Conjugated Estrogens Vaginal

Conjugated Estrogens, Vaginal is a prescription medication used to treat menopause symptoms such as hot flashes and vaginal changes.

• Droperidol is available under the following different brand names: Premarin Vaginal Cream

Adult dosage

Vaginal cream

• 0.625mg/g

Atrophic Vaginitis and Kraurosis Vulvae

Adult dosage

• Start at 0.5 g dosage strength; may adjust dosage (0.5 to 2 g) based on individual response
• Administer cyclic regimen (daily for 21 days followed by 7 days off) intravaginally

Moderate to Severe Dyspareunia

Adult dosage

• 0.5 g intravaginally in a twice-weekly (eg, Monday and Thursday) continuously or in a cyclic regimen of daily administration for 21 days followed by 7 days off

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Conjugated Estrogens, Vaginal include:

• nausea,
• gas,
• stomach pain,
• headache,
• back pain,
• depression,
• sleep problems (insomnia),
• breast pain,
• vaginal itching or discharge,
• changes in the menstrual periods, and
• breakthrough bleeding.

Serious side effects of Conjugated Estrogens, Vaginal include:

• chest pain or pressure,
• pain spreading to the jaw or shoulder,
• nausea,
• sweating,
• sudden numbness or weakness (especially on one side of the body),
• sudden severe headache,
• slurred speech,
• problems with vision or balance,
• sudden vision loss,
• stabbing chest pain,
• feeling short of breath,
• coughing up blood,
• pain or warmth in one or both legs,
• swelling or tenderness in the stomach,
• yellowing of the skin or eyes (jaundice),
• memory problems,
• confusion,
• unusual behavior,
• unusual vaginal bleeding,
• pelvic pain,
• lump in the breast,
• vomiting,
• constipation,
• increased thirst or urination,
• muscle weakness,
• bone pain, and
• lack of energy.

Rare side effects of Conjugated Estrogens, Vaginal include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Conjugated Estrogens, Vaginal has severe interactions with no other drugs.
• Conjugated Estrogens, Vaginal has serious interactions with the following drugs:
  • carbamazepine
  • cimetidine
  • clarithromycin
  • erythromycin base
  • erythromycin ethylsuccinate
  • erythromycin lactobionate
  • erythromycin stearate
  • itraconazole
  • ketoconazole
  • levoketoconazole
  • nefazodone
  • quinidine
  • rifabutin
  • rifampin
  • St John's Wort
• Conjugated Estrogens, Vaginal has moderate interactions with at least 113 other drugs.
• Conjugated Estrogens, Vaginal has minor interactions with at least 35 other drugs:

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Undiagnosed abnormal genital bleeding
• Known, suspected, or history of breast cancer
• Known or suspected estrogen-dependent neoplasia
• Active DVT, PE, or a history of these conditions
• Active arterial thromboembolic disease (e.g., stroke, MI), or a history of these conditions
• Known anaphylactic reaction or angioedema to conjugated estrogen preparations
• Known liver dysfunction or disease
• Known protein C, protein S, antithrombin deficiency, or other known thrombophilic disorders
• Known or suspected pregnancy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Conjugated Estrogens, Vaginal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Conjugated Estrogens, Vaginal?”

Cautions

• Systemic absorption occurs with the use of vaginal cream
• Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, may lower the incidence of endometrial hyperplasia compared to estrogen treatment alone; endometrial hyperplasia may be a precursor to endometrial cancer
• There are possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens, including an increased risk of breast cancer
• If feasible, estrogens should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization
• Most studies show no significant increased risk of endometrial cancer associated with the use of estrogens for less than a year; the greatest risk appears to be associated with prolonged use, with increased risks of 15-to 24-fold for 5 to 10 years or more; this risk has been shown to persist for at least 8-15 years after estrogen therapy discontinued
• All women should receive yearly breast examinations by a healthcare provider and perform monthly breast self-examinations; in addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results
• Risk of cardiovascular, endometrial cancer, breast cancer, and dementia; see Black Box Warnings
• Estrogens increase the risk of gallbladder disease
• Discontinue estrogen if severe hypercalcemia, severe hypertriglyceridemia occurs
• Monitor thyroid function in women on thyroid replacement therapy
• Estrogens may be poorly metabolized in women with impaired liver function; for women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued
• Hormonal therapy for menopausal symptoms associated with increased risk for ovarian cancer; the exact duration of hormone therapy use associated with increased risk of ovarian cancer, is unknown
• Retinal vascular thrombosis has been reported in patients receiving estrogens; discontinue medication pending examination if there is a sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine; if examination reveals papilledema or retinal vascular lesions, estrogens should be permanently discontinued
• May cause fluid retention; women with conditions that might be influenced by this factor, such as cardiac or renal dysfunction, warrant careful observation when estrogen-alone prescribed
• A few cases of malignant transformation of residual endometrial implants were reported in women treated post-hysterectomy with estrogen-alone therapy; for women known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered
• Estrogen therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur
• Rare cases of anaphylaxis and angioedema were reported; may exacerbate symptoms of hereditary angioedema
• May cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas
• Premarin cream may weaken latex condoms; the potential for the vaginal cream to weaken and contribute to the failure of condoms, diaphragms, or cervical caps made of latex or rubber should be considered
• Hypothyroidism
  • Estrogen administration leads to increased thyroid-binding globulin (TBG) levels; women with normal thyroid function can compensate for increased TBG by making more thyroid hormone, thus maintaining free T4 and T3 serum concentrations in the normal range
  • Women dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy; these women should have their thyroid function monitored to maintain their free thyroid hormone levels in an acceptable range
• Venous Thromboembolism
  • Manage appropriately risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus)
  • Should VTE occur or be suspected, estrogen-alone therapy should be discontinued immediately

Pregnancy and Lactation

• Do not use it in pregnancy. The risks involved outweigh the potential benefits. Safer alternatives exist
• Lactation
  • Distributed in human breast milk; caution when breastfeeding, estrogens may decrease the quantity and quality of milk