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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Powder for solution for intravenous and intramuscular administration 1 g: vial 1, 5 or 50 pcs.
Marketing Authorization Holder
Aquarius Enterprises (India)
Dosage Form
 |
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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.
Marketing Authorization Holder
M.Biotech, Limited (United Kingdom)
Manufactured By
Nitin Lifesciences, Limited (India)
Dosage Form
|
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.
Powder for preparation of injection solution 250 mg: fl. 1 pc.
Marketing Authorization Holder
M.J. Biopharm Pvt. Ltd. (India)
Dosage Form
|
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.
Powder for preparation of injection solution 500 mg: fl. 1 pc.
Marketing Authorization Holder
M.J. Biopharm Pvt. Ltd. (India)
Dosage Form
|
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.
Powder for the preparation of injection solution 1 g: bottle 1 pc.
Marketing Authorization Holder
M.J. Biopharm Pvt. Ltd. (India)
Dosage Form
|
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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 10 or 50 pcs.
Marketing Authorization Holder
Mapichem AG (Switzerland)
Manufactured By
CSPS Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. (China)
Dosage Form
|
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.
Powder for solution for injection 1 g: vial 1 pc.
Powder for solution for injection 500 mg: fl. 1 pcs.
Marketing Authorization Holder
Shreya Life Sciences, Pvt.Ltd. (India)
Manufactured By
Serena Pharma, Pvt. Ltd. (India)
Dosage Forms
|
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.
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.
Marketing Authorization Holder
Alvils, LLC (Russia)
Manufactured By
Interpharma, LLC (Russia)
Dosage Forms
|
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).
Powder for solution for intravenous and intramuscular administration 1 g: vial 1 or 40 pcs.
Marketing Authorization Holder
Belmedpreparaty, JSC (Republic of Belarus)
Dosage Form
|
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.
Powder for solution for intravenous and intramuscular administration 500 mg: vial 1 or 40 pcs.
Marketing Authorization Holder
Belmedpreparaty, JSC (Republic of Belarus)
Dosage Form
|
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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1, 5, 10, 25, or 50 pcs. with solvent
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
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.
Powder for solution for intravenous and intramuscular administration 500 mg: vial 1, 5, 10, 25, or 50 pcs. in set with solvent
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
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.
Powder for solution for intravenous and intramuscular administration 500 mg: vial. 1, 10, or 270 pcs.
Marketing Authorization Holder
Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)
Dosage Form
|
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.
Powder for solution for intravenous and intramuscular administration 1 g: fl. 1, 10, or 270 pcs.
Marketing Authorization Holder
Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)
Dosage Form
|
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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 or 50 pcs.
Marketing Authorization Holder
Deko Company, LLC (Russia)
Dosage Form
|
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.
Powder for solution for intravenous and intramuscular administration 1 g: fl. 1, 10, or 50 pcs. with or without solvent
Marketing Authorization Holder
Kraspharma, PJSC (Russia)
Dosage Form
|
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.
Powder for solution for intravenous and intramuscular administration 500 mg: fl. 1, 10, or 50 pcs. with or without solvent
Marketing Authorization Holder
Kraspharma, PJSC (Russia)
Dosage Form
|
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.
Powder for solution for intramuscular injection 500 mg: vial 1 pc.
Marketing Authorization Holder
Kraspharma, PJSC (Russia)
Dosage Form
|
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.
Powder for solution for intramuscular administration 1 g: fl. 1, 10, or 50 pcs.
Marketing Authorization Holder
Kraspharma, PJSC (Russia)
Dosage Form
|
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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.
Marketing Authorization Holder
Makiz-Pharma, LLC (Russia)
Manufactured By
Shijiazhuang Pharmaceutical Group Ouyi, Co., Ltd. (China)
Dosage Form
|
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.
Powder for solution for intravenous and intramuscular administration 1 g: fl. 1, 5, 10 or 50 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Dosage Form
|
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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 5 pcs. with solvent
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Dosage Form
|
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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.
Marketing Authorization Holder
Ruzpharma, LLC (Russia)
Dosage Form
|
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.
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.
Marketing Authorization Holder
Sintez PJSC (Russia)
Dosage Forms
|
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.
Powder for solution for intravenous and intramuscular administration 1 g: vial. 5 or 30 pcs.
Marketing Authorization Holder
Pharmaceutical Firm LECKO, CJS (Russia)
Dosage Form
|
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.
![Cefotaxime [Powder] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Cefotaxime [Powder] 2")