Tycosin Injection (Teicoplanin)

Adult administration

1. Adults and elderly patients without impaired renal function Skin and soft tissue 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 Pneumonia: 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 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 and administered according to the patient's body weight (kg). The duration of administration should be determined based on the clinical response. For infective endocarditis, a treatment duration of at least 21 days is appropriate. Treatment should not exceed 4 months. 4. Elderly patients Dose adjustment is not necessary unless renal impairment is present. 5. Adults and elderly patients with renal impairment When administering to patients with renal impairment, dose reduction is not necessary through Day 4; however, dosage adjustment is required to maintain a minimum serum trough concentration of 10 mg/L. After Day 4 of administration 1) Mild to moderate renal impairment (creatinine clearance 30 ∼ 80 mL/min): Halve the dose by administering the initial unit dose every 2 days or by administering 1/2 of the initial dose daily. 2) Severe renal impairment (patients with creatinine clearance below 30 mL/min) and patients on hemodialysis: Administer the initial unit dose every 3 days or administer 1/3 of the initial dose once daily. This medicine is not removed by dialysis. Patients receiving continuous ambulatory peritoneal dialysis If the patient has a fever, administer a loading dose of 400 mg (6 mg/kg) once by 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; however, for severe infections, administer twice on the first day of treatment to rapidly achieve the target blood concentration. In severe infections, the serum trough concentration should not be less than 10 mg/L. The peak concentration measured 1 hour after intravenous administration of 400 mg is usually in the range of 20 ∼ 50 mg/L, and a concentration of up to 250 mg/L has been reported after intravenous administration of 25 mg per kg of body weight.

Child administration

2. 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. 3. 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.

Caution must be taken when administering this drug using glass ampoule injections as glass fragments may be included, especially when administering to children and the elderly. This drug can cause serious allergic reactions, such as life-threatening hypersensitivity reactions like anaphylactic shock, hence it should be injected immediately when allergy symptoms appear, and appropriate emergency measures should be taken. When administering this drug, slow the infusion rate to prevent infusion-related reactions, such as red man syndrome, and rapid intravenous injection should be avoided. Rarely, severe reactions on the skin may occur, so administration should be stopped immediately if symptoms such as red spots, blisters, or mucosal damage appear. Patients with impaired kidney or liver function, long-term administration, or those taking nephrotoxic or ototoxic medications with this drug should regularly monitor and test hearing, blood, liver, and kidney function. This drug should never be administered intraventricularly due to the risk of seizures. Patients with allergies to this drug or its components should not be administered. Special caution is required for patients who have had allergic reactions to antibiotics of a similar class previously. Care should be taken when administering to elderly patients, those with poor hearing, or those with impaired kidney or liver function. While this drug is generally well-tolerated, side effects such as nausea, vomiting, diarrhea, hypotension, reversible agranulocytosis, leukopenia, neutropenia, thrombocytopenia, thrombocytosis, eosinophilia, dizziness, tinnitus, hearing loss, deafness, vestibular disorders, headache, ALT, AST, ALP, LDH, γ-GTP, total bilirubin elevation (including liver dysfunction), serum creatinine elevation, renal failure, rash, itching, fever, stiffness, bronchospasm, and erythema may occur. Caution is advised when driving or operating machinery if symptoms like dizziness or headache occur. In case of overdose, symptoms such as thrombocytopenia and anxiety may occur, and this drug is not removed by hemodialysis but should be gradually removed by peritoneal dialysis. The duration of this drug should be determined by confirming the susceptibility of the infecting bacteria and administering it only for the minimum necessary period. It should be administered to pregnant or breastfeeding women only when the potential benefits are judged to outweigh the risks. The dissolved solution should be used immediately, and any remaining solution should be discarded within 24 hours, even if stored at 4 degrees Celsius. Proper methods for dissolution and dilution should be followed when administering this drug, and the infusion should be performed slowly as a drip intravenous injection.

• Hypersensitivity
• anaphylactic shock
• shock
• red man syndrome
• mucocutaneous syndrome
• toxic epidermal necrolysis
• ototoxicity
• hematologic toxicity
• hepatotoxicity
• nephrotoxicity

This drug should be stored in a sealed container to prevent contact with air, and it is important to store it in a cool place out of direct sunlight or heat at temperatures below 25 degrees Celsius. By doing so, the efficacy of the drug can be maintained and deterioration can be prevented.

Appearance

A colorless and transparent vial containing a white to light yellow freeze-dried substance and a colorless and transparent ampoule containing a colorless and transparent solution.

Package unit

200mg/vial x 1 (diluent: 3mL/ampoule x 1)