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.
Manufacturer Details