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estradiol and norethindrone acetate
Overview
What is AMABELZ?
What does AMABELZ look like?
What are the available doses of AMABELZ?
Amabelz tablets are available in two strengths:
• Each tablet of Amabelz 1 mg/ 0.5 mg contains 1 mg of estradiol and 0.5 mg of norethindrone acetate. The tablets are white to off-white, round shaped film-coated tablet debossed with "M54" on one side and "LU" on other side.
• Each tablet of Amabelz 0.5 mg/ 0.1 mg contains 0.5 mg of estradiol and 0.1 mg of norethindrone acetate. The tablets are white to off-white, round shaped film-coated tablet debossed with "M53" on one side and "LU" on other side.
What should I talk to my health care provider before I take AMABELZ?
• Nursing Mothers: Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk ()
• Geriatric Use: An increase risk of probable dementia in women over 65 years of age was reported in the Women's Health Initiative Memory ancillary studies of the Women's Health Initiative (, )
How should I use AMABELZ?
Amabelz is an estrogen and progestin combination indicated in a woman with a uterus for:
Amabelz 1 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in a woman with a uterus for:
• Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ()
• Prevention of Postmenopausal Osteoporosis ()
Amabelz 1 mg/0.5 mg is also indicated in a woman with a uterus for:
• Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause ()
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.
What interacts with AMABELZ?
Sorry No Records found
What are the warnings of AMABELZ?
Sorry No Records found
What are the precautions of AMABELZ?
Sorry No Records found
What are the side effects of AMABELZ?
Sorry No records found
What should I look out for while using AMABELZ?
• Undiagnosed abnormal genital bleeding ()
• Known, suspected, or history of breast cancer (, )
• Known or suspected estrogen-dependent neoplasia (, )
• Active DVT, PE, or history of these conditions (, )
• Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (, )
• Known anaphylactic reaction or angioedema or hypersensitivity to Amabelz ()
• Known liver impairment or disease (, )
• Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders ()
• Known or suspected pregnancy (, )
What is the most important information I should know about Amabelz (a combination of estrogen and progestin)?
• Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
• Taking estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
• Taking estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
• Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia.
• Taking estrogen-alone may increase your chance of getting cancer of the uterus (womb).
• Taking estrogen-alone may increase your chances of getting strokes or blood clots.
• Taking estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
• You and your healthcare provider should talk regularly about whether you still need treatment with Amabelz.
What might happen if I take too much AMABELZ?
How should I store and handle AMABELZ?
Store in a dry place protected from light. Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]Lisinopril Tablets, USP, for oral administration, are available as5 mgPink, oval, biconvex, uncoated tablets debossed “54” on one side and bisected on the other side and supplied as:NDC 0185-5400-01 bottles of 100NDC 0185-5400-10 bottles of 1000NDC single dose pack with 1 tablet as by Avera McKennan HospitalStorageStore at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.Lisinopril Tablets, USP, for oral administration, are available as5 mgPink, oval, biconvex, uncoated tablets debossed “54” on one side and bisected on the other side and supplied as:NDC 0185-5400-01 bottles of 100NDC 0185-5400-10 bottles of 1000NDC single dose pack with 1 tablet as by Avera McKennan HospitalStorageStore at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.Lisinopril Tablets, USP, for oral administration, are available as5 mgPink, oval, biconvex, uncoated tablets debossed “54” on one side and bisected on the other side and supplied as:NDC 0185-5400-01 bottles of 100NDC 0185-5400-10 bottles of 1000NDC single dose pack with 1 tablet as by Avera McKennan HospitalStorageStore at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.Lisinopril Tablets, USP, for oral administration, are available as5 mgPink, oval, biconvex, uncoated tablets debossed “54” on one side and bisected on the other side and supplied as:NDC 0185-5400-01 bottles of 100NDC 0185-5400-10 bottles of 1000NDC single dose pack with 1 tablet as by Avera McKennan HospitalStorageStore at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.Lisinopril Tablets, USP, for oral administration, are available as5 mgPink, oval, biconvex, uncoated tablets debossed “54” on one side and bisected on the other side and supplied as:NDC 0185-5400-01 bottles of 100NDC 0185-5400-10 bottles of 1000NDC single dose pack with 1 tablet as by Avera McKennan HospitalStorageStore at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.Lisinopril Tablets, USP, for oral administration, are available as5 mgPink, oval, biconvex, uncoated tablets debossed “54” on one side and bisected on the other side and supplied as:NDC 0185-5400-01 bottles of 100NDC 0185-5400-10 bottles of 1000NDC single dose pack with 1 tablet as by Avera McKennan HospitalStorageStore at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.Lisinopril Tablets, USP, for oral administration, are available as5 mgPink, oval, biconvex, uncoated tablets debossed “54” on one side and bisected on the other side and supplied as:NDC 0185-5400-01 bottles of 100NDC 0185-5400-10 bottles of 1000NDC single dose pack with 1 tablet as by Avera McKennan HospitalStorageStore at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.Lisinopril Tablets, USP, for oral administration, are available as5 mgPink, oval, biconvex, uncoated tablets debossed “54” on one side and bisected on the other side and supplied as:NDC 0185-5400-01 bottles of 100NDC 0185-5400-10 bottles of 1000NDC single dose pack with 1 tablet as by Avera McKennan HospitalStorageStore at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level.
