check with AVC Generic Name: sulfanilamide Dosage Form: vaginal cream Overview Side Effects Dosage Professional Pregnancy More User Reviews Pricing & Coupons AVC CREAM (sulfanilamide) 15% AVC (sulfanilamide) Cream AVC 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. Slideshow Men's Health Month And Movember: Raising The Profile Of Men's Health One Stache At A Time AVC - 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 for AVC For the treatment of vulvovaginitis caused by Candida albicans . (See CLINICAL PHARMACOLOGY .) Contraindications AVC should not be used in patients known to be sensitive to this product or to the sulfonamides. Precautions 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 Teratogenic Effects. Pregnancy Category C: Animal reproductive studies have been conducted with sulfonamides, including sulfanilamide (see below). It is not known whether AVC can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. AVC should be given to a pregnant woman only if clearly needed. Sulfonamides, including sulfanilamide, readily pass through the placenta and reach fetal circulation. The concentration in the fetus is from 50-90% of that in the maternal blood and if high enough, can cause toxic effects. The safe use of sulfonamides, including sulfanilamide, in pregnancy has not been established. The teratogenic potential of most sulfonamides has not been thoroughly investigated in either animals or humans. However, a significant increase in the incidence of cleft palate and other bony abnormalities of offspring has been observed with certain sulfonamides of the short-, intermediate- and long-acting types (including sulfanilamide) when given to pregnant rats and mice at high oral doses (seven to 25 times the human therapeutic oral dose.) 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. 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. Drug Abuse and Dependence Tolerance, abuse, or dependence with AVC have not been reported. Overdosage There have been no reports of accidental overdosage with AVC. The acute oral LD 50 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. AVC Dosage and Administration 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. How is AVC Supplied 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 2014 Meda Pharmaceuticals Inc. MEDA PHARMACEUTICALS and AVC are registered trademarks of Meda AB or a related entity. 129941 IN-663103-01 Rev. 1/2014 PRINCIPAL DISPLAY PANEL - PRODUCT TUBE LABEL NDC 0037-6631-04 Rx only 4 ounces vaginal cream with applicator AVC CREAM (sulfanilamide) 15% Contains: sulfanilamide 15% 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. Usual dose: 1 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. How to use cream applicator: 1. Remove cap from tube. Invert cap and puncture seal of tube with point on top of cap. 2. Screw plastic applicator on tube as far as it will go. 3. Pull out plunger (inner rod) of applicator until it stops. 4. Hold plunger out by placing thumb and forefinger on rod where it enters the barrel (outer cylinder). Squeeze tube from bottom with other hand until barrel is completely filled. Unscrew tube from applicator. 5. Lying on your back, insert applicator into vagina as far as it will go comfortably without using force. Slowly push in plunger of applicator until it stops automatically. 6. Carefully remove applicator from vagina, holding it by the barrel (outer cylinder). 7. Wash applicator with warm, soapy water (do not boil). For easy cleaning, it may be disassembled by pulling plunger from barrel. Rinse and dry. It is recommended that a pad be used to protect clothing. Storage: Store at room temperature (below 86ºF). Protect from cold. Directions for use of applicator are printed under tear-away panel of carton. Rx only. Storage: Store at room temperature (below 86ºF). Protect from cold. Product darkens with age. Potency is maintained throughout labeled shelf life when stored as directed. 117404 Distributed by: MEDA PHARMACEUTICALS Somerset, New Jersey 08873-4120 2017 Meda Pharmaceuticals Inc. MEDA PHARMACEUTICALS and AVC are registered trademarks of Meda AB or a related entity. UC-663103-02 Rev. 3/2017 AVC sulfanilamide cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0037-6631 Route of Administration VAGINAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFANILAMIDE (SULFANILAMIDE) SULFANILAMIDE 15 g in 100 g Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE PROPYLENE GLYCOL STEARIC ACID PEG-2 STEARATE METHYLPARABEN PROPYLPARABEN TROLAMINE WATER LACTIC ACID, UNSPECIFIED FORM Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0037-6631-04 1 TUBE, WITH APPLICATOR in 1 CARTON 1 113 g in 1 TUBE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA006530 12/01/2014 Labeler - Meda Pharmaceuticals (051229602) Revised: 11/2014 Meda Pharmaceuticals Next Pregnancy Warnings Print this page Add to My Med List More about AVC (sulfanilamide topical) Side Effects During Pregnancy Dosage Information Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: vaginal anti-infectives Consumer resources AVC AVC Vaginal Related treatment guides Vaginal Yeast Infection} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Meda Pharmaceuticals Inc. 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