients, careful consideration should be given to extending the dosing interval. For severe liver impairment patients, this medication should not be administered.

Child dose

For children over 12 years and adults: The dosage should be adjusted according to the severity of the patient's pain and the treatment response. An initial dose of 4 tablets is recommended, and the interval between doses thereafter should be at least 6 hours, but not exceeding 1 day.

Precautions

This medication may put strain on the liver, so individuals who consume more than a certain amount of alcohol daily must consult a doctor or pharmacist before use. Severe allergic reactions may occur on the skin while taking this medication. If a rash or hypersensitivity reaction occurs, stop taking it immediately and consult healthcare professionals. The ingredients in this medication can trigger seizures; therefore, patients with a history of seizures or those at high risk of seizures should use this medication cautiously, as the risk may increase when taken with certain medications. Although rare, life-threatening allergic reactions may occur while taking this medication. If any unusual symptoms arise, seek immediate medical attention. In patients with severe respiratory diseases, this medication may cause difficulty in breathing; therefore, it should only be used in an environment where healthcare professionals can monitor the patient. Taking this medication with alcohol or certain central nervous system depressants may lead to severe drowsiness, respiratory depression, or coma, so concurrent use should be avoided unless absolutely necessary, in which case it should be done with extreme caution. Patients with head injuries or brain diseases should be cautious when taking this medication, as respiratory depression could worsen their condition. This medication can lead to psychological and physical dependence, so long-term use should be carefully monitored for signs of dependence. Patients with impaired liver function must consult a doctor before using this medication and must be careful not to exceed the daily dose. Patients with specific genetic metabolic characteristics may have faster metabolism of the active ingredient in this medication, which can increase the risk of serious respiratory depression; alternative medications or dose adjustments may be necessary in such cases. Children under 12 years old or pediatric patients under 18 years old after certain surgeries should not use this medication; administration in adolescents aged 12 to 18 should also be avoided if there are special risk factors. This medication may induce sleep apnea or hypoxia, so it is important to continuously monitor for any symptoms and consider dose adjustments or discontinuation if they appear or worsen. During treatment with this medication, hyponatremia, a rare electrolyte disorder, may occur, so elderly patients or those with risk factors should have their condition checked through blood tests. Patients with hypersensitivity to any components of this medication, those with toxicity from certain central nervous system drugs, severe respiratory depression, head injuries, or those taking MAO inhibitors should not take this medication. Women who are pregnant or breastfeeding must consult a doctor before using this medication, particularly while breastfeeding, as it may pass into breast milk and pose risks to the baby. This medication can cause drowsiness or dizziness; therefore, it is advisable to avoid dangerous tasks such as driving or operating machinery after ingestion. In cases of overdose, severe respiratory depression, seizures, and liver damage may occur, so it is crucial to adhere strictly to the recommended doses and to seek emergency care if an overdose occurs. Care should be taken not to combine this medication with other analgesics or medications containing acetaminophen, as potential drug interactions are a concern; patients should inform healthcare professionals about any other medications they are taking.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, peeling skin, mucosal pain in the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, cough with fever and respiratory abnormalities, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, reduced urinary output

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 disorders
  • confusion
  • disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraines
  • somnolence
  • sensory deficit
  • tremors
  • sensory loss

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

Storage

This medication should be stored in a well-closed container that allows minimal air exchange and at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

Light yellow, rectangular film-coated tablets

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 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

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.