What Are the Signs of a Vancomycin Overdose?

Vancomycin hydrochloride for injection, the indication is suitable for methicillin-resistant Staphylococcus aureus and other bacterial infections: sepsis, infective endocarditis, osteomyelitis, arthritis, burns, surgical trauma, etc. Superficial secondary infection, pneumonia, lung abscess, empyema, peritonitis, meningitis.

Vancomycin hydrochloride for injection, the indication is suitable for methicillin-resistant Staphylococcus aureus and other bacterial infections: sepsis, infective endocarditis, osteomyelitis, arthritis, burns, surgical trauma, etc. Superficial secondary infection, pneumonia, lung abscess, empyema, peritonitis, meningitis.

Drug Name

Vancomycin hydrochloride for injection

Drug type

Prescription drugs, medicines for medical workers' injuries

Use classification

Antibiotics

Vancomycin Hydrochloride Ingredients for Injection

Chemical name: (1S, 2R, 18R, 19R, 22S, 25R, 40S) -50- [2-O- (3-amino-2,3,6-trideoxy-3-C-methyl-- L-pyranosyl) --D-glucopyranosyloxy] -22-carbamoylmethyl-5,15-dichloro-2,8,32,35,37-pentahydroxy-19 -{(2R) -4-methyl-2- (methylamino) pentanamido} -20,23,26,42,44-pentaox-7,13-dioxa-21,24,27, 41,43-pentaazaoctacyclic [26.14.2.23, 6.214, 17.18, 12.129, 33.010, 25.034, 39] Fifty (carbon) -3, 5, 8, 10, 12 (50), 14, 16, 29 , 31,33 (49), 34, 36, 38, 45, 47-pentadecene-40-carboxylic acid monohydrochloride chemical structural formula:

Molecular formula: C ₆₆ H ₇₅ Cl ₂ N ₉ O ₂₄ HCl
Molecular weight: 1486

Characteristics of Vancomycin Hydrochloride for Injection

This product is white powder or lyophilized block.

Indications for vancomycin hydrochloride for injection

This product is suitable for infections caused by methicillin-resistant Staphylococcus aureus and other bacteria: sepsis, infective endocarditis, osteomyelitis, arthritis, burns, surgical trauma and other superficial secondary infections, pneumonia, lung Abscesses, empyema, peritonitis, meningitis.

Vancomycin Hydrochloride Specifications for Injection

500mg / bottle

Vancomycin hydrochloride for injection

Vancomycin hydrochloride is usually used at 2g (titer) per day, which can be divided into 500mg every 6 hours or 1g every 12 hours. Each intravenous drip is more than 60 minutes. It can be increased or decreased according to age, weight and symptoms. The elderly are 500mg every 12 hours or 1g every 24 hours, and each intravenous drip is more than 60 minutes. For children and infants, 40 mg / kg per day is divided into 2 to 4 intravenous drips, each drip is more than 60 minutes. The dose for each newborn is 10-15mg / kg. The newborn is administered once every 12 hours within one week of birth. The newborn is administered once every eight hours from one week to one month. Each intravenous drip is more than 60 minutes.
The preparation method is to add 10 mL of water for injection to a vial containing this product to dissolve it, and dilute it with at least 100 mL of physiological saline or 5% glucose injection, and the intravenous drip time is more than 60 minutes.

