Lactic Acid, Citric Acid, and Potassium Bitartrate Vaginal Contraceptive

WHY is this medicine prescribed?

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.

HOW should this medicine be used?

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:

• 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.

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

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

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.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: August 15, 2020.