Vancolife

Each vial contains Vancomycin hydrochloride, USP 1 g.
White to faint yellowish brown lyophilized powder filled in colorless, clear glass vials.

Pharmacology: Pharmacodynamics: Vancomycin is a glycopeptide antibiotic derived from Nocardia orientalis (formerly Streptomyces orientalis) and is active against many Gram-positive bacteria, including Staphylococcus aureus, Staph. Epidermidis, alpha and beta haemolytic streptococci, Group D streptococci, corynebacteria and clostridia.
Pharmacokinetics: Vancomycin is not significantly absorbed from the normal gastrointestinal tract and is therefore not effective by the oral route for infections other than staphylococcal enterocolitis and pseudomembranous colitis due to Clostridium difficile.
Toxicology: Although no long-term studies in animals have been performed to evaluate carcinogenic potential, no mutagenic potential of vancomycin was found in standard laboratory tests. No other definitive fertility studies have been performed.
Microbiology: The bacterial action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis.
Vancomycin is not active in vitro against gram-negative bacilli, mycobacteria, or fungi.
In foreign study, cross-sensitivity with teicoplanin has been reported.
In domestic study (in 2001), resistance of Enterococcus faecalis (1%) and Enterococcus faecium (16%) for vancomycin has been reported.

Susceptible strains: Streptococci, Staphylococci, Clostridium difficile, Diphtheroids.
Usage: Secondary superficial infections such as endocarditis, osteomyelitis, arthritis, peritonitis, meningitis, burn and operative wound.
Pneumonia, Sepsis, Pulmonary pyosis, Empyema thoracis.
Severe infections which have failed to respond to the penicillins or cephalosporins.
Enterocolitis and antibiotic-associated pseudomembranous colitis caused by Clostridium difficile (treatment by oral administration).

Adults: The usual intravenous dose is 500 mg every 6 hours or 1 g every 12 hours.
Children: The paediatric dosage of Vancomycin is calculated on the basis of 10 mg/kg bodyweight every six hours. In neonates and young infants, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours in the first week of life and every 8 hours thereafter until one month of age.
The majority of patients with infections caused by organisms susceptible to the antibiotic show therapeutic response by 48-72 hours. The total duration of therapy is determined by the type and severity of the infection and the clinical response of the patient. In staphylococcal endocarditis, therapy for three weeks or longer is recommended.
Adults with impaired renal function and the elderly: Dosage adjustment must be made in patients with impaired renal function. In premature and the elderly, dosage reduction may be necessary to a greater extent than expected because of decreasing renal function. (See table.)

Click on icon to see table/diagram/image

The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given in order to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. Since individual maintenance doses of 250-1,000 mg are convenient, 1 dose may be given every several days rather than on a daily basis in patients with marked renal impairment. In anuria, a dose of 1,000 mg every 7-10 days has been recommended.
The following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance: See equation.

Click on icon to see table/diagram/image

The serum creatinine must represent a steady state of renal function. Such as calculated clearance is an overestimate of actual clearance in patients with conditions: characterized by decreasing renal function, such as shock severe heart failure, or oliguria; in which a normal relationship between muscle mass and total body weight is not present, such as obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.
Oral administration for enterocolitis and antibiotic-associated pseudomembranous colitis caused by Clostridium difficile: Vancomycin hydrochloride is administered orally for the treatment of staphylococcal enterocolitis and antibiotic-associated pseudomembranous colitis (produced by C. difficile).
Vancomycin hydrochloride is not effective by the oral route for other types of infections. In systemic infection, it is administered by intravenous injection. The usual adult total daily dosage for antibiotic associated pseudomembranous colitis produced by C. difficile is 500 mg to 2 g in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.
Appropriate dose may be diluted in 30 g of distilled water and given to the patient to drink, or the diluted material may be administered via nasogastric tube. Dosage adjustment is based on age, body weight and symptoms.

Symptoms: Renal impairment such as acute renal failure or 8th the eighth cranial nerve disorder such a deafness may occur.
Treatment: Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion clearance. The median lethal intravenous dose is 319 mg/kg in rats and 400 mg/kg in mice.

Patients with a history of shock with this drug.
Patients with known hypersensitivity to this drug, peptide or aminoglycoside antibiotic.

