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Vancomycin (Lyophilisate, Powder) Instructions for Use

ATC Codes

A07AA09 (Vancomycin)

J01XA01 (Vancomycin)

Active Substance

Vancomycin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antibiotic of the glycopeptide group

Pharmacotherapeutic Group

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

Pharmacological Action

An antibiotic of the glycopeptide group. It exerts a bactericidal effect. It disrupts the synthesis of the bacterial cell wall, the permeability of the cytoplasmic membrane, and the synthesis of 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 meningeal inflammation. It crosses the placental barrier. Plasma protein binding is 55%. The T1/2 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 cases 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

ICD-10 code Indication
A04.7 Enterocolitis due to Clostridium difficile
A40 Streptococcal sepsis
A41 Other sepsis
G00 Bacterial meningitis, not elsewhere classified
I33 Acute and subacute endocarditis
J15 Bacterial pneumonia, not elsewhere classified
J85 Abscess of lung and mediastinum
L02 Cutaneous abscess, furuncle and carbuncle
L03 Cellulitis
L08.0 Pyoderma
L08.8 Other specified local infections of skin and subcutaneous tissue
M00 Pyogenic arthritis
M86 Osteomyelitis
T79.3 Posttraumatic wound infection, not elsewhere classified
ICD-11 code Indication
1A04 Intestinal infections caused by Clostridium difficile
1B70.1 Streptococcal cellulitis of the skin
1B70.2 Staphylococcal cellulitis of the skin
1B70.Z Bacterial cellulitis or lymphangitis caused by unspecified bacterium
1B75.0 Furuncle
1B75.1 Carbuncle
1B75.2 Furunculosis
1B75.3 Pyogenic skin abscess
1B7Y Other specified pyogenic bacterial infections of skin or subcutaneous tissue
1C44 Non-pyogenic bacterial infections of skin
1D01.0Z Bacterial meningitis, unspecified
1G40 Sepsis without septic shock
BB4Z Acute or subacute endocarditis, unspecified
CA40.0Z Bacterial pneumonia, unspecified
CA43.Z Abscess of lung or mediastinum, unspecified
EA50.3 Staphylococcal scarlet fever
EB21 Pyoderma gangrenosum
FA1Z Infectious arthropathies, unspecified
FB84.Z Osteomyelitis or osteitis, unspecified
NF0A.3 Posttraumatic wound infection, not elsewhere classified
1A1Y Other specified bacterial foodborne intoxications
XN0SE Clostridium difficile

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Lyophilisate, Powder

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 over 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, ringing in the ears, 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 the “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 period (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 and 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 and moderate renal impairment, hearing impairment (including in the anamnesis), 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 renal 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 oto- and nephrotoxic effects is noted.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

AlTro, LLC (Russia)

Manufactured By

Reyoung Pharmaceutical, Co., Ltd. (China)

Dosage Forms

Bottle Rx Icon Vancomycin Lyophilizate for concentrate for solution for infusion and solution for oral administration 500 mg: vial 1, 10 or 50 pcs.
Lyophilizate for concentrate for solution for infusion and solution for oral administration 1000 mg: vial 1, 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for concentrate for solution for infusion and solution for oral administration white or almost white with a pinkish or yellowish, or light brown tint.

1 vial
Vancomycin (as hydrochloride) 500 mg

Vials of colorless glass with a capacity of 10 ml (1) – cardboard packs.
Vials of colorless glass with a capacity of 10 ml (10) – contour packs (1) – cardboard packs.
Vials of colorless glass with a capacity of 10 ml (50) – contour packs (1) – cardboard packs.


Lyophilizate for concentrate for solution for infusion and solution for oral administration white or almost white with a pinkish or yellowish, or light brown tint.

1 vial
Vancomycin (as hydrochloride) 1000 mg

Vials of colorless glass with a capacity of 20 ml (1) – cardboard packs.
Vials of colorless glass with a capacity of 20 ml (10) – contour packs (1) – cardboard packs.
Vials of colorless glass with a capacity of 20 ml (50) – contour packs (1) – cardboard packs.

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Bottle Rx Icon Vancomycin Lyophilizate for solution for infusion and oral administration 1000 mg: vial 1 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for solution for infusion and oral administration in the form of a powder or porous mass from white to white with a grayish or pinkish tint.

1 vial
Vancomycin hydrochloride (in terms of Vancomycin) 1000 mg

1000 mg – vials of colorless glass (1) – cardboard packs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Dosage Forms

Bottle Rx Icon Vancomycin Powder for solution for infusion and oral administration 500 mg: vials 1, 5, or 10 pcs.; vial 1 pc. with solvent
Powder for solution for infusion and oral administration 1000 mg: vial 1, 5, or 10 pcs.; vial 1 pc. with solvent

Dosage Form, Packaging, and Composition

Powder for solution for infusion and oral administration white or white with a pinkish, or yellowish, or light brown tint.

