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Premarin tablets contain conjugated estrogens, a mixture of estrogen hormones. Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.
Premarin is used to treat menopause symptoms such as hot flashes and vaginal changes, and to prevent osteoporosis (bone loss) in menopausal women.
Premarin is also used to replace estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body.
Do not use if you are pregnant.
Premarin may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.
Using this medicine can increase your risk of blood clots, stroke, or heart attack, or cancer of the breast, uterus, or ovaries. Estrogen should not be used to prevent heart disease, stroke, or dementia.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Premarin.
You should not use Premarin if you have:
unusual vaginal bleeding that has not been checked by a doctor;
liver disease;
a history of heart attack, stroke, or blood clot;
an increased risk of having blood clots due to a heart problem or a hereditary blood disorder; or
a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.
Do not use Premarin if you are pregnant. Tell your doctor right away if you become pregnant during treatment.
Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.
Estrogen should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
a hysterectomy;
heart disease;
liver problems, or jaundice caused by pregnancy or taking hormones;
kidney disease;
gallbladder disease;
asthma;
epilepsy or other seizure disorder;
migraines;
lupus;
endometriosis or uterine fibroid tumors;
hereditary angioedema;
porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
a thyroid disorder; or
high levels of calcium in your blood.
Use of Premarin may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.
Estrogen lowers the hormone needed to produce breast milk and can slow breast milk production. Tell your doctor if you are breast-feeding.
Take Premarin exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger amounts or for longer than recommended.
Premarin may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to take while you are using Premarin, to help lower this risk. Report any unusual vaginal bleeding right away.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Premarin is sometimes taken on a daily basis. For certain conditions, the medicine is given in a cycle, such as 3 weeks on followed by 1 week off. Follow your doctor's instructions.
If you see what looks like part of a conjugated estrogen tablet in your stool, talk with your doctor.
Your doctor should check your progress on a regular basis to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.
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 Premarin.
Store at room temperature away from moisture, heat, and light.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using conjugated estrogens.
Grapefruit and grapefruit juice may interact with conjugated estrogens and lead to unwanted side effects. Avoid the use of grapefruit products.
Get emergency medical help if you have signs of an allergic reaction to Premarin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
signs of a blood clot - sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
swelling or tenderness in your stomach;
jaundice (yellowing of the skin or eyes);
memory problems, confusion, unusual behavior;
unusual vaginal bleeding, pelvic pain;
a lump in your breast; or
high levels of calcium in your blood - nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.
Common Premarin side effects may include:
nausea, gas, stomach pain;
headache, back pain;
depression, sleep problems (insomnia);
breast pain; or
vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.
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.
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 conjugated estrogens. 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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Premarin 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 Premarin (www.drugs.com/premarin.html).
Note: This document contains side effect information about conjugated estrogens. Some of the dosage forms listed on this page may not apply to the brand name Premarin.
Applies to conjugated estrogens: oral tablet
Other dosage forms:
Oral route (Tablet)
Unopposed estrogens increase the risk of endometrial cancer. Adding a progestin will reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Diagnostic measures should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) using estrogen alone have been reported. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) using estrogens combined with progestins have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported in women receiving estrogen alone or estrogen combined with progestins. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible.
Along with its needed effects, conjugated estrogens (the active ingredient contained in Premarin) 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 conjugated estrogens:
More common
Less common
Incidence not known
Some side effects of conjugated estrogens 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
Less common
Incidence not known
Applies to conjugated estrogens: injectable powder for injection, oral tablet, vaginal cream
-HRT is associated with a 1.3 to 3-fold increased relative risk of developing VTE, i.e., deep vein thrombosis or pulmonary embolism. This event is more likely to occur in the first year of using HRT.
-The use of estrogen-only and estrogen-progestin therapy is associated with an up to 1.5 fold increased relative risk of ischemic stroke.
-The risk of hemorrhagic stroke is not increased during use of HRT. This relative risk is not dependent on age or on duration of use, but as the baseline risk is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age.
