Vancoter-AF (Powder) Instructions for Use

Marketing Authorization Holder

Alpharma, LLC (Russia)

Manufactured By

Triplepharm JV LLC (Republic of Belarus)

ATC Code

J01XA01 (Vancomycin)

Active Substance

Vancomycin (Rec.INN registered by WHO)

Dosage Forms

	Vancoter-AF	Powder for the preparation of concentrate for the preparation of solution for infusion and solution for oral administration 500 mg: vial 1 or 5 pcs.
		Powder for the preparation of concentrate for the preparation of solution for infusion and solution for oral administration 750 mg: vial 1 or 5 pcs.
		Powder for the preparation of concentrate for the preparation of solution for infusion and solution for oral administration 1000 mg: vial 1 or 5 pcs.

Dosage Form, Packaging, and Composition

Powder for the preparation of concentrate for the preparation of solution for infusion and solution for oral administration white or almost white with a light brown tint.

500 ml – colorless glass vials (1) – cardboard packs with insert.
500 ml – colorless glass vials (5) – cardboard packs with insert.

Powder for the preparation of concentrate for the preparation of solution for infusion and solution for oral administration white or almost white.

750 ml – colorless glass vials (1) – cardboard packs with insert.
750 ml – colorless glass vials (5) – cardboard packs with insert.

Powder for the preparation of concentrate for the preparation of solution for infusion and solution for oral administration white or almost white.

1000 mg – colorless glass vials (1) – cardboard packs with insert.
1000 mg – colorless glass vials (5) – cardboard packs with insert.

Clinical-Pharmacological Group

Antibiotic of the glycopeptide group

Pharmacotherapeutic Group

Systemic antibacterial agents; other antibacterial agents; antibacterial agents of glycopeptide structure

Pharmacological Action

Antibiotic of the glycopeptide group. It has a bactericidal effect. It disrupts the synthesis of the cell wall, the permeability of the cytoplasmic membrane, and the synthesis of bacterial RNA.

It is active against gram-positive bacteria: Staphylococcus spp. (including strains producing penicillinase and methicillin-resistant strains), Streptococcus spp., Enterococcus spp., Corynebacterium spp., Listeria spp., Actinomyces spp., Clostridium spp. (including Clostridium difficile).

No cross-resistance with antibiotics of other groups has been noted.

Pharmacokinetics

It is widely distributed in most body tissues and fluids. It penetrates the blood-brain barrier poorly, but permeability increases with inflammation of the meninges. It crosses the placental barrier. Plasma protein binding is 55%.

The T_1/2 is 4-11 hours. 80-90% is excreted in the urine, a small amount is excreted in the bile.

Indications

Severe infectious and inflammatory diseases caused by pathogens sensitive to vancomycin (in case of intolerance or ineffectiveness of therapy with other antibiotics, including penicillins or cephalosporins): sepsis, endocarditis (as monotherapy or as part of combined antibiotic therapy), pneumonia, lung abscess, meningitis, bone and joint infections, skin and soft tissue infections.

Pseudomembranous colitis caused by Clostridium difficile.

ICD codes

Dosage Regimen

It is administered by intravenous drip. For adults – 500 mg every 6 hours or 1 g every 12 hours. To avoid collaptoid reactions, the infusion duration should be at least 60 minutes.

For children – 40 mg/kg/day, each dose should be administered for at least 60 minutes. In patients with impaired renal excretory function, the dose is reduced taking into account the CC values.

Depending on the etiology of the disease, Vancomycin can be taken orally. For adults, the daily dose is 0.5-2 g in 3-4 doses, for children – 40 mg/kg in 3-4 doses.

The maximum daily dose for adults with intravenous administration is 3-4 g.

Adverse Reactions

From the cardiovascular system: cardiac arrest, flushing, decreased blood pressure, shock (these symptoms are mainly associated with rapid infusion of the drug).

From the hematopoietic system: neutropenia, eosinophilia, thrombocytopenia, agranulocytosis.

From the digestive system: nausea.

From the urinary system: interstitial nephritis, changes in renal function tests, impaired renal function.

From the sensory organs: vertigo, tinnitus, ototoxic effects.

Dermatological reactions: exfoliative dermatitis, benign bullous dermatosis, pruritic dermatosis, rash.

Allergic reactions: urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, vasculitis. Anaphylactoid reactions are possible during or shortly after too rapid infusion of vancomycin.

Other: chills, drug fever, tissue necrosis at injection sites, pain at injection sites, thrombophlebitis. With rapid intravenous administration, the development of “red neck syndrome”, associated with histamine release, is possible: erythema, skin rash, redness of the face, neck, upper half of the torso, arms, rapid heartbeat, nausea, vomiting, chills, fever, fainting.

Contraindications

Acoustic neuritis, severe renal impairment, first trimester of pregnancy, lactation (breastfeeding), hypersensitivity to vancomycin.

Use in Pregnancy and Lactation

Use in the first trimester of pregnancy is contraindicated due to the risk of nephro- and ototoxicity. The use of vancomycin in the second and third trimesters is possible only for vital indications.

If it is necessary to use during lactation, breastfeeding should be discontinued.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Use with caution in mild to moderate renal impairment.

Pediatric Use

When used in newborns, it is necessary to monitor the plasma concentration of vancomycin.

Geriatric Use

When used in elderly patients, it is necessary to monitor the plasma concentration of vancomycin.

Special Precautions

Use with caution in mild to moderate renal impairment, hearing impairment (including in history), in the second and third trimesters of pregnancy. During treatment, patients with kidney disease and/or damage to the VIII pair of cranial nerves should undergo monitoring of kidney function and hearing.

Intramuscular administration of vancomycin is not allowed due to the high risk of tissue necrosis.

When used in newborns or elderly patients, it is necessary to monitor the plasma concentration of vancomycin.

Drug Interactions

Simultaneous use of vancomycin and local anesthetics may lead to the development of erythema, histamine-like flushing, and anaphylactic shock.

With simultaneous use of vancomycin with aminoglycosides, amphotericin B, cisplatin, cyclosporine, furosemide, polymyxins, an increase in ototoxic and nephrotoxic effects is noted.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.