1 vial
Vancomycin hydrochloride 512.7 mg,
   Equivalent to vancomycin content 500 mg

Vials of colorless glass (1) – cardboard packs with partitions.
Vials of colorless glass (5) – cardboard packs with partitions.
Vials of colorless glass (10) – cardboard packs with partitions.
Vials of colorless glass (1) in a set with solvent (“Water for injections” amp. 5 ml 2 pcs. or 10 ml 1 pc.) – cardboard packs with partitions.
Vials of colorless glass (1) in a set with solvent (“Water for injections” amp. 5 ml 2 pcs. or 10 ml 1 pc.) – contour cell packs (1) – cardboard packs.


Powder for solution for infusion and oral administration white or white with a pinkish, or yellowish, or light brown tint.

1 vial
Vancomycin hydrochloride 1025.4 mg,
   Equivalent to vancomycin content 1000 mg

Vials of colorless glass (1) – cardboard packs with partitions.
Vials of colorless glass (5) – cardboard packs with partitions.
Vials of colorless glass (10) – cardboard packs with partitions.
Vials of colorless glass (1) in a set with solvent (“Water for injections” amp. 10 ml 2 pcs. or 20 ml 1 pc.) – cardboard packs with partitions.
Vials of colorless glass (1) in a set with solvent (“Water for injections” amp. 10 ml 2 pcs. or 20 ml 1 pc.) – contour cell packs (1) – cardboard packs.

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Forms

Bottle Rx Icon Vancomycin Powder for solution for infusion and oral administration 500 mg: vial 1, 10 or 50 pcs.
Powder for solution for infusion and oral administration 1 g: vial 1, 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for infusion and solution for oral administration

1 vial
Vancomycin hydrochloride 0.513 g
   Equivalent to vancomycin content 0.5 g

500 mg – vials (1) – cardboard packs.
500 mg – vials (10) – cardboard packs.
500 mg – vials (50) – cardboard packs.


Powder for solution for infusion and solution for oral administration

1 vial
Vancomycin hydrochloride 1.026 g
   Equivalent to vancomycin content 1 g

1 g – vials (1) – cardboard packs.
1 g – vials (10) – cardboard packs.
1 g – vials (50) – cardboard packs.

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Forms

Bottle Rx Icon Vancomycin Lyophilizate for solution for infusion and oral administration 0.5 g: vial 1 pcs. with solvent or 10 pcs.
Lyophilizate for solution for infusion and oral administration 1 g: vial 1 pcs. with solvent or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for solution for infusion and oral administration in the form of a lyophilized mass from white to white with a yellowish or pinkish tint.

1 vial
Vancomycin hydrochloride 0.5126 g
   Equivalent to vancomycin content 0.5 g

0.5 g – vials of colorless glass (1) – cardboard packs.
0.5 g – vials of colorless glass (5) – cardboard packs.
0.5 g – vials of colorless glass (10) – cardboard packs.


Lyophilizate for solution for infusion and oral administration in the form of a powder or porous mass from white to white with a pinkish or light brown tint.

1 vial
Vancomycin hydrochloride 1.026 g
   Equivalent to vancomycin content 1 g

1 g – vials of colorless glass (1) – cardboard packs.
1 g – vials of colorless glass (10) – cardboard packs.
1 g – vials of colorless glass (50) – cardboard boxes (for hospitals).
1 g – vials of colorless glass (1) (1-50 pcs.) – cardboard boxes (for hospitals).
1 g – vials of colorless glass (1) (in a set with solvent 10 ml amp. 2 pcs. ) – cardboard packs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Forms

Bottle Rx Icon Vancomycin Lyophilizate for solution for infusion and oral administration 500 mg: vial 1, 5 or 10 pcs.
Lyophilizate for solution for infusion and oral administration 1000 mg: vial 1, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for infusion and oral administration in the form of a white or white with a yellowish, pinkish or brownish tint powder or powder with fragments of a porous mass, or a dry porous mass in the form of a tablet, whole or crumbled.

1 vial
Vancomycin hydrochloride 512.7 mg,
   Equivalent to vancomycin content 500 mg

Glass vials with a capacity of 10 ml (1) – cardboard packs.
Glass vials with a capacity of 10 ml (5) – cardboard packs.
Glass vials with a capacity of 10 ml (10) – cardboard packs.


