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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.
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
| 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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1, 14, 24 or 50 pcs.
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 500 mg: fl. 1, 10, 14, 24, or 50 pcs.
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 1 g: vial 1 or 10 pcs.
Marketing Authorization Holder
Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 or 50 pcs.
Marketing Authorization Holder
Deko Company, LLC (Russia)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1, 10, or 50 pcs.
Marketing Authorization Holder
Kraspharma, PJSC (Russia)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 500 mg: vial. 1,10 or 50 pcs.
Marketing Authorization Holder
Kraspharma, PJSC (Russia)
Dosage Form
| 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.
Powder for solution for intramuscular injection 500 mg: vial 1, 10 or 50 pcs.
Marketing Authorization Holder
Kraspharma, PJSC (Russia)
Dosage Form
| 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.
Powder for solution for intramuscular administration 1 g: fl. 1, 10, or 50 pcs.
Marketing Authorization Holder
Kraspharma, PJSC (Russia)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 2 g: vial 1, 10 or 50 pcs.
Marketing Authorization Holder
Kraspharma, PJSC (Russia)
Dosage Form
| 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.
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.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Forms
| 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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.
Marketing Authorization Holder
Protek-SVM LLC (Russia)
Manufactured By
Sanjivani Parenteral, Limited (India)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 0.5 g: vial 1 pc.
Marketing Authorization Holder
Protek-SVM LLC (Russia)
Manufactured By
Sanjivani Parenteral, Limited (India)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 2 g: vial 1 pc.
Marketing Authorization Holder
Protek-SVM LLC (Russia)
Manufactured By
Sanjivani Parenteral, Limited (India)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1, 5 or 30 pcs.
Marketing Authorization Holder
Pharmaceutical Firm LECKO, CJS (Russia)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.
Marketing Authorization Holder
Pharmguid, CJS (Russia)
Dosage Form
| 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.
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.
Marketing Authorization Holder
Pharmconcept, LLC (Russia)
Dosage Forms
| 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).
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.
Marketing Authorization Holder
Agio Pharmaceuticals, Ltd. (India)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 500 mg: fl. 1 pc.
Marketing Authorization Holder
Agio Pharmaceuticals, Ltd. (India)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 2 g: vial 1 pc.
Marketing Authorization Holder
Agio Pharmaceuticals, Ltd. (India)
Dosage Form
| 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.
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.
Marketing Authorization Holder
Sintez PJSC (Russia)
Dosage Forms
| 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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 or 50 pcs.
Marketing Authorization Holder
Alkem Laboratories Ltd. (India)
Dosage Form
| 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).
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.
Marketing Authorization Holder
Alpa Expoim, LLC (Russia)
Manufactured By
Cooper Pharma (India)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 1 g
Marketing Authorization Holder
Alvils, LLC (Russia)
Manufactured By
Belarusian-Dutch Joint Venture “FARMLAND”, LLC (Republic of Belarus)
Dosage Form
| 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
Powder for solution for intravenous and intramuscular administration 1 g
Marketing Authorization Holder
Jodas Expoim, Pvt. Ltd. (India)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.
Marketing Authorization Holder
Alvils, LLC (Russia)
Manufactured By
NORTH CHINA PHARMACEUTICAL CORPORATION (China)
Dosage Form
| 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.
Powder for solution for intravenous and intramuscular administration 1 g: fl. 1, 600 or 1000 pcs. (packaged by Ozon LLC)
Marketing Authorization Holder
Alvils, LLC (Russia)
Manufactured By
NORTH CHINA PHARMACEUTICAL CORPORATION (China)
Labeled By
OZON, LLC (Russia)
Dosage Form
| 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.