Common (1% to 10%): Hypertension, palpitation, vasodilation
Rare (less than 0.1%): Stroke
Postmarketing reports: Deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, myocardial infarction, stroke
Common (1% to 10%): Acne, alopecia, hirsutism, pruritus, rash, skin discoloration, sweating, fungal dermatitis
Postmarketing reports: Chloasma or melasma (may persist when drug is discontinued), erythema multiforme, erythema nodosum, loss of scalp hair
Common (1% to 10%): Constipation, diarrhea, dyspepsia, eructation, flatulence, nausea
Uncommon (0.1% to 1%): Bloating, abdominal pain
Postmarketing reports: Vomiting, abdominal discomfort, abdominal distension
Common (1% to 10%): Pelvic pain, breast disorder, breast enlargement, breast neoplasm, breast pain, cervix disorder, dysmenorrhea, endometrial disorder, endometrial hyperplasia, leukorrhea, metrorrhagia, urinary tract infection, uterine fibroids enlarged, uterine spasm, abnormal uterine bleeding (breakthrough bleeding/spotting), vaginal dryness, vaginal hemorrhage, vaginal moniliasis, vaginitis
Uncommon (0.1% to 1%): Vaginal candidiasis, changes in menstrual flow, changes in cervical ectropion and secretion
Postmarketing reports: Increases in seize of uterine leiomyomata, change in cervical secretion, ovarian cancer, endometrial cancer, breast tenderness, breast discharge, galactorrhea, fibrocystic breast changes, breast cancer, gynecomastia in males
Common (1% to 10%): Hyperlipidemia, weight gain, increased appetite
Very rare (less than 0.01%): Hypocalcemia
Postmarketing reports: Increase or decrease in weight, glucose intolerance, aggravation of porphyria, increased triglycerides
Common (1% to 10%): Back pain, arthralgia, leg cramps, myalgia, muscle spasm
Common (1% to 10%): Headache, dizziness, paresthesia, migraine, hypertonia, insomnia, nervousness
Very rare (less than 0.01%): Exacerbation of chorea
Postmarketing reports: Exacerbation of epilepsy, dementia
Common (1% to 10%): Accidental injury, asthenia, chills, flu syndrome, pain, edema, peripheral edema, generalized edema, moniliasis
Postmarketing reports: Irritability
Common (1% to 10%): Depression, emotional liabilities, anxiety
Uncommon (0.1% to 1%): Changes in libido, mood disturbances
Common (1% to 10%): Chest pain, bronchitis, increased cough, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection
Postmarketing reports: Exacerbation of asthma
Uncommon (0.1% to 1%): Gallbladder disease
Postmarketing reports: Cholestatic jaundice, pancreatitis, enlargement of hepatic hemangiomas, ischemic colitis
Uncommon (0.1% to 1%): Hypersensitivity
Rare (less than 0.1%): Anaphylactic/anaphylactoid reactions including urticaria and angioedema
Uncommon (0.1% to 1%): Intolerance to contact lenses, steepening of corneal curvature
Postmarketing reports: Retinal vascular thrombosis
Rare (0.01% to 0.1%): Breast cancer, ovarian cancer, fibrocystic breast changes, growth potentiation of benign meningioma.
Very rare (less than 0.01%): Endometrial cancer, enlargement of hepatic hemangiomas
Breast cancer:
-An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined estrogen-progestin therapy for more than 5 years.
-Any increased risk in users of estrogen-only therapy is substantially lower than that seen in users of estrogen-progestin combinations. The level of risk is dependent on the duration of use.
Endometrial Cancer:
-Endometrial cancer risk is about 5 in every 1000 women with a uterus not using HRT.
-In women with a uterus, use of estrogen-only HRT is not recommended because it increases the risk of endometrial cancer.
-Depending on the duration of estrogen-only use and estrogen dose, the increase in risk of endometrial cancer varied from between 5 and 55 extra cases diagnosed in every 1000 women between the ages of 50 and 65.
-Adding a progestin to estrogen-only therapy for at least 12 days per cycle can prevent this increased risk. In the Million Women Study the use of five years of combined HRT did not increase risk of endometrial cancer.
Ovarian cancer:
-Long-term use of estrogen-only and combined estrogen-progestin HRT has been associated with a slightly increased risk of ovarian cancer. In the Million Women Study 5 years of HRT resulted in 1 extra case per 2500 users.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Premarin (www.drugs.com/premarin.html).
May 12, 2020
May 12, 2020
May 12, 2020
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