Estradiol/drospirenone

What is Drospirenone And Estradiol?

• Drospirenone And Estradiol (Angeliq) 0.25 mg drospirenone (DRSP)/0.5 mg estradiol (E2) is an estrogen/progestin.

Drospirenone

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Estradiol

What are the uses of this medicine?

• Angeliq is a medicine that contains 2 kinds of hormones, estrogen and progestin.
• Angeliq 0.25 mg drospirenone (DRSP)/0.5 mg estradiol (E2) and Angeliq 0.5 mg DRSP/1 mg E2 are both used after menopause to reduce moderate to severe hot flashes.
• Angeliq 0.5 mg drospirenone (DRSP)/1 mg estradiol (E2) is used after menopause to treat moderate to severe dryness, itching, and burning in or around the vagina. You and your healthcare provider should talk regularly about whether you still need treatment with Angeliq to control these problems. If you use Angeliq only to treat dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you

How does this medicine work?

• Drospirenone (DRSP) is a synthetic progestin and spironolactone analog with antimineralocorticoid activity.
• In animals and in vitro, drospirenone has antiandrogenic activity, but no glucocorticoid, antiglucocorticoid, estrogenic, or androgenic activity.
• Progestins counter estrogenic effects by decreasing the number of nuclear estradiol receptors and suppressing epithelial DNA synthesis in endometrial tissue.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Undiagnosed abnormal genital bleeding.
• Known, suspected, or history of cancer of the breast.
• Known or suspected estrogen-dependent neoplasia.
• Active deep vein thrombosis, pulmonary embolism or history of these conditions.
• Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).
• Renal insufficiency.
• Liver dysfunction or disease.
• Adrenal insufficiency.
• ANGELIQ should not be used in patients with known hypersensitivity to its ingredients.
• Known or suspected pregnancy
• Do not use ANGELIQ if you have had your uterus removed (hysterectomy).

What drug interactions can this medicine cause?

• Inducers and inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentration.
• Serum potassium concentration may increase in women taking drospirenone with other drugs that have the potential to increase potassium.

Is this medicine FDA approved?

• Initial U.S. Approval: 2005

How should this medicine be used?

Recommended dosage: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

• The dosage is one Angeliq 0.25 mg DRSP/0.5 mg E2 tablet or one Angeliq 0.5 mg DRSP/1 mg E2 tablet taken by mouth once daily.

Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause

• The dosage is one Angeliq 0.5 mg DRSP/1 mg E2 tablet taken by mouth once daily.

Administration:

• Take one Angeliq tablet at the same time each day.
• Take Angeliq tablets whole. Do not break, crush, dissolve, or chew Angeliq tablets before swallowing. If you cannot swallow Angeliq tablets whole, tell your healthcare provider. You may need a different medicine.
• If you miss a dose of Angeliq, take it as soon as possible.
• If more than 24 hours have passed since you missed a dose of Angeliq, you should not take the missed dose.
• 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 Angeliq.

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

This medicine is available in fallowing doasage form:

• As Angeliq 0.25 mg DRSP/0.5 mg E2 tablet: one tablet contains 0.25 mg drospirenone and 0.5 mg estradiol,
• Angeliq 0.5 mg DRSP/1 mg E2 tablet: one tablet contains 0.5 mg drospirenone and 1 mg estradiol

This medicine is available in fallowing brand namesː

• Angeliq

What side effects can this medication cause?

The most common side effects of this medicine include:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach or abdominal pain
• Nausea
• Diarrhea
• Vaginal yeast infection
• Fluid Retention
• Moodiness

This medicine can cause serious side effects including:

• 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”)

What special precautions should I follow?

• Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
• The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and myocardial infarction
• The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
• The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
• There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
• Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
• The WHI estrogen-alone substudy reported increased risks of stroke and DVT
• The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea and vomiting
• breast tenderness
• abdominal pain
• drowsiness and fatigue
• withdrawal bleeding

Treatment of overdosage:

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

Can this medicine be used in pregnancy?

• Angeliq should not be used during pregnancy.

Can this medicine be used in children?

• Angeliq is not indicated in children. Clinical studies have not been conducted in the pediatric populations.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• drospirenone (a progestin) and estradiol

Inactive ingredients 0.5 mg DRSP/1 mg E2 tablets: lactose monohydrate NF, corn starch NF, pregelatinized starch NF, povidone 25000 USP, magnesium stearate NF, hydroxylpropylmethyl cellulose USP, macrogol 6000 NF, talc USP, titanium dioxide USP, and ferric oxide pigment NF.

Inactive ingredients in 0.25 mg DRSP/0.5 mg E2 tablets: lactose monohydrate NF, corn starch NF, pregelatinized starch NF, povidone 25000 USP, magnesium stearate NF, hydroxylpropylmethyl cellulose USP, macrogol 6000 NF, talc USP, titanium dioxide USP, and yellow ferric oxide pigment NF.

Who manufactures and distributes this medicine?

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ

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

• Store Angeliq at room temperature between 59˚F to 86˚F (15˚C to 30˚C).
• Keep Angeliq and all medicines out of the reach of children.

• Dailymed label info on Estradiol/drospirenone
• FDA Estradiol/drospirenone

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