August 30, 2015
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Cenestin

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Cenestin

CENESTIN®
(synthetic conjugated estrogens, A) Tablets




WARNING

ENDOMETRIAL CANCER, CARDIOVASCULAR DISODERS, 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 [see WARNINGS AND PRECAUTIONS].

Cardiovascular Disorders and Probable dementia

Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia [see WARNINGS AND PRECAUTIONS, and Clinical Studies]. 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 [see WARNINGS AND PRECAUTIONS, and Clinical Studies].

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 [see WARNINGS AND PRECAUTIONS, Use in Specific Populations, and Clinical Studies].

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 [see WARNINGS AND PRECAUTIONS, and Clinical Studies].

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 [see WARNINGS AND PRECAUTIONS, and Clinical Studies].

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 [see WARNINGS AND PRECAUTIONS, Use in Specific Populations, and Clinical Studies].

Breast Cancer

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer [see WARNINGS AND PRECAUTIONS, and Clinical Studies].

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.

DRUG DESCRIPTION

Cenestin (synthetic conjugated estrogens, A) tablets contain a blend of nine (9) synthetic estrogenic substances. The estrogenic substances are sodium estrone sulfate, sodium equilin sulfate, sodium 17α-dihydroequilin sulfate, sodium 17α-estradiol sulfate, sodium 17βdihydroequilin sulfate, sodium 17α-dihydroequilenin sulfate, sodium 17β-dihydroequilenin sulfate, sodium equilenin sulfate and sodium 17β-estradiol sulfate.

The structural formulae for these estrogens are:

Sodium Estrone Sulfate

Sodium Estrone Sulfate - Structural Formula Illustration

Sodium Equilin Sulfate

Sodium Equilin Sulfate - Structural Formula Illustration

Sodium 17α-Dihydroequilin Sulfate

Sodium 17α-Dihydroequilin Sulfate - Structural Formula  Illustration

Sodium 17α-Estradiol Sulfate

Sodium 17α-Estradiol Sulfate - Structural Formula  Illustration

Sodium 17β-Dihydroequilin Sulfate

Sodium 17β-Dihydroequilin Sulfate - Structural Formula  Illustration

Sodium 17α-Dihydroequilenin Sulfate

Sodium 17α-Dihydroequilenin Sulfate - Structural Formula  Illustration

Sodium 17β-Dihydroequilenin Sulfate

Sodium 17β-Dihydroequilenin Sulfate - Structural Formula  Illustration

Sodium Equilenin Sulfate

Sodium Equilenin Sulfate - Structural Formula  Illustration

Sodium 17β-Estradiol Sulfate

Sodium 17β-Estradiol Sulfate - Structural Formula  Illustration

Tablets for oral administration, are available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg strengths of synthetic conjugated estrogens, A. Tablets also contain the following inactive ingredients: ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80 (except 0.45 mg tablets ), pregelatinized starch, titanium dioxide, and triethyl citrate.

  • 0.3 mg tablets also contain FD&C Blue No. 2 aluminum lake and D&C Yellow No. 10 aluminum lake.
  • 0.45 mg tablets also contain FD&C Yellow No. 6/Sunset Yellow FCF lake.
  • 0.625 mg tablets also contain FD&C Red No. 40 aluminum lake.
  • 0.9 mg tablets do not contain additional color additives.
  • 1.25 mg tablets also contain FD&C Blue No. 2 aluminum lake.

What are the possible side effects of conjugated estrogens (Cenestin, Enjuvia, Premarin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using conjugated estrogens and call your doctor at once if you have a serious side effect such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • pain,...

Read All Potential Side Effects and See Pictures of Cenestin »

What are the precautions when taking synthetic conjugated estrogens (Cenestin)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaginal bleeding of unknown cause, certain cancers (such as breast cancer, cancer of the uterus/ovaries), blood clots, stroke, heart disease (such as heart attack), liver disease, kidney disease, family medical history (especially breast lumps, cancer, blood clots, angioedema), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, diabetes, high cholesterol/triglyceride levels,...

Read All Potential Precautions of Cenestin »

Last reviewed on RxList: 4/6/2015
This monograph has been modified to include the generic and brand name in many instances.

Cenestin - User Reviews

Cenestin User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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