Vancomycin Elfa, 1000 mg powder 20 ml

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Indications

For intravenous infusion

Vancomycin is used for serious or severe infections caused by susceptible microorganisms, including Staphylococcus spp. (including penicillin- and methicillin-resistant strains), Streptococcus spp. (including penicillin-resistant strains), in an allergic reaction to penicillin and in case of intolerance to other antimicrobial drugs.

Endocarditis

Endocarditis caused by Streptococcus viridans, Streptococcus bovis (monotherapy, combined therapy with aminoglycosides); endocarditis caused by enterococci (including Eterococcus fa.including Eterococcus faecalis; as combination therapy with aminoglycosides for treatment); early endocarditis caused by Staphylococcus epidermidis, Corynebacterium spp. after valve prosthesis (in combination with rifampicin, aminoglycosides/obsolete antibiotics); prophylaxis of bacterial endocarditis in patients with pathogen resistance to penicillin and heart valve disease (regardless of its etiology) before oral surgery, tonsillectomy, removal of adenoids, before bladder catheterization, cystoscopy, surgical interventions on the rectum or colon (monotherapy or in combination with aminoglycosides).

– sepsis;

– bone and joint infections;

– central nervous system infections;

– lower respiratory tract infections;

– skin and soft tissue infections.

Active ingredient

Composition

1 vial contains:

The active ingredient:

Vancomycin hydrochloride in terms of vancomycin 1000.0 mg.

How to take, the dosage

For intravenous infusion. Intramuscular and intravenous boluses should not be administered.

In intravenous administration of vancomycin the recommended concentration is not more than 5 mg/ml and the infusion rate is not more than 10 mg/min.

In adults, the drug should be administered 2 g by IV daily (500 mg every 6 hours and/or 1 g every 12 hours). Each dose should be administered at a rate not exceeding 10 mg/min and for at least 60 min. The maximum single dose is 1000 mg, the maximum daily dose is 2000 mg.

In children older than 1 month, the drug should be administered 10 mg/kg v/v every 6 hours. Each dose should be administered for at least 60 minutes.

In newborns, the starting dose is 15 mg/kg, then 10 mg/kg every 12 hours for the first week of life. Starting from the second week of life – every 8 hours until the age of one month. Each dose should be administered for at least 60 minutes. In such patients it is advisable to monitor closely vancomycin plasma concentrations.

The maximum single dose for children is 15 mg/kg body weight; the daily dose for a child should not be higher than the daily dose for an adult (2 g).

In obese patients the drug is used in usual doses.

Patients with impaired renal function need to adjust the dose individually. Creatinine clearance (CK) may be used to adjust the dose of vancomycin for this group of patients.

Vancomycin dose table for patients with impaired renal function

Creatinine clearance mL/min

Vancomycin dose mg/24 h

100

1545

90

1390

80

1235

70

1080

60

50

770

40

620

30

465

20

310

10

155

This table should not be used to determine the dose of the drug for anuria. In such patients, a starting dose of 15 mg/kg body weight should be administered to quickly build up therapeutic serum concentrations. The dose required to maintain a stable drug concentration is 1.9 mg/kg/24 h. In case of anuria it is recommended to administer 1 g every 7-10 days.

Correction by increasing the intervals between doses

Patients with significant renal insufficiency should adjust the dose by increasing the intervals between doses. If IQ is 10-50 ml/min, 1 g every 3-7 days; if IQ < 10 ml/min, 1 g every 7-14 days.

In premature infants and elderly patients, a significant dose reduction may be required as a result of reduced renal function.

Preparing solution for intravenous administration

The solution is prepared by adding 10 ml of water for injection to 500 mg and 20 ml to 1000 mg. Vancomycin Elfa reconstituted solution 10 ml (or 20 ml) is added to 100 ml (or 200 ml) of 5% dextrose solution or 0.9% sodium chloride solution to obtain vancomycin solution for infusion with a concentration of 5 mg/ml.

Before infusion the prepared solution for parenteral administration should be checked visually for mechanical impurities and color changes.

Interaction

In concomitant use of vancomycin with local anesthetics in children there have been erythema, skin redness and anaphylactoid reactions, in adults – disturbances of intracardiac conduction.

Concomitant use with general anesthetics and vecuronium bromide increases the frequency of side effects (risk of decreased blood pressure, development of neuromuscular blockade).

