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Cefotaxime (Powder) Instructions for Use

ATC Code

J01DD01 (Cefotaxime)

Active Substance

Cefotaxime (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Third generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

A third-generation cephalosporin antibiotic for parenteral administration. It acts bactericidally. The mechanism of action is associated with disruption of the synthesis of mucopeptide in the microbial cell wall. It has a broad spectrum of antimicrobial activity.

The drug is active against gram-positive and gram-negative microorganisms resistant to other antibiotics: Staphylococcus spp. (including Staphylococcus aureus, including penicillinase-producing strains, except for methicillin-resistant strains), Staphylococcus epidermidis (except for methicillin-resistant strains), Streptococcus pneumoniae, Streptococcus pyogenes (beta-hemolytic streptococci group A), Streptococcus agalactiae (group B streptococci), Enterococcus spp., Enterobacter spp., Escherichia coli, Haemophilus influenzae (including penicillinase-producing strains), Haemophilus parainfluenzae, Moraxella catarrhalis, Klebsiella spp. (including Klebsiella pneumoniae, Klebsiella oxytoca), Morganella morganii, Neisseria gonorrhoeae (including penicillinase-producing strains), Acinetobacter spp., Corynebacterium diphtheriae, Erysipelothrix rhusiopathiae, Eubacterium spp., Propionibacterium spp., Clostridium spp. (including Clostridium perfringens), Citrobacter spp., Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri), Serratia spp., some strains of Pseudomonas aeruginosa, Neisseria meningitidis, Bacteroides spp. (including some strains of Bacteroides fragilis), Fusobacterium spp. (including Fusobacterium nucleatum), Peptococcus spp., Peptostreptococcus spp.

It has variable activity against some strains of Pseudomonas aeruginosa, Acinetobacter spp., Helicobacter pylori, Bacteroides fragilis, Clostridium difficile.

It is resistant to most beta-lactamases of gram-positive and gram-negative microorganisms.

Pharmacokinetics

Absorption

After a single intravenous administration in doses of 500 mg, 1 g, and 2 g, Tmax is 5 min, and Cmax is 39, 101.7, and 214 mcg/ml, respectively.

After intramuscular administration in doses of 500 mg and 1 g, Tmax is 0.5 h, and Cmax is 11 and 21 mcg/ml, respectively.

Distribution

Plasma protein binding is 30-50%. Bioavailability is 90-95%. Therapeutic concentrations are achieved in most tissues (myocardium, bones, gallbladder, skin, soft tissues) and body fluids (synovial, pericardial, pleural, sputum, bile, urine, cerebrospinal fluid).

Vd is 0.25-0.39 l/kg.

No accumulation is observed after repeated intravenous administration of 1 g every 6 h for 14 days.

Cefotaxime crosses the placental barrier and is excreted in breast milk in low concentrations.

Elimination

T1/2 after intravenous administration is 1 h, after intramuscular administration it is 1-1.5 h. It is excreted by the kidneys: 20-36% unchanged, the rest as metabolites (15-25% as pharmacologically active desacetylcefotaxime and 20-25% as 2 inactive metabolites).

Pharmacokinetics in Special Clinical Cases

In chronic renal failure and in elderly patients, T1/2 increases 2-fold. T1/2 in newborns is 0.75-1.5 h; in premature newborns (body weight less than 1500 g) it increases to 4.6 h; in children with body weight over 1500 g it is 3.4 h.

Indications

Infectious and inflammatory diseases caused by susceptible microorganisms, including:

  • Infections of the CNS (meningitis);
  • Infections of the respiratory tract and ENT organs;
  • Urinary tract infections;
  • Bone and joint infections;
  • Skin and soft tissue infections;
  • Pelvic organ infections;
  • Abdominal infections;
  • Peritonitis;
  • Sepsis;
  • Endocarditis;
  • Gonorrhea;
  • Infected wounds and burns;
  • Salmonellosis;
  • Lyme disease;
  • Infections against the background of immunodeficiency.