This drug should be used with caution in the following patients: In general rule, this drug should not be used to patients with auditory disorder caused by peptide and aminoglycoside antibiotics or with other auditory disorder. However, if inevitable, it should be used with caution.
Patients with renal dysfunction such as acute urinary retention (since excretion is prolonged, serum level should be monitored with caution).
Patients with hepatic impairment (Hepatic impairment may be manifested or aggravated).
Elderly.
Premature, newborn.
Patients with cochlea damage or vestibular organ damage.
General Cautions: To prevent the development of drug-resistant bacteria, susceptibility should be confirmed and it is recommended to use vancomycin during the minimum period.
Vancomycin should be used with caution in patients with renal insufficiency because the risk of toxicity is appreciably increased by high, prolonged blood concentrations. The dose should be reduced according to the degree of renal impairment. In order to minimize the risk of nephrotoxicity when treating patients with underlying renal dysfunction or patients receiving concomitant therapy with an aminoglycoside, serial monitoring of renal function should be performed and particular care should be taken in following appropriate dosing schedules.
When oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis, if symptoms including diarrhea, belly ache and pyrexia, are not clearly improved within 7-10 days, discontinue therapy.
Prolonged use of this medicine may result in the overgrowth of nonsusceptible organism. If superinfection occurs during therapy, appropriate measures should be taken.
Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity.
In the therapy, blood levels test, urinalysis and renal function tests should be performed regularly. Patients who will undergo prolonged therapy with this medicine or those who are receiving concomitant drugs causing neutropenia should have periodic monitoring of the leukocyte count.
Use in Children: Caution should be exercised in prematures, neonates and infants who are under developmental stage of kidney because high blood concentration can persist for a long time by prolonged half life.
Use in the Elderly: Because elderly usually has decreased renal function, dosage reductions may be necessary.
Therefore, regular renal function should be taken and dosage should be reduced according to the degree of renal impairment.

Reproduction studies in rats and rabbits at doses up to 5 and 3 times the maximum recommended human dose (MRHD), respectively, have revealed no teratogenic effects.
In a controlled clinical study, the potential ototoxic and nephrotoxic effects of this medicine on infants were evaluated when the drug was administered to pregnant women for serious staphylococcal infections complicating intravenous drug abuse. This medicine was found in cord blood. No sensorineural hearing loss or nephrotoxicity attributable to this medicine was noted.
One infant whose mother received this medicine in the third trimester experienced conductive hearing loss that was not attributed to the administration of this medicine. Because the number of patients treated in this study was limited and this medicine was administered only in the second and third trimesters, it is not known whether this medicine causes fatal harm.
The women who are pregnant or considering pregnancy should be administered only if the therapeutic benefits justify the potential risks. If needed, administration requires careful monitoring of blood concentration for reducing the risk of fetal toxicity.
Avoid using vancomycin to nursing mother because vancomycin is excreted in human milk. However, if inevitable, discontinue nursing.

