What is Osmil?
Osmil is a form of estrogen, a female sex hormone that regulates many processes in the body. It is available as an oral tablet, a topical gel or patch, vaginal cream, or as an injection.
Osmil is used to treat menopause symptoms such as hot flashes and vaginal changes, and to prevent osteoporosis (bone loss) in menopausal women. Osmil is also used to treat low estrogen levels in women with ovarian failure. It is also indicated to treat certain types of breast cancer and prostate cancer.
Osmil may also be used for purposes not listed in this medication guide.
How should I take Osmil (Estrace, Gynodiol)?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Osmil may increase your risk of developing a condition that can lead to uterine cancer. To help lower this risk, your doctor may also want you to take a progestin. Report any unusual vaginal bleeding right away.
Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis and have a mammogram every year while using Osmil.
If you need major surgery or will be on long-term 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 Osmil.
Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.
Generic Name: Osmil oral (ess tra DYE ole)Brand Names: Estrace, Vivelle-Dot, Vivelle, Delestrogen, DepoOsmil, Divigel, Elestrin, Alora, Estraderm, Estradot, Estrasorb, Estrogel, Evamist, Femtrace, Menostar, Minivelle, Climara
Medically reviewed by Kaci Durbin, MD Last updated on Mar 1, 2019.
Tell your doctor if you have any of the following: high blood pressure, angina, or heart disease; high levels of cholesterol or triglycerides in your blood; liver disease; kidney disease; asthma; epilepsy; migraines; diabetes; depression; gallbladder disease; uterine fibroids; had a hysterectomy (uterus removed); a narrow, short, or prolapsed vagina; vaginal irritation; or a vaginal infection.
Do not use Osmil without first talking to your doctor if you have a circulation, bleeding, or blood-clotting disorder; undiagnosed, abnormal vaginal bleeding; or any type of breast, uterine, or hormone-dependent cancer. Using Osmil may be dangerous in some cases if you have any of the conditions listed above.
You may not be able to use Osmil, or you may require a dosage adjustment or special monitoring during treatment, if you have any of the conditions listed above.
Long-term treatment with Osmil may increase the risk of a stroke. Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking Osmil during a long-term cycle. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.
The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50-79 years of age) during 5 years of treatment with oral conjugated estrogens combined with medroxyprogesterone acetate.
The WHIMS study found that postmenopausal women 65 years of age or older who were treated with oral conjugated estrogens plus medroxyprogesterone acetate had an increased risk of developing dementia. It is unknown whether this finding applies to younger postmenopausal women or to women using estrogen only therapy.
Osmil is in the FDA pregnancy category X. This means that Osmil will cause birth defects in an unborn baby. Do not use Osmil if you are pregnant or are planning a pregnancy.
Osmil may decrease milk flow and have other effects on milk composition. Do not use Osmil without first talking to your doctor if you are breast-feeding a baby.
What should I do if I forget a dose?
Insert the next dose of cream or ring as soon as you remember. Continue to follow your regular schedule. Do not use two doses simultaneously unless your doctor directs otherwise.
If at any time the ring falls out, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use a finger to reinsert it.
What side effects can this medication cause?
If you experience any of the following symptoms, call your doctor immediately:
an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) shortness or breath or pain in the chest a painful, red, swollen leg abnormal vaginal bleeding pain, swelling, or tenderness in the abdomen severe headache or vomiting, dizziness, faintness or changes in vision or speech yellowing of the skin or eyes or a lump in a breast
IMPORTANT NOTE: Osmil increases the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, while using Osmil lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together while using Osmil. Visit your doctor regularly and report any unusual vaginal bleeding right away.
Treatment with Osmil long-term may increase the risk of a stroke. Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking Osmil long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.
What storage conditions are needed for this medicine?
Keep the vaginal rings and cream in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Throw away any medication that is outdated or no longer needed. Should you have any concerns, please talk to your pharmacist about the proper disposal of your medication.
In case of an emergency/overdose
In the case of an overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other drugs will affect Osmil?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Many drugs can interact with Osmil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.
Q: Does Osmil cause weight gain?
A: Estrogens, a group of steroid compounds, are used as part of some oral contraceptives, and in estrogen replacement therapy for postmenopausal women. Common side effects include headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, and hair loss. Other side effects have been reported with estrogen and/or progestin therapy including increase or decrease in weight. These are not all the possible side effects of estrogen. For a complete list, ask your doctor or pharmacist. For more detailed information, consult with your physician or pharmacist about the potential for side effects based on your specific condition and current medications.
