Progesterone Vaginal Gel

What is this medication?

PROGESTERONE (proe JES ter one) treats low levels of progesterone in your body. Progesterone helps support your body before and during pregnancy, including preparing and maintaining the health of your uterus. It works by increasing levels of the hormone progesterone in your body. This medication is a progestin hormone.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Crinone, Prochieve

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood vessel disease, blood clotting disorder, or suffered a stroke
• Breast, cervical or vaginal cancer
• Heart disease
• Kidney disease
• Liver disease
• Miscarriage or abortion
• Vaginal bleeding
• An unusual or allergic reaction to progesterone, other hormones, medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for use in the vagina. Do not take by mouth. Follow the directions on the prescription label. Use the applicator exactly as directed. Do not use more often than prescribed.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medication?

Interactions are not expected. Do not use any other vaginal products without asking your care team.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress.

If your care team instructs you to use any other medications in the vagina while you are using this medication, you should separate the doses by at least 6 hours.

You may notice a white discharge of medication while using this medication. This is normal. If it becomes bothersome, contact your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Breast tissue changes, new lumps, redness, pain, or discharge from the nipple
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• New or worsening migraines or headaches
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Unusual vaginal discharge, itching, or odor
• Worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Bloating
• Breast pain or tenderness
• Change in sex drive or performance
• Drowsiness
• Headache
• Irregular menstrual cycles or spotting
• Mood swings
• Nausea
• Pain in between the genitals and rectal area
• Vaginal irritation at application site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.