Apentrasemi Tablets (Tramadol Hydrochloride, Acetaminophen)

Adult dose

Children over the age of 12 and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. An initial dose of 4 tablets is recommended, with subsequent doses at intervals of at least 6 hours, but not exceeding 16 tablets in one day. The effective lowest dose should be given for the shortest possible duration. Do not administer this medication for longer than necessary based on the nature and severity of the illness, and when long-term use is required, regular monitoring should be conducted to verify the continuation of this medication. Elderly: Administer the conventional adult dosage. However, in elderly patients over 75 years old, the half-life of tramadol may increase by 17% when taken orally, so intervals should be at least 6 hours apart. Renal impairment patients: In moderately impaired renal patients (creatinine clearance of 10-30 mL/min), extend the administration interval to 12 hours. This medication is not recommended for severely impaired renal patients (creatinine clearance less than 10 mL/min). Tramadol is removed very slowly by hemodialysis and filtration, so there is no need to re-administer this medication post-dialysis to maintain analgesic effect. Hepatic impairment patients: For moderately impaired hepatic patients, carefully consider extending the administration interval. Do not administer to severely impaired hepatic patients.

Child dose

Children over the age of 12 and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. An initial dose of 4 tablets is recommended, with subsequent doses at intervals of at least 6 hours, but not exceeding 16 tablets in one day.

This medicine may burden the liver, so individuals who regularly consume three or more alcoholic beverages daily should consult with a physician or pharmacist before taking it. The acetaminophen component in this medication can rarely cause serious skin reactions, so if skin rashes or allergic symptoms occur, discontinue use immediately and consult a healthcare provider. The tramadol component may increase the risk of seizures if the recommended dosage is exceeded, and the risk may be higher if taken with certain antidepressants or narcotics, so caution is advised. There may rarely be life-threatening allergic reactions while taking this medication, so if symptoms such as difficulty breathing or severe hives develop, notify healthcare personnel immediately. For patients with acute or severe asthma, this medication may risk respiratory suppression, so it should only be administered in a facility equipped with medical equipment, and other non-narcotic analgesics should be considered. Taking this medicine with other central nervous system depressants or alcohol may intensify sedation or respiratory depression, so combination should be avoided or taken under the guidance of a healthcare professional. Patients with head injuries or neurological disorders should be cautious, as it may increase intracranial pressure or inhibit breathing. The tramadol component may cause psychological and physical dependence, so careful monitoring for signs of dependence is necessary during prolonged use. Patients with impaired liver function may face risks of liver damage while taking this medication, so consultation with a physician is essential before use. Individuals with certain genotypes may metabolize this medication faster, increasing the risk of respiratory suppression; therefore, dosage adjustments and monitoring for abnormal symptoms are needed. This medication should not be administered to children under 12 years or to adolescents under 18 years post-surgery, and caution is required for patients with sleep apnea. Taking this medication may lead to hyponatremia, so especially elderly patients or those with risk factors should observe symptoms closely. While taking this medication, do not exceed the recommended dosage and avoid taking with other medications containing tramadol or acetaminophen. Suddenly stopping this medication may cause withdrawal symptoms, so taper the dosage gradually as directed by a physician. Women who are pregnant or breastfeeding should consult a physician before taking this medication, as it may affect the fetus or newborn. This medication may cause drowsiness or dizziness, so caution is necessary when driving or operating machinery. In case of overdose, serious side effects such as respiratory depression, seizures, or liver damage may occur, so strictly adhere to the prescribed dosage and contact emergency services if needed. This medication should be stored out of reach of children, and to prevent drug misuse, it should not be shared with others.

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in the mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with coughing and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, reduced urine output.

Mild side effects

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

Store this medication in a sealed container to prevent air or moisture from entering, and it is recommended to keep it at room temperature between 1°C and 30°C. This will help maintain the medication's effectiveness and prevent deterioration.

Appearance

Pale yellow rectangular film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle