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Cefepime (Powder) Instructions for Use

ATC Code

J01DE01 (Cefepime)

Active Substance

Cefepime (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Fourth generation cephalosporin

Pharmacotherapeutic Group

Systemic antibacterial agents; other beta-lactam antibacterial agents; fourth-generation cephalosporins

Pharmacological Action

A fourth-generation cephalosporin antibiotic for parenteral administration. It exerts a bactericidal effect by disrupting the synthesis of the microbial cell wall.

It is active against most gram-negative bacteria, including those producing beta-lactamases, such as Pseudomonas aeruginosa. It is more active than third-generation cephalosporins against gram-positive cocci.

It is not active against Enterococcus spp., Listeria spp., Legionella spp., and some anaerobic bacteria ( Bacteroides fragilis, Clostridium difficile).

Cefepime is characterized by high stability against various plasmid and chromosomal beta-lactamases.

Pharmacokinetics

Plasma protein binding is less than 19% and is independent of the serum concentration of cefepime.

Therapeutic concentrations of cefepime are found in urine, bile, peritoneal fluid, blister exudate, bronchial mucous secretion, sputum, prostate tissue, appendix, gallbladder, and cerebrospinal fluid in meningitis.

No accumulation of cefepime was observed in healthy subjects after intravenous administration of 2 g every 8 hours for 9 days.

The mean elimination half-life (T1/2) is approximately 2 hours, and the mean total clearance is 120 ml/min. Cefepime is excreted by the kidneys, primarily by glomerular filtration (mean renal clearance is 110 ml/min). Approximately 85% of the administered cefepime is excreted unchanged in the urine.

In patients aged 65 years or older with normal renal function, the renal clearance is lower than in younger patients.

In patients with impaired renal function, the T1/2 is prolonged. In patients with severe renal impairment requiring hemodialysis, the mean T1/2 is 13 hours, and during peritoneal dialysis, it is 19 hours.

The pharmacokinetics of cefepime are not altered in patients with impaired liver function or cystic fibrosis.

Patient age and sex did not significantly affect total body clearance and volume of distribution ( Vd) when adjusted for body weight. No accumulation was observed when cefepime was administered at 50 mg/kg every 12 hours; when administered at the same dose every 8 hours at steady state, Cmax, AUC, and T1/2 increased by approximately 15%.

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms susceptible to cefepime: lower respiratory tract infections (including pneumonia and bronchitis), urinary tract infections (both complicated and uncomplicated), skin and soft tissue infections, intra-abdominal infections (including peritonitis and biliary tract infections), gynecological infections, septicemia, neutropenic fever (as empirical therapy), bacterial meningitis in children.

Prevention of infections during abdominal surgical operations.

