Tracom ER Tablets (Tramadol Hydrochloride, Acetaminophen)

Adult dose

The dosage is adjusted depending on the patient’s pain level and therapeutic response. The initial dose is recommended to be 1 tablet, with subsequent dosing intervals of at least 12 hours, not exceeding 4 tablets a day. Avoid long-term use of this medication beyond what is necessary, and if prolonged administration is needed due to the nature of the illness and severity, regular monitoring should be conducted to verify the ongoing need for this medication.

This medication may put stress on the liver, so individuals who regularly drink more than three alcoholic beverages a day should consult a doctor or pharmacist before taking it. One of the ingredients, acetaminophen, can rarely cause serious skin rashes or life-threatening skin reactions, so you should discontinue use immediately if any skin abnormalities occur. The main ingredient, tramadol, can increase the risk of seizures if the recommended dosage is exceeded, and the risk is further elevated when taken with certain antidepressants or other narcotics. For patients with severe respiratory conditions, this medication can suppress breathing; therefore, it should be administered in a facility equipped with medical equipment, and alternative pain relievers should be considered for those at risk of respiratory depression. When taken with alcohol or central nervous system depressants, this medication can cause severe drowsiness, respiratory depression, and coma, so extreme caution should be exercised, and it should be taken at the minimum effective dose for a short duration. Individuals with head injuries or brain diseases should be cautious, as this medication can increase intracranial pressure. This medication has the potential for dependence similar to opioids; therefore, regular monitoring for signs of dependence is essential during long-term use, and abrupt discontinuation can trigger withdrawal symptoms. Patients with impaired liver function must consult a physician before taking this medication and should ensure that the total daily intake of acetaminophen does not exceed 4,000 mg due to the risk of liver damage. This medication may cause severe side effects like respiratory depression in individuals with a rapid metabolic rate due to CYP2D6 genotype; such patients may require dose adjustments or alternative medications. This medication should not be administered to children under 12 years old or adolescents under 18 years old who have undergone tonsillectomy and adenoidectomy. It may also be advisable to avoid administering it to some adolescents between the ages of 12 and 18. This medication can cause hyponatremia, so elderly patients or those at risk for hyponatremia should closely monitor symptoms and signs during treatment. Patients with hypersensitivity to this medication, or those with central nervous system drug dependence, severe respiratory depression, head injuries, or taking MAO inhibitors should not take this medication. Pregnant or breastfeeding women should consult a doctor before taking this medication as it may pose risks to the fetus or newborn. Breastfeeding can transmit this medication through breast milk, leading to severe side effects such as respiratory depression in the infant. This medication can cause drowsiness or dizziness, thus caution is needed when driving or operating machinery. In case of overdose, severe respiratory depression, coma, and liver damage can occur, thus following the prescribed dosage strictly and contacting a medical institution immediately in case of overdose is crucial. Co-administration with other drugs may increase the risk of side effects due to drug interactions, so it is important to inform and consult with a doctor or pharmacist about any other medications being taken.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rashes with high fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by coughing and fever, jaundice (yellowing of skin or eyes), extreme drowsiness, sudden and severe headaches, lightning headaches, seizures, confusion of consciousness, visual disturbances, paralysis, urinary retention

Mild side effects

• Weakness
• fatigue
• flushing
• rigidity
• fainting
• withdrawal symptoms
• hypertension
• worsening hypertension
• hypotension
• arrhythmia

This medication should be stored in a tightly sealed container to protect it from air and moisture, maintaining a storage temperature between 1 to 30 degrees Celsius. Proper storage will help preserve the effectiveness of the medication and prevent deterioration.

Appearance

Light yellow oblong sustained-release film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle