Indications

Moderate-to-severe vasomotor symptoms associated with estrogen deficiency. Prevention and management of osteoporosis associated with estrogen deficiency. Atrophic vaginitis and Kraurosis Vulvae. Female hypoestrogenism. Treatment of moderate to severe Dyspa reunia. রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন।

Description

Estracons for vaginal administration is a mixture of estrogens, obtained exclusively from natural sources, blended to represent the average composition of material derived from pregnant mares' urine. It contains the sodium salts of water-soluble sulfate esters of estrone, equil in, and 17 alpha-dihydroequilin, together with smaller amounts of 17 alpha-estradiol, equilenin, 17 alpha-dihydroequilenin, 17 beta-dih ydroequilin, 17 beta-dihydroequilenin, 17 beta-estradiol, and delta 8,9-dehydroestrone.

Pharmacology

Estrogens are important in the development and maintenance of the female urogenital system and secondary sex characteristics. They promote growth and development of the vagina, uterus, and fallopian tubes, and enlargement of the breasts. Indirectly, they contribute to the shaping of the skeleton, maintenance of tone and elasticity of urogenital structures, changes in the epiphyses of the long bones associated with the pubertal growth spurt and its termination, growth of axillary and pubic hair, and pigmentation of the nipples and genital tissues. However, in the preovulatory or anovulatory cycle, estrogen is the primary determinant in the onset menstruation. E strogen also affects the release of pituitary gonadotropins. The pharmacologic effects of conjugated estrogens are similar to those of endogenous estrogens. In responsive tissues, estrogens enter the cell and are transported into the nucleus. As a result of estrogenic activity, specific RNA and protein synthesis occurs. Osteoporosis associated with estrogen deficiency: Estrogen replacement therapy is the most effective single modality for the prevention of osteoporosi s in postmenopausal women. Estrogen reduces bone resorption and retards or halts postmenopausal bone loss. Atrophic vaginitis and Kraurosis Vulvae: In the absence of estrogen stimulation, the vulvar and vaginal tissues shrink, the vaginal walls become thin and dry, and rugal folds disappear. Female Hypoestrogenism: Estrogen replacement therapy is indicated in hypoestrogenism related to female hypogonadism or primary ovarian failure.

Dosage

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 and may adjust dosage from 0.5 to 2 gm based on individual response. Moderate to Severe Dyspareunia: Treats symptom of vulvar and vaginal atrophy due to menopause 0.5 gm intravaginally in a twice-weekly continuously or in a cyclic regimen of daily administration for 21 days followed by 7 days off. রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন।

Administration

Step 1: Remove cap from tube. Step 2: Screw nozzle end of applicator onto tube. Step 3: Gently squeeze tube from the bottom to force sufficient cream into the barrel to provide the prescribed dose. Step 4: Unsc rew applicator from tube. Step 5: Place the applicator into the vaginal opening. Step 6: To deliver medicati on, press plunger downward. To cleanse: Pull plunger to remove it from barrel. Wash with mild soap and warm water. Do not boil. রেজিস্টার্ড চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন।

Interaction

Rifampin reportedly decreases estrogenic activity during concomitant use with estrogen. This effect has been attributed to enhanced metabolism of estrogen, presumably by induction of hepatic microsomal enzymes.

Contraindications

Known or suspected cancer of the breast. Known or suspected estrogen-dependent neoplasia. Known or suspected pregnancy. Undiagnosed abnormal genital bleeding. Active thrombophlebitis or thromboembolic disorders. Hypersensitivity to any of the components of Conjugated Estrogen vaginal cream.

Side Effects

Genitourinary System: Breakthrough bleeding, spotting, change in menstrual flow, amenorrhea. Breasts: Tenderness, enlargement, secretion. Gastrointestinal: Nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice . Skin: Chloasma or melasma which may persist when drug is discontinued, alopecia, rash. Eyes: Steepening of the corneal curvature, intolerance to contact lenses. Central Nervous System: Headache, migraine, dizziness, chorea. Miscellaneous: Increase or decrease in weight, edema, changes in libido, aggravation of porphyria. Common side effects include Headache, Breast pain, Irregular vaginal bleeding or spotting, stomach or abdominal cramps, bloating, Nausea and vomiting, Hair loss, Fluid retention, Vaginal yeast infection, Reactions from inserting Estracon Vaginal Cream such as vaginal burning, irritation and itching. Uncommon side effects include Heart attack, Stroke, Blood clots, Dementia, Breast cancer, Cancer of the lining of the uterus, Cancer of the ovary, High blood pressure, High blood sugar, Gallbladder disease, Enlargement of benign tumors of the uterus, Severe allergic reaction.

Pregnancy and Lactation

Estrogen should not be used during pregnancy. Estrogen therapy during pregnancy is associated with an increased risk of congenital defects in the reproductive organs of the male and female fetus, an increased risk of vaginal adenosis, squamous cell dysplasia of the cervix, and vaginal cancer in the female later in life. There is no indication for estrogen therapy during pregnanc y. As a general principle, the administration of any drug to nursing mothers should be done only when clearly necessary since many drugs are excreted in human milk.

Precautions and Warnings

Estrogen therapy without the addition of a progestogen in women with a uterus has been reported to increase the risk of endometrial hyperplasia or carcinoma. The risk appears to depend on both duration of treatment and estrogen dose. The patient should be reassessed at least on an annual basis. An increased risk of gallbladder disease in women receiving postmenopausal estrogen has been reported. A complete medical and family history should be obtained prior to the initiation of any estrogen therapy. Estrogen may be poorly metabolized in patients with impaired liver function and they should be administered with caution in such patients.

Overdose Effects

Overdosage of estrogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of Estracon therapy with institution of appropriate symptomatic care.

Therapeutic Class

Female Sex hormones.

Storage Conditions

Store in a cool below 30°C and dry place, protected from light and moisture.