AVC- sulfanilamide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SULFANILAMIDE (UNII: 21240MF57M) (SULFANILAMIDE - UNII:21240MF57M)

Available from:

Meda Pharmaceuticals

INN (International Name):

SULFANILAMIDE

Composition:

SULFANILAMIDE 15 g in 100 g

Administration route:

VAGINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the treatment of vulvovaginitis caused by Candida albicans . (See CLINICAL PHARMACOLOGY.) AVC should not be used in patients known to be sensitive to this product or to the sulfonamides. Tolerance, abuse, or dependence with AVC have not been reported.

Product summary:

AVC Cream NDC 0037-6631-04 4 oz tube with applicator Store at room temperature, below 86°F. Protect from cold. Product darkens with age. Potency is maintained throughout labeled shelf life when stored as directed. This leaflet provides a summary of the important information about AVC Cream. You can get more information by calling the toll free number (1-877-999-8403). Distributed by: Meda Pharmaceuticals Somerset, New Jersey 08873-4120 ©2018 Mylan Specialty L.P. AVC is a registered trademark of Meda Pharma S.A.R.L., a Mylan company. 141016 IN-663103-02 Rev. 6/2018

Authorization status:

New Drug Application

Summary of Product characteristics

AVC- SULFANILAMIDE CREAM
MEDA PHARMACEUTICALS
----------
AVC CREAM (SULFANILAMIDE) 15%
AVC (sulfanilamide)
Cream
DESCRIPTION
AVC is a preparation for vaginal administration for the treatment of
_Candida albicans_ infections and
available in the following form:
AVC Cream
Each tube contains:
Sulfanilamide.............................................................................................15.0%
in a water-miscible, non-staining base made from lactose, propylene
glycol, stearic acid, diglycol
stearate, methylparaben, propylparaben, trolamine, and water; buffered
with lactic acid to an acid pH of
approximately 4.3.
Sulfanilamide is an anti-infective agent. It is
p-amino-benzenesulfonamide with the chemical structure:
Sulfanilamide occurs as a white odorless crystalline powder with a
slightly bitter taste and sweet
aftertaste. It is slightly soluble in water, alcohol, acetone,
glycerin, propylene glycol, hydrochloric
acid, and solutions of potassium and sodium hydroxide. It is
practically insoluble in chloroform, ether,
benzene, and petroleum ether.
CLINICAL PHARMACOLOGY
Sulfanilamide has been a useful ingredient of vaginal formulations for
about four decades. It blocks
certain metabolic processes essential for the growth of susceptible
bacteria. In AVC, the sulfanilamide
is in a specially compounded base buffered to the pH (about 4.3) of
the normal vagina to encourage the
presence of the normally occurring Döderlein’s bacilli of the
vagina.
The use of AVC for the treatment of vulvovaginitis caused by _Candida
albicans_ is supported by three
clinical investigations. The three studies show AVC with sulfanilamide
to be significantly more
effective (p ≤ 0.01) than placebo as follows:
In Study I, the ratio of effectiveness was 71% for the AVC with
sulfanilamide versus 49% for placebo
with 30 days of treatment;
In Study II, the percentages were 48% and 24%, respectively, with 15
days of treatment;
In Study III, the percentages were 66% versus 33%, respectively, with
30 days of treatment.
INDICATIONS AND USAGE
F