Lyophilizate for preparation of solution for infusion and oral administration in the form of a white or white with a yellowish, pinkish or brownish tint powder or powder with fragments of a porous mass, or a dry porous mass in the form of a tablet, whole or crumbled.

1 vial
Vancomycin hydrochloride 1025.4 mg,
   Equivalent to vancomycin content 1000 mg

Glass vials with a capacity of 20 ml (1) – cardboard packs.
Glass vials with a capacity of 20 ml (5) – cardboard packs.
Glass vials with a capacity of 20 ml (10) – cardboard packs.

Marketing Authorization Holder

Technology Lekarstv LLC (Russia)

Manufactured By

R-Pharm JSC (Russia)

Dosage Form

Bottle Rx Icon Vancomycin Lyophilizate for preparation of solution for infusion and oral administration 0.5 g: fl. 1, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for infusion and oral administration in the form of a lyophilized mass from white to white with a yellowish or pinkish tint.

1 vial
Vancomycin (as hydrochloride) 0.5126 g
   Equivalent to vancomycin content 0.5 g

0.5 g – vials of colorless glass (1) – cardboard packs.
0.5 g – vials of colorless glass (5) – cardboard packs.
0.5 g – vials of colorless glass (10) – cardboard packs.

Marketing Authorization Holder

Technology Lekarstv LLC (Russia)

Manufactured By

R-Pharm JSC (Russia)

Dosage Form

Bottle Rx Icon Vancomycin Lyophilizate for solution for infusion 1 g: vial 1, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for infusion in the form of a lyophilized mass from white to white with a yellowish or pinkish tint.

1 vial
Vancomycin (as hydrochloride) 1.0252 g,
Vancomycin 1 g

1 g – vials of colorless glass (1) – cardboard packs.
1 g – vials of colorless glass (5) – cardboard packs.
1 g – vials of colorless glass (10) – cardboard packs.

Marketing Authorization Holder

Pharmguid, CJS (Russia)

Manufactured By

Lyka Labs, Ltd. (India)

Labeled By

SKOPINSKY PHARMACEUTICAL PLANT, CJSC (Russia)

Dosage Form

Bottle Rx Icon Vancomycin Powder for solution for infusion 500 mg: vials 1 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for infusion 1 vial
Vancomycin (as hydrochloride) 500 mg

500 mg – vials (1) – cardboard packs.
500 mg – vials (50) – cardboard boxes.

Marketing Authorization Holder

Pharmguid, CJS (Russia)

Manufactured By

Lyka Labs, Ltd. (India)

Labeled By

SKOPINSKY PHARMACEUTICAL PLANT, CJSC (Russia)

Dosage Form

Bottle Rx Icon Vancomycin Powder for solution for infusion 1 g: vials 1 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for infusion 1 vial
Vancomycin (as hydrochloride) 1 g

1 g – vials (1) – cardboard packs.
1 g – vials (50) – cardboard boxes.

Marketing Authorization Holder

Pharmconcept, LLC (Russia)

Dosage Forms

Bottle Rx Icon Vancomycin Powder for solution for infusion and solution for oral administration 500 mg: vial 1 pc.
Powder for solution for infusion and solution for oral administration 1000 mg: vial 1 pc.

Dosage Form, Packaging, and Composition

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

1 vial
Vancomycin hydrochloride 513 mg,
   Equivalent to vancomycin content 500 mg

Glass vials (1) – cardboard packs.


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

1 vial
Vancomycin hydrochloride 1026 mg,
   Equivalent to vancomycin content 1000 mg

Glass vials (1) – cardboard packs.

Marketing Authorization Holder

Elfa SPC, JSC (Russia)

Manufactured By

Ruzpharma, LLC (Russia)

Dosage Form

Bottle Rx Icon Vancomycin Elfa Powder for solution for infusion 500 mg: vial 1 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for infusion white or white with a pinkish or yellowish or brownish tint.

1 vial
Vancomycin (as hydrochloride) 500 mg

10 ml – vials (1) – cardboard packs.
10 ml – vials (10) – cardboard boxes (for hospitals).
10 ml – vials (50) – cardboard boxes (for hospitals).

Marketing Authorization Holder

Elfa SPC, JSC (Russia)

Manufactured By

Ruzpharma, LLC (Russia)

Dosage Form

Bottle Rx Icon Vancomycin Elfa Powder for solution for infusion 1000 mg: vial 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for infusion white or white with a pinkish or yellowish or brownish tint.

1 vial
Vancomycin (as hydrochloride) 1000 mg

20 ml – vials (1) – cardboard packs.
20 ml – vials (10) – cardboard boxes (for hospitals).
20 ml – vials (50) – cardboard boxes (for hospitals).

