Endometrin

Endometrin is a prescription medication used to promote embryo implantation and pregnancy in conjunction with fertility treatments in women. Endometrin belongs to a group of drugs called progestins. These work to promote embryo implantation and pregnancy in women by preparing the uterus for embryo implantation and maintaining a suitable uterine environment once pregnancy is achieved.

This medication comes in vaginal insert form and is typically inserted into the vagina 2 to 3 times daily for up to 10 weeks of treatment.

Common side effects of Endometrin include abdominal pain, nausea, and ovarian hyperstimulation syndrome.

Endometrin can can also cause drowsiness. Do not drive or operate heavy machinery until you know how Endometrin affects you.

Endometrin is a prescription medication used to promote embryo implantation and pregnancy in conjunction with fertility treatments in women.

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

• Ferring Pharmaceuticals, Inc.

Serious side effects have been reported with Endometrin. See the “Endometrin Precautions” section.

Common side effects of Endometrin include the following:

• ovarian hyperstimulation syndrome
• stomach pain
• stomach bloating
• urinary infections
• headache
• fatigue
• constipation
• vaginal irritation, burning, and discharge
• vaginal bleeding
• nausea
• uterine cramping
• vomiting

This is not a complete list of Endometrin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• rifampin
• carbamazepine
• other vaginal suppository or vaginal insert products
• antifungal products

This is not a complete list of Endometrin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Endometrin including the following:

• Ovarian Hyperstimulation Syndrome (OHSS). Discontinue using Endometrin and get medical attention immediately if you experience severe pelvic pain, nausea, vomiting, and/or weight gain.
• Heart attacks and strokes. Discontinue using Endometrin and get medical attention immediately if you experience sudden severe chest and/or left side pain and/or sudden severe headache with facial numbness, slurred speech, blindness, and/or abnormal weakness.
• Depression. Discontinue using Endometrin and consult with your physician if you experience mood changes or feel depressed.
• Hyperstimulation and/or enlargement of the ovaries. Discontinue using Endometrin and get medical attention immediately if you experience abnormal severe abdominal pain.
• Blood clots. Endometrin can increase your chance of getting blood clots. Blood clots can be serious and lead to death. Call your doctor or get medical help right away if you have:
  • persistent pain in the lower leg (calf)
  • sudden shortness of breath
  • coughing up blood
  • sudden blindness, partial or complete
  • severe chest pain
  • sudden, severe headache, vomiting, dizziness, or fainting
  • weakness in an arm or leg, or trouble speaking
  • yellowing of the skin and/or white of the eyes indicating possible liver problem

Do not take Endometrin if you:

• Are allergic to Endometrin or to any of its ingredients
• Have unusual vaginal bleeding that has not been evaluated by a doctor.
• Currently have or have had liver problems.
• Have or have had blood clots in the legs, lungs, eyes, or elsewhere in your body.
• Have breast cancer
• Have a known missed abortion or ectopic pregnancy
• Are pregnant or breastfeeding

Endometrin can also cause drowsiness. Do not drive or operate heavy machinery until you know how Endometrin affects you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Endometrin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Endometrin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Are allergic to Endometrin or to any of its ingredients
• Have liver disease
• Have breast cancer
• Have active arterial or venous thromboembolism or severe thrombophlebitis
• Have a known missed abortion or ectopic pregnancy
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you become pregnant.

It has been shown that women taking Endometrin during pregnancy may have babies born with problems. Tell your doctor immediately if you become pregnant. Endometrin may not be safe to use during pregnancy.  

Tell your doctor if you are breastfeeding or plan to breastfeed.

Endometrin has been detected in human breast milk. Using Endometrin during breastfeeding may not be safe. Because of the possibility for adverse reactions in nursing infants from Endometrin, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Use Endometrin exactly as prescribed.

This medication comes in vaginal insert form and is typically inserted into the vagina 2 to 3 times daily for up to 10 weeks of treatment.

Effectiveness of Endometrin 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.

To use Endometrin:

1. Unwrap the applicator.
2. Put one insert in the space provided at the end of the applicator. The insert should fit snugly and not fall out.
3. Place applicator with the insert into the vagina while you are standing, sitting, or when lying on your back with your knees bent.
4. Push the plunger to release the insert.
5. Remove the applicator and throw it away in the trash.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Endometrin at the same time.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Endometrin to promote embryo implantation and pregnancy in conjunction with fertility treatments in women is 100 mg administered two or three times daily for up to 10 weeks total duration.

If you use too much Endometrin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Endometrin at room temperature, 20 - 25°C (68 - 77°F)
• Do not use Endometrin after the expiration date that is printed on the carton
• Keep Endometrin and all medicines out of the reach of children.