(proe jes' ter one)

Brand Name(s): Crinone^®, Endometrin^®

WHY is this medicine prescribed?

Vaginal progesterone (Crinone, Endometrin) is used as part of assisted reproductive technology (ART; fertility treatment) in women experiencing infertility (not getting pregnant despite having carefully timed, unprotected sex) who may need extra progesterone to help them become pregnant and to stay pregnant. Vaginal progesterone (Crinone) is also used to bring on menstruation (period) in women experiencing (absence of menstruation in women of childbearing age who have had normal periods and then stopped). Progesterone is in a class of medications called progestins (female hormones). It works as a part of ART by increase embryo implantation and decrease the risk of miscarriage. Once an embryo is implanted, progesterone acts to maintain the pregnancy. It works to bring on menstruation by replacing the natural progesterone that some women are missing. It works to bring on menstruation by replacing the natural progesterone that some women are missing.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Vaginal progesterone comes as a vaginal tablet (Endometrin) to place in the vagina and as a gel (Crinone) to insert in the vagina. Progesterone vaginal tablets are usually inserted in the vagina two or three times a day for up to 10 days. If progesterone vaginal gel is used as a part of ART/fertility treatment, it is usually inserted once or twice a day for up to 10 to 12 weeks. If progesterone vaginal gel is used to treat amenorrhea, it is usually inserted in the vagina once every other day, for a total of 6 doses. If needed, your doctor may tell you to take an additional 6-dose course of treatment. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use vaginal progesterone exactly as directed. Do not use more or less of it or take it more often than prescribed by your doctor.

Vaginal progesterone comes with a special applicator to use to place the tablet or gel into your vagina. Your medication will come with instructions for use. Read these instructions and follow them carefully. Ask your doctor or pharmacist if you have any questions about how to use vaginal progesterone.

To use the vaginal tablet (Endometrin), follow these steps:

1. Wash and dry your hands before handling the vaginal tablet.
2. Unwrap the applicator and remove the vaginal tablet from the blister pack.
3. Place the vaginal tablet in the space at the end of the applicator. The insert should fit snugly and should not fall out.
4. Stand, sit, or lie down with your knees bent. Choose the position that is most comfortable for you.
5. Gently insert the applicator into your vagina as you would a plastic tampon applicator and press the plunger to release the insert.
6. Remove the applicator from your vagina and dispose of it as you would a plastic tampon applicator. Do not save or reuse the applicator.

To use the vaginal gel (Crinone), follow these steps:

1. Open the sealed wrapper and remove the prefilled applicator and plunger. Do not remove the twist-off cap.
2. Insert the plunger into the open end of the applicator until the plunger snaps into place. You should see about 1 inch of the plunger outside of the applicator.
3. Remove the cap from the end of the applicator by twisting it counterclockwise. Do not push the plunger while you are removing the cap.
4. Lie down on your back with your knees bent or sit on the edge of a bed or a chair with your knees apart. Choose the position that is most comfortable for you.
5. Gently insert the applicator into your vagina as you would a plastic tampon applicator and press the plunger to release the gel.
6. Remove the applicator from your vagina and dispose of it as you would a plastic tampon applicator. Do not save or reuse the applicator.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using vaginal progesterone,

• tell your doctor and pharmacist if you are allergic to progesterone, any other medications, or any of the ingredients in vaginal progesterone tablets or gel. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription or herbal products may interact with vaginal progesterone: other vaginal products, including vaginal antifungal medicines such as clotrimazole and miconazole (Monistat). Be sure to let your healthcare provider know that you are using these medications before you start using vaginal progesterone. Do not start any of these medications while receiving using vaginal progesterone without talking to your healthcare provider

• tell your doctor if you have or ever had unexplained vaginal bleeding between periods; a miscarriage in which some tissue was left in the uterus; a missed abortion (a pregnancy that ended when the unborn child died in the uterus but was not expelled from the body); an ectopic pregnancy ('tubal pregnancy' or pregnancy outside the uterus); blood clots in the legs, lungs, eyes, brain, or anywhere in the body; cancer of the breasts or female organs; or liver disease. Your doctor will probably tell you not to use progesterone vaginal products.

• tell your doctor if you have or have ever had seizures; migraine headaches; asthma; diabetes; depression; stroke or ministroke; or kidney, or heart disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using vaginal progesterone, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Use or insert the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose or apply extra cream to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

Vaginal progesterone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• breast tenderness, pain, or enlargement
• gas or bloating
• stomach pain
• nausea
• vomiting
• constipation
• diarrhea
• tiredness
• drowsiness
• muscle, joint, or bone pain
• mood swings
• irritability
• vaginal discharge
• vaginal pain or discomfort
• changes in sexual desire
• trouble sleeping

Some side effects can be serious. If you experience any of these symptoms, stop using vaginal progesterone and call your doctor immediately or get emergency medical treatment:

• sudden, severe headache
• dizziness or faintness
• slow or difficult speech
• weakness or numbness of an arm or leg
• lack of coordination or loss of balance
• shortness of breath
• sharp chest pain
• coughing up blood
• leg swelling or pain
• loss of vision or blurred vision
• double vision
• unexpected vaginal bleeding
• depression
• yellowing of the skin or eyes
• hives
• rash
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

Vaginal progesterone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: March 15, 2023.