Progynova 2 mg Tablet

Estradiol Valerate Injection is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).

• When estrogen is prescribed for a postmenopausal woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer
• A woman without a uterus does not need progestin
• Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman
• Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary [see BOXED WARNINGS and WARNINGS ]
• For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding
• Care should be taken to inject deeply into the upper, outer quadrant of the gluteal muscle following the usual precautions for intramuscular administration
• By virtue of the low viscosity of the vehicles, the various preparations of Estradiol Valerate Injection may be administered with a small gauge needle (i.e., 20 Gauge x 1 1/2 inches long)
• Since the 40 mg potency provides a high concentration in a small volume, particular care should be observed to administer the full dose
• Estradiol Valerate Injection should be visually inspected for particulate matter and color prior to administration; the solution is clear, colorless to yellow
• Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on warming. …

• Pediatric Use Safety and effectiveness
• In pediatric patients have not been established
• Large and repeated doses of estrogen over an extended period of time may accelerate epiphyseal closure
• Therefore, periodic monitoring of bone maturation and effects on epiphyseal centers is recommended in patients in whom bone growth is not complete

I. Geriatric Use Clinical studies of estradiol valerate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In the Women's Health Initiative Memory Study, including 4,532 women 65 years of age and older, followed for an average of 4 years, 82% (n = 3,729) were 65 to 74 while 18% (n = 803) were 75 and over. Most women (80%) had no prior hormone therapy use. …

B. Patient Information Physicians are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe Estradiol Valerate Injection.

• Estradiol Valerate Injection should not be used in women with any of the following conditions: 1
• Undiagnosed abnormal genital bleeding. 2
• Known, suspected, or history of cancer of the breast. 3
• Known or suspected estrogen-dependent neoplasia. 4
• Active deep vein thrombosis, pulmonary embolism or a history of these conditions. 5
• Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). 6
• Liver dysfunction or disease. 7. …

See BOXED WARNINGS. The use of unopposed estrogens in women who have a uterus is associated with an increased risk of endometrial cancer. 1. Cardiovascular disorders Estrogen and estrogen/progestin therapy has been associated with an increased risk of cardiovascular events such as myocardial infarction and stroke, as well as venous thrombosis and pulmonary embolism (venous thromboembolism or VTE). Should any of these occur or be suspected, estrogens should be discontinued immediately. …

See BOXED WARNINGS, WARNINGS , and PRECAUTIONS . Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. The following additional adverse reactions have been reported with estrogen and/or progestin therapy. 1. …

F. Pregnancy Estradiol Valerate Injection should not be used during pregnancy [see CONTRAINDICATIONS ].

Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing drug products by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.

STORAGE Store at 20° to 25°C (68° to 77°F) [see Controlled USP Room Temperature]. Keep out of reach of children. PROTECT FROM LIGHT. Store vial in carton until used.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.