ICD codes

ICD-10 code Indication
A40 Streptococcal sepsis
A41 Other sepsis
D70 Agranulocytosis
G00 Bacterial meningitis, not elsewhere classified
J15 Bacterial pneumonia, not elsewhere classified
J20 Acute bronchitis
J42 Unspecified chronic bronchitis
K65.0 Acute peritonitis (including abscess)
K81.0 Acute cholecystitis
K81.1 Chronic cholecystitis
K83.0 Cholangitis
L01 Impetigo
L02 Cutaneous abscess, furuncle and carbuncle
L03 Cellulitis
L08.0 Pyoderma
L08.8 Other specified local infections of skin and subcutaneous tissue
N10 Acute tubulointerstitial nephritis (acute pyelonephritis)
N11 Chronic tubulointerstitial nephritis (chronic pyelonephritis)
N30 Cystitis
N34 Urethritis and urethral syndrome
N41 Inflammatory diseases of prostate
N70 Salpingitis and oophoritis
N71 Inflammatory disease of uterus, excluding cervix (including endometritis, myometritis, metritis, pyometra, uterine abscess)
N72 Inflammatory disease of cervix uteri (including cervicitis, endocervicitis, exocervicitis)
N73.5 Unspecified female pelvic peritonitis
T79.3 Posttraumatic wound infection, not elsewhere classified
Z29.2 Other prophylactic chemotherapy (administration of antibiotics for prophylactic purposes)
ICD-11 code Indication
1B70.1 Streptococcal cellulitis of the skin
1B70.2 Staphylococcal cellulitis of the skin
1B70.Z Bacterial cellulitis or lymphangitis caused by unspecified bacterium
1B72.0 Bullous impetigo
1B72.1 Nonbullous impetigo
1B72.Z Impetigo, unspecified
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
4B00 Quantitative defects of neutrophils
4B00.00 Constitutional neutropenia
4B00.01 Acquired neutropenia
CA20.1Z Chronic bronchitis, unspecified
CA40.0Z Bacterial pneumonia, unspecified
CA42.Z Acute bronchitis, unspecified
DC12.0Z Acute cholecystitis, unspecified
DC12.1 Chronic cholecystitis
DC13 Cholangitis
DC50.0 Primary peritonitis
DC50.2 Peritoneal abscess
DC50.Z Peritonitis, unspecified
EA50.3 Staphylococcal scarlet fever
EB21 Pyoderma gangrenosum
GA01.Z Inflammatory diseases of uterus, except cervix, unspecified
GA05.2 Unspecified pelvic peritonitis in women
GA07.Z Salpingitis and oophoritis, unspecified
GA91.Z Inflammatory and other diseases of prostate, unspecified
GB50 Acute tubulo-interstitial nephritis
GB51 Acute pyelonephritis
GB55.Z Chronic tubulo-interstitial nephritis, unspecified
GB5Z Renal tubulo-interstitial diseases, unspecified
GC00.Z Cystitis, unspecified
GC02.Z Urethritis and urethral syndrome, unspecified
NF0A.3 Posttraumatic wound infection, not elsewhere classified
QC05.Y Other specified prophylactic measures
GA0Z Inflammatory diseases of female genital tract, unspecified
XA5WW1 Cervix uteri

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.

Determine the dosage individually based on infection severity, causative pathogen susceptibility, patient age, and renal function status.

Administer via intramuscular or intravenous routes. Use the intravenous route for severe or life-threatening infections, particularly when shock is present or threatened.

For adults with normal renal function (CrCl > 60 mL/min), use a dosage of 1 gram to 2 grams intravenously every 8 to 12 hours. For serious urinary tract infections, administer 1 gram every 12 hours.

For moderate to severe pneumonia, empiric therapy for neutropenic fever, and complicated intra-abdominal infections, administer 2 grams intravenously every 8 hours for 7 to 10 days.

For pediatric patients over 2 months of age and weighing less than 40 kg, administer 50 mg/kg per dose intravenously every 8 to 12 hours. Do not exceed the recommended adult dose.

Adjust the dosage in patients with renal impairment. For creatinine clearance (CrCl) 30 to 60 mL/min, use a maximum of 2 grams every 24 hours or 1 gram every 12 hours.

For CrCl 10 to 30 mL/min, administer 1 gram every 24 hours. For CrCl less than 10 mL/min, including patients on hemodialysis, administer 500 mg every 24 hours.

Administer a supplemental dose following hemodialysis. For patients on continuous renal replacement therapy (CRRT), adjust the dose based on the modality and effluent rate; a typical loading dose is 2 grams, followed by 1 gram every 8 hours or 2 grams every 12 hours.

For surgical prophylaxis, administer 2 grams intravenously 60 minutes before the initial incision. The duration of prophylaxis should not exceed 24 hours.

Reconstitute the powder for injection with a compatible diluent such as Sterile Water for Injection, 0.9% Sodium Chloride, or 5% Dextrose. Shake well until dissolved. For intravenous bolus injection, administer over approximately 5 minutes.

For intermittent intravenous infusion, infuse over 30 minutes. Do not mix with solutions containing aminoglycosides in the same container; administer separately.

