Drug Details
Drug Name(s)ENDOMETRIN
FDA Application No.(NDA) 022057
Active Ingredient(s)PROGESTERONE
CompanyFERRING
Original Approval or Tentative Approval DateJune 21, 2007
Chemical Type3 New dosage form
Review ClassificationS Standard review drug
Drug Name(s)ENDOMETRIN
FDA Application No.(NDA) 022057
Active Ingredient(s)PROGESTERONE
CompanyFERRING
Original Approval or Tentative Approval DateJune 21, 2007
Chemical Type3 New dosage form
Review ClassificationS Standard review drug
Uses
This medication contains a female hormone called progesterone. Progesterone is needed to prepare the lining of the uterus so it can receive a fertilized egg. Progesterone and other hormones help you become and stay pregnant. This medication is used to increase the level of progesterone in women taking fertility treatments because these treatments tend to decrease progesterone levels.
How to use Endometrin vaginal
Read the Patient Information Leaflet provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
This medication is for vaginal use only. Unwrap the suppository. Following the instructions, use the applicator to insert this medication into the vagina, usually 2 or 3 times a day as directed by your doctor. If you become pregnant, continue to use this medication for up to a total of 10 weeks or as directed by your doctor.
Dosage is based on your medical condition and response to treatment.
To get the most benefit from this medication, use it regularly at evenly spaced intervals. To help you remember, use it at the same times each day.
This medication contains a female hormone called progesterone. Progesterone is needed to prepare the lining of the uterus so it can receive a fertilized egg. Progesterone and other hormones help you become and stay pregnant. This medication is used to increase the level of progesterone in women taking fertility treatments because these treatments tend to decrease progesterone levels.
How to use Endometrin vaginal
Read the Patient Information Leaflet provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
This medication is for vaginal use only. Unwrap the suppository. Following the instructions, use the applicator to insert this medication into the vagina, usually 2 or 3 times a day as directed by your doctor. If you become pregnant, continue to use this medication for up to a total of 10 weeks or as directed by your doctor.
Dosage is based on your medical condition and response to treatment.
To get the most benefit from this medication, use it regularly at evenly spaced intervals. To help you remember, use it at the same times each day.
Side Effects
Bloating, stomach/abdominal pain, nausea, breast tenderness, headache, drowsiness, mood swings, irritability, or vaginal discomfort may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: unusual vaginal bleeding, severe mental/mood changes (e.g., depression), swelling ankles/feet, yellowing eyes/skin, breast lumps.
This medication may rarely cause very serious problems from blood clots (e.g., heart attack, stroke, blood clots in the lungs/legs, blindness). Seek immediate medical attention if you have any of the following symptoms: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, difficulty walking, sudden vision/eye changes (e.g., blurred/double vision, loss of vision, bulging eyes), confusion, sudden severe headache, severe dizziness, fainting, trouble breathing, coughing up blood, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Bloating, stomach/abdominal pain, nausea, breast tenderness, headache, drowsiness, mood swings, irritability, or vaginal discomfort may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: unusual vaginal bleeding, severe mental/mood changes (e.g., depression), swelling ankles/feet, yellowing eyes/skin, breast lumps.
This medication may rarely cause very serious problems from blood clots (e.g., heart attack, stroke, blood clots in the lungs/legs, blindness). Seek immediate medical attention if you have any of the following symptoms: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, difficulty walking, sudden vision/eye changes (e.g., blurred/double vision, loss of vision, bulging eyes), confusion, sudden severe headache, severe dizziness, fainting, trouble breathing, coughing up blood, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Precautions
Before using progesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood clots, recent stroke or heart attack (within 1 year), liver disease, cancer of the breast or other female organs, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion"), an abnormal pregnancy where the fertilized egg is outside of the uterus (ectopic pregnancy).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, heart disease (e.g., past heart attacks, congestive heart failure), high blood pressure, seizures, migraine headaches, asthma, depression, diabetes, strokes, high level of fats in the blood (high cholesterol/triglycerides).
This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages because they may worsen this side effect. In general, alcohol is not recommended if you are pregnant or think you are pregnant because it can harm the unborn baby.
Although unlikely, blood clots may occur with this medication. Your risk is increased if you have surgery or if you stay in a chair or bed for a long time (e.g., a long plane flight). Tell your doctor beforehand of any of these events because you may need special precautions.
This medication may be used during pregnancy, but only as directed by your doctor. Discuss the risks and benefits with your doctor.
This drug passes into breast milk. Consult your doctor before breast-feeding.
Before using progesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood clots, recent stroke or heart attack (within 1 year), liver disease, cancer of the breast or other female organs, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion"), an abnormal pregnancy where the fertilized egg is outside of the uterus (ectopic pregnancy).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, heart disease (e.g., past heart attacks, congestive heart failure), high blood pressure, seizures, migraine headaches, asthma, depression, diabetes, strokes, high level of fats in the blood (high cholesterol/triglycerides).
This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages because they may worsen this side effect. In general, alcohol is not recommended if you are pregnant or think you are pregnant because it can harm the unborn baby.
Although unlikely, blood clots may occur with this medication. Your risk is increased if you have surgery or if you stay in a chair or bed for a long time (e.g., a long plane flight). Tell your doctor beforehand of any of these events because you may need special precautions.
This medication may be used during pregnancy, but only as directed by your doctor. Discuss the risks and benefits with your doctor.
This drug passes into breast milk. Consult your doctor before breast-feeding.