Psychoneurotic: Careful observation is required because shock or anaphylactoid reaction may occur rarely. If undesirable effects occur, administration is discontinued and appropriate measures are taken.
Gastrointestinal: Rarely watery stool, diarrhea, nausea, vomiting, or stomach ache may occur.
Haematological: Erythrocytopenia, leukocytopenia, thrombocytopenia and eosinophilia may uncommonly occur. Reversible neutropenia has rarely been reported, but it appears to be promptly reversible when this medicine is discontinued. Reversible agranulocytosis (granulocytes <500/mm3) has been reported rarely, although causality has not been established.
Central Nervous System: Rarely 8th the eight cranial disorder including dizziness, tinnitus or hearing loss may occur. Close observation should be taken with auditory function test. In the event of such symptom, therapy should be discontinued. However, if inevitable, therapy should be taken with caution. Hearing loss associated with vancomycin has been reported in patients with kidney dysfunction, pre-existing hearing loss or concomitant treatment with an ototoxic drug.
Hepatic: Because elevations in bilirubin, AST, ALT and ALP, rarely elevations of LDH, y-GTP and LAP may occur, close monitoring including periodic examination should be taken. In the onset of undesirable event, appropriate measures including drug discontinuation are taken.
Renal: Renal failure, principally manifested by increased serum creatinine or BUN concentrations, may occur. Therefore, periodic tests should be given with careful observation. In the events of adverse reactions, therapy should be discontinued. But inevitable, careful administration including dosage reduction should be required.
Rare cases of interstitial nephritis have been reported in patients who were given aminoglycosides concomitantly or who had pre-existing kidney dysfunction. When vancomycin hydrochloride was discontinued, azotemia resolved in most patients.
Dermal: Exfoliative dermatitis, bullous dermatitis, Steven-johnson syndrome and toxic epidermal necrolysis may occur. In the event of such symptom, appropriate measures are taken.
Hypersensitivity: Rash, flare, facial flushing, Hypotension, wheezing, dyspnea, urticaria, pruritus, etc. may occur. In the event of such symptom, appropriate measures are taken. Rapid infusion may also be associated with pain and muscle spasm of the chest and back or the red neck or red man syndrome (characterized by erythematous hemorrhage over the face, neck, and body). These reactions usually resolve within 20 minutes but may persist for several hours. In animal studies, hypotension and bradycardia occurred in animals given large doses of vancomycin at high concentrations and rates. Such events are infrequent if vancomycin is given by slow infusion over 60 minutes. In studies of normal volunteers, infusion-related events did not occur when vancomycin was administered at a rate of 10 mg/min.
Others: Uncommonly pyrexia, angialgia and phlebitis, rarely nausea, chills and angiitis may occur. Pseudomembranous colitis due to Clostridium difficile has been rarely reported in patients with intravenous infusion of vancomycin.
The following adverse reactions have been identified during domestic post-approval use of vancomycin.
Skin: maculopapular rash, purpura (purpuric eruption), follicular eruption.
Hepatobiliary: Jaundice.
Injection site: Rash.

Concomitant administration of vancomycin and anesthetic agents may enhance anaphylactoid reactions including erythema, histamine-like flushing, hypotension, wheezing, dyspnea, urticaria or pruritus. However, such reactions may be minimized by the administration of vancomycin as a 60-minute infusion prior to anaesthetic induction.
Concurrent or sequential systemic or topical use of other potentially neurotoxic or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, cisplatin, Nedaplatin when indicated, requires careful monitoring.
Change in INR: In patients who received antibiotics including vancomycin with anticoagulant concurrently, increased anticoagulant effect has been reported. Infectious disease (including inflammatory process), age and general condition of patients are the risky factors. Although drug interaction between vancomycin and warfarin has not been established through clinical trials, INR monitoring should be instituted, Dosage of anticoagulant should be adjusted if necessary. (Some kind of antibiotics, in particular fluoroquinolone, macrolide, cycline, co-trimoxazole and some cephalosporin it is necessary.)

This medicine is irritating to tissue and pain, tenderness, and necrosis occur with intramuscular injection of vancomycin or inadvertent extravasation. Therefore, this medicine must be given by a secure intravenous route of administration.
If administered in higher concentrations, there is the possibility of thrombophlebitis. The frequency and severity of thrombophlebitis can be minimized by administering the drug slowly as a dilute solution (2.5 to 5 g/L) and by rotating the sites of infusion.
Rapid bolus administration (e.g., over several minutes) may be associated with hypotension and, rarely, cardiac arrest. Vancomycin should be administered over a period of not less than 60 minutes to avoid rapid-infusion-related reactions.
Stopping the infusion usually results in prompt cessation of these reactions.
The safety and efficacy of this drug administration by the intrathecal (intralumbar or intraventricular) routes have not been assessed.
Vancomycin hydrochloride solutions have a low pH and may cause chemical or physical instability when mixed with other compounds. This medical product must not be mixed with alkaline solution.
Mixtures of solution of vancomycin and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to dilute to adequately flush the intravenous lines between the administration of these antibiotics. It is also recommended to dilute solutions of vancomycin to 5 mg/mL or less.
Although intravitreal injection is not an approved route of administration for vancomycin, precipitation has been reported after intravitreal injection of vancomycin and ceftazidime for endophthalmitis using different syringes and needles. The precipitates dissolved gradually, with complete clearing of the vitreous cavity over two months and with improvement of visual acuity.
Prior to administration, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution or container permits.

Store at temperatures not exceeding 30°C.
Shelf life: 24 months from manufactured date.

Other Antibiotics

J01XA01 - vancomycin ; Belongs to the class of glycopeptide antibacterials. Used in the systemic treatment of infections.

Rx