Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
167. Cefadroxyl (as monohydrate) 125mg 24-07-08
+ Clavulanic acid (as potassium) 31.25 per 5ml
syrup
(Addl.stgth)
same as approved
U.S FDA APPROVED DRUGS DURING 2006
121. Cefadroxil 500mg + 30-08-2006
Clavulanic acid 125mg tablet Antibiotic
122. Cefadroxil 250mg + 30-08-2006
Clavulanic acid 62.5mg dispersible tablet Antibiotic
123. Cefadroxil 250mg + 30-08-2006
Clavulanic acid 62.5mg per 5ml syrup Antibiotic
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 First generation drug
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Cefadroxl Antibiotic February 1989
2.Cefadroxyl 250mg +Clavulanic acid 30-08-2006
62-5mg per 5ml syrup
Antibiotic
3.Cefadroxil 250mg + Clavulanic acid 30-08-2006
62.5mg dispersible tablet
Antibiotic
4. Cefadroxyl 500mg + Clavulanic acid 30-08-2006
125mg tablet
Antibiotic
5. Cefadroxyl (as monohydrate ) 125mg 25-07-2008
+ Clavulanic acid (as potassium)
31.25 5ml syrup
Addl.strength
Same as approved
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Cefadroxyl 250mg+ 30-08-2006
Clavulanic acid 62.5mg dispersible tablet
For the treatment of adult patients with infectionscaused by susceptible
microorganisms caused by S.Auteus .viz. Urinary tract infection. Lower
Respiratory Tract Infections and gonococccal urethritis
2. Cefadroxil 250mg+ 30-08-2006
Clavulanic acid 62.5mg per 5ml syrup
For the treatment of adult patients with infectionscaused by susceptible
microorganisms caused by S.Auteus .viz. Urinary tract infection. Lower
Respiratory Tract Infections and gonococccal urethritis
3.Cefadroxil 500mg + 30-08-2006
Clavulanic acid 125mg film coated tablets
For the treatment of adult patients with infectionscaused by susceptible
microorganisms caused by S.Auteus .viz. Urinary tract infection. Lower
Respiratory Tract Infections and gonococccal urethritis
4.Cefadroxyl as monohydrate 125mg + 25-07-2008
Clavulanic acid (as Potassium) 31.25per 5ml syrup
Addl.stgth
For the treatment of adult patients with infectionscaused by susceptible
microorganisms caused by S.Auteus .viz. Urinary tract infection. Lower
Respiratory Tract Infections and gonococccal urethritis
Adverse Reaction:
Anaphylactic reactions.
Nausea,vomiting, diarrhoea, abdominal discomfort.
Allergic reactions such as skin rash, urticaria, eosinophilla, angioedema. Rise in liver enzyme values.
Superinfection with resistent organisms(esp candida) Possibility of pseudomembranous colitis.
False urinary reaction of urinary glucose, development of positive coombs test.
Interferes with cross matching of blood.
False positive precipitation test with proteins.
Manufacturer Details