Itrafen Tablets

Adult dose

Children over 12 years of age and adults: Dosage should be adjusted according to the patient's level of pain and therapeutic response. A loading dose of 4 tablets is recommended, and subsequent dosing intervals should be at least 6 hours apart, with a maximum of 16 tablets per day. The effective minimum dosage should be administered for the shortest period necessary. Avoid administering this medication for longer durations than necessary, and if long-term use is required due to the nature and severity of the condition, regular monitoring should be conducted to assess the need for continued use of this medication. Elderly Administer the typical adult dosage. However, for elderly patients over 75, the elimination half-life of tramadol may be increased by 17%, so it should be administered with intervals of at least 6 hours. Renal Impairment For moderately impaired renal patients (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. It is not recommended for severely impaired renal patients (creatinine clearance of less than 10 mL/min). Tramadol is removed very slowly during hemodialysis and filtration, therefore, no re-dosing is necessary to maintain analgesic effect post-dialysis. Hepatic Impairment For moderately impaired hepatic patients, consider extending dosing intervals carefully. It is not to be administered to severely impaired hepatic patients.

Child dose

Children over 12 years of age and adults: Dosage should be adjusted according to the patient's level of pain and therapeutic response. A loading dose of 4 tablets is recommended, and subsequent dosing intervals should be at least 6 hours apart.

This medication may place stress on the liver, so individuals who frequently consume alcohol in excess of a certain amount daily should consult a doctor or pharmacist before taking it. While taking this medication, severe rashes or allergic reactions may occur, so it is important to discontinue use and consult a doctor immediately if symptoms such as skin rashes or itching develop. One of the ingredients in this medication can trigger seizures; hence, patients with a history of seizures or those at high risk for seizures should use it cautiously. The risk of seizures may increase when taken with certain specific medications. Rarely, severe allergic reactions may occur after taking this medication, so immediate medical attention should be sought if symptoms such as difficulty breathing or hives appear. In acute asthma patients, the use of this medication may lead to severe respiratory distress, so it should only be administered in a setting where medical personnel are present. Taking this medication with alcohol or sedatives may result in severe drowsiness, respiratory depression, or coma, therefore, combination should be avoided or undertaken only under medical supervision. Patients with head injuries or brain disorders may experience severe symptoms such as respiratory depression while taking this medication, and caution is warranted. This medication can cause physical and psychological dependence, so strict adherence to dosage and duration as instructed by a physician is necessary for long-term use. Patients with impaired liver function should consult a physician before taking this medication, as one of its ingredients may stress the liver. Patients with specific genetic characteristics may metabolize this medication rapidly, increasing the risk of side effects; therefore, monitoring is required. This medication is not to be used in children under 12 years of age or in children after certain surgeries, and adolescents between 12 and 18 years should avoid it if they possess certain risk factors. This medication may cause sleep apnea or hypoxia; if such symptoms occur or worsen, consideration should be given to dosage adjustment or discontinuation in consultation with a doctor. Rarely, during the course of taking this medication, low serum sodium levels may occur, so especially in elderly patients or those with risk factors, regular checks of their condition should be performed. This medication is not to be administered to individuals allergic to its specific components, those with central nervous system drug addiction, severe respiratory depression, head injuries, or those taking certain other medications. This medication may cause drowsiness or dizziness, so caution should be exercised when driving or operating machinery. In case of overdose, serious respiratory depression, seizures, liver damage, etc., may occur, so prescribed dosages should be strictly adhered to, and emergency treatment should be obtained if overdose is suspected. When storing this medication, keep it in a safe place out of reach of children and take care to avoid confusion with other medications.

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash accompanied by fever, blisters, skin peeling, pain in the oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

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 that permits little air exchange and kept at room temperature between 1 to 30 degrees Celsius. This will help maintain the drug's efficacy for a longer duration.

Appearance

Pale yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle