Active substance
Cefotaxime
- SFDA 18
- US FDA 21
- Health Canada 2
- WHO EML 2
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| FOXIME 1GM VIAL+5ML SOLVENT LIDOCAINE IM | 1 g | Powder and solvent for solution for injection · Intramuscular use | 1 Vial | SAR 36.55 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| FOXIME 1GM VIAL+5ML WATER FOR INJ IV USE | 1 g | Powder and solvent for solution for injection · Parenteral use | 1 Vial | SAR 36.55 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| FOXIME 500MG VIAL+AMP OF WATER IM-IV USE | 500 mg | Powder and solvent for solution for injection · Parenteral use | 1 Vial | SAR 22.70 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| PRIMOCEF 0.5 GM I.M- I.V VIAL | 500 mg | Powder and solvent for solution for injection · Intramuscular and intravenous use | 1 Vial | SAR 17.40 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Valid |
| PRIMOCEF 1 GM I.V VIAL | 1 g | Powder and solvent for solution for injection · Intravenous use | 1 Vial | SAR 28.05 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Valid |
| PRIMOCEF 1 g Powder for injection | 1 g | Powder and solvent for solution for injection · Intramuscular use | 1 Vial | SAR 28.05 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Valid |
| TOTAM 1GM IV\IM INJECTION | 1 g | powder for solution for injection · Parenteral use | 1 Vial | SAR 29.60 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| CEFTAX 1000MG VIAL+SOLVENT | 1 g | Injection · Parenteral use | 1 Vial | SAR 37.65 | Generic · Prescription | Hikma Pharmaceuticals PLC | Withdrawn by MAH · Not Marketed |
| CEFTAX 500MG VIAL+SOLVENT | 500 mg | Injection · Parenteral use | 1 Vial | SAR 23.35 | Generic · Prescription | Hikma Pharmaceuticals PLC | Withdrawn by MAH · Not Marketed |
| CLAFO 0.5GM POWDER FOR INJ. I.M I.V VIAL | 500 mg | Powder for injection · Parenteral use | 1 Vial | SAR 4.50 | Generic · Prescription | SHIFA PHARMACEUTICAL INDUSTRIES | Invalid · Not Marketed |
| CLAFO 1GM POWDER FOR INJ. I.M I.V VIAL | 1 g | Powder for injection · Parenteral use | 1 Vial | SAR 7.80 | Generic · Prescription | SHIFA PHARMACEUTICAL INDUSTRIES | Invalid · Not Marketed |
| CLAFORAN 1 GM (LIDOCAINE) IM VIAL | 1 g | Powder and solvent for solution for injection · Parenteral use | 1 Vial | SAR 45.00 | NCE · Prescription | SANOFI WINTHROP INDUSTRIE | Withdrawn by MAH · Not Marketed |
| CLAFORAN 1 GM I.V. VIAL | 1 g | powder for solution for injection · Parenteral use | 1 Vial | SAR 45.00 | NCE · Prescription | SANOFI WINTHROP INDUSTRIE | Withdrawn by MAH · Not Marketed |
| CLAFORAN 500 MG I.M.-I.V.VIALS | 500 mg | Powder and solvent for solution for injection · Parenteral use | 1 Vial | SAR 27.90 | NCE · Prescription | SANOFI WINTHROP INDUSTRIE | Withdrawn by MAH · Not Marketed |
| CLAFOTAX 1GM I.M VIAL | 1 g | Injection · Intramuscular use | 1 Vial | SAR 29.65 | Generic · Prescription | APM | Withdrawn by MAH · Not Marketed |
| CLAFOTAX 1GM I.V VIAL | 1 g | Injection · Intravenous use | 1 Vial | SAR 29.65 | Generic · Prescription | APM | Withdrawn by MAH · Not Marketed |
| CLAFOTAX 500MG I.V VIAL | 500 mg | Injection · Intravenous use | 1 Vial | SAR 18.35 | Generic · Prescription | APM | Withdrawn by MAH · Not Marketed |
| TOTAM 500MG IV\IM INJECTION | 500 mg | Powder for injection · Parenteral use | 1 Vial | SAR 18.35 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ACUTE BACTERIAL PROSTATITIS; ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS); ACUTE PANCREATITIS; ACUTE PYELONEPHRITIS; ANTIBIOTIC SURGICAL PROPHYLAXIS; BACTERIAL MENINGITIS; BACTERIAL SKIN INFECTIONS - NECROTIZING FASCIITIS; BACTERIAL SKIN INFECTIONS - SURGICAL SITE INFECTIONS; COMMUNITY ACQUIRED PNEUMONEA; ENDOCARDITIS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; INTRA-ABDOMINAL INFECTIONS; MUCOPURULENT CONJUCTIVITIS - GONOCOCCAL INFECTION OF THE EYE; OSTEOMYELITIS; PELVIC INFLAMMATORY DISEASE; PERITONITIS; Pyogenic Arthritis; RECURRENT URINARY TRACT INFECTIONS (UTI); Septic Shock; SICKLE CELL DISEASE - ACS MANAGEMENT; TRAVEL RELATED INFECTIONS-TREATMENT
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CLAFORAN | EQ 1GM BASE/VIAL | injectable · injection | STERIMAX | Prescription | 11 Mar 1981 |
| CLAFORAN | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | STERIMAX | Discontinued | 11 Mar 1981 |
| CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 20MG BASE/ML; EQ 40MG BASE/ML | injectable · injection | STERIMAX | Discontinued | 20 May 1985 |
| CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/ML; EQ 40MG BASE/ML | injectable · injection | STERIMAX | Discontinued | 20 May 1985 |
| CLAFORAN | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | SANOFI AVENTIS US | Discontinued | 13 Jan 1987 |
| CEFOTAXIME | EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | FRESENIUS KABI USA | Discontinued | 24 Mar 2000 |
| CEFOTAXIME | EQ 10GM BASE/VIAL; EQ 20GM BASE/VIAL | injectable · injection | FRESENIUS KABI USA | Discontinued | 24 Mar 2000 |
| CEFOTAXIME | EQ 10GM BASE/VIAL | injectable · injection | HIKMA | Discontinued | 20 Nov 2002 |
| CEFOTAXIME | EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | HIKMA | Discontinued | 20 Nov 2002 |
| CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | LUPIN | Discontinued | 24 Sep 2003 |
| CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER | EQ 2GM BASE | injectable · injection | B BRAUN | Discontinued | 29 Jul 2004 |
| CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER | EQ 1GM BASE | injectable · injection | B BRAUN | Discontinued | 29 Jul 2004 |
| CEFOTAXIME SODIUM | EQ 10GM BASE/VIAL | injectable · injection | HOSPIRA INC | Discontinued | 10 Aug 2006 |
| CEFOTAXIME SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | HOSPIRA INC | Discontinued | 10 Aug 2006 |
| CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | HOSPIRA INC | Discontinued | 11 Aug 2006 |
| CEFOTAXIME | EQ 1GM BASE/VIAL | injectable · injection | WOCKHARDT | Discontinued | 29 Aug 2006 |
| CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | WOCKHARDT | Discontinued | 29 Aug 2006 |
| CEFOTAXIME SODIUM | EQ 10GM BASE/VIAL | injectable · injection | AUROBINDO PHARMA LTD | Discontinued | 5 Nov 2009 |
| CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | AUROBINDO PHARMA | Discontinued | 5 Nov 2009 |
| CEFOTAXIME SODIUM | EQ 10GM BASE/VIAL | injectable · injection | CEPHAZONE PHARMA | Discontinued | 25 Jan 2010 |
| CEFOTAXIME SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | HOSPIRA | Discontinued | 19 Feb 2016 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| CEFOTAXIME SODIUM FOR INJECTION, BP | 02434091 | 1 G / VIAL | POWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUS | STERIMAX INC |
| CEFOTAXIME SODIUM FOR INJECTION, BP | 02434105 | 2 G / VIAL | POWDER FOR SOLUTION · INTRAVENOUS; INTRAMUSCULAR | STERIMAX INC |
WHO WHO Model List of Essential Medicines (2025)
- 6.2.2. Watch group antibiotics · core
First choice: Acute pyelonephritis (severe); First choice: Bacterial pneumonia (Community-acquired pneumonia - severe) [children]; First choice: Bacterial pneumonia (Community-acquired pneumonia - severe); First choice: Other specified pneumonia (Hospital-acquired pneumonia); First choice: Bacterial meningitis; First choice: Inflammatory or other diseases of prostate (severe) (co-prescribed with amikacin); First choice: Peritoneal abscess (mild-moderate) (co-prescribed with metronidazole); First choice: Peritoneal abscess (severe) (co-prescribed with metronidazole); First choice: Peritonitis (mild-moderate) (co-prescribed with metronidazole); First choice: Peritonitis (severe) (co-prescribed with metronidazole); Second choice: Acute pyelonephritis (mild to moderate); Second choice: Sepsis without septic shock; Second choice: Bacterial infection of joint; Second choice: Inflammatory or other diseases of prostate (mild to moderate); Second choice: Osteomyelitis or osteitis
Parenteral > General injections > unspecified: 250 mg in vial powder for injection (as sodium salt); 500 mg in vial powder for injection (as sodium salt); 1 g in vial powder for injection (as sodium salt); 2 g in vial powder for injection (as sodium salt) | Parenteral > General injections > unspecified: 250 mg in vial powder for injection (as sodium salt) (EMLc); 500 mg in vial powder for injection (as sodium salt) (EMLc); 1 g in vial powder for injection (as sodium salt) (EMLc); 2 g in vial powder for injection (as sodium salt) (EMLc) - 5.1.6.1. Medicines for bacterial central nervous system infections · core
First choice: Bacterial meningitis
Parenteral > General injections > unspecified: 250 mg in vial powder for injection (as sodium salt); 500 mg in vial powder for injection (as sodium salt); 1 g in vial powder for injection (as sodium salt); 2 g in vial powder for injection (as sodium salt)
Safety signals and safety-related labeling changes
- EMA PRAC 11 Jan 2024 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: Yes - EMA PRAC 31 Aug 2023 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.