Prevention of infections after surgical operations (including urological, obstetric-gynecological, gastrointestinal surgeries).

ICD codes

ICD-10 code Indication
A02 Other salmonella infections
A39 Meningococcal infection
A40 Streptococcal sepsis
A41 Other sepsis
A54 Gonococcal infection
A69.2 Lyme disease
G00 Bacterial meningitis, not elsewhere classified
H68 Inflammation and obstruction of Eustachian tube
I33 Acute and subacute endocarditis
J01 Acute sinusitis
J02 Acute pharyngitis
J03 Acute tonsillitis
J04 Acute laryngitis and tracheitis
J15 Bacterial pneumonia, not elsewhere classified
J20 Acute bronchitis
J31 Chronic rhinitis, nasopharyngitis and pharyngitis
J32 Chronic sinusitis
J35.0 Chronic tonsillitis
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
M00 Pyogenic arthritis
M86 Osteomyelitis
N10 Acute tubulointerstitial nephritis (acute pyelonephritis)
N11 Chronic tubulointerstitial nephritis (chronic pyelonephritis)
N15.1 Renal and perinephric abscess
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)
N73.0 Acute parametritis and pelvic cellulitis
T79.3 Posttraumatic wound infection, not elsewhere classified
Z29.2 Other prophylactic chemotherapy (administration of antibiotics for prophylactic purposes)
ICD-11 code Indication
1A09.Z Salmonella infection, unspecified
1A7Z Gonococcal infection, unspecified
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
1C1C.Z Meningococcal disease, unspecified
1C1G.13 Lyme arthritis
1C1G.1Z Disseminated Lyme borreliosis, unspecified
1C1G.Z Lyme borreliosis, unspecified
1D01.0Z Bacterial meningitis, unspecified
1G40 Sepsis without septic shock
AB10.Z Diseases of the auditory [eustachian] tube, unspecified
BB4Z Acute or subacute endocarditis, unspecified
CA01 Acute rhinosinusitis
CA02.Z Acute pharyngitis, unspecified
CA03.Z Acute tonsillitis, unspecified
CA05 Acute laryngitis or tracheitis
CA09 Chronic rhinitis, nasopharyngitis or pharyngitis
CA0A.Z Chronic rhinosinusitis, unspecified
CA0F.Y Other specified chronic diseases of the palatine tonsils and adenoids
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
EB21 Pyoderma gangrenosum
FA1Z Infectious arthropathies, unspecified
FB84.Z Osteomyelitis or osteitis, unspecified
GA01.Z Inflammatory diseases of uterus, except cervix, unspecified
GA05.0 Acute inflammatory disease of female pelvic organs
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
GB59 Abscess of kidney or perirenal tissue
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.

Powder

The drug is administered intravenously (bolus or infusion) and intramuscularly.

The drug is prescribed to adults and children over 12 years of age (with body weight ≥50 kg).

For uncomplicated infections, as well as for urinary tract infections – IM or IV 1 g every 8-12 h.

For uncomplicated acute gonorrhea – IM in a dose of 1 g once.

For moderate infections – IM or IV 1-2 g every 12 h.

For severe infections, such as meningitis – IV 2 g every 4-8 h, maximum daily dose is 12 g. The duration of treatment is determined individually.

For the prevention of infections before surgery, it is administered once during induction anesthesia in a dose of 1 g. If necessary, the administration is repeated after 6-12 h.

For cesarean section – at the moment of clamping the umbilical vein – IV in a dose of 1 g, then after 6 and 12 h after the first dose – an additional 1 g each.

If GFR ≤20 ml/min/1.73 m2, the daily dose is reduced by half.

For premature and newborn infants under 1 week of age – IV in a dose of 50 mg/kg every 12 h; at the age of 1-4 weeks – IV in a dose of 50 mg/kg every 8 h. For children with body weight ≤50 kg – IV or IM (for children over 2.5 years of age) 50-180 mg/kg in 4-6 administrations.

