Lactic acid + Citric acid + Potassium bitartrate

This is a combination of lactic acid, citric acid, and potassium bitartrate indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

The combination of lactic acid, citric acid, and potassium bitartrate comes as a gel in a pre-filled applicator to be applied into the vagina. It is usually applied into the vagina immediately before (up to one hour) before each act of vaginal intercourse. If more than one act of vaginal intercourse occurs within one hour, apply another dose into the vagina. Do not apply more or less of it or apply it more often than prescribed by your doctor.

Lactic acid, citric acid, and potassium bitartrate vaginal gel may be used at any time during the menstrual cycle. It may be used with hormonal contraceptives (birth control pills, patches, or implants); latex, polyurethane and polyisoprene condoms; or a vaginal diaphragm. Do not use this medication along with a contraceptive vaginal ring. Lactic acid, citric acid, and potassium bitartrate vaginal gel may be applied after your doctor has told you that it is safe to resume vaginal intercourse after childbirth, abortion, or miscarriage.

Administration

To use the lactic acid, citric acid, and potassium bitartrate vaginal gel, follow these steps:

• Wash your hands with soap and water before opening the foil pouch.
• Remove the pre-filled applicator and plunger rod from the foil pouch.
• Slowly insert the plunger rod into the pre-filled applicator. Push until you feel the tip of the plunger rod connect to the inside of the pre-filled applicator.
• Do not push hard or continue to push after the tip of the plunger rod connects to the inside of the pre-filled applicator as it could cause the gel to go into the pink cap. Use a new pre-filled applicator if the gel enters the pink cap.
• After the plunger rod is connected to the pre-filled applicator, remove the pink cap from the pre-filled applicator. The extra space between the gel and the end of the pre-filled applicator is normal.
• Hold the pre-filled applicator at the grooved area closest to the plunger rod. Gently insert the pre-filled applicator into the vagina as far as it will comfortably go while you continue to hold the plunger rod. You can do this while sitting with your knees apart, lying on your back with your knees bent, or while standing with your feet apart or knees bent.
• While the pre-filled applicator is inserted in your vagina, use your index finger to push the plunger rod down until it stops to ensure that you receive the entire dose. It is normal for a small amount of gel to be left in the applicator.
• Gently remove the plunger rod and pre-filled applicator from the vagina. Discard the used pre-filled applicator and cap in the trash.

Most common adverse reactions (≥2%) were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain.

There is no use in pregnancy; therefore, discontinue this during pregnancy. There are no data on the presence of lactic acid, citric acid, and potassium bitartrate or their metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.

Before using lactic acid, citric acid, and potassium bitartrate vaginal,

• tell your doctor and pharmacist if you or your sexual partner are allergic to lactic acid, citric acid, and potassium bitartrate, any other medications, or any of the ingredients in lactic acid, citric acid, and potassium bitartrate vaginal gel. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take or use. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or had urinary tract infections or problems with urination.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using lactic acid, citric acid, and potassium bitartrate vaginal, call your doctor.

Miscellaneous topical agents.

Pediatric Use: The safety and effectiveness of this gel have been established in females of reproductive potential. Efficacy is expected to be the same for post-menarchal females under the age of 17 as for users 17 years and older. The use of this gel before menarche is not indicated.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture.