Lactic Acid, Citric Acid, and Potassium Bitartrate Vaginal Contraceptive

The combination of lactic acid, citric acid, and potassium bitartrate is used to prevent pregnancy when used just before vaginal sex in women who can become pregnant. It does not prevent pregnancy when used after vaginal sex. The combination of lactic acid, citric acid, and potassium bitartrate is in a class of medications called non-hormonal contraceptives. It works by lowering the pH of the vagina and reducing sperm motility. Lactic acid, citric acid, and potassium bitartrate may prevent pregnancy, but this medication will not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.

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. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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.

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

1. Wash your hands with soap and water before opening the foil pouch.

2. Remove the pre-filled applicator and plunger rod from the foil pouch.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. Gently remove the plunger rod and pre-filled applicator from the vagina. Discard the used pre-filled applicator and cap in the trash.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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.

Unless your doctor tells you otherwise, continue your normal diet.

• Lactic acid, citric acid, and potassium bitartrate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • burning, itching, pain, or discomfort in or around the vaginal area

  • vaginal discharge

• Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

  • fever, pain or burning with urination, cloudy urine, blood in urine, or back pain

• Lactic acid, citric acid, and potassium bitartrate may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.