For severe infections (including meningitis), the daily dose for children is increased to 100-200 mg/kg, IM or IV in 4-6 injections, maximum daily dose is 12 g.

Rules for preparation of injection solutions

For IV injection: 1 g of the drug is diluted in 4 ml of sterile water for injections; the drug is administered slowly over 3-5 min.

For IV infusion: 1-2 g of the drug is diluted in 50-100 ml of solvent. Use 0.9% sodium chloride solution or 5% dextrose (glucose) solution as a solvent. The duration of infusion is 50 – 60 min.

For IM administration: 1 g is dissolved in 4 ml of solvent. Use water for injections or 1% lidocaine solution as a solvent.

Adverse Reactions

From the CNS: headache, dizziness.

From the urinary system: impaired renal function, oliguria, interstitial nephritis.

From the digestive system: nausea, vomiting, diarrhea or constipation, flatulence, abdominal pain, dysbacteriosis, impaired liver function; rarely – stomatitis, glossitis, pseudomembranous enterocolitis, increased activity of hepatic transaminases and ALP, hyperbilirubinemia.

From the hematopoietic organs: hemolytic anemia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia, agranulocytosis, hypocoagulation.

From the cardiovascular system: potentially life-threatening arrhythmias after rapid bolus injection into a central vein.

Laboratory parameters: azotemia, increased blood urea concentration, hypercreatininemia, positive Coombs test.

Local reactions: phlebitis, pain along the vein, pain and infiltrate at the IM injection site.

Allergic reactions: urticaria, chills or fever, rash, skin itching; rarely – bronchospasm, eosinophilia, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), angioedema, anaphylactic shock.

Other: superinfection (vaginal and oral candidiasis).

Contraindications

  • Pregnancy;
  • Children under 2.5 years of age (for intramuscular administration);
  • Hypersensitivity (including to penicillins, other cephalosporins, carbapenems).

The drug should be used with caution in newborns, during lactation (excreted in breast milk in low concentrations), in chronic renal failure, in ulcerative colitis (including history).

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy.

If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.

Use in Renal Impairment

Use with caution in chronic renal failure.

Special Precautions

During the first weeks of treatment, pseudomembranous colitis may occur, manifested by severe prolonged diarrhea. In this case, discontinue the drug and prescribe adequate therapy, including vancomycin or metronidazole.

Patients with a history of allergic reactions to penicillins may have increased sensitivity to cephalosporin antibiotics.

When treating with the drug for more than 10 days, monitoring of the peripheral blood picture is necessary.

During treatment with cefotaxime, a false-positive Coombs test and a false-positive urine glucose reaction may be obtained.

During treatment, alcohol should not be consumed, as effects similar to the action of disulfiram are possible (facial flushing, abdominal and stomach cramps, nausea, vomiting, headache, decreased blood pressure, tachycardia, shortness of breath).

Overdose

Symptoms: convulsions, encephalopathy (in case of high-dose administration, especially in patients with renal failure), tremor, neuromuscular excitability.

Treatment: symptomatic, there is no specific antidote.

Drug Interactions

Cefotaxime increases the risk of bleeding when combined with antiplatelet agents, NSAIDs.

The risk of kidney damage increases with simultaneous use of aminoglycosides, polymyxin B, and “loop” diuretics.

Drugs that block tubular secretion increase plasma concentrations of cefotaxime and slow its elimination.

Pharmaceutical Interaction

Pharmaceutically incompatible with solutions of other antibiotics in the same syringe or infusion set.

Storage Conditions

List B. The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 2 years.

Dispensing Status

The drug is dispensed by prescription.

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

Aquarius Enterprises (India)

Dosage Form

Bottle Rx Icon Cefotaxime Powder for solution for intravenous and intramuscular administration 1 g: vial 1, 5 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefotaxime sodium salt 1 g

1 g – vials (5) – cardboard boxes.
1 g – vials (50) – cardboard boxes.
1 g – vials (1) – cardboard boxes.
1 g – vials (50) – cardboard boxes.

