Lopreeza
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Limitation of Use
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.
Limitation of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.
History
There is currently no drug history available for this drug.
Other Information
Lopreeza 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), copovidone, talc, magnesium stearate, hypromellose and triacetin.
Lopreeza0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), hydroxypropylcellulose, talc, magnesium stearate, hypromellose and triacetin.
Estradiol (E2), an estrogen, is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17β-diol hemihydrate with the empirical formula of C18H24O2,½ H2O and a molecular weight of 281.4. The structural formula of E2 is as follows:
Estradiol
Norethindrone acetate (NETA), a progestin, is a white or yellowish-white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α -pregn-4-en-20-yn-3-one with the empirical formula of C22H28O3 and molecular weight of 340.5. The structural formula of NETA is as follows:
Norethindrone Acetate
Sources
Lopreeza Manufacturers
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Amneal Pharmaceuticals Of New York, Llc
![Lopreeza (Estradiol/norethindrone Acetate) Tablet, Film Coated [Amneal Pharmaceuticals Of New York, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Lopreeza | Amneal Pharmaceuticals Of New York, Llc
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. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to MenopauseLopreeza therapy consists of a single tablet to be taken once daily for the treatment of moderate to severe vasomotor symptoms due to menopause.
Lopreeza 1 mg/0.5 mg Lopreeza 0.5 mg/0.1 mg 2.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to MenopauseLopreeza therapy consists of a single tablet to be taken once daily for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
Lopreeza 1 mg/0.5 mg 2.3 Prevention of Postmenopausal OsteoporosisLopreeza therapy consists of a single tablet to be taken once daily for the prevention of postmenopausal osteoporosis.
Lopreeza 1 mg/0.5 mg Lopreeza 0.5 mg/0.1 mg
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