Vancomycin Hydrochloride for Injection

Vancomycin is a glycopeptide narrow-spectrum antibiotic produced by Streptomyces Orientalis. It is mainly effective against Gram-positive bacteria, such as Staphylococcus aureus and Staphylococcus epidermidis (including methicillin-resistant strains), streptococci (including pyogenic Streptococcus, pneumoniae, agalactiae, and viridans), Corynebacterium, Clostridium (highly sensitive to Clostridium difficile), Actinomycetes, Streptococcus, Bovine Streptococcus, Enterococcus, and diphtheroid bacteria. In vitro tests showed that the strains sensitive to this product include Listeria monocytogenes, Lactobacillus, Actinomyces, Clostridium and Bacillus. The MIC for most sensitive bacteria is 0.1-2 mu;g/ml. It is ineffective against Gram-negative rods, mycobacteria or fungi. In vitro tests showed that this product has a synergistic antibacterial effect against enterococci when used in combination with aminoglycoside antibiotics. Vancomycin exerts a rapid bactericidal effect by inhibiting the synthesis of bacterial cell walls. However, its site of action is different from that of penicillins and cephalosporins. It mainly inhibits the synthesis of cell wall glycopeptides, and may also change the permeability of bacterial cell membranes and selectively inhibit RNA biosynthesis. This product does not compete with penicillins for binding sites. Bacteria are not easy to develop resistance to it, and there is no cross-resistance with other antibiotics, but recently, plasmid-mediated acquired resistance in enterococci has attracted attention. Toxicological effects: Although there are no long-term animal tests to prove the possibility of carcinogenicity, vancomycin has not been found to be mutagenic in regular laboratory tests, and no definite reproductive toxicity studies have been conducted. The LD50 of intravenous injection in mice is 400 mg/kg, the LD50 of intraperitoneal injection in mice is 1734 mg/kg, the LD50 of subcutaneous injection is 5600 mg/kg, and the LD50 of intravenous injection in rats is 319 mg/kg.

The main ingredient of this product is vancomycin hydrochloride.

This product is mainly used for intravenous infusion to treat infections caused by methicillin-resistant Staphylococci, patients who are allergic to penicillin, and patients who cannot use other antibiotics including penicillin and cephalosporins, or patients with infections caused by Staphylococci, Enterococci, Corynebacterium, Diphtheroids, etc., such as endocarditis, osteomyelitis, sepsis or soft tissue infections. It can also be used to prevent and treat arterial and venous blood shunt infections caused by Staphylococci in hemodialysis patients. This product is used orally to treat pseudomembranous colitis or staphylococcal enteritis caused by Clostridium difficile due to long-term use of broad-spectrum antibiotics.

Intravenous drip: The side effects caused by drip are related to the drug concentration and infusion speed. The recommended dosage for adults is 5 mg/kg, and the administration speed should not exceed 10 mg/min. For some patients who need to restrict fluid, the concentration of no more than 10 mg/kg can be used, but the use of high concentrations may increase the corresponding adverse reactions. However, adverse reactions may occur regardless of the concentration. Patients with normal renal function: Adults: The usual daily dose is 2g, which can be divided into 0.5g every 6 hours or 1g every 12 hours. Before use, dissolve 0.5g with 10ml of injection water, and then dilute with 100ml or more of 0.9% sodium chloride or 5% glucose injection. Each intravenous drip time should be at least 60 minutes or should be administered at a speed not higher than 10 mg/min. Please follow the doctor's advice for special circumstances. Children: The total amount is 10 mg/kg each time, drip once every 6 hours, and the administration time should be at least 60 minutes each time. Infants and newborns: The daily dose may be lower. For newborns and infants, the recommended initial dose is 15 mg per kilogram of body weight, and then 10 mg per kilogram of body weight; for newborns one week old, the dose is given every 12 hours, and for those one week to one month old, the dose is given every 8 hours, with each dose lasting at least 60 minutes. For such patients, their serum concentration of vancomycin should be closely monitored. Patients with renal insufficiency and the elderly: The dose must be adjusted for patients with renal insufficiency. If the creatinine clearance can be measured or accurately estimated, the dose for most patients with impaired renal function can be calculated using the following table. The daily dose of vancomycin is in mg, which is approximately 15 times the glomerular filtration rate (ml/min). Even for patients with mild to moderate renal insufficiency, the initial dose should not be less than 15 mg per kilogram of body weight. The above table does not apply to patients with functional nephropathy. For such patients, the initial dose should be 15 mg/kg body weight to achieve therapeutic serum concentrations immediately. The dose is 1.9 mg/kg/24 hr to maintain a stable concentration. For patients with severe renal insufficiency, since it is more convenient to give a single dose of 0.25 g to 1 g, the drug may be given once every few days instead of according to daily needs. For patients with anuria, it is recommended to give only 1 g of the dose within 7 to 10 days. When only serum creatinine data are available, the following formula (based on the patient's gender, weight, and age) can be used to calculate the creatinine clearance (ml/min). The calculated creatinine clearance is an estimated value. Male: Weight (kg) × (140-age) 72 × serum creatinine concentration (mg/dl) Female: 0.85 × The above serum creatinine data should represent the renal function in a stable state, otherwise the creatinine clearance value cannot be used. The following situations often lead to an overestimation of the patient's clearance (1) There are manifestations of impaired renal function, such as shock, severe heart failure or decreased urine output. (2) Patients with abnormal muscle-to-body weight ratio, such as obese patients or patients with liver disease, edema, and ascites. (3) Patients with weakness, malnutrition, or inability to move. Oral method: For pseudomembranous colitis caused by C. difficile and associated with the use of antibiotics, the daily total dose for adults is 0.5 g to 2 g, divided into 3 to 4 doses, and taken for 7 to 10 days. The daily total dose for children is 40 mg per kilogram of body weight, divided into 3 to 4 doses, and taken for 7 to 10 days. The total daily dose should not exceed 2 g. The required dose should be diluted with 30 ml of drinking water and then drunk by the patient. The diluted drug can also be administered nasally. Ordinary flavored syrups can also be added to the solution to improve the taste of the oral solution.

