Indications
Estracon 15gm Vaginal Cream is indicated in the following indications-
Vasomotor symptoms ranging from mild to severe due to estrogen insufficiency.
Osteoporosis prevention and treatment in women with estrogen insufficiency.
Kraurosis Vulvae and atrophic vaginitis
Hypoestrogenism in women.
Dyspareunia treatment for mild to severe cases.
Pharmacology
Endogenous estrogens play a significant role in the development and maintenance of the female reproductive system, as well as secondary sexual traits. Although circulating estrogens are in a constant state of metabolic interconversion, estradiol is the primary intracellular human estrogen and is far more powerful at the receptor level than its metabolites, estrone and estriol. The ovarian follicle, which secretes 70 to 500 mcg of estradiol daily depending on the phase of the menstrual cycle, is the principal source of estrogen in properly cycling adult women. After menopause, most endogenous estrogen is produced by conversion of androstenedione, which is secreted by the adrenal cortex, to estrone in the peripheral tissues. Thus, estrone and the sulfate-conjugated form, estrone sulfate, are the most abundant circulating estrogen in postmenopausal women.
Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), through a negative feedback mechanism. Estrogens work to lower postmenopausal women's high levels of these gonadotropins.
Dosage & Administration
Atrophic Vaginitis and Kraurosis Vulvae: Administer cyclic regimen (daily for 21 days followed by 7 days off) intravaginally. Start at 0.5 gm dosage strength; may adjust dosage (0.5 to 2 gm) based on individual response.
Moderate to Severe Dyspareunia: Treats symptoms of vulvar and vaginal atrophy due to menopause 0.5 gm 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.
Step 1: Remove the cap from the tube.
Step 2: Screw the nozzle end of the applicator onto the tube.
Step 3: Gently squeeze the tube from the bottom to force sufficient cream into the barrel to provide the prescribed dose.
Step 4: Unscrew the applicator from the tube.
Step 5: Place the applicator into the vaginal opening.
Step 6: To deliver medication, press the plunger downward.
To cleanse: Pull the plunger to remove it from the barrel. Wash with mild soap and warm water. Do not boil.
Interactions
Concomitant use of anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives, which are known to activate drug-metabolising enzymes, notably cytochrome P450 enzymes, may increase estrogen metabolism (e.g. rifampicin, rifabutin, nevirapine, efavirenz). Despite their reputation as strong inhibitors, ritonavir and nelfinavir have inducing capabilities when combined with steroid hormones.
Contraindication
Severe liver impairment; breast carcinoma; thromboembolic disorders; CV disease; undiagnosed vag bleeding; estrogen-dependent neoplasms; hypersensitivity; pregnancy.
Mode of Action
Estrogens modulate pituitary secretion of gonadotropins, leutinising hormones and follicle-stimulating hormones through -ve feedback mechanism, thus reducing elevated levels of hormones in postmenopausal women during oestrogen replacement therapy.
Pregnancy & Lactation
If pregnancy occurs during medication with Conjugated Oestrogens treatment should be withdrawn immediately. The results of most epidemiological studies to date relevant to inadvertent fetal exposure to estrogens indicate no teratogenic or foetotoxic effects.
Precautions & Warnings
CV disease; cerebrovascular disorders; diabetes, hypercalcemia; gall bladder disease; Asthma, epilepsy, migraine; heart or kidney dysfunction; porphyria. Children. Lactation.
Therapeutic Class
Female Sex hormones
Storage Conditions
Store in a cool (below 30°C) and dry place, protected from light and moisture.
The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.