DrugindexOnline^{2nd edition}

Generic Name: Progesterone Vaginal 8% Gel (pro-JESS-ter-ohn)
Brand Name: Crinone and Prochieve

Progesterone Gel is used for:

Supplementing or replacing progesterone in infertile women with progesterone deficiency. It is also used in certain women who do not menstruate and have not responded to lower strengths of Progesterone Gel. It may also be used for other conditions as determined by your doctor.

Progesterone Gel is a hormone. It works by preparing the uterus (womb) for implantation of a fertilized egg and protecting the lining of the uterus. It is also needed for the maintenance of a healthy pregnancy.

Do NOT use Progesterone Gel if:

• you are allergic to any ingredient in Progesterone Gel
• you have cancer of the breast , ovary, lining of the uterus, cervix, or vagina; a history of blood clots or clotting problems; vaginal bleeding of unknown cause; or liver disease; or you have had a stroke, a recent miscarriage, or bleeding in the brain

Contact your doctor or health care provider right away if any of these apply to you.

Before using Progesterone Gel:

Some medical conditions may interact with Progesterone Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have heart or blood vessel problems, bleeding problems, high blood pressure, high cholesterol or lipid levels, diabetes, kidney problems, asthma, migraine headaches, or lupus
• if you have a history of seizures, depression or other mental/mood problems, cancer, or tobacco use
• if you have a family history of blood clots
• if you are very overweight

Some MEDICINES MAY INTERACT with Progesterone Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rifampin because it may decrease Progesterone Gel's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Progesterone Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Progesterone Gel:

Use Progesterone Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Progesterone Gel. Talk to your pharmacist if you have questions about this information.
• Review the patient insert for proper preparation and use of the vaginal applicator.
• If you miss a dose of Progesterone Gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Progesterone Gel.

Important safety information:

• Progesterone Gel may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Progesterone Gel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Progesterone Gel may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.
• Do not use Progesterone Gel at the same time as other vaginal therapy without checking with your doctor. If other vaginal therapy is to be used, administer it 6 or more hours before or after Progesterone Gel, unless advised otherwise by your health care provider.
• Progesterone Gel may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• Diabetes patients - Progesterone Gel may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including monthly breast self-exams, yearly breast exams, Pap smears, and pelvic exams, may be performed while you use Progesterone Gel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Progesterone Gel should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Progesterone Gel while you are pregnant. Progesterone Gel is found in breast milk. If you are or will be breast-feeding while you use Progesterone Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Progesterone Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast enlargement; breast pain; changes in sex drive; constipation; cramps; depression; diarrhea; difficult or painful sexual intercourse; drowsiness; fatigue; fluid retention/bloating; headache; increased appetite; joint pain; nausea; nervousness; pain around vaginal area; sleep disorder; urination at night; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps; calf/leg pain or tenderness; change in emotions, mood, or behavior; chest pain; coughing blood; dizziness; fainting; inflammation of the eye; numbness of arm or leg; one-sided weakness; pain in the groin; partial or complete loss of vision; seizure; stomach pain, swelling, or tenderness; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of hands, ankles, or feet; tremor; unusual vaginal discharge or odor; vaginal itching; visual or speech disturbances; weakness or numbness in an arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Progesterone Gel:

Store Progesterone Gel at room temperature, below 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Keep Progesterone Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Progesterone Gel, please talk with your doctor, pharmacist, or other health care provider.
• Progesterone Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Progesterone Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.