Adverse Reactions

From the digestive system: diarrhea, nausea, vomiting, colitis (including pseudomembranous colitis) may occur; rarely – abdominal pain, constipation, taste alteration.

Allergic reactions: rash, itching, urticaria may occur; rarely – anaphylactic reactions.

From the central and peripheral nervous system: headache may occur; rarely – dizziness, paresthesia; in some cases – seizures.

Dermatological reactions: rarely – skin redness. Rash is most common in children.

From the hematopoietic system: anemia may occur.

From laboratory test parameters: increased ALT, AST, alkaline phosphatase activity, increased total bilirubin, eosinophilia, prolonged prothrombin time may occur; rarely – transient increase in blood urea nitrogen and/or serum creatinine, transient thrombocytopenia, transient leukopenia and neutropenia; frequently – positive Coombs’ test without hemolysis.

Other: fever, vaginitis, erythema may occur; rarely – genital itching, nonspecific candidiasis.

Local reactions: with intravenous infusion, phlebitis may occur, rarely – inflammation; with intramuscular injection, inflammation or pain may occur.

Contraindications

Hypersensitivity to cefepime or L-arginine, as well as to cephalosporin antibiotics, penicillins, or other beta-lactam antibiotics.

Use in Pregnancy and Lactation

Adequate and strictly controlled studies on the safety of cefepime use during pregnancy have not been conducted; use is possible only under medical supervision.

Cefepime is excreted in breast milk in very low concentrations. Use with caution during lactation.

In experimental studies, no effect on reproductive function or fetotoxic effects of cefepime were identified.

Use in Renal Impairment

In cases of renal impairment (creatinine clearance less than 30 ml/min), dosage adjustment is necessary. The initial dose of cefepime should be the same as for patients with normal renal function. Maintenance doses are determined based on creatinine clearance values or serum creatinine concentration.

Pediatric Use

The safety and efficacy of cefepime in children under 2 months of age have not been established. For children over 2 months of age, use is possible according to the dosage regimen. For children with impaired renal function, the same dosage adjustments are recommended as for adults, as the pharmacokinetics of cefepime are similar in adults and children.

Special Precautions

When used in patients at increased risk of infection due to mixed aerobic/anaerobic flora (including cases where one of the pathogens is Bacteroides fragilis), it is recommended to concomitantly administer an agent active against anaerobes along with cefepime until the pathogen is identified.

Use with caution in patients at risk of developing allergic reactions, especially to medications.

If allergic reactions develop, Cefepime should be discontinued.

In cases of serious immediate-type hypersensitivity reactions, the use of epinephrine (adrenaline) and other supportive measures may be required.

If diarrhea occurs during treatment, the possibility of pseudomembranous colitis should be considered. In such cases, Cefepime should be discontinued immediately and appropriate treatment instituted if necessary.

If a superinfection develops, Cefepime should be discontinued immediately and appropriate treatment instituted.

The safety and efficacy of cefepime in children under 2 months of age have not been established.

Use Cefepime with particular caution concomitantly with aminoglycosides and “loop” diuretics.

Drug Interactions

Pharmaceutical interaction is possible when cefepime solution is administered concomitantly with solutions of metronidazole, vancomycin, gentamicin, tobramycin sulfate, and netilmicin sulfate.

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

SK Meditech, Private Limited (India)

Manufactured By

Lincoln Parenterals, Pvt. Ltd. (India)

Packaging and Quality Control Release

LINCOLN PARENTERALS, Pvt. Ltd. (India)

Or

FARKONTSEPT, LLC (Russia)

Dosage Form

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.

Dosage Form, Packaging, and Composition

Powder for solution for intravenous and intramuscular administration from white to yellowish-white in color.

1 vial
Cefepime (as cefepime hydrochloride*) 1 g

* calculated as cefepime, not containing L-arginine.

Excipients: L-arginine – to adjust pH from 4.0 to 6.0.