Adverse reactions of vancomycin hydrochloride for injection

Of the 107 subjects who were evaluated for safety at the time of review, 33 patients (30.8%) who had abnormal changes in their clinical examination values were found. At the end of the retrial, their clinical examination values were found in 3009 subjects who were evaluated for safety. There were 404 side effects with abnormal changes (13.43%).
(The frequency of side effects is based on the data at the end of the review and re-examination and our research report.)
Major side effects :
1) Shock and allergy-like symptoms (less than 0.1%): Because shock and allergy-like symptoms (dyspnea, flushing, edema, etc.) can occur, you should pay attention to observation. If symptoms occur, stop administration and take appropriate measures. .
2) Acute renal insufficiency (0.5%), interstitial nephritis (unknown frequency): Because of important renal dysfunction such as acute renal insufficiency and interstitial nephritis, it is necessary to carry out regular inspections. Good to stop administration, if you must continue to use the drug, you should reduce the dose carefully and give the drug.
3) A variety of cytopenias (less than 0.1%), agranulocytosis, and oligocytopenia (unknown frequency): due to the occurrence of aplastic anemia, neutropenia, and oligocytopenia, stop if abnormalities are found. Dosing and taking appropriate measures.
4) Skin and mucosal syndrome (Stevens-Johnson syndrome), toxic epidermal necrosis (Lyell syndrome), exfoliative dermatitis (unknown frequency): due to the appearance of skin and mucosal syndrome (Stevens-Johnson syndrome), poisoning Epidermal necrosis (Lyell syndrome) and exfoliative dermatitis should be observed carefully. If such symptoms occur, stop administration and take appropriate measures.
5) No. 8 brain nerve injury (less than 0.1%): Since symptoms of no. 8 brain nerve injury such as dizziness, tinnitus, and hearing may occur, hearing tests are necessary, and if the above symptoms appear, it is best to stop administration. It must be continued, and it should be administered carefully.
6) Pseudomembranous colitis (frequency unknown): Due to severe enteritis such as pseudomembranous colitis with bloody stool, stop administration when symptoms of abdominal pain and diarrhea occur, and take appropriate measures.
7) Hepatic impairment, jaundice (unknown frequency): As AST (GOT), ALT (GPT), AFP rises, and jaundice, regular inspection is necessary. If abnormalities occur, stop drug administration and take appropriate measures. .
Other side effects :

Vancomycin hydrochloride for contraindications

Patients with a previous history of anaphylactic shock are contraindicated.
The following patients are not to be administered in principle, and they need to be careful if they have special needs:
1. Patients with previous allergies to this product and glycopeptide antibiotics and aminoglycoside antibiotics.
2. Deafness caused by glycopeptide antibiotics and aminoglycoside antibiotics and other deaf patients (can make deafness worse).
The following patients should be administered with caution:
1. Patients with impaired renal function (due to delayed excretion and drug accumulation, the drug concentration in the blood should be monitored carefully, see Drug Dynamics)
2. Patients with impaired liver function (can increase functional impairment)
3. Elderly patients (see 5. Medication for elderly patients, drug dynamics)
4. Low birth weight infants and newborns (see 7. Medication for children, drug dynamics)

Precautions for vancomycin hydrochloride for injection

Basic precautions 1. This product is clearly effective against methicillin-resistant Staphylococcus aureus infection, but its effectiveness has not yet been determined for non-oral administration of staphylococcal enteritis.
2. It is hoped that the blood drug concentration can be monitored during the treatment. <br /> Relevant usage and dosage:
1. Rapid bolus injection or intravenous infusion of this drug within a short period of time can cause histamine release to cause side effects such as red man syndrome (face, neck erythema congestion, pruritus, etc.), hypotension, etc., so each intravenous infusion should be within 60 minutes the above.
2. Renal function impairment and elderly patients should adjust the dosage and interval, and monitor the drug concentration in the blood carefully (see 1. Careful administration, 5. Elderly medication, drug dynamics)
3. In order to prevent the generation of drug-resistant bacteria after using this drug, the sensitivity of the bacteria should be clarified in principle. Attention should be paid to the use of the drug within the minimum period necessary for treatment.
Dispensing: At present, it has been clarified that mixing this product with the following injections will cause drug changes, so it cannot be mixed. Mixing with aminophylline and 5-fluorouracil can cause the appearance to change, and the drug titer can be significantly reduced when the time is extended.
Administration:
1. Because it can cause thrombophlebitis, it is necessary to pay great attention to the concentration of the drug solution and the speed of the intravenous drip, and the intravenous drip site should be replaced when the intravenous drip is repeated.
2. Leakage of the medicinal solution outside the blood vessel can cause necrosis, so care should be taken when administering the drug, not to leak out of the blood vessel.
Route of administration: Intramuscular injection can be accompanied by pain, so it cannot be injected intramuscularly.
Other matters needing attention: There are reports of rapid intravenous infusion of this drug causing cardiac arrest.

Vancomycin hydrochloride for injections for pregnant and lactating women

For pregnant women and women suspected of having a pregnancy, the safety associated with pregnancy administration has not been established. Breastfeeding mothers should avoid administering the medicine, if necessary, stop breastfeeding (this medicine can be excreted in breast milk).

