Progesterone Vaginal

Progesterone Vaginal is a prescription medication used to restore normal menstrual periods that have stopped for several months (amenorrhea).

• Progesterone Vaginal is available under various brand names: Crinone, Endometrin, FIRST Progesterone VGS 100, FIRST Progesterone VGS 200, FIRST Progesterone VGS 25, FIRST-Progesterone VGS 400, FIRST-Progesterone VGS 50, Prochieve 

Common side effects of Progesterone Vaginal include:

• dizziness, confusion, drowsiness, and tiredness.
• headache, mood changes, feeling nervous or irritable.
• stomach pain, nausea, diarrhea, constipation.
• bloating, swelling in the hands or feet.
• breast pain, swelling, or tenderness.
• cramps, pelvic pain. 
• vaginal itching, burning, or discharge.

Serious side effects of Progesterone Vaginal include:

• hives,
• difficult breathing,
• swelling of the face, lips, tongue, or throat,
• unusual vaginal bleeding,
• pain or burning while urinating,
• symptoms of depression (sleep problems, weakness, mood changes);
• a breast lumps,
• sudden vision problems, severe headache, or pain behind the eyes,
• heart attack symptoms--chest pain or pressure, pain spreading to the 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 the leg--pain, swelling, warmth, or redness in one or both legs.

Rare side effects of Progesterone Vaginal include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Intravaginal gel

• 4%
• 8%

Vaginal insert

• 100 mg

Assisted Reproductive Technology (ART)

Adult dosage

• 90 mg (8% gel) intravaginal once a day
• Women with partial or complete ovarian failure: 90 mg twice daily intravaginal
• May continue 10-12 weeks post conception until placental autonomy

Secondary Amenorrhea

Adult dosage

• 45 mg (4% gel) intravaginal every other day for 6 doses
• If no response, try 90 mg (8% gel) every other day for 6 doses

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Progesterone Vaginal has no noted severe interactions with any other drugs.
• Progesterone Vaginal has no noted serious interactions with any other drugs.
• Progesterone Vaginal has no noted moderate interactions with any other drugs.
• Progesterone Vaginal has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• hypersensitivity to Progesterone Vaginal
• 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. 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Progesterone Vaginal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Progesterone Vaginal?”

Cautions

• Using Progesterone Vaginal can increase your risk of blood clots, stroke, heart attack, or breast cancer. Talk to your doctor about this risk.
• 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.
• 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 Progesterone Vaginal.
• 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.
• Do not use another vaginal medicine within 6 hours before or after using Progesterone Vaginal gel. Use only the vaginal products that your doctor has recommended.
• Avoid using vaginal yeast treatments unless your doctor tells you to.
• This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Pregnancy and Lactation

• 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 Progesterone Vaginal.
• Lactation
  • Progesterone Vaginal can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breastfeeding a baby.