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VANCOMYCIN is a brand name for Vancomycin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Intravenous administration Vancomycin is indicated in all age groups for the treatment of the following infections (see sections 4.2, 4.4 and 5.1): - complicated skin and soft tissue infections (cSSTI) - bone and joint infections - community acquired pneumonia (CAP) - hospital acquired pneumonia (HAP), including…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Where appropriate, vancomycin should be administered in combination with other antibacterial agents. Intravenous administration The initial dose should be based on total body weight. Subsequent dose adjustments should be based on serum concentrations to achieve targeted therapeutic concentrations.
Renal function must be taken into consideration for subsequent doses and interval of administration. Patients aged 12 years and older The recommended dose is 15 to 20 mg/kg of body weight every 8 to 12 h (not to exceed 2 g per dose).
In seriously ill patients, a loading dose of 25–30 mg/kg of body weight can be used to facilitate rapid attainment of target trough serum vancomycin concentration. 4). Term neonates (from birth to 27 days of post-natal age) and preterm neonates (from birth to the expected date of delivery plus 27 days).
For establishing the dosing regimen for neonates, the advice of a physician experienced in the management of neonates should be sought. 4) PMA (weeks) Dose (mg/kg) Interval of administration (h) <29 15 24 29-35 15 12 >35 15 8 PMA: post-menstrual age [time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (post-natal age)].
Peri-operative prophylaxis of bacterial endocarditis in all age groups The recommended dose is an initial dose of 15 mg/kg prior to induction of anaesthesia. Depending on the duration of surgery, a second vancomycin dose may be required.
Duration of treatment Suggested treatment duration is shown in table below. In any case, the duration of treatment should be tailored to the type and severity of infection and the individual clinical response. Indication Treatment duration Complicated skin and soft tissue infections -Non necrotizing - Necrotizing 7 to 14 days 4 to 6 weeks* Bone and joint infections 4 to 6 weeks** Community-acquired pneumonia 7 to 14 days Hospital-acquired pneumonia, including ventilator-associated pneumonia 7 to 14 days Infective endocarditis 4 to 6 weeks*** *Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours **Longer courses of oral suppression treatment should be considered for prosthetic joint infections ***Duration and need for combination therapy is based on valve-type and organism Special populations Elderly Lower maintenance doses may be required due to the age-related reduction in renal function.
Summary of the Safety profile The most common adverse reactions are phlebitis, pseudo-allergic reactions and flushing of the upper body (“red-neck syndrome”) in connection with too rapid intravenous infusion of vancomycin. The absorption of vancomycin from the gastrointestinal tract is negligible.
However, in severe inflammation of the intestinal mucosa, especially in combination with renal insufficiency, adverse reactions that occur when vancomycin is administered parenterally may appear. 4). Tabulated List of Adverse reactions Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
The adverse reactions listed below are defined using the following MedDRA convention and system organ class database: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
System organ class Frequency Adverse reaction Blood and the lymphatic system disorders: Rare Reversible neutropenia, agranulocytosis, eosinophilia, thrombocytopenia, pancytopenia.
Immune system disorders:
Rare Hypersensitivity reactions, anaphylactic reactions Ear and labyrinth disorders: Uncommon Transient or permanent loss of hearing Rare Vertigo, tinnitus, dizziness Cardiac disorders Very rare Cardiac arrest Vascular disorders: Common Decrease in blood pressure Rare Vasculitis Respiratory, thoracic and mediastinal disorders: Common Dyspnoea, stridor Gastrointestinal disorders: Rare Nausea Very rare Pseudomembranous enterocolitis Not known Vomiting, Diarrhoea Skin and subcutaneous tissue disorders: Common Flushing of the upper body (“red man syndrome”), exanthema and mucosal inflammation, pruritus, urticaria Very rare Exfoliative dermatitis, Stevens-Johnson syndrome, Toxic epidermal necrolysis (TEN), Linear IgA bullous dermatosis Not known Eosinophilia and systemic symptoms (DRESS syndrome), AGEP (Acute Generalized Exanthematous Pustulosis) Renal and urinary disorders: Common Renal insufficiency manifested primarily by increased serum creatinine and serum urea Rare Interstitial nephritis, acute renal failure.
8). In case of hypersensitivity reactions, treatment with vancomycin must be discontinued immediately and the adequate emergency measures must be initiated. In patients receiving vancomycin over a longer-term period or concurrently with other medications which may cause neutropenia or agranulocytosis, the leukocyte count should be monitored at regular intervals.
All patients receiving vancomycin should have periodic haematologic studies, urine analysis, liver and renal function tests. Vancomycin should be used with caution in patients with allergic reactions to teicoplanin, since cross hypersensitivity, including fatal anaphylactic shock, may occur.
Spectrum of antibacterial activity Vancomycin has a spectrum of antibacterial activity limited to Gram-positive organisms. It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a high suspicion that the most likely pathogen(s) would be suitable for treatment with vancomycin.
The rational use of vancomycin should take into account the bacterial spectrum of activity, the safety profile and the suitability of standard antibacterial therapy to treat the individual patient. 8) has been reported in patients with prior deafness, who have received excessive intravenous doses, or who receive concomitant treatment with another ototoxic active substance such as an aminoglycoside.
Vancomycin should also be avoided in patients with previous hearing loss. Deafness may be preceded by tinnitus. Experience with other antibiotics suggests that deafness may be progressive despite cessation of treatment. To reduce the risk of ototoxicity, blood levels should be determined periodically and periodic testing of auditory function is recommended.