Marketing Authorization Holder

M.Biotech, Limited (United Kingdom)

Manufactured By

Nitin Lifesciences, Limited (India)

Dosage Form

Bottle Rx Icon Cefotaxime 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 white or almost white with a yellowish tint.

1 vial
Cefotaxime (as cefotaxime sodium) 1 g

Colorless glass vials with a volume of 10 ml (1) – cardboard packs.

Marketing Authorization Holder

M.J. Biopharm Pvt. Ltd. (India)

Dosage Form

Bottle Rx Icon Cefotaxime Powder for preparation of injection solution 250 mg: fl. 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of injection solution white or light yellow in color, odorless.

1 vial
Cefotaxime (as sodium salt) 250 mg

Glass vials (1) – cardboard packs.

Marketing Authorization Holder

M.J. Biopharm Pvt. Ltd. (India)

Dosage Form

Bottle Rx Icon Cefotaxime Powder for preparation of injection solution 500 mg: fl. 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of injection solution white or light yellow in color, odorless.

1 vial
Cefotaxime (as sodium salt) 500 mg

Glass vials (1) – cardboard packs.

Marketing Authorization Holder

M.J. Biopharm Pvt. Ltd. (India)

Dosage Form

Bottle Rx Icon Cefotaxime Powder for the preparation of injection solution 1 g: bottle 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of injection solution white or light yellow in color, odorless.

1 vial
Cefotaxime (as sodium salt) 1 g

Glass vials (1) – cardboard packs.

Marketing Authorization Holder

Mapichem AG (Switzerland)

Manufactured By

CSPS Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. (China)

Dosage Form

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

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefotaxime (as sodium salt) 1 g

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

Marketing Authorization Holder

Shreya Life Sciences, Pvt.Ltd. (India)

Manufactured By

Serena Pharma, Pvt. Ltd. (India)

Dosage Forms

Bottle Rx Icon Cefotaxime Powder for solution for injection 1 g: vial 1 pc.
Powder for solution for injection 500 mg: fl. 1 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for injection from white to pale yellow in color.

1 vial
Cefotaxime sodium (equivalent to anhydrous cefotaxime) 500 mg

Glass vials (1) – cardboard packs.

Powder for preparation of solution for injection from white to pale yellow in color.

1 vial
Cefotaxime sodium (equivalent to anhydrous cefotaxime) 1 g

Glass vials (1) – cardboard packs.

Marketing Authorization Holder

Alvils, LLC (Russia)

Manufactured By

Interpharma, LLC (Russia)

Dosage Forms

Bottle Rx Icon Cefotaxime Powder for solution for intravenous and intramuscular administration 0.5 g: vial 1 pc.
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 crystalline, white or white with a yellowish tint, hygroscopic.

1 vial
Cefotaxime sodium 0.524 g,
   Corresponding to cefotaxime content 0.5 g

0.5 g – glass vials with a capacity of 10 ml (1) – cardboard packs.
0.5 g – glass vials with a capacity of 10 ml (24) – cardboard boxes (for hospitals).
0.5 g – glass vials with a capacity of 10 ml (36) – cardboard boxes (for hospitals).

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

1 vial
Cefotaxime sodium 1.048 g,
   Corresponding to cefotaxime content 1 g

1 g – glass vials with a capacity of 10 ml (1) – cardboard packs.
1 g – glass vials with a capacity of 10 ml (24) – cardboard boxes (for hospitals).
1 g – glass vials with a capacity of 10 ml (36) – cardboard boxes (for hospitals).

Marketing Authorization Holder

Belmedpreparaty, JSC (Republic of Belarus)

Dosage Form

Bottle Rx Icon Cefotaxime Powder for solution for intravenous and intramuscular administration 1 g: vial 1 or 40 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefotaxime (as sodium salt) 1 g

1 g – vials (1) – cardboard packs.
1 g – vials (40) (for hospitals) – cardboard boxes.

