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ELESTRIN
Overview
What is ELESTRIN?
ELESTRIN (estradiol gel) contains 0.06% of estradiol, an estrogen, in a colorless, non-staining hydroalcoholic gel base. One pump actuation delivers ELESTRIN in a unit dose of 0.52 mg of estradiol in 0.87 g of gel. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17-diol, (17β)-. It has a molecular formula of CHO•½HO and molecular weight of 281.4.
The structural formula is:
The active component of ELESTRIN is estradiol. The remaining components of the gel (ethanol, propylene glycol, diethylene glycol monoethyl ether, carbomer homopolymer type C, triethanolamine, edetate disodium, and purified water) are pharmacologically inactive.
What does ELESTRIN look like?
What are the available doses of ELESTRIN?
Elestrin 0.06% is available in a metered dose pump which delivers 0.52 mg of estradiol in 0.87 g of gel per pump actuation
What should I talk to my health care provider before I take ELESTRIN?
How should I use ELESTRIN?
ELESTRIN is an estrogen indicated for:
Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer.
A woman without a uterus does not need progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [].
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.
The gel is applied onto the skin in a thin layer. The recommended area of application is the upper arm to shoulder (approximately 320 cm).
What interacts with ELESTRIN?
Sorry No Records found
What are the warnings of ELESTRIN?
Sorry No Records found
What are the precautions of ELESTRIN?
Sorry No Records found
What are the side effects of ELESTRIN?
Sorry No records found
What should I look out for while using ELESTRIN?
ELESTRIN should not be used in women with any of the following conditions:
What might happen if I take too much ELESTRIN?
Overdosage of estrogen 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 ELESTRIN therapy with institution of appropriate symptomatic care.
How should I store and handle ELESTRIN?
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin.The 1 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-971-01bottles of 100 capsulesNDC 60429-971-10bottles of 1000 capsulesThe 2 mg capsule is a hard-shell gelatin capsule with a brown opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-972-01bottles of 100 capsulesNDC 60429-972-10bottles of 1000 capsulesThe 5 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-973-01bottles of 100 capsulesNDC 60429-973-25bottles of 250 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and light.Dispense in a tight, light-resistant container as defined by the USP using a child-resistant closure.Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin.The 1 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-971-01bottles of 100 capsulesNDC 60429-971-10bottles of 1000 capsulesThe 2 mg capsule is a hard-shell gelatin capsule with a brown opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-972-01bottles of 100 capsulesNDC 60429-972-10bottles of 1000 capsulesThe 5 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-973-01bottles of 100 capsulesNDC 60429-973-25bottles of 250 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and light.Dispense in a tight, light-resistant container as defined by the USP using a child-resistant closure.Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin.The 1 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-971-01bottles of 100 capsulesNDC 60429-971-10bottles of 1000 capsulesThe 2 mg capsule is a hard-shell gelatin capsule with a brown opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-972-01bottles of 100 capsulesNDC 60429-972-10bottles of 1000 capsulesThe 5 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-973-01bottles of 100 capsulesNDC 60429-973-25bottles of 250 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and light.Dispense in a tight, light-resistant container as defined by the USP using a child-resistant closure.Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin.The 1 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-971-01bottles of 100 capsulesNDC 60429-971-10bottles of 1000 capsulesThe 2 mg capsule is a hard-shell gelatin capsule with a brown opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-972-01bottles of 100 capsulesNDC 60429-972-10bottles of 1000 capsulesThe 5 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-973-01bottles of 100 capsulesNDC 60429-973-25bottles of 250 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and light.Dispense in a tight, light-resistant container as defined by the USP using a child-resistant closure.Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin.The 1 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-971-01bottles of 100 capsulesNDC 60429-971-10bottles of 1000 capsulesThe 2 mg capsule is a hard-shell gelatin capsule with a brown opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-972-01bottles of 100 capsulesNDC 60429-972-10bottles of 1000 capsulesThe 5 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-973-01bottles of 100 capsulesNDC 60429-973-25bottles of 250 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and light.Dispense in a tight, light-resistant container as defined by the USP using a child-resistant closure.Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin.The 1 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-971-01bottles of 100 capsulesNDC 60429-971-10bottles of 1000 capsulesThe 2 mg capsule is a hard-shell gelatin capsule with a brown opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-972-01bottles of 100 capsulesNDC 60429-972-10bottles of 1000 capsulesThe 5 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-973-01bottles of 100 capsulesNDC 60429-973-25bottles of 250 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and light.Dispense in a tight, light-resistant container as defined by the USP using a child-resistant closure.Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin.The 1 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-971-01bottles of 100 capsulesNDC 60429-971-10bottles of 1000 capsulesThe 2 mg capsule is a hard-shell gelatin capsule with a brown opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-972-01bottles of 100 capsulesNDC 60429-972-10bottles of 1000 capsulesThe 5 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-973-01bottles of 100 capsulesNDC 60429-973-25bottles of 250 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and light.Dispense in a tight, light-resistant container as defined by the USP using a child-resistant closure.Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin.The 1 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-971-01bottles of 100 capsulesNDC 60429-971-10bottles of 1000 capsulesThe 2 mg capsule is a hard-shell gelatin capsule with a brown opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-972-01bottles of 100 capsulesNDC 60429-972-10bottles of 1000 capsulesThe 5 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-973-01bottles of 100 capsulesNDC 60429-973-25bottles of 250 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and light.Dispense in a tight, light-resistant container as defined by the USP using a child-resistant closure.Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin.The 1 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-971-01bottles of 100 capsulesNDC 60429-971-10bottles of 1000 capsulesThe 2 mg capsule is a hard-shell gelatin capsule with a brown opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-972-01bottles of 100 capsulesNDC 60429-972-10bottles of 1000 capsulesThe 5 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-973-01bottles of 100 capsulesNDC 60429-973-25bottles of 250 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and light.Dispense in a tight, light-resistant container as defined by the USP using a child-resistant closure.Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin.The 1 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-971-01bottles of 100 capsulesNDC 60429-971-10bottles of 1000 capsulesThe 2 mg capsule is a hard-shell gelatin capsule with a brown opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-972-01bottles of 100 capsulesNDC 60429-972-10bottles of 1000 capsulesThe 5 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-973-01bottles of 100 capsulesNDC 60429-973-25bottles of 250 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and light.Dispense in a tight, light-resistant container as defined by the USP using a child-resistant closure.Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin.The 1 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-971-01bottles of 100 capsulesNDC 60429-971-10bottles of 1000 capsulesThe 2 mg capsule is a hard-shell gelatin capsule with a brown opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-972-01bottles of 100 capsulesNDC 60429-972-10bottles of 1000 capsulesThe 5 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-973-01bottles of 100 capsulesNDC 60429-973-25bottles of 250 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and light.Dispense in a tight, light-resistant container as defined by the USP using a child-resistant closure.Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin.The 1 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-971-01bottles of 100 capsulesNDC 60429-971-10bottles of 1000 capsulesThe 2 mg capsule is a hard-shell gelatin capsule with a brown opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-972-01bottles of 100 capsulesNDC 60429-972-10bottles of 1000 capsulesThe 5 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-973-01bottles of 100 capsulesNDC 60429-973-25bottles of 250 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and light.Dispense in a tight, light-resistant container as defined by the USP using a child-resistant closure.Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin.The 1 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-971-01bottles of 100 capsulesNDC 60429-971-10bottles of 1000 capsulesThe 2 mg capsule is a hard-shell gelatin capsule with a brown opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-972-01bottles of 100 capsulesNDC 60429-972-10bottles of 1000 capsulesThe 5 mg capsule is a hard-shell gelatin capsule with a light blue opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with over in white ink on both the cap and body. They are available as follows:NDC 60429-973-01bottles of 100 capsulesNDC 60429-973-25bottles of 250 capsulesStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and light.Dispense in a tight, light-resistant container as defined by the USP using a child-resistant closure.
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.
Non-Clinical Toxicology
ELESTRIN should not be used in women with any of the following conditions:Prazosin hydrochloride capsules have been administered without any adverse drug interaction in limited clinical experience to date with the following: (1) cardiac glycosides-digitalis and digoxin; (2) hypoglycemics-insulin, chlorpropamide, phenformin, tolazamide, and tolbutamide; (3) tranquilizers and sedatives-chlordiazepoxide, diazepam, and phenobarbital; (4) antigout-allopurinol, colchicine, and probenecid; (5) antiarrhythmics-procainamide, propranolol (see however), and quinidine; and (6) analgesics, antipyretics and anti-inflammatories-propoxyphene, aspirin, indomethacin, and phenylbutazone.
Addition of a diuretic or other antihypertensive agent to prazosin hydrochloride capsules have been shown to cause an additive hypotensive effect. This effect can be minimized by reducing the prazosin hydrochloride capsules dose to 1 mg to 2 mg three times a day, by introducing additional antihypertensive drugs cautiously, and then by retitrating prazosin hydrochloride capsules based on clinical response.
Concomitant administration of prazosin hydrochloride capsules with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension (see ).
An increased risk of stroke and DVT has been reported with estrogen-alone therapy.
An increased risk of PE, DVT, stroke and MI has been reported with estrogen plus progestin 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-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).
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.
Coronary Heart Disease
In the WHI estrogen-alone substudy, no overall effect on coronary heart disease (CHD) events (defined as nonfatal MI, silent MI and CHD death) 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 the WHI estrogen plus progestin substudy, there was a statistically non-significant increased risk of CHD events 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 postmenopausal women with documented heart disease (n = 2,763, average age 66.7 years), 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 coronary heart disease. 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-alone substudy, the risk of VTE (DVT and PE) 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.
In the WHI estrogen plus progestin substudy, a statistically significant 2-fold greater rate of VTE 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.
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/"
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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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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).