Tagonin Kit Injection (Teicoplanin)

Adult administration

This medicine should be administered as follows, adjusted according to the type and severity of infection, the patient's clinical response, sex, and renal function. 1. Adults and elderly patients with normal renal function Skin and soft tissue infections Pneumonia Complicated urinary tract infections Initial dose: 400 mg (6 mg/kg) by intravenous injection every 12 hours for 3 doses Maintenance dose: 6 mg/kg by intravenous injection once daily Bone and joint infections Initial dose: 800 mg (12 mg/kg) by intravenous injection every 12 hours for 3 ∼ 5 doses Maintenance dose: 12 mg/kg by intravenous injection once daily Infective endocarditis Initial dose: 800 mg (12 mg/kg) by intravenous injection every 12 hours for 3 ∼ 5 doses Maintenance dose: 12 mg/kg by intravenous injection once daily For patients weighing > 85 kg, calculate and administer the dose per kg of body weight. The duration of administration should be determined based on clinical response. For infective endocarditis, treatment for 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 In 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 half the initial dose daily. 2) Severe renal impairment (patients with creatinine clearance less than 30 mL/min) and patients undergoing 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) by intravenous injection once, followed by 20 mg per L of dialysis solution: in every dialysis bag during the first week, every other bag during the second week, and only in the overnight bag during the third week. Preparation of injection solution (kit injection product) : The kit injection product is for intravenous infusion only. Connect the transfer needle and dissolve the product in the supplied diluent (normal saline for injection), then administer by intravenous infusion (see “12. Instructions for dissolving the kit injection product” under Precautions for Use). <Method of administration> May be administered by intravenous infusion over 30 minutes. The frequency of administration is generally once daily; however, in severe infections, two doses should be given on the first day of treatment to reach the target blood concentration rapidly. Most infections caused by susceptible strains respond to treatment within 48 ∼ 72 hours. The total duration of treatment is determined by the type and severity of infection and the patient's clinical response. Measurement of serum concentrations of this medicine can help optimize treatment. In severe infections, the minimum serum 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. The relationship between serum concentration and toxicity has not been established.

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 is a glass ampoule injection, so care should be taken to open the ampoule as glass shards may mix in. Extra caution is necessary when used in children or the elderly. This drug can cause serious allergic reactions, for example, anaphylactic shock which can be life-threatening, so if any allergic symptoms occur, administration should be immediately halted and emergency treatment sought. During the infusion process, symptoms such as facial or neck redness or itching may appear. If these symptoms occur, slowing down or stopping the infusion may alleviate them, so it should be infused slowly over more than 30 minutes by intravenous drip. Rarely, severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if a severe rash or ulcer develops on the skin, administration should be stopped immediately. This drug may be toxic to the ears and kidneys, so patients with impaired kidney function or those using it for long periods should undergo regular hearing tests and blood, liver, and kidney function tests. If the initial dosing is high, adverse effects should be closely monitored, and serum creatinine levels must be checked. This drug poses a risk of seizures if administered intrathecally, so it should never be administered this way. Patients allergic to this drug or any component should not use it. Patients with allergies to specific antibiotics, hearing impairment, kidney or liver dysfunction, and elderly patients should be especially cautious when using this drug. Generally, this drug has few side effects and is well tolerated, but gastrointestinal symptoms such as nausea, vomiting, diarrhea, changes in blood pressure, dizziness, and hearing loss may occur. While administering this drug, attention should be paid to hypersensitivity reactions such as skin rash, itching, fever, and difficulty breathing, and if abnormal symptoms arise, medical personnel should be notified immediately. To prevent the development of resistant bacteria, it is recommended to use it only for the minimum duration necessary for treatment. Especially patients with renal failure or those on long-term administration should ensure regular tests for hearing and liver and kidney function, as taking other drugs that can cause nephrotoxicity or ototoxicity along with this drug can worsen side effects. Pregnant or breastfeeding women should use this drug only when its benefits exceed its risks, and it is not yet known if this drug is transmitted through breast milk. This drug can cause dizziness and headache, so caution is needed when driving or operating machinery. In cases of overdose, symptoms such as thrombocytopenia or anxiety may occur, and it cannot be removed by dialysis but can only be slowly removed by peritoneal dialysis, so symptomatic treatment should be obtained in the event of an overdose. This drug should only be administered by intravenous injection, and due to the risk of cerebral convulsions, it should not be administered by any other route. After preparing the solution, it should be used immediately, and any remaining solution should be discarded within 24 hours even if stored at 4 degrees Celsius. Before use, the packaging condition and the state of the solvent must be checked and should not be used if any abnormality is found.

• Hypersensitivity reaction
• anaphylactic shock
• Red Man syndrome
• shock
• nausea
• vomiting
• diarrhea
• increased blood pressure
• palpitations
• decreased blood pressure

This drug should be stored in a sealed container to avoid contact with air and kept in a cool place out of direct sunlight and heat, at a temperature below 25 degrees Celsius. Storing it this way will help maintain the drug's effectiveness and prevent degradation.

Appearance

A kit injection consisting of a colorless, transparent glass vial containing a white to light yellow powder and a colorless, transparent polyethylene container containing the solvent.

Package unit

1 kit (1 vial part + 1 solvent part) × 10