Product Description.:
WATSON 416
tablet , blue , scored , round round
OGEN (estropipate tablets), (formerly piperazine estrone sulfate), is a natural estrogenic substance prepared from purified crystalline estrone, solubilized as the sulfate and stabilized with piperazine. It is appreciably soluble in water and has almost no odor or taste ? properties which are ideally suited for oral administration. The amount of piperazine in OGEN is not sufficient to exert a pharmacological action. Its addition ensures solubility, stability, and uniform potency of the estrone sulfate. Chemically estropipate, molecular weight: 436.56, is represented by estra-1,3,5(10)-trien-17-one,3-(sulfooxy)-, compound with piperazine (1:1).
OGEN is available as tablets for oral administration containing either 0.75 mg (OGEN .625), 1.5 mg (OGEN 1.25), or 3 mg (OGEN 2.5) estropipate (Calculated as sodium estrone sulfate 0.625 mg, 1.25 mg, and 2.5 mg, respectively).
Inactive Ingredients
Each tablet contains: Colloidal silicon dioxide, dibasic potassium phosphate, hydrogenated vegetable oil wax, hydroxypropyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and tromethamine.
OGEN .625 also contains: D&C Yellow No. 10 and FD&C Yellow No. 6.
OGEN 1.25 also contains: FD&C Yellow No. 6.
OGEN 2.5 also contains: FD&C Blue No. 2.
INDICATIONS
OGEN is indicated in the:
1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
2. Treatment of moderate to severe symptoms of vulval 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. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate.
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400?800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
SIDE EFFECTS
See BOXED WARNINGS, WARNINGS and PRECAUTIONS.
The following additional adverse reactions have been reported with estrogens and/or progestin therapy.
Genitourinary system
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow breakthrough bleeding spotting dysmenorrhea increase in size of uterine leiomyomata vaginitis including vaginal candidiasis change in amount of cervical secretion changes in cervical ectropion ovarian cancer endometrial hyperplasia endometrial cancer.
Breasts
Tenderness, enlargement, pain, nipple discharge, galactorrhea fibrocystic breast changes breast cancer.
Cardiovascular
Deep and superficial venous thrombosis pulmonary embolism thrombophlebitis myocardial infarction stroke increase in blood pressure.
Gastrointestinal
Nausea, vomiting abdominal cramps, bloating cholestatic jaundice increased incidence of gallbladder disease pancreatitis enlargement of hepatic hemangiomas.
Skin
Chloasma or melasma that may persist when drug is discontinued erythema multiforme erythema nodosum hemorrhagic eruption loss of scalp hair hirsutism pruritus, rash.
Eyes
Retinal vascular thrombosis steepening of corneal curvature intolerance to contact lenses.
Central nervous system
Headache, migraine, dizziness mental depression chorea nervousness mood disturbances irritability exacerbation of epilepsy dementia.
Miscellaneous
Increase or decrease in weight reduced carbohydrate tolerance aggravation of porphyria edema arthralgias leg cramps urticaria angioedema anaphylactoid/anaphylactic reactions hypocalcemia exacerbation of asthma changes in libido triglycerides.