Brand Name
US Brand Name
Activella
Alesse
Angeliq
Estinyl
Hemocyte
Loestrin 1/20
Mircette
Myfembree
Ortho-Cyclen
Ortho-Novum
Premphase
Zemlyv
Description
Estrogens and progestins are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.
The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness. Progestins help to regulate the effects of estrogens.
Estrogens are prescribed for several reasons:
- to provide additional hormone when the body does not produce enough of its own, such as during menopause. They can also help to relieve a genital skin condition called vaginal or vulvar atrophy.
- to help prevent weakening of bones (osteoporosis) in women past menopause.
Estrogens may also be used for other conditions as determined by your doctor.
There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.
Estrogens and progestins are available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Tablet, Chewable
- Tablet, Disintegrating
- Capsule
Before Using
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Geriatric
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of estrogens and progestins in the elderly with use in other age groups.
Pregnancy
Estrogens and progestins are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.
Breastfeeding
Estrogens and progestins pass into the breast milk and can change the content or lower the amount of breast milk. Use of this medicine is not recommended in nursing mothers.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.
- Atazanavir
- Bepridil
- Boceprevir
- Cisapride
- Cobicistat
- Cyclosporine
- Darolutamide
- Dasabuvir
- Dronedarone
- Eltrombopag
- Enasidenib
- Fezolinetant
- Fostemsavir
- Gemfibrozil
- Grazoprevir
- Ketoconazole
- Levoketoconazole
- Lonafarnib
- Mavacamten
- Mesoridazine
- Ombitasvir
- Paritaprevir
- Pimozide
- Piperaquine
- Posaconazole
- Rifampin
- Ritonavir
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Tolvaptan
- Tranexamic Acid
- Velpatasvir
- Ziprasidone
Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Adagrasib
- Alclometasone
- Aldosterone
- Alfuzosin
- Alprazolam
- Amcinonide
- Amifampridine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amobarbital
- Amoxicillin
- Ampicillin
- Amprenavir
- Anagrelide
- Apalutamide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Arsenic Trioxide
- Artemether
- Asenapine
- Astemizole
- Atazanavir
- Avacopan
- Azithromycin
- Bacampicillin
- Beclomethasone
- Bedaquiline
- Belzutifan
- Benzhydrocodone
- Berotralstat
- Betamethasone
- Bexarotene
- Boceprevir
- Bosentan
- Budesonide
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Using medicines in this class with any of the following is not recommended. Your doctor may decide not to treat you with a medication in this class, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
- Tobacco
Using medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:
- Asthma or
- Calcium, too much or too little in blood or
- Diabetes mellitus (sugar diabetes)
- Epilepsy (seizures) or
- Heart problems or
- Kidney problems or
- Liver tumors, benign or
- Lupus erythematosus, systemic or
- Migraine headaches or
- Porphyria—Estrogens may worsen these conditions.
- Blood clotting problems (or history of during previous estrogen therapy)—Estrogens usually are not used until blood clotting problems stop; using estrogens is not a problem for most patients without a history of blood clotting problems due to estrogen use.
- Breast cancer or
- Bone cancer or
- Cancer of the uterus or
- Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present.
- Changes in genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen condition. The reason for the bleeding should be determined before estrogens are used.
- Endometriosis or
- Gallbladder disease or gallstones (or history of) or
- High cholesterol or triglycerides (or history of) or
- Liver disease or
- Pancreatitis (inflammation of pancreas)—Estrogens may worsen these conditions; while estrogens can improve blood cholesterol, they may worsen blood triglycerides for some people.
- Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.
- Vision changes, sudden onset including
- Bulging eyes or
- Double vision or
- Migraine headache or
- Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems, especially while taking estrogen or oral contraceptives (“birth control pills”).
Proper Use
Estrogens and progestins usually come with patient information or directions. Read them carefully before taking this medicine.
Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.
For patients taking estrogens and progestins by mouth:
- Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.
Dosing
The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For 17 beta-estradiol and norgestimate
- For oral dosage forms (tablets):
- For treating a genital skin condition (vaginal or vulvar atrophy), or vasomotor symptoms of menopause:
- Adults—Oral, 1 mg estradiol for three days followed by 1 mg of estradiol combined with 0.09 mg of norgestimate for three days. The regimen is repeated continuously without interruption.
- To prevent loss of bone (osteoporosis):
- Adults—Oral, 1 mg estradiol for three days followed by 1 mg of estradiol combined with 0.09 mg of norgestimate for three days. The regimen is repeated continuously without interruption.
- For treating a genital skin condition (vaginal or vulvar atrophy), or vasomotor symptoms of menopause:
For ethinyl estradiol and norethindrone
- For oral dosage forms (tablets):
- For treating vasomotor symptoms of menopause:
- Adults—Oral, 2.5 mcg (0.025 mg) ethinyl estradiol and 0.5 mg norethindrone once daily.
- To prevent loss of bone (osteoporosis):
- Adults—Oral, 2.5 mcg (0.025 mg) ethinyl estradiol and 0.5 mg norethindrone once daily.
- For treating vasomotor symptoms of menopause:
For estradiol and norethindrone
- For oral dosage forms (tablets):
- For treating vasomotor symptoms of menopause or treatment of vaginal or vulvar atrophy:
- Adults—Oral, 1 mg estradiol and 0.5 mg norethindrone once daily.
- To prevent loss of bone (osteoporosis):
- Adults—Oral, 1 mg estradiol and 0.5 mg norethindrone once daily.
- For treating vasomotor symptoms of menopause or treatment of vaginal or vulvar atrophy:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not keep outdated medicine or medicine no longer needed.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every year, but some doctors require them more often.
It is not yet known whether the use of estrogens increases the risk of breast cancer in women. Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it. Because breast cancer has occurred in men taking estrogens, regular breast self-exams and exams by your doctor for any unusual lumps or discharge should be done.
Tell the doctor in charge that you are taking this medicine before having any laboratory test because some results may be affected.
Side Effects
Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:
The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer, and no need to take an estrogen and progestin combination.
It is not yet known whether the use of estrogens increases the risk of breast cancer in women. Although some large studies show an increased risk, most studies and information gathered to date do not support this idea.
Check with your doctor immediately if any of the following side effects occur:
Check with your doctor as soon as possible if any of the following side effects occur:
More common
- Breast pain or tenderness
- dizziness or light-headedness
- headache
- rapid weight gain
- swelling of feet and lower legs
- vaginal bleeding
Rare
- Breast lumps
- change in vaginal discharge
- discharge from nipple
- nausea and vomiting
- pains in chest, groin, or leg, especially calf
- pains in stomach, side, or abdomen
- pain or feeling of pressure in pelvis
- severe or sudden headache
- sudden and unexplained shortness of breath
- sudden loss of coordination
- sudden slurred speech
- sudden vision changes
- weakness or numbness in arm or leg
- yellow eyes or skin
Some side effects 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
- Back pain
- bloating or gas
- dizziness
- general feeling of tiredness
- flu-like symptoms
- mental depression
- muscle aches
- nausea—taking tablet with food may decrease
- vaginitis
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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