Estracon Vaginal Cream 0.625 mg/gm

Estracon Vaginal Cream 0.625 mg/gm Uses, Dosage, Side Effects, Food Interaction and all others data.

Trade Name Estracon Vaginal Cream 0.625 mg/gm
Generic Conjugated Estrogen (Cream)
Weight 0.625 mg/gm
Type Vaginal Cream
Therapeutic Class Female Sex hormones
Manufacturer Renata Limited
Available Country Bangladesh
Last Updated: October 19, 2023 at 6:27 am
Estracon Vaginal Cream 0.625 mg/gm
Estracon Vaginal Cream 0.625 mg/gm

Uses

Conjugated Estrogen cream is indicated in the following 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 Dyspareunia.

Dosage

Estracon Vaginal Cream 0.625 mg/gm 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; may adjust dosage (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 (eg, Monday and Thursday) continuously or in a cyclic regimen of daily administration for 21 days followed by 7 days off. 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: Unscrew applicator from tube.Step 5: Place the applicator into the vaginal opening.Step 6: To deliver medication, press plunger downward. To cleanse: Pull plunger to remove it from barrel. Wash with mild soap and warm water. Do not boil.

Side Effects

The most serious adverse reactions associated with the use of estrogen are indicated under Warnings and Precautions. The following additional adverse reactions have been reported with estrogenic therapy. 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 Conjugated Estrogen Vaginal Cream, such as vaginal burning, irritation and itching.Uncommon side Effects Heart attack, Stroke, Blood clots, Dementia, Breast cancer, Cancer of the lining of the uterus (womb), Cancer of the ovary, High blood pressure, High blood sugar, Gallbladder disease, Enlargement of benign tumors of the uterus(fibroids), Severe allergic reaction.

Precaution

Estrogen therapy without the addition of a progestogen in women with a uterus has been reported to increase the risk of endometrial hyperplasia/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. Studies have indicated a reduced risk of endometrial cancer when a progestogen is administered with estrogen replacement therapy. There are possible additional risks which may be associated with the inclusion of a progestogen in hormone replacement therapy regimens. These include adverse effects on carbohydrate and lipid metabolism. An increased risk of gallbladder disease in women receiving postmenopausal estrogen has been reported. Some studies have suggested a possible increased incidence of breast cancer in those women on estrogen therapy taking higher doses for prolonged periods of time. Women on this therapy should have regular breast examinations and should be instructed in breast self-examination. Doses of Conjugated Estrogen used should not exceed the recommended doses.A complete medical and family history should be obtained prior to the initiation of any estrogen therapy. The pretreatment and periodic physical examinations should include special reference to blood pressure, breasts, abdomen, and pelvic organs, and should include a Papanicolaou smear. Where no pathologic cause is found for abnormal vaginal bleeding, dose reduction of cycling may be indicated. Women on estrogen replacement therapy have not been reported to have an increased risk of thrombophlebitis and/or thromboembolic disease. However, there is insufficient information regarding women who have a history of thromboembolic disease to determine risk. Estrogen may be poorly metabolized in patients with impaired liver function and they should be administered with caution in such patients.

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.

Pregnancy & Breastfeeding use

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 pregnancy. Estrogens are effective in the prevention or treatment of threatened or habitual abortion.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.

Contraindication

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.

Acute Overdose

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 Conjugated Estrogen therapy with institution of appropriate symptomatic care.

Storage Condition

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

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