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All about: Progesterone Insert

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Generic Name: Progesterone Vaginal Insert (proe-JES-ter-one)
Brand Name: Endometrin

Progesterone Insert is used for:

Supporting embryo implants and early pregnancy in certain women. It is also used as part of an assisted reproductive technology (ART) treatment program. It may also be used for other conditions as determined by your doctor.

Progesterone Insert is a hormone. It works by changing the lining of the uterus.

Do NOT use Progesterone Insert if:

  • you are allergic to any ingredient in Progesterone Insert
  • you have vaginal bleeding of an unknown cause, you have had a recent miscarriage, or the embryo is implanted outside the uterus (ectopic pregnancy)
  • you know or suspect that you have breast cancer
  • you have bleeding in the brain or severe blood vessel problems
  • you have a history of bleeding or blood clotting problems (eg, blood clots in the legs, lungs, or eyes), heart attack, stroke, or liver disease
  • you are using other vaginal products (eg, vaginal antifungal creams)

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

Before using Progesterone Insert:

Some medical conditions may interact with Progesterone Insert. 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 a history of heart or blood vessel problems, depression or other mental/mood problems, or cancer

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

  • Carbamazepine or rifampin because they may decrease Progesterone Insert's effectiveness
  • Other vaginal products (eg, vaginal antifungal creams) because they may alter Progesterone Insert's actions

This may not be a complete list of all interactions that may occur. Ask your health care provider if Progesterone Insert 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 Insert:

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

  • An extra patient leaflet is available with Progesterone Insert. Talk to your pharmacist if you have questions about this information.
  • Wash your hands before and after using Progesterone Insert.
  • Unwrap the applicator and place one insert in the space provided at the end of the applicator.
  • You may use Progesterone Insert while standing, sitting, or when lying on your back with your knees bent. Gently place the thin end of the applicator well into the vagina. Push the plunger to release the insert, then remove the applicator and throw it away in the trash.
  • If you miss a dose of Progesterone Insert, 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 Insert.

Important safety information:

  • Progesterone Insert may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Progesterone Insert with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not use Progesterone Insert at the same time as other vaginal therapy without checking with your doctor.
  • Progesterone Insert 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.
  • Progesterone Insert should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Progesterone Insert is used to support early pregnancy. Progesterone Insert is found in breast milk. If you are or will be breast-feeding while you use Progesterone Insert, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Progesterone Insert:

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:

Bloating; breast tenderness; constipation; cramping; drowsiness; fluid retention; headache; nausea; stomach pain; tiredness; vaginal burning or irritation; vomiting.

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

Severe allergic reactions (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; calf or leg pain, swelling, or tenderness; change in emotions, mood, or behavior; chest pain; coughing up blood; fainting; one-sided weakness; pain in the groin; partial or complete loss of vision; stomach pain, swelling, or tenderness; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of hands, ankles, or feet; unusual vaginal itching, discharge, or odor; 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 Insert:

Store Progesterone Insert at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Progesterone Insert out of the reach of children and away from pets.

General information:

  • If you have any questions about Progesterone Insert, please talk with your doctor, pharmacist, or other health care provider.
  • Progesterone Insert 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 Insert. 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.

Issue Date: September 5, 2007
Database Edition 07.3.1.003
Copyright © 2007 Wolters Kluwer Health, Inc.

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