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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.
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.
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.
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.
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Call your doctor if you miss more than one dose.
An overdose of Endometrin is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.
Do not use another vaginal medicine within 6 hours before or after using Endometrin. Use only vaginal products that your doctor has recommended.
Avoid using vaginal yeast treatments unless your doctor tells you to.
Endometrin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
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.
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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Endometrin only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Endometrin (www.drugs.com/endometrin.html).
Note: This document contains side effect information about progesterone. Some of the dosage forms listed on this page may not apply to the brand name Endometrin.
Applies to progesterone: oral capsule, oral capsule liquid filled
Oral route (Capsule, Liquid Filled)
Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported with estrogen plus progestin therapy. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration possible.
Along with its needed effects, progesterone (the active ingredient contained in Endometrin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking progesterone:
More common
Less common
Incidence not known
Some side effects of progesterone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Incidence not known
Applies to progesterone: compounding powder, intramuscular solution, oral capsule, topical cream, vaginal gel, vaginal insert, vaginal suppository
Very common (10% or more): Breast enlargement (40%), breast tenderness (27%), perineal pain female (17%), breast pain (16%), nocturia (13%), urinary problems (11%), vaginal discharge (11%)
Common (1% to 10%): Ovarian hyperstimulation syndrome, breast pain, vaginal dryness, pruritus genital, uterine spasm, vaginal bleeding, altered periods, amenorrhea, intercurrent bleeding
Uncommon (0.1% to 1%): Vulvovaginal disorders, vaginal mycosis, breast disorders, pollakiuria, incontinence, ovarian enlargement, pelvic pain, vulvovaginal pruritus, galactorrhea
Frequency not reported: Vaginal irritation, vaginal burning, vaginal discomfort, fatty discharge, changes in cervical erosion and secretions
Postmarketing reports: Hypospadia, intra-uterine death, menorrhagia, menstrual disorder, metrorrhagia, ovarian cyst, spontaneous abortion
Very common (10% or more): Headache (31%), somnolence (27%), dizziness (24%)
Uncommon (0.1% to 1%): Dysgeusia
Frequency not reported: Extreme dizziness and/or drowsiness, slurred speech, difficulty walking, loss of consciousness, vertigo, confusion, disorientation, insomnia
Postmarketing reports: Convulsion, depressed consciousness, dysarthria, loss of consciousness, paresthesia, sedation, stupor, syncope (with and without hypotension), transient ischemic attack, abnormal gait, difficulty walking
Very common (10% or more): Emotional lability (23%), depression (19%), sleep disorder (18%), nervousness (16%), libido decreased (10%)
Common (1% to 10%): Worry
Uncommon (0.1% to 1%): Mood altered
Postmarketing reports: Aggression, depersonalization, disorientation, suicidal ideation
Very common (10% or more): Hot flashes (11%)
Uncommon (0.1% to 1%): Hemorrhage
Rare (less than 0.1%): Thromboembolism or thrombus formation
Postmarketing reports: Circulatory collapse, congenital heart disease (including ventricular septal defect and patent ductus arteriosis), hypertension, hypotension, tachycardia
Very common (10% or more): Abdominal pain (20%), abdominal bloating (12%)
Common (1% to 10%): Nausea/vomiting, diarrhea, abdominal distension, constipation
Uncommon (0.1% to 1%): Flatulence, gastric dilatation
Postmarketing reports: Acute pancreatitis, dysphagia, swollen tongue, cleft palate
Very common (10% or more): Joint pain (20%), cramps NOS (15%), musculoskeletal pain (12%)
Common (1% to 10%): Back pain, arthralgia, myalgia
Postmarketing reports: Cleft lip, muscle cramp
Common (1% to 10%): Coughing, upper respiratory tract infection
Frequency not reported: Shortness of breath
Postmarketing reports: Choking, dyspnea, asthma, throat tightness
Common (1% to 10%): Night sweats
Uncommon (0.1% to 1%): Pruritus, acne
Very rare (less than 0.01%): Urticaria, chloasma
Frequency not reported: Itching, hirsutism
Postmarketing reports: Alopecia, face edema
Very common (10% or more): Post oocyte retrieval pain (28%), viral infection (12%), hot flashes (11%)
Common (1% to 10%): Fatigue, pain, chest pain, swelling of hands and feet, breast excisional biopsy
Uncommon (0.1% to 1%): Peripheral edema, feeling cold, feeling of body temperature change, discomfort, weight increased
Frequency not reported: Feeling drunk, pyrexia
Postmarketing reports: Feeling abnormal, tinnitus, weight decreased
Common (1% to 10%): Cholecystectomy
Uncommon (0.1% to 1%): Cholestatic jaundice
Postmarketing reports: Cholestasis, cholestatic hepatitis, hepatic failure, hepatic necrosis, hepatitis, increased liver function tests (including alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase increases), jaundice
Common (1% to 10%): Hyperglycemia
Postmarketing reports: Blood glucose increased
Common (1% to 10%): Breast carcinoma
Uncommon (0.1% to 1%): Rectal neoplasm
Postmarketing reports: Endometrial carcinoma
Frequency not reported: Blurred vision
Postmarketing reports: Diplopia, visual disturbance
Uncommon (0.1% to 1%): Hypersensitivity reactions
Postmarketing reports: Anaphylactic reaction
Rare (less than 0.1%): Adrenal suppression or insufficiency
Frequency not reported: Injection site reaction
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Endometrin (www.drugs.com/endometrin.html).
March 28, 2020
March 28, 2020
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March 28, 2020
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March 28, 2020
