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sulfanilamide
Overview
What is AVC?
AVC is a preparation for vaginal administration for the treatment of 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.
What does AVC look like?
What are the available doses of AVC?
Sorry No records found.
What should I talk to my health care provider before I take AVC?
Sorry No records found
How should I use AVC?
For the treatment of vulvovaginitis caused by . (See .)
One applicatorful (about 6 g) intravaginally once or twice daily. Improvements in symptoms should occur within a few days, but treatment should be continued for a period of 30 days.
Douching with a suitable solution before insertion may be recommended for hygienic purposes.
What interacts with AVC?
AVC should not be used in patients known to be sensitive to this product or to the sulfonamides.
What are the warnings of AVC?
Sorry No Records found
What are the precautions of AVC?
General
Because sulfonamides are absorbed from the vaginal mucosa, the usual precautions for oral sulfonamides apply. Patients should be observed for skin rash or evidence of systemic toxicity, and if these develop, the medications should be discontinued.
Deaths associated with administration of oral sulfonamides have reportedly occurred from hypersensitivity reactions, agranulocytosis, aplastic anemia, and other blood dyscrasias.
Goiter production, diuresis, and hypoglycemia have reportedly occurred rarely in patients receiving oral sulfonamides. Cross-sensitivity may exist with these agents. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term administration has reportedly produced thyroid malignancies in this species.
Vaginal applicators or inserters should be used with caution after the seventh month of pregnancy.
Information For Patients
The doctor should advise the patient that in the event unusual local itching and burning occur, or other unusual symptoms develop, medication should be discontinued and not restarted without further consultation.
Drug Interactions
Drug interactions have not been documented with AVC.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No data are available on long-term potential of AVC for carcinogenicity, mutagenicity, or impairment of fertility in animals or humans.
Pregnancy
Nursing Mothers
Sulfanilamide should be avoided in nursing mothers because absorbed sulfonamides will appear in maternal milk and have caused kernicterus in the newborn. Because of the potential for serious adverse reactions in nursing infants from sulfonamides, a decision should be made whether to discontinue nursing or to discontinue the drug.
Pediatric Use
Safety and effectiveness of AVC in pediatric patients have not been established.
What are the side effects of AVC?
Sorry No records found
What should I look out for while using AVC?
AVC should not be used in patients known to be sensitive to this product or to the sulfonamides.
What might happen if I take too much AVC?
There have been no reports of accidental overdosage with AVC.
The acute oral LD of sulfanilamide is 3700-4200 mg/kg in mice.
The minimum human lethal dose of AVC has not been established.
It is not known if AVC is dialyzable.
How should I store and handle AVC?
After Reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol): The reconstituted solution should be stored under refrigeration (2 to 8°C/36 to 46°F) for no more than 14 days. Avoid freezing reconstituted vials of Zorbtive.AVC CreamNDC 0037-6631-04 4 oz tube with applicatorStore 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 PharmaceuticalsSomerset, New Jersey 08873-4120©2014 Meda Pharmaceuticals Inc.MEDA PHARMACEUTICALS and AVC are registered trademarks of Meda AB or a related entity.129941IN-663103-01Rev. 1/2014AVC CreamNDC 0037-6631-04 4 oz tube with applicatorStore 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 PharmaceuticalsSomerset, New Jersey 08873-4120©2014 Meda Pharmaceuticals Inc.MEDA PHARMACEUTICALS and AVC are registered trademarks of Meda AB or a related entity.129941IN-663103-01Rev. 1/2014AVC CreamNDC 0037-6631-04 4 oz tube with applicatorStore 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 PharmaceuticalsSomerset, New Jersey 08873-4120©2014 Meda Pharmaceuticals Inc.MEDA PHARMACEUTICALS and AVC are registered trademarks of Meda AB or a related