AstraSet Tablet

Adult dose

Children over 12 years of age and adults: The dosage is adjusted according to the patient's pain level and therapeutic response. It is recommended to start with a dose of 2 tablets, and thereafter, the dosing interval should be at least 6 hours, but should not exceed 8 tablets in one day. The valid minimum dosage should be administered for the shortest duration possible. This medication should not be used for longer than necessary, and where prolonged administration is needed due to the nature and severity of the disease, regular monitoring should be performed to confirm whether continued administration of this medication is appropriate. Elderly patients Standard adult dosages should be applied. However, in elderly patients over 75 years, oral administration of tramadol has been found to increase the elimination half-life by 17%, hence this medication should be administered at intervals of at least 6 hours. Patients with renal impairment For moderate renal impairment (creatinine clearance of 10-30 ml/min), the dosing interval should be extended to 12 hours. Severe renal impairment (creatinine clearance of less than 10 ml/min) is not recommended for this medication. Tramadol is removed very slowly during hemodialysis, so it is not necessary to re-administer this medication to maintain analgesic effect post-dialysis. Patients with hepatic impairment In patients with moderate hepatic impairment, it is advisable to carefully consider extending the dosing interval. This medication should not be administered to patients with severe hepatic impairment.

Child dose

The same dosage regimen applies to children over 12 years of age and adults.

This medication may pose a risk of liver damage for individuals who regularly consume more than three alcoholic drinks per day, so consultation with a physician or pharmacist is essential. Serious skin reactions may occur rarely due to the acetaminophen component; therefore, if a skin rash or hypersensitivity reaction develops, discontinue use immediately. The tramadol component may increase the risk of seizures, particularly when taken with certain antidepressants or narcotics, so caution is advised. Rarely, severe allergic reactions like anaphylaxis may occur; thus any unusual symptoms should prompt immediate medical attention. For patients with acute and severe bronchial asthma, respiratory depression may pose a risk, so administration should only occur in a professional setting. Combination of this medication with alcohol or central nervous system depressants can lead to severe sedation and respiratory depression, so it should be avoided or used with extreme caution. Patients with elevated intracranial pressure or head injuries should be cautious as this medication could worsen brain pressure. Tramadol has the potential for physical and psychological dependence; thus, long-term use should be carefully monitored for signs of dependence. Patients with impaired liver function are at risk of liver damage due to the acetaminophen component, and consultation with a physician is required before use. Particularly for patients with rapid drug metabolism due to CYP2D6 gene variants, there is an increased risk of serious side effects such as respiratory depression. Children under 12 years old or those under 18 years old who have undergone tonsillectomy or adenoidectomy should not be administered this medication, and adolescents aged 12 to 18 should avoid it if risk factors are present. Patients with sleep apnea or hypoxia may experience worsening of their condition while taking this medication, therefore continuous evaluation and possible dose reduction or discontinuation is necessary. Elderly patients or those at risk of hyponatremia should be monitored for the development of hyponatremia. This medication can interact with specific drugs increasing the risk of seizures, serotonin syndrome, respiratory depression, and therefore it is crucial to check for drug interactions with any ongoing medications. Women who are pregnant or may become pregnant should thoroughly discuss the benefits and risks of this medication with their physician before use; it is advisable for breastfeeding women to avoid this medication. Drowsiness or dizziness may occur with use, so caution is required when driving or operating machinery. In the case of overdose, serious respiratory depression, seizures, or liver damage may occur, so do not exceed the recommended dosage, and seek immediate medical assistance in the event of overdose. This medicine should be stored in a secure place out of reach of children, and precautions should be taken to prevent misuse and abuse.

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, seizures, asthmatic attack, respiratory abnormalities accompanying cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and very severe headache, thunderclap headache, confusion, visual disturbances, paralysis, significantly reduced urine output, severe symptoms overall

Mild side effects

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

This medication should be stored in a tightly closed container to prevent air exposure and kept at room temperature between 1 to 30 degrees Celsius. This storage method will help maintain the effectiveness of the medication and prevent deterioration.

Appearance

Pale yellow oblong film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle