Pronunciation:

LAK-tik AS-id, SIT-rik AS-id, poe-TAS-ee-um bye-TAR-trate

Brand Names:

• Phexxi

Dosage Forms:

• Gel/Jelly

Classifications:

Therapeutic—

Contraceptive, Local

Uses of This Medicine:

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

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies on the relationship of age to the effects of lactic acid, citric acid, and potassium bitartrate combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medicine in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Older adults—

No information is available on the relationship of age to the effects of lactic acid, citric acid, and potassium bitartrate combination in geriatric patients. This medicine is not indicated for use in elderly women.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Urinary tract problem (eg, recurrent urinary tract infection), history of—Use with caution. May make this condition worse.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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

Although 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 have become pregnant while using this medicine, call your doctor right away. Tell your doctor if you 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. Check with your doctor right away 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, talk with your doctor.

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

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than vaginal systems. Discuss your options for birth control with your doctor.

Side Effects of This Medicine:

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