Trasetpen Tablet

Adult dose

Children aged 12 and older and adults: The dosage should be adjusted according to the level of pain and therapeutic response. The initial recommended dose is two tablets; thereafter, the dosing interval should be at least 6 hours, but not exceeding 8 tablets per day. Administer the lowest effective dose for the shortest duration possible. Avoid prolonged use beyond what is necessary, and if long-term treatment is required due to the characteristics and severity of the disease, regular monitoring should be performed to determine the continued administration of this medication. Elderly Administer the usual adult dose. However, for elderly patients aged 75 and older, when tramadol is administered orally, the elimination half-life of tramadol increased by 17%, so doses should be administered at intervals of at least 6 hours. Renal impairment patients For moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. For severe renal impairment (creatinine clearance of less than 10 mL/min), administration is not recommended. Tramadol is eliminated very slowly during hemodialysis and filtration, so there is no need to readminister this medication to maintain analgesic effect after dialysis. Liver impairment patients For moderate liver impairment, consider extending the dosing interval cautiously. Do not administer this medication to patients with severe liver impairment.

Child dose

Children aged 12 and older and adults: The dosage should be adjusted according to the level of pain and therapeutic response. The initial recommended dose is two tablets; thereafter, the dosing interval should be at least 6 hours, but not exceeding 8 tablets per day.

This medication can cause liver damage if taken by individuals who regularly consume more than three alcoholic beverages a day, so consultation with a physician or pharmacist is essential. One of the ingredients, acetaminophen, can occasionally cause serious skin reactions; if a rash or hypersensitivity occurs, discontinue use immediately. The tramadol ingredient may increase the risk of seizures if taken above the recommended dosage or with certain antidepressants and narcotics, thus caution is required. Rarely, serious allergic reactions or anaphylaxis may occur during the use of this medication, so if abnormal symptoms appear, you must inform medical personnel immediately. Patients with acute or severe bronchial asthma may experience severe respiratory suppression when using this medication, so it should only be administered in a properly equipped medical facility. Caution is needed when taking this medication with alcohol or benzodiazepines, as it may cause severe sedation, respiratory suppression, or unconsciousness. Patients with elevated intracranial pressure or head injury should be careful when taking this medication, as it may increase intracranial pressure through respiratory suppression. Tramadol can cause physical and psychological dependence, so it is essential to closely monitor for dependency if taken long-term. Acetaminophen can cause severe liver damage if overdosed, so ensure that the total daily dosage does not exceed 4,000 mg, and patients with poor liver function should consult a physician before use. Patients with the genetic characteristic of being ultra-rapid metabolizers of CYP2D6 may overproduce the active metabolite, thereby increasing the risk of respiratory suppression; consultation with a physician and enhanced monitoring are necessary before use. Children under 12 years of age or adolescents under 18 years who have undergone tonsillectomy and adenoidectomy should not take this medication, and teenagers between 12 and 18 years old should avoid it if specific risk factors are present. This medication can induce sleep apnea or hypoxia, and the risk increases with higher doses, so continuous monitoring for symptom exacerbation is necessary, and dosage should be reduced or discontinued if needed. Elderly patients or those at risk of hyponatremia should be monitored for the occurrence of hyponatremia while taking this medication. This medication may interact with certain drugs, particularly MAO inhibitors, serotonin-acting drugs, CYP3A4 and CYP2D6-related medications, central nervous system depressants, and warfarin, so caution and consulting with a physician are necessary. The safety for the fetus during pregnancy is not established, so it should only be used when the benefits outweigh the risks, and it is advisable for breastfeeding women to avoid taking this medication. Caution is required when driving or operating machinery, as this medication can cause drowsiness or dizziness. In case of overdose, serious symptoms such as respiratory suppression, seizures, and liver damage can occur, requiring immediate emergency treatment and, if necessary, administration of an antidote. This medication should be stored out of reach of children, and care should be taken to prevent abuse or accidental ingestion.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, trouble breathing, asthma attack, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination issues

Mild side effects

• Decreased appetite
• insomnia
• depression
• dizziness
• headache
• drowsiness
• nausea
• vomiting
• constipation
• dry mouth

This medication should be stored in a tightly sealed container to prevent air ingress. Additionally, avoid storing in excessively hot or cold places; it is best kept at room temperature between 1 to 30 degrees Celsius.

Appearance

Pale yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle