Each 500mg vial contains vancomycin hydrochloride active ingredient 512.57mg equivalent to vancomycin 500mg
Each 1g vial contains vancomycin hydrochloride active ingredient 1,025.14mg equivalent to vancomycin 1g
Powder for injectable solution
VANCOTEX 500mg: 1 powder vial of 500mg vancomycin/box
VANCOTEX 1g: 1 powder vial of 1g vancomycin/box
VANCOTEX is used in patients critically ill with infections caused by Gram(+) bacteria which are resistant to the com¬monly used antibiotics and in patients who are allergic to penicillin. It is particularly recommended for the treatment of infections caused by methicillin-resistant Staphylococci. If a response is not obtained with vancomycin another agent may also be given.
VANCOTEX is recommended alone, or in association with gentamycin, as an alternative to penicillin in the treatment or prophylaxis of endocarditis; in association with an aminoglycoside for the treatment of peritonitis in patients on CAPD; or it may added to regimens for the treatment of febrile episodes in neutropenic patients. It may also be used for the prophylaxis of infection in surgical procedures.
VANCOTEX is administered in the treatment of staphylococcal enterocolitis and antibiotic-associated colitis. It has also been investigated for the treatment of other syndromes of diarrhoea or colitis which may be associated with the overgrowth of Clostridium difficile. VANCOTEX is considered the mainstay for treatment of serious infections due to methicilline-resistant Staphylococci. There is disagreement as to the value of adding rifampicin to treatment with vancomycin, due in part to conflicting in vitro data on the efficacy of such a combination and uncertainty as to the clinical significance of these findings. VANCOTEX may also be used in association with an amynoglycoside since in vitro and animal studies have indicated that aminoglycoside may increase the anti-bacterial of vancomycin. Most methicillin-resistant staphylococcal infections are treated initially with vancomycin alone, and a second agent, such as an aminoglycoside, rifampicin, or fusidic acid, added if the patient fails to respond. Injectable VANCOTEX may be given orally in the treatment of antibiotic-associated colitis; intravenous treatment is unreliable and should not be used. Since the clinical studies on efficacy of vancomycin given i.v. have not been conducted, this route of administration has been recommended by both American Heart Association and American Dental Association, in bacterial endocarditis in penicillin-allergic patients affected by congenital or rheumatic valvular cardiac diseases when undergoing dental or superior-respiratory tract surgeries.
DOSAGE AND ADMINISTRATIONS
* Adults: The usual adult dose is 500mg of vancomycin every 6 hours or 1g every 12 hours, diluted with physiological or a 5% glucose solution. Therapeutic response is generally verified in 48-72 hours. The treatment duration should be adjusted with respect to the disease and other clinical infection circumstances. In staphylococcal endocarditis the recommended duration of treatment is at least 3 weeks.
* Children may be given 44mg per kg body-weight daily in divided doses (every 6 hours). The quantity of diluted solution must be enough for a 24-hour administration.
* Neonates and nurslings may be given an initial dose of 15mg per kg body-weight followed, in neonates, by 10mg per kg body-weight every 12 hours in the first week of life, and every 8 hours up to one-month age. Each infusion should be used over 60 minutes. In these patients serum-vancomycin concentrations should be monitored (see the following SPECIAL WARNINGS AND PRECAUTIONS).
* Oral administration: VANCOTEX is administered orally in adults in the treatment of antibiotic-associated pseudo¬membranous colitis in a dose of 500 mg to 2g daily divided in 3-4 doses for the period of 7-10 days. It has also be investigated for the treatment of other syndromes of diarrhoea or colitis which may be associated with the overgrowth of Clostridium difficile.
This medicine should not be given to patients who have had historic hypersensitivity to vancomycin or any other components and formulation.
SPECIAL WARNINGS AND PRECAUTIONS
VANCOTEX causes tissue necrosis and should not be injected intramuscularly. It is given parenterally by intravenous infusion; 500mg of vancomycin should be given in at least 100 ml of fluid and infused over not less than 60 minutes to minimise thrombophlebitis and other adverse effects associated with rapid administration. It should be used with extreme caution in patients with renal insufficiency or who have a history of hearing loss. Adjustment of the parenteral dose, according to the frequent determinations of serum-vancomycin concentrations, has been advised particularly in patients with renal impairment or in premature infants. Monitoring of auditory function is advised, especially in elderly patients. Haematological status and kidney and liver function should be assessed periodically in all patients. Other ototoxic or nephrotoxic drugs should be used concurrently only with extreme caution. Since vancomycin is poorly absorbed, toxicity is much less of a problem following oral administration than with the intravenous route.
* Use in Pediatrics: VANCOTEX should be given with caution in premature neonates and infants due to renal immaturity and possible increase of serum-vancomycin concentrations. In these patients, blood-vancomycin levels should be at¬tentively monitored. In concomitant administration of vancomycin and anaesthetic drugs, in small children, cutaneous erythema, histamine-like rashes and anaphylactoid reactions have been attributed to vancomycin.
* Use in Geriatrics: Physiological decrease of glomelural filtration in elderly patients may, in case of unadjusted doses, provoke elevation of blood vancomycin levels. Prolonged treatment may provoke bacterial-resistant and drug-insensitive uncontrolled proliferation. A patient should be attentively observed. Clostridium difficile- pseudomembra¬nous colitis has rarely been observed in patients who received intravenous VANCOTEX. Clinically significant serum concentrations have been observed in patients who received multiple oral vancomycin in the treatment of Clostridium difficile-associated pseudomembranous colitis. In case of superinfection an appropriate therapy should be instituted. Subcutaneous or intramuscular VANCOTEX should be avoided since it may cause pain, irritation and tissues necrosis. Intravenous VANCOTEX is recommended avoiding possible extravasation. However, with intravenous VANCOTEX thrombophlebitis has sometimes been observed. Incidence of these phenomena may be decreased if the rate of infu¬sion is decreased (from 2,5 to 5 g/l), changing the site of infusion. Bolus administration may, in a few minutes, provoke severe hypotension, shock and rarely cardiac arrest. To avoid these effects intravenous infusion should be effected over the period not less than 60 minutes, controlling cardiac rate and arterial pressure. The incidence of possible hypotension, erythema, urticaria and pruritus is more frequent if anaesthetic agents are concomitantly administered. e effects may be decreased if VANCOTEX is given by slow infusion over 60 minutes prior to the use of anaesthetic.
Safety and efficacy of intrathecal VANCOTEX has not been sufficiently evaluated.
VANCOTEX, after being initially reconstituted, may be kept in refrigerator for 14 days. Any further dilution is stable for 24 hours if kept at room temperature.
Topical or systemic concomitant or followed-by treatments with oto-nephrotoxic and/or nephrotoxic agents (ami¬noglycosides, amphotericin B, bacitracin, cisplatin, colistin, polimycin B) should be avoided particularly in patients with hypoacusis and renal insufficiency existed before the treatment. Concomitant administration of VANCOTEX and anaesthetic drugs may provoke cutaneous erythema, histamine-like rashes and anaphylactoid reactions.
USE IN PREGNANCY AND LACTATION
Safety of VANCOTEX in pregnancy, lactation and early infancy has not been sufficiently evaluated. However, the drug should be administered in an absolute necessity, when according to a physician, possible benefits are superior to the eventual risks.
EFFECT ON DRIVING AND OPERATION MACHINES
No interference on driving and operating machines
Febrile reactions, nausea, chills, skin rashes, eosinophilia, and alterations in kidney function may occur, and anaphy¬laxis and neutropenia have been reported rarely. Trombocytopenia has been rarely observed. Reports of neutropenia indicate that it is reversible with interruption of the treatment. Hypersensitivity reaction may be verified in 5-10% of treated patients. Ototoxicity and nephrotoxicity have been observed (see SPECIAL WARNINGS AND PRECAUTIONS).
* Ototoxicity Hearing loss has been associated with the administration of VANCOTEX. Most of these patients have had renal disfunction or hypoacusis or have been concomitantly treated with an ototoxic drug. Tinnitus and dizziness have rarely been observed.
* Nephrotoxicity Renal insufficiency has rarely been observed in patients underwent VANCOTEX elevated doses, ap¬pearing generally as either serum-creatinine concentration or blood urea nitrogen concentration increment. Interstitial nephritis has rarely been reported, frequently appearing in patients who were receiving concomitant therapy with aminoglycosides or with pre-existing renal disfunction. After the interruption of VANCOTEX treatment, blood nitrogen has been normalised in most patients.
* Infusion-correlated effects During and after a rapid VANCOTEX infusion (less than 60 minutes) the following reac¬tions may be observed:
1. Body and neck erythematous eruption with possible neck eruption, accompanied by dyspnea, respiratory sibilus, urticaria and pruritus. “Red neck syndrome” has been reported
2. Hypotension syndrome appearing in reducing systolic pressure from moderate to severe level
3. Spastic dolorous syndrome has been rarely observed characterised by acute pulsating pain attacks and thoracic or paraspinal musculature spasms.
These reactions may generally be managed within 20 minutes but may persist for a few hours as well. These effects are less frequent if VANCOTEX is administered by slow infusion (more than 60 minutes). Effects that are correlated to infusion may refer to both concentration and rate of VANCOTEX administration. Concentrations not exceeding 5 mg/ml and infusion rate less than 10 mg/min are recommended in adults. Concentrations up to 10 mg/ml may be administered in patients requiring restrictions to the fluids contribution. In high concentrations the risk of events correlated to the infusion may increase. Effects correlated to the infusion may, however, be verified at any concentration and infusion rate.
Phlebitis inflammation on the site of injection has been reported.
Anaphylaxis, exfoliative dermatisis, Stevens-Johnson Syndrome and vasculitis have rarely been reported.
In case of overdosage it is recommended to maintain the glomerular filtration. Vancomycin has been rarely withdrawn from dialysis. Increase of vancomycin-clearance has been reached by hemofiltration with polysulphonic resin. In the treatment of overdosage, the possibility of overdosage caused by other drugs or uncommon pharmacokinetics of the patient should be considered.
SHELF-LIFE AND STORAGE
Prior to reconstitution, the product packaged for dispensing and stored at room temperature 15 degree C – 30 degree C has a shelf life of 24 months.
After dilution, the solution may be kept in refrigerator from +2 degree C to +8 degree C for 14 days at maximum.
* Preparation of the solution:
Add 10ml of water for injection into the vial containing 500mg of the drug or 20ml of water for injection into the vial containing 1g of the drug. Intermittence intravenous administration (the most preferable route)
Add to the solution obtained as described above (containing 500mg and 1g, respectively) 100ml and 200ml of a 5% physiological or glucose solution, respectively. Intravenous infusion is given over not less than 60 minutes (see Side Effects) and repeated at 6-hour intervals.
1. Continuous infusion administration (to be instituted only when intermittent route is not possible): The quantity of the solution of one or two vials obtained as above (1-2g) is to be added to the quantity of a 5 % physiological or glucose solution required for a 24-hour, drop-wise, slow infusion.
2. Oral administration: The content of 1vial (500mg) may be diluted in approx. 50ml of water and given by a nose-gastric probe.
TO BE USED IN HOSPITALS AND NURSERY HOUSES ONLY, NOT FOR PUBLIC USE.
KEEP OUT OF THE REACH OF CHILDREN
READ THE LEAFLET CAREFULLY BEFORE USE
For further information, consult your physician.