Indication:
        
        
            
	U.S FDA  APPROVED DRUGS FROM 01-01-08 TO 31-12-08
	 
	Drug name                               Indication                    Date of Approval
	 
	65.  Sertaconazole Nitrate Cream 2%                           31-01-08
	                      
	       For the topical treatment of the superficial
	       mycosis like dermatophytosis
	 
	220. Sertaconazole Nitrate Vaginal Tab.500mg         09-10-08
	 
	       For the treatment of vulvo-vaginal candidiasis
	       in women
	                                                                         
	US.FDA APPROVED DRUGS DURING 2007
	 
	177.  Sertanidazole 300mg +                      29-11-07 
	          Ofloxacin 200mg tablet                                                                                      
	          For treatment of diarrhoea of mixed infection in adults
	 
	 
	Tinea pedis
	 
	New Drugs Approved by (DCI) Drug Controller  GENERAL -  India  For Marketing
	                                                                                            (Ref- IDMA Publication)
	 
	Name of Drug                   Indication                             Date of Approval
	 
	1.Sertaconazole 2%w/v                                                    05-03-2010
	  + Zinc Pyrithione 1% w/v
	   shampoo
	 
	 For the treatment of adult patients with Dandruff/Seborrheic Dermatitis
	 of the scalp
	 
	
		FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
	
		FROM JANUARY 1961 TILL NOVEMBER 2014
	
		 
	
		Name of Drug                                     Indication                      Date of Approval   
	
		 
	
		 Seratanconazole 2% w/v +                                                         03-05-2010
	
		 Zinc Pyrithione 1% w/v Shampoo
	
		 
	
		  For the treatment in adult patients with dandruff /
	
		  seborrheic dermatitis of the scalp
 
	 
	2.Sertaconazole Nitrate 2%                                            31-01-2008
	  cream
	 
	For the Topical treatment of the Superficial Mycosis like Dermatophyosis
	 
	3.Sertaconazole Nitrate Powder                                       02- 05-2009
	   2% w/w & Lotion 2%w/v
	 
	   For the topical Treatment of the superficial Fungal nfections of the
	   skin
	 
	4.Sertaconazole Nitrate Vaginal                                      09-10-2008
	  Tablet 500mg 
	 
	   For the treatment of Vulvo-Vaginal Candidiasis in women
	 
	5.Sertaconazole 300mg                                                    29-11-2007 
	   + Ofloxacin 200mg tablet
	 
	   For the treatment of Diarrhoea of mixed infection in Adult patients
	 
	 
	 
	 For the topical treatment of the superficial Fungal infections of the skin                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
	 
        
     
    
    
           
            Contra-Indications:
        
        
            
	Sensitivity to sertaconazole
	Warnings-
	For external use only-  sertaconazole nitrate cream is not  indicated for opthalmic, oral or
	intravaginal use
	Sensitivity - if irritation or sensitivity develops , treatment should be discontinued and appropiate
	treatment instituted.
	Pregnancy- evidence has been found to suggest adverse reactions on pregnant women.
	Excercise caution if use is required
	Lactation- Caution should be when prescribing to a nursing woman
	Children- effeicacy and safety have not been established in pediatric patients below the age
	 of 12 years
        
     
    
    
           
            Patient Information:
        
        
            
	1. Use serataconazole cream as directed by the doctor.
	2. Wash hands after appyling medication to the affected area.
	3. Avoid contact with  eyes, nose, mouth, and other mucous membranes. It is only extrenal use only
	4. Complete the full course of treatment as recommended by the physician, even though symptoms may have improved
	5. Notify the physician if there is no improvement after the end of treatment period or if the condition worsens
        
     
    
    
           
            Pharmacology/ Pharmacokinetics:
        
        
            
	Pharmacodynamics-
	Sertaconazole nitrate contains one asymemteric carbon atom and exits as a racemic mixture of equal amounts of R and S enantiomers and acts similar to that of other imidazoles It inhibits the cytochrome P 450 dependent synthesis of ergosterol resulting in disorganization of the fungal plasma membrane and altered permeability
	Pharmacokinetics-
	Sertaconazole nitrate was shown to penetrate into the stratum comeum shortly after application, with mean apparent half life of 60 hours. Systemic absorption is minimal to undetectable. The drug is undetectable in serum or urine samples from healthy subjects for upto 24 hrs with 16g of sertaconazole 2% cream.