Side effects caused by intravenous infusion: Allergic reactions may occur during or after rapid intravenous infusion of vancomycin, including hypotension, wheezing, dyspnea, urticaria or itching. Rapid intravenous infusion may also cause flushing (red neck) or pain in the upper part of the body and muscle cramps in the chest and back. These reactions usually resolve within 20 minutes, but may also last for several hours. This situation rarely occurs if vancomycin is slowly infused for more than 60 minutes. In healthy subjects, adverse reactions are less likely to occur if the infusion rate is 10 mg/min or lower. Nephrotoxicity: In patients using this product, there are rarely cases of increased serum creatinine or BUN concentrations or interstitial nephritis. Such situations usually occur in patients who are taking aminoglycosides in combination or who originally have renal insufficiency. When vancomycin is discontinued, the azotemia of most patients can return to normal. Ototoxicity: There have been reports of hearing loss associated with the use of vancomycin. Most of these patients have renal dysfunction, pre-existing hearing loss, or are taking other ototoxic drugs at the same time. Dizziness, vertigo, and tinnitus have been reported rarely. Hematopoietic function: After 1 week or several weeks of vancomycin treatment, or after a total dose of more than 25 g, there have been reports of reversible neutropenia. When this product is discontinued, neutropenia can quickly return to normal. Reversible agranulocytosis (granulocytes; 500/mm3) has been reported rarely, and the cause is still unclear. Thrombocytopenia has been reported rarely. Phlebitis: It has been reported to occur at the injection site. Others: Allergic reactions, drug fever, chills, nausea, eosinophilia, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, and rarely vasculitis have occasionally occurred with the use of vancomycin.

It is contraindicated for people who are allergic to this product, those with severe liver or kidney dysfunction, and pregnant or lactating women.

1. Pay attention to the interaction with various drugs. The combination or sequential application with aminoglycosides, amphotericin B, aspirin and other salicylates, bacitracin for injection and bumetanide, capreomycin, carmustine, cisplatin, cyclosporine, ethacrynic acid, paromomycin and polymyxin drugs may increase ototoxicity and nephrotoxicity. If combined use is necessary, hearing and renal function should be monitored and dose adjustments should be made. When antihistamines, buclizine, cyclizine, phenothiazines, thioxanthenes and trimethobenzamide are used in combination with this product, ototoxic symptoms such as tinnitus, dizziness and vertigo may be masked. 2. It has been reported that the simultaneous use of vancomycin and anesthetics may cause erythema, histamine-like flushing and allergic reactions. 3. This product is incompatible with alkaline solutions and may precipitate when it encounters heavy metals.

Vancomycin hydrochloride for injection can be stored at room temperature 15°C to 30°C before reconstitution.

0.5 g (based on vancomycin)