AVC

AVC

AVC Prescribing Information

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• Beschreibung
• Klinische Pharmakologie
• Indikationen und Verwendung
• Kontraindikationen
• Vorsichtsmaßnahmen
• Informationen zur Patientenberatung
• Nebenwirkungen/Nebenwirkungen
• Drogenmissbrauch und -abhängigkeit
• Überdosierung
• Dosierung und Anwendung
• Wie geliefert/Lagerung und Handhabung

AVC CREAM®(Sulfanilamide) 15%

AVC®(sulfanilamide)

cream

AVC description

AVC®is a preparation for vaginal administration for the treatment ofCandida albicansinfections and is available in the following form:

AVC cream

Each tube contains:

Sulfanilamide…..15.0%
in a water-miscible, non-staining base of lactose, propylene glycol, stearic acid, diglycol stearate, methylparaben, propylparaben, trolamine and water; buffered with lactic acid to an acidic pH of approx. 4.3.

Sulfanilamide is an anti-infective. It is p-aminobenzenesulfonamide with the chemical structure:

Sulfanilamide exists as a white, odorless, crystalline powder with a slightly bitter taste and a sweet aftertaste. It is slightly soluble in water, alcohol, acetone, glycerin, propylene glycol, hydrochloric acid, as well as potassium and sodium hydroxide solutions. It is practically insoluble in chloroform, ether, benzene and petroleum ether.

AVC – Clinical Pharmacology

Sulfanilamide has been a useful ingredient in vaginal formulations for approximately four decades. It blocks certain metabolic processes that are important for the growth of susceptible bacteria. In AVC, the sulfanilamide is present in a specially formulated base that is buffered to the pH (approximately 4.3) of the normal vagina to promote the presence of the normally occurring Döderlein bacilli in the vagina.

The use of AVC to treat vulvovaginitis caused byCandida albicansis supported by three clinical studies. The three studies show that AVC with sulfanilamide is significantly more effective (p ≤ 0.01) than placebo, as follows:

In Study I, the efficacy ratio was 71% for AVC with sulfanilamide versus 49% for placebo at 30 days of treatment;

In Study II, the percentages at 15 days of treatment were 48% and 24%, respectively;

In Study III, the percentages at 30 days of treatment were 66% and 33%, respectively.

Indications and Uses for AVC

For the treatment of vulvovaginitis caused byCandida albicans. (See CLINICAL PHARMACOLOGY.)

Contraindications

AVC should not be used in patients known to be sensitive to this product or the sulfonamides.

Precautions

Generally

Since sulfonamides are absorbed through the vaginal mucosa, the usual precautions for oral sulfonamides apply. Patients should be observed for rash or signs of systemic toxicity. If these occur, the medication should be discontinued.

Deaths due to hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood dyscrasias have reportedly occurred in association with the administration of oral sulfonamides.

Goiter formation, diuresis, and hypoglycemia have been reported to occur rarely in patients receiving oral sulfonamides. Cross-sensitivity may exist with these active ingredients. Rats appear to be particularly susceptible to the goitrogenic effects of sulfonamides, and long-term administration has reportedly caused thyroid malignancies in this species.

Vaginal applicators or introducers should be used with caution after the seventh month of pregnancy.

Information for patients

The doctor should advise the patient that if unusual local itching and burning or other unusual symptoms occur, the medication should be discontinued and not restarted without further consultation.

Interactions with other medications

Drug interactions with AVC have not been documented.

Carcinogenesis, mutagenesis, impairment of fertility

There are no data on the long-term potential of AVC for carcinogenicity, mutagenicity or impairment of fertility in animals or humans.

pregnancy

Teratogenic effects.Animal reproduction studies have been conducted with sulfonamides, including sulfanilamide (see below). It is not known whether AVC can cause fetal harm or reproductive impairment when administered to a pregnant woman. AVC should only be given to a pregnant woman if clearly necessary.

Sulfonamides, including sulfanilamide, readily cross the placenta and enter the fetal circulation. The concentration in the fetus is 50-90% of the concentration in the mother's 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 studied in animals or humans. However, for certain sulfonamides of the short-, intermediate-, and long-acting types (including sulfanilamide), a significant increase in the incidence of cleft palate and other bone abnormalities in offspring was observed when administered to pregnant rats and mice at high oral doses (seven to 25 times the human therapeutic oral dose.)

