Apenra Tablets

Adult dose

Children over 12 years and adults: The dose should be adjusted based on the patient's level of pain and therapeutic response. It is recommended to start with a dose of 2 tablets, and subsequent doses should be at least 6 hours apart, not exceeding 8 tablets in one day. The effective minimum dose should be administered for the shortest possible duration. This medication should not be administered for longer than necessary, and if long-term use is required due to the nature and severity of the condition, regular monitoring should be conducted to confirm the continued administration of this medication. Elderly Administer the usual adult dose; however, in patients over 75 years old, tramadol’s elimination half-life is extended by 17%, thus doses should be given at least 6 hours apart. Renal impairment In patients with moderate renal impairment (creatinine clearance 10-30 ml/min), extend the dosing interval to every 12 hours. In cases of severe renal impairment (creatinine clearance less than 10 ml/min), administration is not recommended. Tramadol is removed very slowly by dialysis, so re-administration of this medication after dialysis for pain relief is unnecessary. Hepatic impairment In patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval. For patients with severe hepatic impairment, this medication should not be administered.

This medication may cause liver damage if taken by individuals who regularly consume more than three drinks a day, so it should be discussed with a doctor or pharmacist. The acetaminophen component has been rarely associated with severe skin reactions, so if a rash or hypersensitivity occurs, discontinue use immediately. The tramadol component increases the risk of seizures if the recommended dose is exceeded, and the risk is even higher when combined with certain antidepressants or narcotics. Patients with a history of seizures or epilepsy should be especially cautious while taking this medication. In addition, severe allergic reactions like anaphylaxis have been reported very rarely, so any unusual symptoms should be reported to healthcare providers immediately. Patients with acute and severe bronchial asthma face a risk of respiratory depression, and should only be administered in a monitored environment. This medication may cause sedation, respiratory depression, or coma if taken with central nervous system depressants or alcohol; thus, co-administration should be avoided or used very cautiously. Patients with increased intracranial pressure or head injuries may experience worsening symptoms due to respiratory depression, so caution is required. Tramadol can lead to physical and psychological dependence, so long-term use requires careful monitoring for signs of dependency. Patients with impaired liver function face a higher risk of hepatotoxicity with this medication, so they must consult a doctor before use, ensuring they do not exceed recommended acetaminophen levels. For ultra-rapid metabolizers of CYP2D6, increased plasma levels of active metabolites may heighten the risk of respiratory depression, necessitating dosage adjustment and monitoring. This medication should not be administered to children under 12 years of age or to adolescents under 18 years who have undergone tonsillectomy or adenoidectomy. In cases of sleep apnea or hypoxia, symptoms may worsen after taking this medication, so changes in symptoms should be closely monitored. Patients at risk for hyponatremia should regularly check their blood sodium levels while taking this medication. This medication is contraindicated in certain patient populations, especially those with hypersensitivity to the components, severe respiratory depression, head injuries, or those taking MAO inhibitors. When taking this medication, do not exceed the recommended dose, and do not combine it with other acetaminophen or tramadol formulations. Sudden discontinuation of this medication may lead to withdrawal symptoms, so dosage should be tapered off gradually when stopping. During treatment, closely monitor for symptoms of seizures, allergic reactions, or respiratory difficulties. Also, be cautious while driving or operating machinery, as drowsiness or dizziness may occur. In cases of overdose, serious respiratory depression, seizures, or liver damage may occur, so emergency treatment should be sought immediately.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory issues accompanying cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, vision problems, paralysis, urination difficulties

Mild side effects

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

Store this medication in a tightly closed container to prevent air exposure. It is best to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature. This will help maintain the effectiveness of the medication.

Appearance

Pale yellow rectangular film-coated tablets

Package unit

300 tablets per bottle, 30 tablets per bottle