Show Lopreeza Side Effects Center 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 LopreezaLopreeza 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 ChildrenLopreeza 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 BreastfeedingLopreeza 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 InformationOur 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. QUESTIONIf menopause occurs in a woman younger than ___ years, it is considered to be premature. See AnswerLopreeza Consumer Information Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have:
Common side effects may include:
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. SLIDESHOWWhat Is Osteoporosis? Treatment, Symptoms, Medication See SlideshowLopreeza Professional Information SIDE EFFECTSThe following serious adverse reactions are discussed elsewhere in the labeling:
Clinical Trials ExperienceBecause 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
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
Postmarketing ExperienceThe 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 SystemChanges 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. BreastTenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer. CardiovascularDeep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction, stroke; increase in blood pressure. GastrointestinalNausea, vomiting; changes in appetite; cholestatic jaundice; abdominal pain/cramps, flatulence, bloating; increased incidence of gallbladder disease and pancreatitis. SkinChloasma 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. EyesRetinal vascular thrombosis, intolerance to contact lenses. Central Nervous SystemHeadache; migraine; dizziness; mental depression; chorea; insomnia; nervousness; mood disturbances; irritability; exacerbation of epilepsy; dementia. MiscellaneousIncrease 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) © 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. Health Solutions From Our Sponsors
What does norethindrone do to the body?Norethindrone is in a class of medications called progestins. It works by stopping the lining of the uterus from growing and by causing the uterus to produce certain hormones. Norethindrone is also used to prevent pregnancy.
Does estradiol and norethindrone acetate cause weight gain?The most common side effects are typically mild hormonal issues caused by the combination of estrogens and progestins inside the medication. These side effects include: Weight gain. Bloating and weight gain are common on Estrostep and other birth control pills that use norethindrone and ethinyl estradiol.
What are the side effects of norethindrone acetate?What side effects may I notice from receiving this medicine?. breast tenderness or discharge.. pain in the abdomen, chest, groin or leg.. severe headache.. skin rash, itching, or hives.. sudden shortness of breath.. unusually weak or tired.. vision or speech problems.. yellowing of skin or eyes.. What are the long term side effects of taking estradiol?In cases of prolonged use, the risk of the following side effects is also raised:. Ovarian cancer, endometrial cancer, breast cancer.. Endometrial hyperplasia or thickening of the womb lining.. Chest pain.. Deep vein thrombosis.. Pulmonary embolism.. Thrombophlebitis.. Heart attack or myocardial infarction.. Stroke.. |