Breastfeeding mother

Sulfanilamide should be avoided in nursing mothers because absorbed sulfonamides are excreted in breast milk and have caused kernicterus in the newborn. Because of the potential for serious adverse reactions in breast-fed infants from sulfonamides, a decision should be made whether to discontinue breast-feeding or to discontinue the drug.

Pediatric use

Safety and effectiveness of AVC in pediatric patients have not been established.

To report suspected side effects, contact Meda Pharmaceuticals Inc. at 1-877-999-8403 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

SIDE EFFECTS

Local hypersensitivity reactions such as increased discomfort or burning have occasionally been reported following topical application of sulfonamides. When using AVC cream, hypersensitivity reactions (local only) were reported in 0.2% of the patients studied.

Treatment should be discontinued if local or systemic manifestations of sulfonamide toxicity or hypersensitivity occur.

Drug abuse and addiction

Tolerance, abuse, or dependence on AVC has not been reported.

Overdose

There have been no reports of accidental overdose with AVC.

Acute oral LD50The concentration of sulfanilamide in mice is 3700-4200 mg/kg.

The minimum lethal dose of AVC for humans has not been established.

It is not known whether AVC is dialyzable.

AVC dosage and administration

One applicator (approx. 6 g) intravaginally once or twice daily. Improvement in symptoms should occur within a few days, but treatment should be continued for 30 days.

For hygiene reasons, rinsing with a suitable solution before insertion may be recommended.

How is AVC delivered?

AVC cream

NDC 0037-6631-04 4 ounce tube with applicator

Store at room temperature below 30°C.

Protect from cold.

The product will darken over time. When stored as intended, the effectiveness is retained throughout the entire specified shelf life.

This brochure contains a summary of important information about AVC Cream. For more information, call toll free (1-877-999-8403).

Distributed by:

Meda Pharmaceuticals
Somerset, NJ 08873-4120

©2018 Mylan Specialty LP

AVC is a registered trademark of Meda Pharma SARL, a Mylan company.

141016
IN-663103-02
Rev. 6/2018

MAIN DISPLAY PANEL – PRODUCT BOX LABEL

NDC 0037-6631-04Rx only

4 ounces vaginal cream with applicator

AVC®CREAM
(Sulfanilamide) 15%

Contains:Sulfanilamide 15% in a water-miscible, non-coloring base based on lactose,
Propylene glycol, stearic acid, diglycol stearate, methylparaben, propylparaben, trolamine,
and water; buffered with lactic acid to an acidic pH of approx. 4.3.

Usual dose:1 applicator (approx. 6 g) intravaginally once or twice daily. Improvements in
Symptoms should appear within a few days, but treatment should continue for a few more days
Period of 30 days.

How to use the cream applicator:

1. Remove cap from tube. Turn the cap over and pierce the cap of the tube with the tip on top of the cap. 2. Screw the plastic applicator onto the tube as far as it will go. 3. Pull out the plunger (inner rod) of the applicator until it stops. 4. Hold the piston out by placing your thumb and forefinger on the rod where it enters the cylinder (outer cylinder). Squeeze the tube from the bottom with your other hand until the barrel is completely filled. Unscrew the hose from the applicator. 5. Lie on your back and insert the applicator as far into the vagina as possible without using force. Slowly push the applicator plunger in until it stops automatically. 6. Carefully remove the applicator from the vagina while holding it by the cylinder (outer cylinder). 7. Wash applicator with warm, soapy water (do not boil). For easy cleaning it can be disassembled by pulling the piston out of the barrel. Rinse and dry.

It is recommended to use a pad to protect clothing.

Storage:Store at room temperature (below 86°F).
Protect from cold.

Instructions for using the applicator are printed under the tear-off fold of the box.

Rx only.

Storage:Store at room temperature (below 86°F).
Protect from cold.

The product will darken over time. When stored as intended, the effectiveness is retained throughout the entire specified shelf life.

117404

Distributed by:
MEDA PHARMACEUTICS®

Somerset, NJ 08873-4120

© 2018 Mylan Specialty LP

AVC is a registered trademark of Meda Pharma SARL, a Mylan
Pursue

UC-663103-03
Rev. 5/2018