Vancomycin hydrochloride for children

Children's kidneys are in the developmental stage, especially for low birth weight infants and newborns. The blood half-life of the drug is prolonged and the high concentration of the blood drug lasts for a long time. Therefore, the blood drug concentration should be monitored and administered carefully.

Vancomycin hydrochloride for injection

Due to weakened renal function in the elderly, renal function should be checked before and during administration, the amount and interval of medication should be adjusted according to the degree of weakened renal function, the blood concentration should be measured, and the drug should be administered carefully.

Vancomycin Hydrochloride Drug Interactions for Injection

Vancomycin hydrochloride overdose for injection

Symptoms: Kidney damage such as acute renal insufficiency may occur. Deafness and other symptoms of the 8th nerve damage.
Treatment: There have been reports of a decrease in plasma concentration after hemodialysis using HPM.

Pharmacology and Toxicology of Vancomycin Hydrochloride for Injection

Antibacterial effect : In vitro drug sensitivity tests, vancomycin is effective against methicillin-resistant Staphylococcus aureus (MRSA) and has no cross-resistance with other types of antibacterial drugs. Vancomycin also has low induced resistance. In in vitro drug sensitivity tests, vancomycin was not effective against Gram-negative bacteria.
Mechanism of action : Vancomycin can inhibit the synthesis of bacterial cell walls and has a bactericidal effect. In addition, it can also change the permeability of bacterial cell membranes and hinder the synthesis of bacterial RNA.

Pharmacokinetics of Vancomycin Hydrochloride for Injection

Blood concentration monitoring : In order to ensure the effectiveness of the drug and avoid the occurrence of side effects, it should be combined with long-term patients, low birth weight infants, newborns and young children, and drugs that can cause kidney and hearing damage (aminoglycoside antibiotics, etc.) It is best for patients to monitor their blood levels. The blood concentration is 25-40 g / mL after 1-2 hours after the end of the intravenous drip, and the minimum blood concentration (valley value, value before the next dose) should not exceed 10 g / mL. It is reported that the end of the intravenous drip is 1-2 hours. After the blood concentration is 60-80 g / mL or more, the minimum blood drug concentration continues to exceed 30 g / mL or more, and side effects such as kidney and hearing impairment may occur.
Administration in patients with impaired renal function: Patients with impaired renal function compared to healthy individuals. The half-life of the drug concentration in the blood is prolonged, and it is necessary to modify the dosage of the drug. From Figure 1, the correction value of the dosage can be calculated based on the creatinine clearance.

Blood concentration :
(1) Healthy adults (drug concentration and pharmacokinetic parameters in plasma)

(2) Pediatric patients (drug concentration and pharmacokinetic parameters in intravenous drip)

(3) Patients with low birth weight (pharmacokinetic parameters)
The half-life of low birth weight infants, especially ultra-low birth weight infants weighing less than 1000 g, is significantly longer.

(4) Elderly (Plasma drug concentration and pharmacokinetic parameters during intravenous drip)

(5) Patients with impaired renal function (drug concentration and pharmacokinetic parameters in plasma)
Reduced renal function is accompanied by prolonged half-life. AUC increases, so it is necessary to adjust the dose and interval according to the degree of renal impairment.

Distribution : This product can penetrate into bone marrow, bone tissue, joint fluid and ascites. In addition, this product can also penetrate into cerebrospinal fluid during meningitis.
Metabolism : More than 90% of this drug is excreted from the urine without change for 72 hours after intravenous drip, and the metabolites of this product are unknown.
Excretion : This product is mainly excreted by glomerular filtration, and the cumulative urine excretion rate in healthy adults is 500mg (potency), 1.0g (potency) (each n = 6) after 60 minutes of intravenous drip. 24 hours after the end was about 85% of the dose, 72 hours after the intravenous drip was more than 90% of the dose, and the total clearance was 10 mL / min.
Others : Serum protein binding rate: The serum protein binding rate of healthy adults was determined by centrifugation filtration method when 1.0 g (titer) of this product was dripped.

Vancomycin Hydrochloride Storage for Injection

Store at room temperature (1 to 30 ° C). The prepared solution should be used as soon as possible. If it must be stored, it can be stored in room temperature and refrigerator for 24 hours.

Vancomycin Hydrochloride Packaging for Injection

1 bottle / box; 10 small boxes / big boxes.

Vancomycin hydrochloride for injection

24 months

Vancomycin hydrochloride for injection

JX20020308 ^[1]