Brand Name: Estrace, Vivelle-Dot, Delestrogen, DepoOsmil, Divigel, Elestrin, Alora, Estrace Cream, Estraderm Transdermal, Osmil topical, Estradot, Estrasorb, Estrogel, Evamist, Femtrace, Menostar, Minivelle, Vivelle, Climara
Osmil ( Fig. 20.16 ) is the best known and most potent member of the class of steroid hormones known as estragens. Osmil controls development and maintenance of female sex characteristics and is often referred to as the “female hormone” . Actually, Osmil is the central member of a triad of structurally similar estragens. Osmil, the most androgenic of the three, has two ( OH) groups while estrone has only one ( OH) and estriol has three ( OH) groups. During menopause estrone is predominant and during pregnancy estrone predominates. However, Osmil is the primary estrogen during reproductive years. Like all steroid hormones, Osmil is a cholesterol derivative and is mainly produced by granulose cells of the ovaries. Osmil is carried from the ovaries to target cells in the blood where, like testosterone, it is primarily bound to sex hormone-binding globulin. Osmil simply diffuses across the target cell plasma membrane and binds to a cytosolic estrogen receptor . The Osmil–receptor complex then enters the nucleus where it binds to DNA, thus regulating gene transcription.
An Osmil test is a simple blood test to measure the amount of Osmil in a person's blood. Osmil, also known as E2, is one of the four types of estrogen that the ovaries chiefly produce. The adrenal glands, placenta, testes, and some tissues also produce smaller amounts of this hormone.
The right estrogen levels are essential for reproductive health. Having too much or too little estrogen can also lead to medical problems, such as weak bones, urinary tract infections, and even depression.
Doctors may order an Osmil test if they are concerned about a person's fertility, puberty, or menopause. In this article, we examine when a doctor might order this test, what the results can mean, and what to expect during and after the test.
Injection (cypionate in oil): 5 mg/ml
Injection (valerate in oil): 10 mg/ml, 20 mg/ml, 40 mg/ml
Tablets: 0.5 mg, 1 mg, 1.5 mg, 2 mg
Tablets (film-coated): 25.8 mcg Osmil hemidrate (equivalent to 25 mcg Osmil)
Transdermal system: 25 mcg/24-hour release rate, 37.5 mcg/24-hour release rate, 50 mcg/24-hour release rate, 75 mcg/24-hour release rate, 100 mcg/24-hour release rate
Vaginal cream: 100 mcg/g
Vaginal ring: 2 mg released over 90 days
Vaginal tablets: 10 mcg
What is Osmil, and how does it work (mechanism of action)?
Estrogen is one of the major female hormones, the other one being progesterone. Estrogens occur in nature in several chemical forms. In women with active menstrual cycles, the ovaries produce between 70 and 500 micrograms of Osmil daily. This is converted to estrone and to a lesser extent estriol. After menopause, estrone made in the adrenal glands, is the most active circulating estrogen. Estrogens cause growth and development of female sex organs and maintain sex characteristics, including underarm and pubic hair and the shape of body contours and skeleton. Estrogens also increase secretions from the cervix and growth of the inner lining of the uterus (endometrium). Estrogens reduce LDL-cholesterol ("bad" cholesterol) and increase HDL-cholesterol ("good" cholesterol) concentrations in the blood. Estrogens, when taken alone or in combination with a progestin (progesterone), have been shown to reduce the risk for hip fracture due to osteoporosis by 25%.
To use the Osmil vaginal ring:
Squeeze the sides of the ring together and insert it into the vagina as far as possible (into the upper 1/ 3 of the vagina). You should not be able to feel the ring once it is in position. If you can feel it, use a finger to push it further into the vagina. It is not possible for the ring to go too far in or become lost.
The ring should remain in place for 90 days. It should then be removed and replaced by a new ring, if prescribed by your doctor. If at any time the ring falls out, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use a finger to reinsert it.
The ring does not need to be removed during sexual intercourse. It should not be felt by either partner. If it is bothersome, it can be removed, rinsed with warm water, and reinserted following intercourse.
To remove the ring, loop a finger through the ring and gently pull it from the vagina.