Marketing Authorization Holder

Belmedpreparaty, JSC (Republic of Belarus)

Dosage Form

Bottle Rx Icon Cefotaxime Powder for solution for intravenous and intramuscular administration 500 mg: vial 1 or 40 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefotaxime (as sodium salt) 500 mg

500 mg – vials (1) – cardboard packs.
500 mg – vials (40) (for hospitals) – cardboard boxes.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Cefotaxime Powder for solution for intravenous and intramuscular administration 1 g: vial. 1, 5, 10, 25, or 50 pcs. with solvent

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration from white to slightly yellow in color.

1 vial
Cefotaxime sodium salt 1 g

Solvent water for injections – 5 ml.

1 g – vials (1) – cardboard packs.
1 g – Vials with a volume of 10 ml (5) in a set with solvent (amp. 5 pcs.) – cardboard boxes.
1 g – vials (for hospitals).
1 g – vials (10) – cardboard packs.
1 g – vials (25) – cardboard boxes.
1 g – vials (50) – cardboard boxes.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Cefotaxime Powder for solution for intravenous and intramuscular administration 500 mg: vial 1, 5, 10, 25, or 50 pcs. in set with solvent

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration from white to slightly yellow in color.

1 vial
Cefotaxime sodium salt 500 mg

Solvent water for injections – 5 ml.

500 mg – Vials with a volume of 10 ml (5) in a set with solvent (amp. 5 pcs.) – cardboard boxes.
500 mg – Vials with a volume of 10 ml (1) in a set with solvent (amp. 5 pcs.) – cardboard boxes.
500 mg – Vials with a volume of 10 ml (1) – cardboard boxes.
500 mg – Vials with a volume of 10 ml (10) – cardboard boxes.
500 mg – Vials with a volume of 10 ml (25) – cardboard boxes.
500 mg – Vials with a volume of 10 ml (50) – cardboard boxes.

Marketing Authorization Holder

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

Dosage Form

Bottle Rx Icon Cefotaxime Powder for solution for intravenous and intramuscular administration 500 mg: vial. 1, 10, or 270 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefotaxime (as sodium salt) 500 mg

500 mg – vials (1) – cardboard packs.
500 mg – vials (10) – packs.
500 mg – vials (10) – cardboard packs with insert.
500 mg – vials (270) (for hospitals) – cardboard boxes.

Marketing Authorization Holder

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

Dosage Form

Bottle Rx Icon Cefotaxime Powder for solution for intravenous and intramuscular administration 1 g: fl. 1, 10, or 270 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefotaxime (as sodium salt) 1 g

1 g – vials (1) – cardboard packs.
1 g – vials (10) – packs.
1 g – vials (10) – cardboard packs with insert.
1 g – vials (270) (for hospitals) – cardboard boxes.

Marketing Authorization Holder

Deko Company, LLC (Russia)

Dosage Form

Bottle Rx Icon Cefotaxime 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 white or white with a yellowish tint in color.

1 vial
Cefotaxime (as sodium salt) 1 g

1 g – Vials with a capacity of 10 ml (1) – cardboard packs.
1 g – Vials with a capacity of 10 ml (50) – cardboard boxes.

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Form

Bottle Rx Icon Cefotaxime Powder for solution for intravenous and intramuscular administration 1 g: fl. 1, 10, or 50 pcs. with or without solvent

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefotaxime (as sodium salt) 1 g

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

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Form

Bottle Rx Icon Cefotaxime Powder for solution for intravenous and intramuscular administration 500 mg: fl. 1, 10, or 50 pcs. with or without solvent

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefotaxime (as sodium salt) 500 mg

500 mg – glass vials (1) – cardboard packs.
500 mg – glass vials (1) in a set with solvent (5 ml amp. 1 pc.) – cardboard packs.
500 mg – glass vials (5) in a set with solvent (5 ml amp. 5 pcs.) – cardboard packs.
500 mg – glass vials (10) – cardboard boxes.
500 mg – glass vials (50) – cardboard boxes.

