Estracon Vaginal Cream

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 tre

X 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

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.