Colorless glass vials with a capacity of 15 ml (1) – cardboard packs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 1 g: vial. 1, 14, 24 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for intravenous and intramuscular administration 1 vial
Cefepime hydrochloride 1 g

Solvent: water for injections – 5 ml.

1 g – vials (1) in a set with solvent (amp.) – cardboard packs.
1 g – vials (1) – cardboard packs.
1 g – vials.
1 g – vials (10) – cardboard packs.
1 g – vials (14) – cardboard packs.
1 g – vials (24) – cardboard packs.
1 g – vials (50) – cardboard packs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 500 mg: fl. 1, 10, 14, 24, or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for intravenous and intramuscular administration 1 vial
Cefepime hydrochloride 500 mg

Solvent: water for injections – 5 ml.

500 mg – vials (1) in a set with solvent (amp.) – cardboard packs.
500 mg – vials.
500 mg – vials (10) in a set with solvent (amp.) – cardboard packs.
500 mg – vials (14) in a set with solvent (amp.) – cardboard packs.
500 mg – vials (24) in a set with solvent (amp.) – cardboard packs.
500 mg – vials (50) in a set with solvent (amp.) – cardboard packs.

Marketing Authorization Holder

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

Dosage Form

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 1 g: vial 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for intravenous and intramuscular administration from white to light yellow in color.

1 vial
Cefepime hydrochloride monohydrate 1.189 g,
   Equivalent to cefepime content 1 g

Excipients: L-arginine – 0.7943 g.

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

Marketing Authorization Holder

Deko Company, LLC (Russia)

Dosage Form

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefepime hydrochloride 1 g

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

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Form

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 1 g: vial. 1, 10, or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefepime hydrochloride 1 g

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

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Form

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 500 mg: vial. 1,10 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefepime hydrochloride 500 mg

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

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Form

Bottle Rx Icon Cefepime Powder for solution for intramuscular injection 500 mg: vial 1, 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intramuscular administration 1 vial
Cefepime hydrochloride 500 mg

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

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Form

Bottle Rx Icon Cefepime Powder for solution for intramuscular administration 1 g: fl. 1, 10, or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intramuscular administration 1 vial
Cefepime hydrochloride 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 Form

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 2 g: vial 1, 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration from white to white with a yellowish tint.

1 vial
Cefepime (as hydrochloride monohydrate) 1 g

Excipients: arginine – 1.46 g.

2 g – vials (1) – cardboard packs.
2 g – vials (10) – cardboard boxes.
2 g – vials (50) – cardboard boxes (for hospitals).
2 g – vials (1) in a set with solvent 1 amp. 10 ml or 2 amp. 5 ml – contour cell packs (1) – cardboard packs.
2 g – vials (5) in a set with solvent 5 amp. 10 ml or 10 amp. 5 ml – contour cell packs (5) – cardboard packs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Forms

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 0.5 g: 1, 5 or 10 pcs.
Powder for solution for intravenous and intramuscular administration 1 g: 1, 5 or 10 pcs.
Powder for solution for intravenous and intramuscular administration 2 g: 1, 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration white or white with a yellowish tint, crystalline.

1 vial
Cefepime hydrochloride monohydrate 0.5945 g,
   Equivalent to cefepime content 0.5 g

Excipients: L-arginine – 0.3625 g.

0.5 g – vials (1) – cardboard packs.
0.5 g – vials (5) – cardboard packs.
0.5 g – vials (10) – cardboard packs.
0.5 g – vials (50) – cardboard boxes (for hospitals).
0.5 g – vials (1) in a set with solvent 5 ml amp. 1 pc. – cardboard packs.
0.5 g – vials (5) in a set with solvent 5 ml amp. 5 pcs. – cardboard packs.
0.5 g – vials (10) in a set with solvent 5 ml amp. 10 pcs. – cardboard packs.


Powder for preparation of solution for intravenous and intramuscular administration white or white with a yellowish tint, crystalline.

