Lactic acid, citric acid, and potassium bitartrate (Vaginal)

Lactic acid, citric acid, and potassium bitartrate combination is used to prevent pregnancy. This medicine is a gel that you insert into the vagina using an applicator before any genital contact or sexual intercourse begins. It works by lowering the pH and reducing sperm movement in the vagina.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly and does not cause unwanted effects.

Even though you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you may be pregnant while using this medicine, call your doctor right away. Inform your doctor if you have recently had a baby, miscarriage, or abortion.

This medicine may cause urinary tract infections, including cystitis (bladder infection) or pyelonephritis (kidney infection), which can be serious. Contact your doctor immediately if you have difficult, burning, or painful urination, cloudy urine, or lower back or side pain.

This medicine will not protect you from getting HIV infection or other sexually transmitted diseases. If this is a concern for you, discuss it with your doctor.

You may use another form of birth control (e.g., condom, diaphragm) for added protection against pregnancy. You may also use this medicine with other products for vaginal infections (e.g., metronidazole, miconazole, or tioconazole).

No contraceptive method is 100 percent effective. Birth control methods like surgery to become sterile or abstaining from sex are more effective than vaginal systems. Discuss your options for birth control with your doctor.

In deciding to use a medicine, you must think about the risks of taking it compared to the benefits it will provide. This is a choice you and your doctor will make together. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare provider know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Research on how lactic acid, citric acid, and potassium bitartrate combination affects children has not been done. However, there are no expected problems specific to teenagers that would limit the use of this medicine. This medicine may be used for birth control in teenage females but should not be used before menstruation begins.

Geriatric

There is no information available on how lactic acid, citric acid, and potassium bitartrate combination affects older patients. This medicine is not meant for use in elderly women.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there is a chance of interaction. In these situations, your doctor may adjust the dose, or take other precautions. Tell your healthcare provider if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at the same time as food or certain types of food due to possible interactions. Mixing alcohol or tobacco with certain medicines can also lead to interactions. Talk to your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Urinary tract problem (e.g., recurrent urinary tract infection)—Use with caution. This may worsen this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do happen, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bladder pain
• Bloody or cloudy urine
• Burning sensation in the vagina
• Difficult, burning, or painful urination
• Frequent urge to urinate
• Itching or pain in the vagina or genital area
• Lower back or side pain
• Thick, white vaginal discharge with mild or no odor

More common—male partners

• Burning, itching, pain, or other discomfort in the genital area

Rare

• Chills
• Fever
• Headache
• Stomach pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Feeling of vaginal pressure

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Phexxi

Available Dosage Forms:

• Gel/Jelly

Therapeutic Class: Contraceptive, Local

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is to be used only in the vagina.

This combination medicine is contained in a prefilled single-dose applicator that delivers the medicine when inserted into your vagina. Use each applicator only once, and then throw it away.

You may use this medicine during any part of your menstrual cycle.

Wash your hands with soap and water before and after you use this medicine.

This medicine should be used before having sexual intercourse. It will not prevent pregnancy if used after intercourse.

Do not use this medicine together with vaginal rings. Ask your doctor before you use other products or medicines into your vagina.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For vaginal dosage form (gel):For contraception (to prevent pregnancy): Adults—One prefilled applicator inserted into the vagina within 1 hour before each time you have sexual intercourse. Insert a new prefilled applicator if you have vaginal sex more than once within 1 hour or if you do not have vaginal sex within 1 hour of using this medicine and still plan to have sex. Each applicator contains 5 grams (g) of the vaginal gel. Children—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.