The elderly are particularly susceptible to auditory damage. Monitoring of vestibular and auditory function in the elderly should be carried out during and after treatment. Concurrent or sequential use of other ototoxic substances should be avoided.
4). Vancomycin should not be administered intramuscularly due to the risk of necrosis at the site of administration.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Renal impairment In adult and paediatric patients with renal impairment, consideration should be given to an initial starting dose followed by serum vancomycin trough levels rather than to a scheduled dosing regimen, particularly in patients with severe renal impairment or those who undergo renal replacement therapy (RRT) due to the many varying factors that may affect vancomycin levels in them.
In patients with mild or moderate renal failure, the starting dose must not be reduced. In patients with severe renal failure, it is preferable to prolong the interval of administration rather than administer lower daily doses. 4). Vancomycin is poorly dialyzable by intermittent haemodialysis.
However, use of high-flux membranes and continuous renal replacement therapy (CRRT) increases vancomycin clearance and generally requires replacement dosing (usually after the haemodialysis session in case of intermittent haemodialysis).
85 x value calculated by the above formula. The usual starting dose for adult patients is 15 to 20 mg/kg that could be administered every 24 hours in patients with creatinine clearance between 20 to 49 mL/min. 4). Depending on the clinical situation, consideration could be given to withhold the next dose while awaiting the results of vancomycin levels.
In the critically ill patient with renal insufficiency, the initial loading dose (25 to 30 mg/kg) should not be reduced. 2)/serum creatinine (μmol/L) For neonates and infants below 1 year of age, expert advice should be sought as the revised Schwartz formula is not applicable to them.
Orientative dosing recommendations for the paediatric population are shown in table below that follow the same principles as in adult patients. 73 m2) IV dose Frequency 50-30 15 mg/kg 12 hourly 29-10 15 mg/kg 24 hourly < 10 Intermittent haemodialysis 10-15 Re-dose based on Peritoneal dialysis mg/kg levels* Continuous renal replacement therapy 15 mg/kg Re-dose based on levels* *The appropriate timing and amount of subsequent doses largely depends on the modality of RRT and should be based on serum vancomycin levels obtained prior to dosing and on residual renal function.
Depending on the clinical situation, consideration could be given to withhold the next dose while awaiting the […]
Not known Acute tubular necrosis General disorders and administration site conditions: Common Phlebitis, redness of the upper body and face. Rare Drug fever, shivering, Pain and muscle spasm of the chest and back muscles Description of selected adverse drug reactions Reversible neutropenia usually starting one week or more after onset of intravenous therapy or after total dose of more than 25 g.
During or shortly after rapid infusion anaphylactic/anaphylactoid reactions including wheezing may occur. The reactions abate when administration is stopped, generally between 20 minutes and 2 hours. 4). Necrosis may occur after intramuscular injection.
Tinnitus, possibly preceding onset of deafness, should be regarded as an indication to discontinue treatment. Ototoxicity has primarily been reported in patients given high doses, or in those on concomitant treatment with other ototoxic medicinal product like aminoglycosides, or in those who had a pre-existing reduction in kidney function or hearing.
Paediatric population The safety profile is generally consistent among children and adult patients. Nephrotoxicity has been described in children, usually in association with other nephrotoxic agents such as aminoglycosides. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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e. over several minutes) may be associated with exaggerated hypotension (including shock and, rarely, cardiac arrest), histamine like responses and maculopapular or erythematous rash (“red man’s syndrome” or “red neck syndrome”). 0 mg/mL) at a rate no greater than 10 mg/min and over a period not less than 60 minutes to avoid rapid infusion- related reactions.
Stopping the infusion usually results in a prompt cessation of these reactions. 5). This may be reduced by administering vancomycin by infusion over at least 60 minutes, before anaesthetic induction. 8). Most of these reactions occurred within a few days and up to eight weeks after commencing treatment with vancomycin.
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, vancomycin should be withdrawn immediately, and an alternative treatment considered.
If the patient has developed a SCAR with the use of vancomycin, treatment with vancomycin must not be restarted at any time. Administration site related reactions Pain and thrombophlebitis may occur in many patients receiving intravenous vancomycin and are occasionally severe.
2) and by changing the sites of infusion regularly. The efficacy and safety of vancomycin has not been established for the intrathecal, intralumbar and intraventricular routes of administration. Nephrotoxicity Vancomycin should be used with care in patients with renal insufficiency, including anuria, as the possibility of developing toxic effects is much higher in the presence of prolonged high blood concentrations.
The risk of toxicity is increased by high blood concentrations or prolonged therapy. 5). Eye disorders Vancomycin is not authorized for intracameral or intravitreal use, including prophylaxis of endophthalmitis. Hemorrhagic occlusive retinal vasculitis (HORV), including permanent loss of vision, have been observed in individual cases following intracameral or intravitreal use of vancomycin during or after cataract surgery.
Paediatric population The current intravenous dosing recommendations for the paediatric population, in particular for children below 12 years of age, may lead to sub-therapeutic vancomycin levels in a substantial number of children.
However, the safety of increased vancomycin dosing has not been properly assessed and higher doses than 60 mg/kg/day cannot be generally recommended. Vancomycin should be used with particular care in premature neonates and young infants, because of their renal immaturity […]