The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle. After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone in the peripheral tissues. Thus, estrone and the sulfate-conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women.
Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue.
Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH), and FSH through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.
Progestin compounds enhance cellular differentiation and generally oppose the actions of estrogens by decreasing estrogen receptor levels, increasing local metabolism of estrogens to less active metabolites, or inducing gene products that blunt cellular responses to estrogen. Progestins exert their effects in target cells by binding to specific progesterone receptors that interact with progesterone response elements in target genes. Progesterone receptors have been identified in the female reproductive tract, breast, pituitary, hypothalamus, and central nervous system.
Non-Clinical Toxicology
• Undiagnosed abnormal genital bleeding ()• Known, suspected, or history of breast cancer (, )
• Known or suspected estrogen-dependent neoplasia (, )
• Active DVT, PE, or history of these conditions (, )
• Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (, )
• Known anaphylactic reaction or angioedema or hypersensitivity to Amabelz ()
• Known liver impairment or disease (, )
• Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders ()
• Known or suspected pregnancy (, )
What is the most important information I should know about Amabelz (a combination of estrogen and progestin)?
• Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
• Taking estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
• Taking estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
• Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia.
• Taking estrogen-alone may increase your chance of getting cancer of the uterus (womb).
• Taking estrogen-alone may increase your chances of getting strokes or blood clots.
• Taking estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
• You and your healthcare provider should talk regularly about whether you still need treatment with Amabelz.
An increased risk of PE, DVT, stroke and MI has been reported with estrogen plus progestin therapy. An increased risk of stroke and DVT has been reported with estrogen-alone therapy. Should any of these occur or be suspected, estrogen with or without progestin therapy should be discontinued immediately.
Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.
Stroke
In the WHI estrogen plus progestin substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women in the same age group receiving placebo (33 versus 25 per 10,000 women-years) The increase in risk was demonstrated after the first year and persisted.Should a stroke occur or be suspected, estrogen plus progestin therapy should be discontinued immediately.
In the WHI estrogen-alone substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving daily CE (0.625 mg)-alone compared to women in the same age group receiving placebo (45 versus 33 per 10,000 women-years). The increase in risk was demonstrated in year 1 and persisted Should a stroke occur or be suspected, estrogen-alone therapy should be discontinued immediately.
Subgroup analyses of women 50 to 59 years of age suggest no increased risk of stroke for those women receiving CE (0.625 mg)-alone versus those receiving placebo (18 versus 21 per 10,000 women-years).
Coronary Heart Disease
In the WHI estrogen plus progestin substudy, there was a statistically non-significant increase risk of coronary heart disease (CHD) events (defined as nonfatal MI, silent MI, or CHD death) reported in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (41 versus 34 per 10,000 women-years) An increase in relative risk was demonstrated in year 1, and a trend toward decreasing relative risk was reported in years 2 through 5
In the WHI estrogen-alone substudy, no overall effect on CHD events was reported in women receiving estrogen-alone compared to placebo
Subgroup analyses of women 50 to 59 years of age suggest a statistically non-significant reduction in CHD events (CE [0.625 mg]-alone compared to placebo) in women with less than 10 years since menopause (8 versus 16 per 10,000 women-years).
In postmenopausal women with documented heart disease (n=2,763), average 66.7 years of age, in a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/Progestin Replacement Study [HERS]), treatment with daily CE (0.625 mg plus MPA (2.5 mg) demonstrated no cardiovascular benefit. During an average follow-up of 4.1 years, treatment with CE plus MPA did not reduce the overall rate of CHD events in postmenopausal women with established CHD. There were more CHD events in the CE plus MPA- treated group than in the placebo group in year 1, but not during the subsequent years. Two thousand, three hundred and twenty-one (2,321) women from the original HERS trial agreed to participate in an open label extension of HERS, HERS II. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall. Rates of CHD events were comparable among women in the CE plus MPA group and the placebo group in HERS, HERS II, and overall.
Venous Thromboembolism
In the WHI estrogen plus progestin substudy, a statistically significant 2-fold greater rate of VTE (DVT and PE), was reported in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (35 versus 17 per 10,000 women-years). Statistically significant increases in risk for both DVT (26 versus 13 per 10,000 women-years) and PE (18 versus 8 per 10,000 women-years) were also demonstrated. The increase in VTE risk was demonstrated during the first year and persisted Should a VTE occur or be suspected, estrogen plus progestin therapy should be discontinued immediately.
In the WHI estrogen-alone substudy, the risk of VTE was increased for women receiving daily CE (0.625 mg)-alone compared to placebo (30 versus 22 per 10,000 women-years), although only the increased risk of DVT reached statistical significance (23 versus 15 per 10,000 women-years). The increase in VTE risk was demonstrated during the first 2 years Should a VTE occur or be suspected, estrogen-alone therapy should be discontinued immediately.
If feasible, estrogens should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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