entity.129941IN-663103-01Rev. 1/2014AVC CreamNDC 0037-6631-04 4 oz tube with applicatorStore 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 PharmaceuticalsSomerset, New Jersey 08873-4120©2014 Meda Pharmaceuticals Inc.MEDA PHARMACEUTICALS and AVC are registered trademarks of Meda AB or a related entity.129941IN-663103-01Rev. 1/2014AVC CreamNDC 0037-6631-04 4 oz tube with applicatorStore 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 PharmaceuticalsSomerset, New Jersey 08873-4120©2014 Meda Pharmaceuticals Inc.MEDA PHARMACEUTICALS and AVC are registered trademarks of Meda AB or a related entity.129941IN-663103-01Rev. 1/2014AVC CreamNDC 0037-6631-04 4 oz tube with applicatorStore 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 PharmaceuticalsSomerset, New Jersey 08873-4120©2014 Meda Pharmaceuticals Inc.MEDA PHARMACEUTICALS and AVC are registered trademarks of Meda AB or a related entity.129941IN-663103-01Rev. 1/2014AVC CreamNDC 0037-6631-04 4 oz tube with applicatorStore 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 PharmaceuticalsSomerset, New Jersey 08873-4120©2014 Meda Pharmaceuticals Inc.MEDA PHARMACEUTICALS and AVC are registered trademarks of Meda AB or a related entity.129941IN-663103-01Rev. 1/2014AVC CreamNDC 0037-6631-04 4 oz tube with applicatorStore 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 PharmaceuticalsSomerset, New Jersey 08873-4120©2014 Meda Pharmaceuticals Inc.MEDA PHARMACEUTICALS and AVC are registered trademarks of Meda AB or a related entity.129941IN-663103-01Rev. 1/2014AVC CreamNDC 0037-6631-04 4 oz tube with applicatorStore 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 PharmaceuticalsSomerset, New Jersey 08873-4120©2014 Meda Pharmaceuticals Inc.MEDA PHARMACEUTICALS and AVC are registered trademarks of Meda AB or a related entity.129941IN-663103-01Rev. 1/2014AVC CreamNDC 0037-6631-04 4 oz tube with applicatorStore 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 PharmaceuticalsSomerset, New Jersey 08873-4120©2014 Meda Pharmaceuticals Inc.MEDA PHARMACEUTICALS and AVC are registered trademarks of Meda AB or a related entity.129941IN-663103-01Rev. 1/2014AVC CreamNDC 0037-6631-04 4 oz tube with applicatorStore 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 PharmaceuticalsSomerset, New Jersey 08873-4120©2014 Meda Pharmaceuticals Inc.MEDA PHARMACEUTICALS and AVC are registered trademarks of Meda AB or a related entity.129941IN-663103-01Rev. 1/2014
Clinical Information
Chemical Structure
No Image foundClinical 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 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.
Non-Clinical Toxicology
AVC should not be used in patients known to be sensitive to this product or to the sulfonamides.As with other drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic inhibition or enhancement, etc.) is a possibility (see
Because sulfonamides are absorbed from the vaginal mucosa, the usual precautions for oral sulfonamides apply. Patients should be observed for skin rash or evidence of systemic toxicity, and if these develop, the medications should be discontinued.
Deaths associated with administration of oral sulfonamides have reportedly occurred from hypersensitivity reactions, agranulocytosis, aplastic anemia, and other blood dyscrasias.
Goiter production, diuresis, and hypoglycemia have reportedly occurred rarely in patients receiving oral sulfonamides. Cross-sensitivity may exist with these agents. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term administration has reportedly produced thyroid malignancies in this species.
Vaginal applicators or inserters should be used with caution after the seventh month of pregnancy.
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8403 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
ADVERSE REACTIONS
Local sensitivity reactions such as increased discomfort or a burning sensation have occasionally been reported following the use of topical sulfonamides. With the use of AVC Cream, sensitivity reactions (only local) were reported for 0.2% of the investigational patients.
Treatment should be discontinued if either local or systemic manifestations of sulfonamide toxicity or sensitivity occur.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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