Estrogens, conjugated synthetic a

What is Synthetic conjugated estrogens a?

• Synthetic conjugated estrogens a (Cenestin) contain a blend of nine (9) synthetic estrogenic substances used reduce moderate or severe hot flashes and to treat moderate to severe dryness, itching, and burning in and around the vagina.

What are the uses of this medicine?

Synthetic conjugated estrogens a (Cenestin) is used after menopause to:

• reduce moderate or severe hot flashes.
• treat moderate to severe dryness, itching, and burning in and around the vagina.

• Estrogens are hormones made by a woman’s ovaries. The ovaries normally stop making estrogens when a woman is between 45 to 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 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 Cenestin.

How does this medicine work?

• Estrogens increase the risk of gallbladder disease.
• Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs.
• Monitor thyroid function in women on thyroid replacement therapy.
• Estrogen administration may lead to severe hypercalcemia in women with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have unusual vaginal bleeding
• currently have or have had certain cancers
• 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 Cenestin or any of its ingredients
• if you think you may be pregnant

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Cenestin.

Is this medicine FDA approved?

• Initial U.S. Approval: 1999

How should this medicine be used?

Recommended dosage:

• Cenestin 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg tablets are taken orally, once daily for the treatment of moderate to severe vasomotor symptoms due to menopause.
• Cenestin 0.3 mg tablets are taken orally, once daily for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

Administration:

• Take one Cenestin tablet each day at about the same time.
• 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.
• Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you.
• Estrogens should be used 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 Cenestin.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 0.3 mg tablet
• 0.45 mg tablet
• 0.625 mg tablet
• 0.9 mg tablet
• 1.25 mg tablet

This medicine is available in fallowing brand namesː

• CENESTIN

What side effects can this medication cause?

The most common side effects of this medicine include:

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

Other side effects include:

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

Less common but serious side effects include:

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

What special precautions should I follow?

• 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 about whether you still need treatment with Cenestin.
• A 2 to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving estrogens.
• Estrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs.
• Monitor thyroid function in women on thyroid replacement therapy.
• Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Serious ill effects have not been reported following acute ingestion of large doses of estrogen containing drug products by young children.
• Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.

Management of overdosage:

• Treatment of overdose consists of discontinuation of CENESTIN therapy with institution of appropriate symptomatic care.

Can this medicine be used in pregnancy?

• Cenestin should not be used during pregnancy.

Can this medicine be used in children?

• Cenestin is not indicated in children.

What are the active and inactive ingredients in this medicine?

• 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, 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 any additional color additives.
• 1.25 mg tablets also contain FD&C Blue No. 2 aluminum lake.

Who manufactures and distributes this medicine?

Manufactured By:

• Duramed Pharmaceuticals, Inc.
• Subsidiary of Barr Pharmaceuticals, Inc.
• Pomona, New York

Relabeling and Repackaging by:

• Physicians Total Care, Inc.
• Tulsa, OK

What should I know about storage and disposal of this medication?

• Store at 20-25°C (68-77°F); excursions are permitted to 15-30°C (59-86°F).
• Dispense in tight container.
• Dispense in child-resistant packaging.

• Dailymed label info on Estrogens, conjugated synthetic a
• FDA Estrogens, conjugated synthetic a

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