Progesterone is a female hormone important for ovulation and menstruation. Progesterone causes changes in the lining of your uterus, making it easier for a fertilized egg to attach to the uterus at the beginning of pregnancy. Progesterone then helps your body maintain the pregnancy.

FIRST-Progesterone VGS 100 (for use in the vagina) is used to cause menstrual periods in women who have not yet reached menopause but are not having periods due to a lack of progesterone in the body.

FIRST-Progesterone VGS 100 is also used in fertility treatment as part of Assisted Reproductive Technology (ART) for women unable to get pregnant due to a lack of natural progesterone in the body.

FIRST-Progesterone VGS 100 is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

FIRST-Progesterone VGS 100 may also be used for purposes not listed in this medication guide.

You should not use FIRST-Progesterone VGS 100 if you have: a history of stroke or blood clot, circulation problems, liver disease, breast or uterine cancer, abnormal vaginal bleeding, or if you have recently had a tubal pregnancy or an incomplete abortion.

Some forms of vaginal progesterone may contain plant-based oils. Tell your doctor if you have any type of food allergy.

Do not use if you are pregnant, unless you are using progesterone as part of your fertility treatment.

Follow all directions on your prescription label. Do not use FIRST-Progesterone VGS 100 in larger or smaller amounts or for longer than recommended.

Do not take by mouth. FIRST-Progesterone VGS 100 is for use only in the vagina.

Insert this medicine directly into the vagina using only the applicator provided. Use a disposable applicator only once and then throw it away.

FIRST-Progesterone VGS 100 suppositories are made at the pharmacy and provided in a special container. Your pharmacist can show you how to remove a suppository from the container. Avoid handling the suppository too long or it will begin to melt in your hand.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Use this medicine at bedtime if it causes dizziness or drowsiness.

FIRST-Progesterone VGS 100 is sometimes given for only 6 to 12 days at a time. When used as part of fertility treatment, this medicine may be given for up to 12 weeks into a pregnancy. Follow your doctor's dosing instructions very carefully.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using FIRST-Progesterone VGS 100.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using FIRST-Progesterone VGS 100.

It is normal to have vaginal discharge for several days after using this medicine. Talk with your doctor if you have concerns about any vaginal discharge.

Store FIRST-Progesterone VGS 100 inserts or gel at room temperature away from moisture, heat, and light.

FIRST-Progesterone VGS 100 suppositories should be stored in a refrigerator. Follow the instructions provided with your medicine.

You should not use FIRST-Progesterone VGS 100 if you have ever had an allergic reaction to it, or if you have:

• a history of stroke, blood clot, or circulation problems;

• breast or uterine cancer;

• abnormal vaginal bleeding;

• liver disease;

• any type of food allergy (some forms of vaginal progesterone may contain plant-based oils); or

• if you have recently had a tubal pregnancy or an incomplete or "missed" abortion.

To make sure this medicine is safe for you, tell your doctor if you have:

• high blood pressure, heart disease, congestive heart failure;

• migraines,

• asthma;

• kidney disease;

• seizures or epilepsy;

• a history of depression; or

• risk factors for coronary artery disease (such as diabetes, lupus, high cholesterol, family history of coronary artery disease, smoking, or being overweight).

Using FIRST-Progesterone VGS 100 can increase your risk of blood clots, stroke, heart attack, or breast cancer. Talk to your doctor about this risk.

Do not use FIRST-Progesterone VGS 100 if you are pregnant, unless you are using this medicine as part of your fertility treatment.

Tell your doctor if you become pregnant during treatment. If you are not being treated for infertility, use effective birth control to prevent pregnancy while using FIRST-Progesterone VGS 100.

Progesterone vaginal can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Call your doctor if you miss more than one dose.

An overdose of FIRST-Progesterone VGS 100 is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Do not use another vaginal medicine within 6 hours before or after using FIRST-Progesterone VGS 100 gel. Use only vaginal products that your doctor has recommended.

Avoid using vaginal yeast treatments unless your doctor tells you to.

FIRST-Progesterone VGS 100 may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

FIRST-Progesterone VGS 100 may cause serious side effects. Call your doctor at once if you have:

• unusual vaginal bleeding;

• pain or burning when you urinate;

• symptoms of depression (sleep problems, weakness, mood changes);

• a breast lump;

• sudden vision problems, severe headache or pain behind your eyes;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with speech or balance;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects of FIRST-Progesterone VGS 100 may include:

• dizziness, confusion, drowsiness, tiredness;

• headache, mood changes, feeling nervous or irritable;

• stomach pain, nausea, diarrhea, constipation;

• bloating, swelling in your hands or feet;

• breast pain, swelling, or tenderness;

• cramps, pelvic pain; or

• vaginal itching, burning, or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with progesterone vaginal, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.