Activella

ESTRADIOL/NORETHINDRONE ACETATE

Manufacturer: Amneal Pharmaceuticals LLC

Score: 148.0

Quick Summary

Lopreeza is an estrogen and progestin combination used for the treatment of moderate to severe vasomotor symptoms due to menopause, the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, and the prevention of postmenopausal osteoporosis in women with a uterus. The therapy consists of a single tablet taken once daily. However, it is contraindicated in women with certain conditions such as undiagnosed abnormal genital bleeding, known or suspected breast cancer, and active arterial thromboembolic disease. Common adverse reactions include back pain, headache, and breast pain. The medication should not be used during pregnancy or lactation, and its use in pediatric and geriatric populations requires careful consideration.

Key Clinical Findings and Indications

Treatment of moderate to severe vasomotor symptoms due to menopause
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause
Prevention of postmenopausal osteoporosis

Important Safety Information

Warning

Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia

Contraindications

Undiagnosed abnormal genital bleeding
Known, suspected, or history of breast cancer
Known, past or suspected estrogen-dependent neoplasia
Active DVT, PE, or history of these conditions
Active arterial thromboembolic disease
Known anaphylactic reaction or angioedema or hypersensitivity to Lopreeza
Known liver impairment or disease
Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders
Known or suspected pregnancy

Adverse Reactions

Back pain
Headache
Pain in extremity
Nausea
Diarrhea
Gastroenteritis
Insomnia
Emotional lability
Upper respiratory tract infection
Sinusitis
Nasopharyngitis
Weight increase
Breast pain
Post-menopausal bleeding
Uterine fibroid vaginal hemorrhage
Ovarian cyst
Endometrial thickening
Viral infection
Moniliasis genital
Accidental injury

Dosing Recommendations

General Guidance

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

Moderate to severe vasomotor symptoms due to menopause

Adult Dose

One Lopreeza 1 mg/0.5 mg tablet or one Lopreeza 0.5 mg/0.1 mg tablet once daily

Pediatric Dose

Not recommended

Moderate to severe symptoms of vulvar and vaginal atrophy due to menopause

Adult Dose

One Lopreeza 1 mg/0.5 mg tablet once daily

Pediatric Dose

Not recommended

Prevention of postmenopausal osteoporosis

Adult Dose

One Lopreeza 1 mg/0.5 mg tablet or one Lopreeza 0.5 mg/0.1 mg tablet once daily

Pediatric Dose

Not recommended

Special Population Considerations

Pregnancy

Lopreeza should not be used during pregnancy

Nursing Mothers

Lopreeza should not be used during lactation
Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk

Pediatric Use

Lopreeza is not indicated in children
Clinical studies have not been conducted in the pediatric population

Geriatric Use

There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Lopreeza to determine whether those over 65 years of age differ from younger subjects in their response to Lopreeza
The Women’s Health Initiative Studies reported increased risks of nonfatal stroke and invasive breast cancer in women greater than 65 years of age

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