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Mimvey
Overview
What is Mimvey?
Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol, USP and 0.5 mg of norethindrone acetate, USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, and titanium dioxide.
Mimvey Lo (estradiol and norethindrone acetate tablets USP) 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol, USP and 0.1 mg of norethindrone acetate, USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, corn starch, lactose monohydrate, and magnesium stearate.
Estradiol (E), is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17β-diol hemihydrate. The structural formula of E is as follows:
Estradiol, USP
Norethindrone acetate (NETA), is a white or yellowish-white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α-pregn-4-en-20-yn-3-one. The structural formula of NETA is as follows:
Norethindrone Acetate, USP
What does Mimvey look like?
What are the available doses of Mimvey?
Mimvey tablets are available in two strengths:
What should I talk to my health care provider before I take Mimvey?
How should I use Mimvey?
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 Mimvey?
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What are the warnings of Mimvey?
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What are the precautions of Mimvey?
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What are the side effects of Mimvey?
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What should I look out for while using Mimvey?
Mimvey and Mimvey Lo are contraindicated in women with any of the following conditions:
What might happen if I take too much Mimvey?
Overdosage of estrogen plus progestin may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of Mimvey and Mimvey Lo therapy with institution of appropriate symptomatic care.
How should I store and handle Mimvey?
Store in a dry place protected from light.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Store in a dry place protected from light.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].HALDOL (haloperidol) Decanoate 50 for IM injection, 50 mg haloperidol as 70.52 mg per mL haloperidol decanoate:NDC 50458-253-03 3 × 1 mL ampules.HALDOL (haloperidol) Decanoate 100 for IM injection, 100 mg haloperidol as 141.04 mg per mL haloperidol decanoate:NDC 50458-254-14, 5 × 1 mL ampules.HALDOL (haloperidol) Decanoate 50 for IM injection, 50 mg haloperidol as 70.52 mg per mL haloperidol decanoate:NDC 50458-253-03 3 × 1 mL ampules.HALDOL (haloperidol) Decanoate 100 for IM injection, 100 mg haloperidol as 141.04 mg per mL haloperidol decanoate:NDC 50458-254-14, 5 × 1 mL ampules.HALDOL (haloperidol) Decanoate 50 for IM injection, 50 mg haloperidol as 70.52 mg per mL haloperidol decanoate:NDC 50458-253-03 3 × 1 mL ampules.HALDOL (haloperidol) Decanoate 100 for IM injection, 100 mg haloperidol as 141.04 mg per mL haloperidol decanoate:NDC 50458-254-14, 5 × 1 mL ampules.HALDOL (haloperidol) Decanoate 50 for IM injection, 50 mg haloperidol as 70.52 mg per mL haloperidol decanoate:NDC 50458-253-03 3 × 1 mL ampules.HALDOL (haloperidol) Decanoate 100 for IM injection, 100 mg haloperidol as 141.04 mg per mL haloperidol decanoate:NDC 50458-254-14, 5 × 1 mL ampules.
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
Mimvey and Mimvey Lo are contraindicated in women with any of the following conditions:Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). The risks of using haloperidol in combination with other drugs have been evaluated as described below.
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.
The following serious adverse reactions are discussed elsewhere in the labeling:
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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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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