Premarin Information and Uses

Premarin

Premarin (generic: conjugated estrogens) is a prescription medication used to treat moderate to severe hot flashes, vaginal dryness, and osteoporosis (thinning and weak bones) after menopause. It is also used ease symptoms of certain cancers in both men and women. Premarin belongs to a group of drugs called estrogen hormones, which work by replacing estrogen that is normally produced by the body.

This medication comes in tablet form and is taken once a day, with or without food.

Common side effects of Premarin include headache, breast pain, and irregular vaginal bleeding.

Uses of Premarin

Premarin is a prescription medication used to treat moderate to severe hot flashes, vaginal dryness, and osteoporosis (thinning and weak bones) after menopause. It is also used ease symptoms of certain cancers in both men and women.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Side Effects of Premarin

Side effects are grouped by how serious they are and how often they happen when you are treated. Serious, but less common side effects include:

Heart attack
Stroke
Blood clots
Dementia
Breast cancer
Cancer of the lining of the uterus (womb)
Cancer of the ovary
High blood pressure
High blood sugar
Gallbladder disease
Liver problems
Enlargement of benign tumors of the uterus (“fibroids”)
Severe allergic reactions

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

New breast lumps
Unusual vaginal bleeding
Changes in vision or speech
Sudden new severe headaches
Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
Swollen lips, tongue and face

Less serious, but common side effects include:

Headache
Breast pain
Irregular vaginal bleeding or spotting
Stomach or abdominal cramps, bloating
Nausea and vomiting
Hair loss
Fluid retention
Vaginal yeast infection

These are not all the possible side effects of Premarin. For more information, ask your healthcare provider or pharmacist for advice about side effects.

Premarin Interactions

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

St. John's Wort (Hypericum perforatum)
phenobarbital
carbamazepine
rifampin
erythromycin
clarithromycin
ketoconazole
itraconazole
ritonavir

This is not a complete list of Premarin drug interactions. Ask your doctor or pharmacist for more information.

Premarin Precautions

Using estrogen-alone increases your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking Premarin. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function)
Using estrogen-alone may increase your chances of getting strokes or blood clots
Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
You and your healthcare provider should talk regularly about whether you still need treatment with Premarin

Do not start taking Premarin if you:

Have unusual vaginal bleeding
Currently have or have had certain cancers. Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take Premarin.
Had a stroke or heart attack
Currently have or have had blood clots
Currently have or have had liver problems
Have been diagnosed with a bleeding disorder
Are allergic to Premarin or any of its ingredients.
Think you may be pregnant

Premarin Food Interactions

Grapefruit and grapefruit juice may interact with Premarin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Inform MD

Tell your healthcare provider:

If you have any unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find the cause.
About all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
About all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Premarin works. Premarin may also affect how your other medicines work.
If you are going to have surgery or will be on bedrest. You may need to stop using Premarin.
If you are breastfeeding. The hormones in Premarin can pass into your milk.

Premarin and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. Premarin should not be used during pregnancy.

Premarin and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed. Premarin may be excreted in human breast milk. Premarin should not be used while breastfeeding.

Premarin Usage

Take one Premarin tablet at the same time each day
If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your normal schedule. Do not take 2 doses at the same time
Estrogens should be used at the lowest dose possible for your treatment only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with Premarin
If you see something that resembles a tablet in your stool, talk to your healthcare provider.

Premarin Dosage

Take Premarin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. The dosage of Premarin must be individualized as follows:

For treatment of moderate to severe menopausal symptoms:
Patients should be treated with the lowest effective dose. Generally, women should be started at 0.3 mg Premarin daily. The dose may be increased if necessary.
Premarin may be given continuously (every day with no breaks), or in cyclical regimens (regimens such as 25 days on drug followed by five days off drug), as is medically appropriate on an individualized basis.
For prevention of postmenopausal osteoporosis:
Generally, women should be started at 0.3 mg Premarin daily. The dose may be increased if necessary.
Premarin therapy may be given continuously (every day with no breaks), or in cyclical regimens (regimens such as 25 days on drug followed by five days off drug), as is medically appropriate on an individualized basis.
For treatment of female hypoestrogenism due to hypogonadism, castration, or primary ovarian failure:
Female hypogonadism — 0.3 mg or 0.625 mg daily, administered cyclically (e.g., three weeks on and one week off). Doses are adjusted depending on the severity of symptoms and responsiveness of the endometrium.
Female castration or primary ovarian failure — 1.25 mg daily, cyclically. Adjust dosage, upward or downward, according to severity of symptoms and response of the patient. For maintenance, adjust dosage to lowest level that will provide effective control.
To relieve the symptoms of breast cancer that has spread, in both men and women, the suggested dosage is 10 mg three times daily, for a period of at least three months.
To relieve the symptoms of advanced prostate cancer the recommended dosage is 1.25 mg to 2 x 1.25 mg three times daily.

Premarin Overdose

If you take too much Premarin, call your local Poison Control Center or seek emergency medical attention right away.

Forms of Premarin

Premarin contains a mixture of conjugated estrogens, which are a mixture of sodium estrone sulfate and sodium equilin sulfate and other components including sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol, and 17 β-dihydroequilin.

Premarin 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg tablets also contain the following inactive ingredients: calcium phosphate tribasic, carnauba wax, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, powdered cellulose, sucrose and titanium dioxide.

The tablets come in different strengths and each strength tablet is a different color. The color ingredients are:

— 0.3 mg tablet (green color): D&C Yellow No. 10 and FD&C Blue No. 2.

— 0.45 mg tablet (blue color): FD&C Blue No. 2.

— 0.625 mg tablet (maroon color): FD&C Blue No. 2 and FD&C Red No. 40.

— 0.9 mg tablet (white color): D&C Red No. 30 and D&C Red No. 7.

— 1.25 mg tablet (yellow color): black iron oxide, D&C Yellow No. 10, and FD&C Yellow No. 6.

Store at Controlled Room Temperature 20° to 25°C (68° to 77°F).

Other Requirements

To lower your chances of getting a serious side effect with Premarin:

Talk with your healthcare provider regularly about whether you should continue using Premarin
If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you. The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus.
See your healthcare provider right away if you get vaginal bleeding while taking Premarin.
Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.

Premarin FDA Warning

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA

Estrogen-Alone Therapy

Endometrial Cancer

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

Cardiovascular Disorders and Probable Dementia

Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.

The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.

The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.

Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Estrogen Plus Progestin Therapy

Cardiovascular Disorders and Probable Dementia

Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.

The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.

The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Breast Cancer

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other 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 consistent with treatment goals and risks for the individual woman.