Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
149. Cefotaxime sodium 24-06-08
+ Sulbactam sodium for injection
(Addl.Indication)
For the treatment of lower respiratory tract infection
in children
U.S FDA APPROVED DRUGS DURING 2007
70. Cefotaxim (as sodium) 0.5mg/1gm + 18-05-07
Sulbactum (as sodium) 250mg/500mg injection
(For addtl.indctn) For surgical prophylaxis (addl.Indtn)
Lower respiratory tract infection, urinary tract infection, gynaecological infection, Bacteremia, spectecaemia, Skin and structure injection, Intra-abdominal infection,
Bone and joint infection CNS infection.
Drugs covered:
1st generation 2nd generation 3rd generation .
Cephalexin Cefaclor Cefixime Cefadroxil Cefamandole Cefoperazone Cephadrine Cefotoxitin Cefotaxime Cephalothin Cefuroxime Ceftizoxime Cephapirin Cefonicid Ceftriaxone Cefazolin Cefmetazole Ceftazidime Cefotetan Ceftibuten Cefprozil Cefepime Cefpodoxime Loracarbef
Refer Cephalosporins
A third generation drug
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Cefotaxime sodium 0.5mg/1gm + 18-05-2007
Sulbactum sodium 250mg/500mg
for injection
Addl.Indication
For surgical prophylaxis
2. Cefotaxime sodium + Sulbactum 24-06-2008
sodium for injection
Addl.injection
For the treatment of lower respiratory tract infection in children
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Sterile Cefotaxime sodium USP eq.to 26-12-2003
Cefotataxime 500mg/1000mg +
Sterile Sulbatum 250mg/500mg per vial injection
For the treatment of lower respiratory tract injection
and genito urinary tract infection
Adverse Reaction:
Anaphylactic reactions.
Pain at inj site. Hypersensitivity reactions.
GI disturbances, Candidadiasis,
Eosinophilla, Neutropenia, leucopenia, thrombocytopenia,
Rise in liver enzymes and blood urea.
Positive Coombs test.
Dosages/ Overdosage Etc:
A third generation drug.
Indications:
Lower respiratory tract infection, urinary tract infection, gynaecological infection, Bacteremia, spectecaemia, Skin and structure injection, Intra-abdominal infection, Bone and joint infection CNS infection.
Dosage:
Administer IM or IV. 1g upto 12g daily dose divided and given at frequent intervals depending on the severity of infection.
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Manufacturer Details