Tafosin Injection (Teicoplanin)

Adult administration

Adults and elderly patients with normal renal function Skin and soft tissue infections, pneumonia, complicated urinary tract infections: Loading dose of 6 mg/kg intravenously or intramuscularly every 12 hours for 3 doses; maintenance dose of 6 mg/kg intravenously or intramuscularly once daily Bone and joint infections: Loading dose of 12 mg/kg intravenously every 12 hours for 3 ∼ 5 doses; maintenance dose of 12 mg/kg intravenously or intramuscularly once daily Infective endocarditis: Loading dose of 12 mg/kg intravenously every 12 hours for 3 ∼ 5 doses; maintenance dose of 12 mg/kg intravenously or intramuscularly once daily The dose should be calculated according to the patient's body weight (kg). The duration of administration should be determined based on clinical response. For infective endocarditis, administration for at least 21 days is appropriate. The treatment period should not exceed 4 months. Elderly patients: No dose adjustment is necessary unless renal impairment is present. Adults and elderly patients with renal impairment: In patients with renal impairment, dose reduction is not required through Day 4; however, dosage adjustment is required to maintain a minimum serum trough concentration of 10 mg/L. After Day 4 of treatment Mild to moderate renal impairment (creatinine clearance 30 ∼ 80 mL/min): Reduce the dose by half by administering the initial unit dose every 2 days or by administering half the initial dose daily. Severe renal impairment (patients with creatinine clearance below 30 mL/min) and patients undergoing hemodialysis: Administer the initial unit dose every 3 days or administer one-third of the initial dose once daily. This drug is not removed by dialysis. Patients undergoing continuous ambulatory peritoneal dialysis: If the patient has a fever, administer a loading dose of 400 mg (6 mg/kg) as a single intravenous injection, followed by 20 mg per L of dialysate in every dialysis bag during the first week, in alternate bags during the second week, and only in the overnight bag during the third week. Administration is generally once daily, but for severe infections, two doses should be administered on the first day of treatment to rapidly achieve the target blood concentration. For severe infections, the serum trough concentration should not be below 10 mg/L. The peak concentration measured 1 hour after intravenous administration of 400 mg is generally in the range of 20 ∼ 50 mg/L; a peak concentration of 250 mg/L has been reported after intravenous administration of 25 mg per kg of body weight.

Child administration

Children (2 months ∼ 12 years of age): Administer an initial dose of 10 mg/kg intravenously every 12 hours for 3 doses, followed by a maintenance dose of 6 ∼ 10 mg/kg intravenously once daily. Neonates (up to 2 months of age): Administer an initial dose of 16 mg/kg by intravenous infusion once on the first day, followed from the next day by a maintenance dose of 8 mg/kg once daily by intravenous infusion over 30 minutes.

This drug may cause glass fragments to enter when using glass ampoule injections, so great care must be taken when cutting the injection container. Extra caution is required when administering to children and the elderly. Hypersensitivity reactions may occur with this drug, and in severe cases, life-threatening anaphylactic shock may occur, so administration must be stopped immediately and emergency measures taken if allergic symptoms develop. Patients with allergies to similar classes of drugs should also be cautious. During the infusion, red-man syndrome with redness or itching on the face, neck, or body may occur, so if these symptoms arise, the infusion should be stopped or administered slowly. Rapid infusion should be avoided. Severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, may appear, so if abnormalities in the skin and mucous membranes are observed, the use of the drug must be stopped immediately. Adverse reactions such as hearing impairment, blood disorders, liver dysfunction, and renal dysfunction have been reported, and patients with impaired kidney or liver function or those receiving long-term administration should regularly undergo hearing, blood, liver, and kidney function tests. The dose should be carefully adjusted at the time of initial administration, and blood creatinine levels should be confirmed. This drug should not be administered intraventricularly as it may induce seizures. Patients with allergies to this drug or its components should not receive it. Patients with allergies to specific antibiotic classes, those with hearing loss, patients with decreased kidney or liver function, and the elderly should exercise additional caution when administering this drug. The side effects of this drug are generally mild and temporary, but rarely serious symptoms such as shock, gastrointestinal symptoms, blood disorders, neurological disturbances, and skin reactions may occur, so any abnormal symptoms should be reported to medical personnel immediately. When using this drug, it is advisable to conduct sensitivity testing to prevent the occurrence of resistant strains and to administer it only for the minimum necessary period. Patients with decreased kidney function or those taking nephrotoxic or ototoxic drugs with this drug are at increased risk of side effects, so they must be closely monitored. Pregnant or breastfeeding women should only use this drug when the benefits outweigh the risks, and it is not known whether it passes into breast milk. This drug may cause dizziness and headaches, so caution is required when driving or operating machinery. In case of overdose, thrombocytopenia or anxiety symptoms may occur, and this drug is not removed by hemodialysis; therefore, symptomatic treatment should be administered in case of overdose. This drug is contraindicated for intraventricular administration, and after dissolution, it should be used immediately, with any remaining solution discarded within 24 hours.

• Hypersensitivity reaction
• anaphylactic shock
• shock
• Red Man syndrome
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• ototoxicity
• hematotoxicity
• hepatotoxicity
• nephrotoxicity

This drug should be stored in a sealed container to prevent contact with air and in a cool place away from direct sunlight or heat, specifically at or below 25 degrees Celsius. Storing it this way helps maintain the drug's effectiveness and prevent degradation.

Appearance

A colorless and transparent vial containing white or light yellow freeze-dried powder

Package unit

1 vial (200 mg potency) x 10 per carton