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Form

Bottle Rx Icon Cefotaxime Powder for solution for intramuscular injection 500 mg: vial 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intramuscular administration 1 vial
Cefotaxime (as sodium salt) 500 mg

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

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Form

Bottle Rx Icon Cefotaxime 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
Cefotaxime (as sodium salt) 1 g

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

Marketing Authorization Holder

Makiz-Pharma, LLC (Russia)

Manufactured By

Shijiazhuang Pharmaceutical Group Ouyi, Co., Ltd. (China)

Dosage Form

Bottle Rx Icon Cefotaxime 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 almost white or yellowish in color.

1 vial
Cefotaxime (as sodium salt) 1 g

Glass vials (1) – cardboard packs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Dosage Form

Bottle Rx Icon Cefotaxime Powder for solution for intravenous and intramuscular administration 1 g: fl. 1, 5, 10 or 50 pcs.

Dosage Form, Packaging, and Composition

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

1 vial
Cefotaxime sodium salt 500 mg

1 g – vials.
1 g – vials – cardboard packs.
1 g – vials (1) – cardboard packs.
1 g – vials (5) – cardboard boxes.
1 g – vials (5) – cardboard packs.
1 g – vials (10) – cardboard packs.
1 g – vials (10) – cardboard boxes.
1 g – Vials with a volume of 10 ml (50) – cardboard boxes.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Dosage Form

Bottle Rx Icon Cefotaxime Powder for solution for intravenous and intramuscular administration 1 g: vial. 5 pcs. with solvent

Dosage Form, Packaging, and Composition

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

1 vial
Cefotaxime sodium salt 1 g

Solvent water for injections – 5 ml.

1 g – Vials with a volume of 10 ml (5) in a set with solvent (amp. 5 pcs.) – cardboard boxes.

Marketing Authorization Holder

Ruzpharma, LLC (Russia)

Dosage Form

Bottle Rx Icon Cefotaxime 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 from white to slightly yellow.

1 vial
Cefotaxime sodium salt 500 mg

500 mg – vials (1) – cardboard packs.
500 mg – vials (5) – cardboard packs.
500 mg – vials (50) – cardboard boxes.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Forms

Bottle Rx Icon Cefotaxime 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.
Powder for solution for intravenous and intramuscular administration 2 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.

1 vial
Cefotaxime (as cefotaxime sodium) 0.5 g

Solvent water for injection (ampoules).

0.5 g – glass vials with a capacity of 10 ml or 20 ml (1) – cardboard packs.
0.5 g – glass vials with a capacity of 10 ml or 20 ml (1) in a set with solvent (amp. 1 pc.) – contour cell packs (1) – cardboard packs.
0.5 g – glass vials with a capacity of 10 ml or 20 ml (10) – cardboard packs.

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

1 vial
Cefotaxime (as cefotaxime sodium) 1 g

Solvent: water for injection (ampoules).

1 g – glass vials with a capacity of 10 ml or 20 ml (1) – cardboard packs.
1 g – glass vials with a capacity of 10 ml or 20 ml (1) in a set with solvent (amp. 1 pc.) – contour cell packs (1) – cardboard packs.
1 g – glass vials with a capacity of 10 ml or 20 ml (10) – cardboard packs.

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

1 vial
Cefotaxime (as cefotaxime sodium) 2 g

Solvent: water for injection (ampoules).

2 g – glass vials with a capacity of 10 ml or 20 ml (1) – cardboard packs.
2 g – glass vials with a capacity of 10 ml or 20 ml (1) in a set with solvent (amp. 2 pcs.) – contour cell packs (1) – cardboard packs.
2 g – glass vials with a capacity of 10 ml or 20 ml (10) – cardboard packs.

Marketing Authorization Holder

Pharmaceutical Firm LECKO, CJS (Russia)

Dosage Form

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

Dosage Form, Packaging, and Composition

Powder for preparation of solution for intravenous and intramuscular administration 1 vial
Cefotaxime sodium salt 1 g

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

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