Marketing Authorization Holder

Jodas Expoim, Pvt. Ltd. (India)

Manufactured By

Bryntsalov-A, JSC (Russia)

Dosage Form

Bottle Rx Icon Vancomycin J Lyophilizate for the preparation of solution for infusion 500 mg: vial 1 or 5 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for infusion 1 vial
Vancomycin 500 mg

500 mg – vials (1) – cardboard packs.
500 mg – vials (5) – cardboard packs.

Marketing Authorization Holder

Jodas Expoim, Pvt. Ltd. (India)

Manufactured By

Bryntsalov-A, JSC (Russia)

Dosage Form

Bottle Rx Icon Vancomycin J Lyophilizate for solution for infusion 1 g: vial 1 or 5 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for infusion 1 vial
Vancomycin 1 g

1 g – vials (1) – cardboard packs.
1 g – vials (5) – cardboard packs.

Marketing Authorization Holder

Jodas Expoim, Pvt. Ltd. (India)

Manufactured By

Stanex Drugs & Chemicals Pvt. Ltd. (India)

Dosage Forms

Bottle Rx Icon Vancomycin Jodas Lyophilizate for solution for infusion and oral administration 500 mg: vial in set with solvent.
Lyophilisate for preparation of solution for infusion and oral administration 1000 mg: vial in set with solvent.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for infusion and oral administration in the form of a powder or porous mass from white to white with a pinkish or brownish tint; powder clumping is allowed and does not affect solubility and quality.

1 vial
Vancomycin hydrochloride 512.7 mg,
   Equivalent to vancomycin content 500 mg

500 mg – vials (1) + 1 amp. with solvent – cardboard packs.
500 mg – vials (5) + 5 amp. with solvent – trays (1) – cardboard packs.
500 mg – vials (5) + 5 amp. with solvent – trays (2) – cardboard packs.


Lyophilizate for preparation of solution for infusion and oral administration in the form of a powder or porous mass from white to white with a pinkish or brownish tint; powder clumping is allowed and does not affect solubility and quality.

1 vial
Vancomycin hydrochloride 1025.4 mg,
   Equivalent to vancomycin content 1000 mg

1000 mg – vials (1) + 2 amp. with solvent – cardboard packs.
1000 mg – vials (5) + 10 amp. with solvent – trays (1) – cardboard packs.
1000 mg – vials (5) + 10 amp. with solvent – trays (2) – cardboard packs.

Marketing Authorization Holder

Binnopharm Group LLC (Russia)

Manufactured By

Sintez PJSC (Russia)

Dosage Forms

Bottle Rx Icon Vancomycin-Akos Powder for concentrate for solution for infusion and solution for oral administration 500 mg
Powder for concentrate for solution for infusion and solution for oral administration 1000 mg

Dosage Form, Packaging, and Composition

Powder for preparation of concentrate for preparation of solution for infusion and solution for oral administration

1 vial
Vancomycin (as hydrochloride) 500 mg

500 g – vials – cardboard packs – By prescription
500 g – vials (10 pcs.) – cardboard packs – By prescription
500 g – vials (50 pcs.) – cardboard boxes – for hospitals


Powder for preparation of concentrate for preparation of solution for infusion and solution for oral administration

1 vial
Vancomycin (as hydrochloride) 1000 mg

1000 mg – vials – cardboard packs – By prescription
1000 mg – vials (10 pcs.) – cardboard packs – By prescription
1000 mg – vials (50 pcs.) – cardboard boxes – for hospitals

Marketing Authorization Holder

Triplepharm JV LLC (Republic of Belarus)

Dosage Forms

Bottle Rx Icon Vancomycin-TF Powder for concentrate for solution for infusion and solution for oral administration 500 mg: vial 1 or 5 pcs.
Powder for concentrate for solution for infusion and solution for oral administration 1000 mg: vial 1 or 5 pcs.

Dosage Form, Packaging, and Composition

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

1 vial
Vancomycin hydrochloride 513 mg,
   In terms of Vancomycin 500 mg
   Equivalent to Not less than 525000 IU

500 mg – vials of colorless glass (1) – carton packs.
500 mg – vials of colorless glass (5) – carton packs.


Powder for concentrate for solution for infusion and oral solution white or almost white; hygroscopic.

1 vial
Vancomycin hydrochloride 1026 mg
   In terms of Vancomycin 1000 mg,
   Equivalent to Not less than 1050000 IU

1000 mg – vials of colorless glass (1) – carton packs.
1000 mg – vials of colorless glass (5) – carton packs.

Table of Contents

TABLE OF CONTENTS