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Lopreeza

Last reviewed on RxList: 4/15/2020
Lopreeza Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Lopreeza?

Lopreeza (estradiol/norethindrone acetate tablet) is a combination of female hormones used to treat moderate to severe symptoms of vulvar and vaginal atrophy due to menopause and to prevent postmenopausal osteoporosis.

What Are Side Effects of Lopreeza?

Side effects of Lopreeza include:

Dosage for Lopreeza

Lopreeza therapy consists of a single tablet to be taken once daily for the treatment of moderate to severe vasomotor symptoms due to menopause and comes in doses of Lopreeza 1 mg/0.5 mg and Lopreeza 0.5 mg/0.1 mg.

Lopreeza In Children

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

What Drugs, Substances, or Supplements Interact with Lopreeza?

Lopreeza may interact with other medicines such as:

Tell your doctor all medications and supplements you use.

Lopreeza During Pregnancy and Breastfeeding

Lopreeza is not recommended for use during pregnancy. Lopreeza should not be used during while breastfeeding. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogen and progestin have been identified in the breast milk of women receiving estrogen plus progestin therapy.

Additional Information

Our Lopreeza (estradiol/norethindrone acetate tablet), Film Coated Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer
Lopreeza Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Malignant Neoplasms [see BOXED WARNING, WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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.

Adverse reactions reported with Lopreeza 1 mg/0.5 mg by investigators in the Phase 3 studies regardless of causality assessment are shown in Table 1.

TABLE 1: ALL TREATMENT-EMERGENT ADVERSE REACTIONS REGARDLESS OF RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5 PERCENT WITH LOPREEZA 1 MG/0.5 MG

Endometrial Hyperplasia Study (12-Months)Vasomotor Symptoms Study (3-Months)Osteoporosis Study (2-Years)
Lopreeza 1 mg/0.5 mg
(n=295)
1 mg E2
(n=296)
Lopreeza
1 mg/0.5 mg
(n=29)
Placebo
(n=34)
Lopreeza 1 mg/0.5 mg
(n=47)
Placebo
(n=48)
Body as a Whole
Back Pain6%5% 3%3%6%4%
Headache16%16%17%18%11%6%
Digestive System
Nausea3%5%10%0%11%0%
Gastroenteritis2%2%0%0%6%4%
Nervous System
Insomnia6%4%3%3%0%8%
Emotional Lability1%1%0%0%6%0%
Respiratory System
Upper Respiratory Tract Infection18%15%10%6%15%19%
Sinusitis7%11%7%0%15%10%
Metabolic and Nutritional
Weight Increase0%0%0%0%9%6%
Urogenital System
Breast Pain24%10%21%0%17%8%
Post-Menopausal Bleeding5%15%10%3%11%0%
Uterine Fibroid5%4%0%0%4%8%
Ovarian Cyst3%2%7%0%0%8%
Resistance Mechanism
Infection Viral4%6%0%3%6%6%
Moniliasis Genital4%7%0%0%6%0%
Secondary Terms
Injury Accidental4%3%3%0%17%*4%*
Other Events2%3%3%0%6%4%
* including one upper extremity fracture in each group

Adverse reactions reported with Lopreeza 0.5 mg/0.1 mg by investigators during the Phase 3 study regardless of causality assessment are shown in Table 2.

TABLE 2: ALL TREATMENT-EMERGENT ADVERSE REACTIONS REGARDLESS OF RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5 PERCENT WITH LOPREEZA 0.5 MG/0.1 MG

Lopreeza 0.5 mg/0.1 mg
(n=194)
Placebo
(n=200)
Body as a Whole
Back Pain10%4%
Headache22%19%
Pain in extremity5%4%
Digestive System
Nausea5%4%
Diarrhea6%6%
Respiratory System
Nasopharyngitis21%18%
Urogenital System
Endometrial thickening10%4%
Vaginal hemorrhage26%12%

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Lopreeza. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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; pre-menstrual-like syndrome; cystitis-like syndrome; ovarian cancer; endometrial hyperplasia; endometrial cancer.

Breast

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; changes in appetite; cholestatic jaundice; abdominal pain/cramps, flatulence, bloating; increased incidence of gallbladder disease and pancreatitis.

Skin

Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; seborrhea; hirsutism; itching; skin rash; pruritus.

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central Nervous System

Headache; migraine; dizziness; mental depression; chorea; insomnia; nervousness; mood disturbances; irritability; exacerbation of epilepsy; dementia.

Miscellaneous

Increase or decrease in weight; edema; leg cramps; changes in libido; fatigue; exacerbation of asthma; increased triglycerides; hypersensitivity; anaphylactoid/anaphylactic reactions.

Read the entire FDA prescribing information for Lopreeza (Estradiol/Norethindrone Acetate Tablets)

SLIDESHOW

What Is Osteoporosis? Treatment, Symptoms, Medication See Slideshow
Related Resources for Lopreeza

© Lopreeza Patient Information is supplied by Cerner Multum, Inc. and Lopreeza Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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