1 vial
Cefepime hydrochloride monohydrate 1.1891 g,
   Equivalent to cefepime content 1 g

Excipients: L-arginine – 0.725 g.

1 g – vials (1) – cardboard packs.
1 g – vials (5) – cardboard packs.
1 g – vials (10) – cardboard packs.
1 g – vials (50) – cardboard boxes (for hospitals).
1 g – vials (1) in a set with solvent 5 ml amp. 2 pcs. – cardboard packs.
1 g – vials (5) in a set with solvent 5 ml amp. 10 pcs. – cardboard packs.
1 g – vials (10) in a set with solvent 5 ml amp. 20 pcs. – cardboard packs.


Powder for preparation of solution for intravenous and intramuscular administration white or white with a yellowish tint, crystalline.

1 vial
Cefepime hydrochloride monohydrate 2.3782 g,
   Equivalent to cefepime content 2 g

Excipients: L-arginine – 1.45 g.

2 g – vials (1) – cardboard packs.
2 g – vials (5) – cardboard packs.
2 g – vials (10) – cardboard packs.
2 g – vials (50) – cardboard boxes (for hospitals).
2 g – vials (1) in a set with solvent 5 ml amp. 2 pcs. – cardboard packs.
2 g – vials (5) in a set with solvent 5 ml amp. 10 pcs. – cardboard packs.
2 g – vials (10) in a set with solvent 5 ml amp. 20 pcs. – cardboard packs.

Marketing Authorization Holder

Protek-SVM LLC (Russia)

Manufactured By

Sanjivani Parenteral, Limited (India)

Dosage Form

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefepime (as hydrochloride) 1 g

1 g – vials (1) – cardboard packs.

Marketing Authorization Holder

Protek-SVM LLC (Russia)

Manufactured By

Sanjivani Parenteral, Limited (India)

Dosage Form

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 0.5 g: vial 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefepime (as hydrochloride) 0.5 g

0.5 g – vials (1) – cardboard packs.

Marketing Authorization Holder

Protek-SVM LLC (Russia)

Manufactured By

Sanjivani Parenteral, Limited (India)

Dosage Form

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 2 g: vial 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefepime (as hydrochloride) 2 g

2 g – vials (1) – cardboard packs.

Marketing Authorization Holder

Pharmaceutical Firm LECKO, CJS (Russia)

Dosage Form

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 1 g: vial. 1, 5 or 30 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefepime (as hydrochloride) 1 g

1 g – vials (1) – cardboard packs.
1 g – vials (5) – cardboard boxes.
1 g – vials (30) – cardboard packs.

Marketing Authorization Holder

Pharmguid, CJS (Russia)

Dosage Form

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefepime hydrochloride 1 g

1 g – vials (1) – cardboard packs.
1 g – vials (50) – cardboard boxes (20) – cardboard boxes.

Marketing Authorization Holder

Pharmconcept, LLC (Russia)

Dosage Forms

Bottle Rx Icon Cefepime Powder for solution for intravenous and intramuscular administration 0.5 g: 1 pc.
Powder for solution for intravenous and intramuscular administration 1 g: 1 pc.
Powder for solution for intravenous and intramuscular administration 2 g: 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration white or white with a yellowish tint, crystalline.

1 vial
Cefepime hydrochloride monohydrate* 0.6 g,
   Equivalent to cefepime content 0.5 g

*The substance is a sterile mixture of cefepime hydrochloride monohydrate and L-arginine. L-arginine is added as a pH regulator of the reconstituted solution in the range from 4.0 to 6.0. The amount of L-arginine may vary depending on the activity of the specific batch of cefepime hydrochloride.

Excipients: L-arginine – 0.3625 g.

0.5 g – colorless glass vials (type I) (1) – cardboard packs.
0.5 g – vials (50) – cardboard boxes (for hospitals).
0.5 g – vials (100) – cardboard boxes (for hospitals).
0.5 g – vials (150) – cardboard boxes (for hospitals).


