Avc

Frequency Not Defined

Local sensitivity reactions (discomfort, burning)

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.

There have been no reports of accidental overdosage with AVC.

The acute oral LD50 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.

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.

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

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:

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

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad vaginal irritation.
• Very bad skin irritation.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Any unexplained bruising or bleeding.
• Pale skin.
• Feeling very tired or weak.

Applies to sulfanilamide topical: vaginal cream, vaginal suppository

Local

Local side effects associated with sulfanilamide topical (the active ingredient contained in AVC) cream have included local sensitivity reactions in 0.2% of patients. Local sensitivity reactions (such as increased discomfort or a burning sensation) have occasionally been reported after topical sulfonamide use.[Ref]

Some side effects of AVC may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Sulfanilamide topical has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity at high oral doses (7 to 25 times the human therapeutic oral dose), with an increased incidence of cleft palate and other bony abnormalities observed in rats and mice. There are no controlled data in human pregnancy. The safe use of sulfonamides, including sulfanilamide topical, in pregnancy has not been established. Sulfanilamide topical is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Sulfonamides, including sulfanilamide, readily cross the placental barrier and enter fetal circulation. The concentration in the fetus averages from 50% to 90% of that in the maternal blood and if high enough, can cause toxic effects.

Sulfanilamide topical is excreted into human milk. Absorbed sulfonamides have caused kernicterus in the newborn. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.