Medication info
Tramadol Sustained-Release Tablets

Tramadol Sustained-Release Tablets

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›75mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
제일약품(주)
Appearance
Light yellow rectangular film-coated sustained-release tablets
Packaging
30 tablets, 100 tablets per bottle
Approval status
Active

MFDS item code 201207590 · Approved 2012.10.31 · Insurance code 645403830

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
Adjust the dosage according to the level of pain and therapeutic response. Administer 1 tablet as an initial dose, with a minimum dosing interval of 12 hours thereafter. Do not exceed 4 tablets per day. Avoid prolonged use beyond what is necessary, and conduct regular monitoring if prolonged use is required. Monitor closely for reactions such as nausea, vomiting, itching, constipation, dizziness, drowsiness during administration and make adjustments as needed.

Ingredients

Manufacturer
제일약품(주)

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

Adjust the dosage according to the level of pain and therapeutic response. Administer 1 tablet as an initial dose, with a minimum dosing interval of 12 hours thereafter. Do not exceed 4 tablets per day. Avoid prolonged use beyond what is necessary, and conduct regular monitoring if prolonged use is required. Monitor closely for reactions such as nausea, vomiting, itching, constipation, dizziness, drowsiness during administration and make adjustments as needed.

Precautions

This medication may cause liver damage in individuals who regularly consume more than three alcoholic beverages per day; consult a doctor or pharmacist. This medication contains acetaminophen, which may rarely cause serious skin reactions, so if a rash or hypersensitivity symptoms occur, discontinue use immediately. Exceeding the recommended dosage may increase the risk of seizures, and the risk may further increase when used with certain antidepressants or other central nervous system medications, so caution is needed. Rarely, life-threatening anaphylaxis may occur during the use of this medication; inform medical personnel immediately if unusual symptoms arise. There is a higher risk of respiratory depression in patients with acute and severe bronchial asthma; this medication should be administered in a location equipped for resuscitation. Taking this medication with alcohol or benzodiazepines and other central nervous system depressants may cause severe sedation, respiratory depression, and coma; exercise extreme caution when used together. Patients with increased intracranial pressure or head injuries may experience worsened symptoms due to the respiratory depressant effects of this medication; caution is warranted. This medication may cause dependence similar to morphine, so the duration of use should be regulated in consideration of the possibility of dependence with prolonged use. Patients with impaired liver function may experience liver damage from acetaminophen, so consultation with a doctor is essential before use. There may be a higher risk of respiratory depression in patients with certain genetic variations that cause rapid metabolism; these patients require dosage adjustments and symptom monitoring. This medication should not be used in children under 12 years of age or in children under 18 years who have undergone tonsillectomy and adenoidectomy; also avoid use in adolescents between 12 and 18 years if there are risk factors. Elderly individuals or patients at risk for hyponatremia may experience potential symptoms of hyponatremia during use and should be monitored. This medication should not be administered to individuals with hypersensitivity to any components, severe respiratory depression, head injuries, or those taking MAO inhibitors. Patients with liver disease, renal impairment, heart failure, nursing mothers, certain asthma patients, and those with drug-resistant epilepsy should also be administered with caution. During use, drowsiness or dizziness may occur, so care should be taken when driving or operating machinery. In case of overdose, serious side effects such as respiratory depression, coma, and liver failure may occur, so visit a medical institution immediately in an emergency. This medication has many interactions with other drugs, so if taking other medications, it is essential to inform a doctor or pharmacist, especially when used with central nervous system depressants or antidepressants. Pregnant or nursing women should carefully consider the risks and benefits of using this medication, and if nursing, observe the infant for signs of sedation or respiratory depression.

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, blistering, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by coughing and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary changes

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • stiffness
  • withdrawal symptoms
  • hypertension
  • exacerbation of hypertension
  • hypotension
  • arrhythmia
  • palpitations
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  • tachycardia
  • dizziness
  • headache
  • tremor
  • ataxia
  • restlessness
  • migraine
  • exacerbation of migraine
  • involuntary muscle contractions
  • sensory disturbances
  • confusion
  • dizziness
  • nausea
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • vomiting
  • difficulty swallowing
  • tongue swelling
  • decreased appetite
  • anxiety
  • confusion
  • euphoria
  • insomnia
  • irritability
  • drowsiness
  • forgetfulness
  • derealization

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. Additionally, it is best to store the medication at room temperature between 1°C and 30°C. Storing the medication this way can help maintain its efficacy for an extended period.

Appearance and packaging

Appearance

Light yellow rectangular film-coated sustained-release tablets

Package unit

30 tablets, 100 tablets per 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.