Powder for preparation of solution for intravenous and intramuscular administration white or white with a yellowish tint, crystalline.

1 vial
Cefepime hydrochloride monohydrate* 1.2 g,
   Equivalent to cefepime content 1 g

*The substance is a sterile mixture of cefepime hydrochloride monohydrate and L-arginine. L-arginine is added as a pH regulator of the reconstituted solution in the range from 4.0 to 6.0. The amount of L-arginine may vary depending on the activity of the specific batch of cefepime hydrochloride.

Excipients: L-arginine – 0.725 g.

1 g – colorless glass vials (type I) (1) – cardboard packs.
1 g – vials (50) – cardboard boxes (for hospitals).
1 g – vials (100) – cardboard boxes (for hospitals).
1 g – vials (150) – cardboard boxes (for hospitals).


Powder for preparation of solution for intravenous and intramuscular administration white or white with a yellowish tint, crystalline.

1 vial
Cefepime hydrochloride monohydrate* 2.4 g,
   Equivalent to cefepime content 2 g

*The substance is a sterile mixture of cefepime hydrochloride monohydrate and L-arginine. L-arginine is added as a pH regulator of the reconstituted solution in the range from 4.0 to 6.0. The amount of L-arginine may vary depending on the activity of the specific batch of cefepime hydrochloride.

Excipients: L-arginine – 1.45 g.

2 g – colorless glass vials (type I) (1) – cardboard packs.
2 g – vials (50) – cardboard boxes (for hospitals).
2 g – vials (100) – cardboard boxes (for hospitals).
2 g – vials (150) – cardboard boxes (for hospitals).

Marketing Authorization Holder

Agio Pharmaceuticals, Ltd. (India)

Dosage Form

Bottle Rx Icon Cefepime-Agio Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefepime (in the form of hydrochloride) 1 g

1 g – vials (1) – carton packs.

Marketing Authorization Holder

Agio Pharmaceuticals, Ltd. (India)

Dosage Form

Bottle Rx Icon Cefepime-Agio Powder for solution for intravenous and intramuscular administration 500 mg: fl. 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefepime (in the form of hydrochloride) 500 mg

500 mg – vials (1) – carton packs.

Marketing Authorization Holder

Agio Pharmaceuticals, Ltd. (India)

Dosage Form

Bottle Rx Icon Cefepime-Agio Powder for solution for intravenous and intramuscular administration 2 g: vial 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefepime (in the form of hydrochloride) 2 g

2 g – vials (1) – carton packs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Forms

Bottle Rx Icon Cefepime-AKOS Powder for solution for intravenous and intramuscular administration 0.5 g: vial 1 or 10 pcs.
Powder for solution for intravenous and intramuscular administration 1 g: vial 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration white or white with a yellowish tint, hygroscopic.

1 vial
Cefepime (in the form of cefepime hydrochloride monohydrate) 0.5 g

Excipients: arginine.

0.5 g – vials (1) – carton packs.
0.5 g – vials (10) – carton packs.


Powder for preparation of solution for intravenous and intramuscular administration white or white with a yellowish tint, hygroscopic.

1 vial
Cefepime (in the form of cefepime hydrochloride monohydrate) 1 g

Excipients: arginine.

1 g – vials (1) – carton packs.
1 g – vials (10) – carton packs.

Marketing Authorization Holder

Alkem Laboratories Ltd. (India)

Dosage Form

Bottle Rx Icon Cefepime-Alkem Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration from white to pale yellow.

1 vial
Cefepime hydrochloride 1 g

Excipients: arginine 732.7 mg.

1 g – vials (1) – carton packs.
1 g – vials (50) – carton boxes (for hospitals).

Marketing Authorization Holder

Alpa Expoim, LLC (Russia)

Manufactured By

Cooper Pharma (India)

Dosage Form

Bottle Rx Icon Cefepime-Alpa Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefepime hydrochloride 1 g

1 g – vials (1) – carton packs.

