Endometrin

Generic name: Progesterone Vaginal
Drug class: Progestins

Usage of Endometrin

Endometrin is a vaginal insert containing progesterone 100mg. 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.

Endometrin is 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.

Endometrin may also be used for purposes not listed in this medication guide.

Endometrin side effects

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

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 Endometrin side effects 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.

Before taking Endometrin

You should not use Endometrin if you have ever had an allergic reaction to progesterone, or if you have:

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

breast or uterine cancer;

abnormal vaginal bleeding;

liver disease; or

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

To make sure Endometrin 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 Endometrin can increase your risk of blood clots, stroke, heart attack, or breast cancer. Talk to your doctor about this risk.

Do not use Endometrin 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.

Endometrin can pass into breast milk and may harm a nursing baby.

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How to use Endometrin

Use Endometrin exactly as it was prescribed for you. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Endometrin 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.

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.

The dose of Endometrin is 100 mg inserted into the vagina two or three times daily starting the day after egg (oocyte) retrieval and continuing for up to 10 weeks.

The effectiveness in women 35 years of age and older has not been clearly established. The appropriate dose of Endometrin in this age group has not been determined.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using progesterone vaginal.

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 Endometrin.

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 Endometrin inserts at room temperature away from moisture, heat, and light.

Warnings

You should not use Endometrin 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.

When used as part of fertility treatment, Endometrin may be given for up to 10 weeks into a pregnancy. Following your dosing schedule is very important for this medication to be effective. Try not to miss any doses.

Endometrin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What other drugs will affect Endometrin

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.

Disclaimer

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