Premarin

Conjugated estrogens, a mixture of the water-soluble salts of sulfate esters from estrone, equilin, 17 α-dihydroequilin, and other related steroids, may be derived from pregnant equine urine or yam and soy plants. Estrogens are important in the development and maintenance of the female reproductive system and secondary sex characteristics.

Medicinal name:
  • Estrogens, Conjugated (USP) 0.3 MG Oral Tablet [Premarin]
  • Estrogens, Conjugated (USP) 0.625 MG Oral Tablet [Premarin]
  • Estrogens, Conjugated (USP) 1.25 MG Oral Tablet [Premarin]
  • Estrogens, Conjugated (USP) 0.45 MG Oral Tablet [Premarin]
  • Estrogens, Conjugated (USP) 0.9 MG Oral Tablet [Premarin]

Premarin - Pharmacology:

Estrogens enter the cells of responsive tissues (e.g., female organs, breasts, hypothalamus, pituitary) where they interact with a protein receptor, subsequently increasing the rate of synthesis of DNA, RNA, and some proteins. Estrogens decrease the secretion of gonadotropin-releasing hormone by the hypothalamus, reducing the secretion of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from the pituitary.

Premarin mini report

Premarin NDA
NDA - A product marketed under an approved New Drug Application
Premarin VAGINAL
VAGINAL
Premarin INTRAMUSCULAR; INTRAVENOUS
INTRAMUSCULAR; INTRAVENOUS
Premarin ORAL
ORAL
Premarin CREAM
CREAM
Premarin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Premarin TABLET, FILM COATED
TABLET, FILM COATED
Premarin HUMAN PRESCRIPTION DRUG
HUMAN PRESCRIPTION DRUG
Premarin global name
conjugated estrogens
Premarin global name
estrogens, conjugated
Start - Stop data
START DATA:
1978-Nov-01
Start - Stop data
STOP DATA
not occurred

Premarin for patients

(Updated June 28, 2004)

ENJUVIA™

(synthetic conjugated estrogens, B) Tablets

Read this patient information before you start taking ENJUVIA, and read what you get each time you refill ENJUVIA. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ENJUVIA (AN ESTROGEN HORMONE)?

· Estrogens increase the chances of getting cancer of the uterus.

Report any unusual vaginal bleeding right away while you are taking estrogens. 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 estrogens with or without progestins to prevent heart disease, heart attacks, or strokes.

Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your healthcare provider should talk regularly to determine whether you still need treatment with ENJUVIA.

What is ENJUVIA?

ENJUVIA is a medicine that contains estrogen hormones.

What is ENJUVIA used for?

ENJUVIA is used after menopause to reduce moderate to severe hot flashes. Estrogens are hormones made by a womans ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the "change of life" or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes "surgical menopause."

When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating ("hot flashes" or "hot flushes"). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with ENJUVIA.

Who should not take ENJUVIA?

Do not start taking ENJUVIA if you:

  • have unusual vaginal bleeding
  • currently have or have had certain cancers - estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or had cancer, talk with your healthcare provider about whether you should take ENJUVIA.
  • had a stroke or heart attack in the past year
  • currently have or have had blood clots
  • currently have or have had liver problems
  • are allergic to ENJUVIA or any of its ingredients - see the end of this leaflet for a list of ingredients in ENJUVIA.
  • think you may be pregnant

Tell your healthcare provider:

  • if you are breastfeeding - the hormones in ENJUVIA can pass into your milk.
  • 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), 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 ENJUVIA works. ENJUVIA 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 taking estrogens.

How should I take ENJUVIA?

  • Take one ENJUVIA tablet by mouth at the same time each day.
  • Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you.
  • 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 whether you still need treatment with ENJUVIA.
  • ENJUVIA may be taken with or without food.

What are the possible side effects of estrogens?

Less common but serious side effects include:

  • Breast cancer
  • Cancer of the uterus
  • Stroke
  • Heart attack
  • Blood clots
  • Dementia
  • Gallbladder disease
  • Ovarian cancer

These are some of the warning signs of serious side effects:

  • Breast lumps
  • Unusual vaginal bleeding
  • Dizziness and faintness
  • Changes in speech
  • Severe headaches
  • Chest pain
  • Shortness of breath
  • Pains in your legs
  • Changes in vision
  • Vomiting
Call your healthcare provider right away if you get any of these warning signs, or any other symptoms that concern you.

Common side effects include:

  • Headache
  • Breast pain
  • Irregular vaginal bleeding or spotting
  • Stomach/abdominal cramps, bloating
  • Nausea and vomiting
  • Hair loss

Other side effects include:

  • High blood pressure
  • Liver problems
  • High blood sugar
  • Fluid retention
  • Enlargement of benign tumors of the uterus ("fibroids")
  • Vaginal yeast infection

These are not all the possible side effects of ENJUVIA. For more information, ask your health-care provider or pharmacist.

What can I do to lower my chances of a serious side effect with ENJUVIA?

  • Talk with your healthcare provider regularly about whether you should continue taking ENJUVIA.
  • If you have a uterus, talk to your healthcare provider about whether the addition of a progestin is right for you.
  • See your healthcare provider right away if you get vaginal bleeding while taking ENJUVIA.
  • Have a 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 of getting heart disease.

General information about safe and effective use of ENJUVIA.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take ENJUVIA for conditions for which it is not prescribed. Do not give ENJUVIA to other people, even if they have the same symptoms you have. It may harm them.

Keep ENJUVIA out of the reach of children.

This leaflet provides a summary of the most important information about ENJUVIA. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about ENJUVIA that is written

What are the ingredients in ENJUVIA?

ENJUVIA tablets for oral administration are available in 0.3 mg, 0.45 mg, 0.625 mg and 1.25 mg strengths of synthetic conjugated estrogens, B. These tablets contain the following inactive ingredients: ascorbyl palmitate, butylated hydroxyanisole, colloidal silicon dioxide, edetate disodium dehydrate, plasticized ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, purified water, iron oxide red, titanium dioxide, polyethylene glycol, polysorbate 80, triacetate and triacetin/glycerol. In addition, the 0.45 mg tablets contain iron oxide black and iron oxide yellow and the 1.25 mg tablets contain iron oxide yellow.

Premarin Interactions

DRUG/LABORATORY TEST INTERACTIONS

1. Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.

2. Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.

3. Other binding proteins may be elevated in serum, (i.e., corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG)) leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).

4. Increased plasma HDL and HDL2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglyceride levels.

5. Impaired glucose tolerance.

6. Reduced response to metyrapone test.

Premarin Contraindications

ENJUVIA tablets should not be used in individuals with any of the following conditions:

1. Undiagnosed abnormal genital bleeding.

2. Known, suspected, or history of cancer of the breast.

3. Known or suspected estrogen-dependent neoplasia.

4. Active deep vein thrombosis, pulmonary embolism or a history of these conditions.

5. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).

6. Liver dysfunction or disease.

7. ENJUVIA tablets should not be used in patients with known hypersensitivity to its ingredients.

8. Known or suspected pregnancy. There is no indication for ENJUVIA in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.

Manufacturers name:

  • Aphena Pharma Solutions - Tennessee, Inc
  • State of Florida DOH Central Pharmacy
  • A-S Medication Solutions LLC
  • Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
  • Wyeth Pharmaceuticals Inc, a subsidiary of Pfizer Inc
  • Physicians Total Care, Inc
  • Cardinal Health

Premarin tags categories:

Generic name, Overdose, Half Life Premarin, Food Interactions, Chemical, etc..

Premarin see also FDA report Saw Palmetto

Women's Health
Brand Names containing Conjugated Estrogens