Marketing Authorization Holder

Alvils, LLC (Russia)

Manufactured By

Belarusian-Dutch Joint Venture “FARMLAND”, LLC (Republic of Belarus)

Dosage Form

Bottle Rx Icon Cefepime-Alvils Powder for solution for intravenous and intramuscular administration 1 g

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration

1 vial
Cefepime (in the form of hydrochloride) 1 g

1 g – vials – carton packs – By prescription
1 g – vials (10 pcs.) – carton packs – By prescription
1 g – vials (5 pcs.) – carton packs – By prescription

Marketing Authorization Holder

Jodas Expoim, Pvt. Ltd. (India)

Dosage Form

Bottle Rx Icon Cefepime-Jodas Powder for solution for intravenous and intramuscular administration 1 g

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration

1 vial
Cefepime (in the form of hydrochloride monohydrate) 1 g

1000 mg – vials – carton packs – By prescription
1000 mg – vials – carton packs /included with solvent: water for injections (ampoules) 10 ml-1 pc./ – By prescription
1000 mg – vials – carton packs /included with solvent: water for injections (ampoules) 5 ml-2 pcs./ – By prescription
1000 mg – vials (10 pcs.) – carton boxes – for hospitals
1000 mg – vials (10 pcs.) – carton boxes /included with solvent: water for injections (ampoules) 10 ml-10 pcs./ – for hospitals
1000 mg – vials (10 pcs.) – carton boxes /included with solvent: water for injections (ampoules) 5 ml-20 pcs./ – for hospitals
1000 mg – vials (100 pcs.) – carton boxes – for hospitals
1000 mg – vials (100 pcs.) – carton boxes /included with solvent: water for injections (ampoules) 10 ml-100 pcs./ – for hospitals
1000 mg – vials (100 pcs.) – carton boxes /included with solvent: water for injections (ampoules) 5 ml-200 pcs./ – for hospitals
1000 mg – vials (25 pcs.) – carton boxes – for hospitals
1000 mg – vials (25 pcs.) – carton boxes /included with solvent: water for injections (ampoules) 10 ml-25 pcs./ – for hospitals
1000 mg – vials (25 pcs.) – carton boxes /included with solvent: water for injections (ampoules) 5 ml-50 pcs./ – for hospitals
1000 mg – vials (48 pcs.) – carton boxes – for hospitals
1000 mg – vials (48 pcs.) – carton boxes /included with solvent: water for injections (ampoules) 10 ml-48 pcs./ – for hospitals
1000 mg – vials (48 pcs.) – carton boxes /included with solvent: water for injections (ampoules) 5 ml-96 pcs./ – for hospitals

1 g – vials (1) – carton boxes.
1 g – vials (10) – carton boxes.
1 g – vials (20) – carton boxes.
1 g – vials (25) – carton boxes.
1 g – vials (48) – carton boxes.
1 g – vials (50) – carton boxes.
1 g – vials (100) – carton boxes.

Marketing Authorization Holder

Alvils, LLC (Russia)

Manufactured By

NORTH CHINA PHARMACEUTICAL CORPORATION (China)

Dosage Form

Bottle Rx Icon Cefepime-Vial Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefepime hydrochloride 1 g

1 g – dark glass vials (1) – carton packs.

Marketing Authorization Holder

Alvils, LLC (Russia)

Manufactured By

NORTH CHINA PHARMACEUTICAL CORPORATION (China)

Labeled By

OZON, LLC (Russia)

Dosage Form

Bottle Rx Icon Cefepime-Vial Powder for solution for intravenous and intramuscular administration 1 g: fl. 1, 600 or 1000 pcs. (packaged by Ozon LLC)

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefepime hydrochloride 1 g

1 g – dark glass vials (1) – carton packs.
1 g – dark glass vials (600) – carton boxes.
1 g – dark glass vials (1000) – carton packs.

Table of Contents

TABLE OF CONTENTS