Vaginal Contraceptive Gel
Action And Clinical Pharmacology: Nonoxynol-9 (paranonyl-phenoxypolyethoxyethanol) is a commonly used spermicidal agent. Nonoxynol-9 is responsible for cell membrane breakage; it decreases surface tension and kills epithelial cells.
The vaginal contraceptive gel is a new gel designed to provide a steady release of nonoxynol-9 after a single vaginal application. Commonly available spermicidal formulations must be used close to the time of intercourse if they are not in a steady release preparation. The vaginal contraceptive gel utilizes a bioadhesive polymer delivery system to achieve its steady release profile. The delivery system has been shown to remain on epithelial surfaces for extended periods of time following application. The nonoxynol-9 is present at a concentration of 3.5% in the bioadhesive delivery system which attaches to the vaginal epithelial surface. Once attached, the vaginal contraceptive gel allows the release of nonoxynol-9 to occur at a slow, steady rate over a period of 24 hours. Available clinical data show that the gel provides effective contraceptive protection for up to 24 hours following initial application prior to a single act of intercourse.
Indications And Clinical Uses: For the prevention of conception. Provides contraceptive protection for up to 24 hours prior to a single act of intercourse.
The contraceptive gel will not harm latex condoms.
Contra-Indications: Known sensitivity to nonoxynol-9 or other constituents of the product.
Precautions: If pregnancy is medically contraindicated, the patient’s contraceptive program should be prescribed by a physician or family planning clinic.
The vaginal contraceptive gel provides an effective and convenient method of contraception. However, no product, even with regular use, can provide an absolute guarantee against becoming pregnant.
Keep out of reach of children.
Adverse Reactions: Occasional burning and irritation of the vagina or penis can occur. If this happens, discontinue use and/or consult your physician.
Dosage And Administration: One applicatorful of the vaginal contraceptive gel should be inserted into the vagina prior to each act of intercourse. An additional applicatorful is required prior to each time intercourse is repeated.
The vaginal contraceptive gel offers the advantage of a lower dose of nonoxynol-9 without compromising the efficacy in pregnancy protection due to its patented bioadhesive technology. Each dose contains 3.5% (52.5 mg) nonoxynol-9. This lower dose of nonoxynol-9 enhances product tolerability.
Availability And Storage: Each dose of the nongreasy, nonstaining gel contains: 3.5% (52.5 mg) nonoxynol-9. Each applicator delivers 1.5 g of gel. Nonmedicinal ingredients: carbomer 934P, glycerin, hydrogenated palm oil glyceride, methylparaben, mineral oil, polycarbophil, purified water, sorbic acid and sodium hydroxide added to adjust pH. Fragrance-free. Boxes of 3 individually wrapped, disposable, prefilled applicators.
ADVANTAGE 24 Roberts Nonoxynol-9 Vaginal Contraceptive Gel