Tamiu Selbasan 45 mg (Oseltamivir Phosphate)

Adult dosage

Influenza A and influenza B virus infections: Start treatment on the first or second day after influenza symptoms appear. This medicine may be taken with or without food; taking it with food may improve tolerability in some patients. Adults and adolescents 13 years of age and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine for dosing. Patients with renal impairment (treatment): No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with a creatinine clearance of 10 ~ 30 mL/min, a reduced dose of 30 mg once daily for 5 days is recommended. Patients receiving intermittent hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range, and treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may be given before dialysis begins. For peritoneal dialysis, a single 30mg dose of this medicine after dialysis is recommended. The pharmacokinetics of oseltamivir have not been studied in patients with end-stage renal disease who are not receiving dialysis (e.g., creatinine clearance less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dosage adjustment is required for treatment of adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prevention of influenza A and influenza B virus infections Adults and adolescents 13 years of age and older: For close contacts of an infected person, administer 75 mg of oseltamivir orally once daily for 10 days. Start administration within 2 days of contact with the infected person. The recommended dose for prevention during an influenza outbreak is 75 mg once daily. The safety and efficacy of this medicine have been demonstrated for up to 6 weeks. The preventive effect continues while the medicine is being taken. Patients with renal impairment (prevention): No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with a creatinine clearance of 10 ～ 30 mL/min, a reduced dose of 30 mg once daily every other day is recommended. Patients receiving intermittent hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. The first dose may also be given before dialysis begins. For peritoneal dialysis, administration of 30mg of this medicine after dialysis once weekly is recommended. The pharmacokinetics of oseltamivir have not been studied in patients with end-stage renal disease who are not receiving dialysis (e.g., creatinine clearance less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dosage adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Children's dosage

Treatment of influenza A and influenza B virus infections — Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take a 75mg capsule twice daily or a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this medicine. ≤ 15 kg: 30 mg (packet) twice daily 15 kg<, ≤ 23 kg: 45 mg (packet) twice daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg packets) twice daily > 40 kg: 75 mg (packet) twice daily Infants 2 weeks to less than 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age is 3mg/kg of this medicine orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. Pediatric patients who have difficulty taking this medicine as a powder should use the suspension. 3 kg: 9 mg twice daily; suspension (6mg/mL) dose 1.5mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL) dose 2.0mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL) dose 2.5mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL) dose 3.0mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL) dose 3.5mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL) dose 4.0mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL) dose 4.5mL twice daily 10 kg: 30 mg twice daily; suspension (6mg/mL) dose 5.0mL twice daily A dose of 3mg/kg of this medicine is recommended for children younger than 1 year. Prevention of influenza A and influenza B virus infections — Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take a 75mg capsule once daily or a 30mg capsule and a 45mg capsule once daily for 10 days instead of the recommended dose of this medicine. ≤ 15 kg: 30 mg (packet) once daily 15 kg<, ≤ 23 kg: 45 mg (packet) once daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg packets) once daily > 40 kg: 75 mg (packet) once daily The safety and efficacy of prevention of influenza A and B virus infections in children younger than 1 year have not been evaluated.

This medication is used to treat or prevent infections caused by influenza viruses. However, it cannot replace the influenza vaccination and should be used alongside annual vaccination. Efficacy has been demonstrated only against influenza A and B viruses, and it should not be used for other types of infections. Rare neuropsychiatric reactions, such as seizures or delirium, may occur in children and adolescents, so abnormal behavior should be closely monitored in this age group. As a principle, this medication should not be used in children over 10 years old except in special circumstances. Patients with allergies to this medication should not use it, and those with impaired kidney function may require dosage adjustment. It should be administered with caution to patients with asthma, chronic bronchitis, or immune suppression. Common side effects during treatment may include nausea, vomiting, headache, and pain, mostly temporary and mild. Rarely, symptoms like shock, anaphylaxis, liver dysfunction, skin rashes, acute renal failure, and neuropsychiatric disturbances may occur, and immediate consultation with healthcare personnel is necessary if abnormal symptoms appear. Pregnant or breastfeeding women should consider the limited information regarding the effects of this medication on the fetus or newborn and use it after careful consideration of the benefits and risks. Safety and efficacy in children, particularly infants under 1 year of age, have not been adequately established. No special dosage adjustments are necessary for elderly patients, but careful monitoring is required due to possible decline in physical function and multiple diseases. This drug contains sorbitol, making it unsuitable for patients with hereditary fructose intolerance. During treatment, one should be mindful of possible impairment caused by the influenza itself when driving or operating machinery. There is a low possibility of drug interactions with this medication, but caution is advised when combined with some drugs that may affect renal excretion. There are no specific antidotes for overdose, so it is important to visit a healthcare facility for appropriate treatment immediately. Keep out of reach of children and ensure it is not transferred to other containers.

• Convulsions
• delirium
• abnormal behavior
• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1°C and 30°C at room temperature.

Appearance

White or pale yellow powder

Package unit

10 packets/box