Estracon Vaginal Cream

Estracon Vaginal Cream is used for: Atrophic Vaginitis, Kraurosis Vulvae, Dyspareunia

Vaginal Prep Vaginal cream 0.0625% (0.625mg/g) Atrophic Vaginitis and Kraurosis Vulvae Administer cyclic regimen (daily for 21 days followed by 7 days off) intravaginally Start at 0.5 g dosage strength; may adjust dosage (0.5 to 2 g) based on individual response Moderate to Severe Dyspareunia, a symptom of Vulvar and Vaginal Atrophy, due to Menopause 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

Instructions for Applicator Use: Step 1. Open the sealed wrapper and remove the applicator. Step 2. Insert the tip of the applicator into the tube. Step 3. Press down the tube and squeeze the specified amount of gel into the applicator tube. Step 4. Remove the applicator from the tube. Step 5. Gently insert the rounded tip of the applicator. Step 6. Push the plunger to release the gel. Step 7. Remove the applicator. (It is normal for a small amount of gel to be left in the applicator. You will still get the right dose of medicine.) Keep the applicator clean and germ-free for later use. Plastic applicator calibrated in 0.5 g increments to a maximum of 2 g

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 (eg, 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, or antithrombin deficiency, or other known thrombophilic disorders Known or suspected pregnancy

Estrogen-Alone Therapy There is an increased risk of endometrial cancer in a woman with a uterus that uses unopposed estrogens Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older Estrogen Plus Progestin Therapy Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI) The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older Endometrial cancer Estrogens increase risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens Close clinical surveillance of all women taking estrogens is important Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than the use of synthetic estrogens at equivalent estrogen doses Breast cancer Using conjugated estrogens in combination with medroxyprogesterone increases risk of invasive breast cancer Systemic absorption occurs with 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 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 use of progestins with estrogens compared to estrogen-alone regimens, including 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 use of estrogens for <1 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 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 reported in women treated post-hysterectomy with estrogen-alone therapy; for women known to have residual endometriosis post-hysterectomy, 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 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 in order 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 Category: X Lactation: Distributed in human breast milk; caution when breastfeeding, estrogens may decrease the quantity and quality of milk

Contraindicated (0) Serious (15) carbamazepine cimetidine clarithromycin erythromycin base erythromycin ethylsuccinate erythromycin lactobionate erythromycin stearate itraconazole ketoconazole levoketoconazole nefazodone quinidine rifabutin rifampin St John's Wort

Side effects of Conjugated Estrogens Vaginal prep : 1-10% Breast pain (4.9%) Headache (3.5%) Pelvic pain (2.8%) Vulvovaginal disorder (2.8%) Vasodilation (2.1%) Leukorrhea (2.1%) Moniliasis (1.4%) Pain (1.4%) Muscle cramps (1.4%) Pruritus (1.4%) Dysuria (1.4%) Vaginal hemorrhage (1.4%) Vaginitis (1.4%) <1% Abdominal pain Dizziness Breast enlargement Urinary urgency

Conjugated Estrogens is a mixture of estrogens, obtained exclusively from natural sources. It helps rebuild vaginal tissue and manages moderate to severe dyspareunia, and other vaginal complications after menopause.

Estracon 0.625 mg/gm Vaginal Cream manufactured by Renata PLC.. Its generic name is Conjugated Estrogens Vaginal prep. Estracon is availble in Bangladesh. Farmaco BD drug index information on Estracon Vaginal Cream is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.