The administration of vancomycin at least 60 minutes before anesthetic administration may reduce the likelihood of these reactions.

The vancomycin solution has a low pH, which may cause physical or chemical instability when mixed with other solutions. Mixing with alkaline solutions should be avoided.

Vancomycin and beta-lactam antibiotic solutions are pharmaceutically incompatible when mixed. The likelihood of precipitation increases with increasing vancomycin concentration. The IV system should be thoroughly flushed between applications of these antibiotics. In addition, it is recommended that vancomycin concentrations be reduced to 5 mg/ml or less.

Special Instructions

When the drug is administered to newborn infants (especially premature infants), monitoring of serum vancomycin concentrations is desirable.

Vancomycin is used in severe or serious infections caused by susceptible microorganisms, including Staphylococcus spp. (including penicillin- and methicillin-resistant strains), Streptococcus spp. (including penicillin-resistant strains) with allergic reaction to penicillin and intolerance to other antimicrobial agents.

Vancomycin should be used with caution in patients with renal insufficiency and in patients over 60 years old (it is advisable to determine plasma concentrations of vancomycin) because high, long lasting concentrations of the drug in blood may increase the risk of the toxic effects of the drug (maximum concentrations of vancomycin in blood serum (Cmax) should not exceed 40 microgram/ml, and minimum – 10 microgram/ml, concentration >80 µg/ml is considered toxic).

For patients with renal insufficiency, vancomycin doses should be adjusted individually.

Thrombophlebitis may occur when the drug is prescribed; this can be reduced by slow administration of dilute solutions (2.5-5 g/L) and by alternating the sites where the drug is administered.

It has been reported that ototoxicity most often develops in patients who have received high doses of vancomycin; patients who have a history of hearing impairment; or patients who have received concomitant therapy with other ototoxic agents (such as aminoglycosides).

Vancomycin Elfa may show signs of ototoxicity, both temporary and persistent. Ototoxicity is usually observed in patients receiving high doses of the drug, as well as in patients with hearing impairment or with concomitant use of other ototoxic drugs.

The risk of ototoxicity of vancomycin increases with concomitant renal failure.

Long-term use of vancomycin may lead to the emergence of resistant strains of bacteria and the development of superinfection. If superinfection develops during therapy, appropriate measures should be taken.

Contraindications

– Breast-feeding period;

– hypersensitivity to vancomycin and other components of the drug;

– neuritis of the auditory nerve.

Side effects

Cardiovascular system disorders: cardiac arrest, “blood flushes”; decreased blood pressure, shock (symptoms mainly associated with rapid infusion of the drug), vasculitis, thrombophlebitis.

In the digestive system: nausea, pseudomembranous colitis, increased activity of “hepatic” transaminases.

Hematopoietic system disorders: agranulocytosis, eosinophilia, neutropenia, thrombocytopenia, pancytopenia, anemia, leukopenia.

Urinary system disorders: interstitial nephritis, change of renal function tests, renal dysfunction.

Senses: ototoxic effects (transient/permanent): tinnitus, dizziness and hearing loss. In most cases ototoxic effects were observed in patients who received excessive doses of vancomycin, with a history of hearing loss or in patients who received concomitant treatment with other drugs with possible development of ototoxicity, such as aminoglycosides.

Dermatological reactions: exfoliative dermatitis, rash.

Allergic reactions: Urticaria, anaphylactoid reactions (associated with rapid infusion of the drug), Stevens-Johnson syndrome, toxic epidermal necrolysis, itchy dermatosis, benign vesicular dermatosis, diffuse exfoliative erythroderma (red man syndrome – upper body redness, pain and muscle spasm in chest and back; after stopping the infusion, reactions usually go away within 20 minutes, but can sometimes last up to several hours), a rash accompanied by eosinophilia and systemic manifestations.

Others: drug fever, phlebitis at the injection site, tissue necrosis at the injection site, pain at the injection site, chills.

Overdose

Symptoms: increase in the severity of dose-dependent side effects.

Treatment: symptomatic therapy to maintain glomerular filtration. Vancomycin is poorly eliminated by dialysis. There is evidence that hemofiltration and hemoperfusion through polysulfone ion-exchange resin leads to increased clearance of vancomycin.

Pregnancy use

Pregnant use of the drug during pregnancy – only for “vital” indications if the estimated benefit to the mother outweighs the potential risk to the fetus.

The use of the drug during breastfeeding is contraindicated.