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estradiol

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Overview

What is ESTRACE?

Each gram of ESTRACE (estradiol vaginal cream, USP, 0.01%) contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and -butylhydroquinone. Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17(beta)-diol. It has an empirical formula of CHOand molecular weight of 272.37. The structural formula is:



What does ESTRACE look like?



What are the available doses of ESTRACE?

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What should I talk to my health care provider before I take ESTRACE?

Sorry No records found

How should I use ESTRACE?

ESTRACE (estradiol vaginal cream, USP, 0.01%) is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

Use of ESTRACE alone or in combination with a progestin, should be limited to the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should reevaluate periodically as clinically appropriate to determine if treatment is still necessary. For treatment of vulvar and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible. For women who have a uterus, adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal genital bleeding.

Usual Dosage: The usual dosage range is 2 to 4 g (marked on the applicator) daily for one or two weeks, then gradually reduced to one half initial dosage for a similar period. A maintenance dosage of 1 g, one to three times a week, may be used after restoration of the vaginal mucosa has been achieved.

NOTE: The number of doses per tube will vary with dosage requirements and patient handling.


What interacts with ESTRACE?

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What are the warnings of ESTRACE?

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What are the precautions of ESTRACE?

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What are the side effects of ESTRACE?

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What should I look out for while using ESTRACE?

ESTRACE (estradiol vaginal cream, USP, 0.01%) should not be used in women with any of the following conditions:

See .

Systemic absorption may occur with the use of ESTRACE (estradiol vaginal cream, USP, 0.01%). The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.


What might happen if I take too much ESTRACE?

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 ESTRACE therapy together with institution of appropriate symptomatic care.


How should I store and handle ESTRACE?

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].ESTRACE® (estradiol vaginal cream, USP, 0.01%). NNOTE: The number of doses per tube will vary with dosage requirements and patient handling. Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40° C (104° F).Distributed by:Allergan USA, Inc.Irvine, CA 92612© 2018 Allergan. All rights reserved.Revised: 02/2018ESTRACE® (estradiol vaginal cream, USP, 0.01%). NNOTE: The number of doses per tube will vary with dosage requirements and patient handling. Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40° C (104° F).Distributed by:Allergan USA, Inc.Irvine, CA 92612© 2018 Allergan. All rights reserved.Revised: 02/2018ESTRACE® (estradiol vaginal cream, USP, 0.01%). NNOTE: The number of doses per tube will vary with dosage requirements and patient handling. Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40° C (104° F).Distributed by:Allergan USA, Inc.Irvine, CA 92612© 2018 Allergan. All rights reserved.Revised: 02/2018ESTRACE® (estradiol vaginal cream, USP, 0.01%). NNOTE: The number of doses per tube will vary with dosage requirements and patient handling. Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40° C (104° F).Distributed by:Allergan USA, Inc.Irvine, CA 92612© 2018 Allergan. All rights reserved.Revised: 02/2018ESTRACE® (estradiol vaginal cream, USP, 0.01%). NNOTE: The number of doses per tube will vary with dosage requirements and patient handling. Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40° C (104° F).Distributed by:Allergan USA, Inc.Irvine, CA 92612© 2018 Allergan. All rights reserved.Revised: 02/2018ESTRACE® (estradiol vaginal cream, USP, 0.01%). NNOTE: The number of doses per tube will vary with dosage requirements and patient handling. Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40° C (104° F).Distributed by:Allergan USA, Inc.Irvine, CA 92612© 2018 Allergan. All rights reserved.Revised: 02/2018ESTRACE® (estradiol vaginal cream, USP, 0.01%). NNOTE: The number of doses per tube will vary with dosage requirements and patient handling. Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40° C (104° F).Distributed by:Allergan USA, Inc.Irvine, CA 92612© 2018 Allergan. All rights reserved.Revised: 02/2018ESTRACE® (estradiol vaginal cream, USP, 0.01%). NNOTE: The number of doses per tube will vary with dosage requirements and patient handling. Store at room temperature 20° to 25°C (59° to 77°F). Protect from temperatures in excess of 40° C (104° F).Distributed by:Allergan USA, Inc.Irvine, CA 92612© 2018 Allergan. All rights reserved.Revised: 02/2018


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Clinical Information

Chemical Structure

No Image found
Clinical 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 by 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 follicle stimulating hormone (FSH), through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.

Non-Clinical Toxicology
ESTRACE (estradiol vaginal cream, USP, 0.01%) should not be used in women with any of the following conditions:

See .

Systemic absorption may occur with the use of ESTRACE (estradiol vaginal cream, USP, 0.01%). The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.

Furosemide may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination.

Furosemide should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. Patients receiving high doses of salicylates concomitantly with furosemide, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.

There is a risk of ototoxic effects if cisplatin and furosemide are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if furosemide is not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.

Furosemide has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine.

Lithium generally should not be given with diuretics because they reduce lithium's renal clearance and add a high risk of lithium toxicity.

Furosemide combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure. An interruption or reduction in the dosage of furosemide, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary.

Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.

Furosemide may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.

Simultaneous administration of sucralfate and furosemide tablets may reduce the natriuretic and antihypertensive effects of furosemide. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved. The intake of furosemide and sucralfate should be separated by at least two hours.

In isolated cases, intravenous administration of furosemide within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Use of furosemide concomitantly with chloral hydrate is therefore not recommended.

Phenytoin interferes directly with renal action of furosemide. There is evidence that treatment with phenytoin leads to decrease intestinal absorption of furosemide, and consequently to lower peak serum furosemide concentrations.

Methotrexate and other drugs that, like furosemide, undergo significant renal tubular secretion may reduce the effect of furosemide. Conversely, furosemide may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of both furosemide and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of furosemide.

Furosemide can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.

Concomitant use of cyclosporine and furosemide is associated with increased risk of gouty arthritis secondary to furosemide-induced hyperurecemia and cyclosporine impairment of renal urate excretion.

High doses (> 80 mg) of furosemide may inhibit the binding of thyroid hormones to carrier proteins and result in transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels.

One study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with NSAIDs.

Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of furosemide in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and furosemide should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved.

1.

Addition of a

P

rogestin

W

hen a

W

oman

H

as

N

ot

H

ad a

H

ysterectomy

Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer.

There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include a possible increased risk of breast cancer.

2.

Elevated

B

lood

P

ressure

In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogens on blood pressure was not seen.

3.

Hypertriglyceridemia

In women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications. Consider discontinuation of treatment if pancreatitis occurs. 

4.

Hepatic

Impair

ment

and

/or

 

P

ast

H

istory of

C

holestatic

J

aundice

Estrogens may be poorly metabolized in patients with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised and in the case of recurrence, medication should be discontinued.

5.

Hypothyroidism

Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. Women with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T and T serum concentrations in the normal range. Women dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. These women should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range.

6.

Fluid

R

etention

Estrogens may cause some degree of fluid retention. Women with conditions that might be influenced by this factor, such as a cardiac or renal dysfunction, warrant careful observation when estrogen-alone is prescribed.

7.

Hypocalcemia

Estrogen therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur

8.

Exacerbation of

E

ndometriosis

A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen-alone therapy. For patients known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered.

9

.

 

      Exacerbation of

O

ther

C

onditions

Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.

See and .

Systemic absorption may occur with the use of ESTRACE. The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.

The following adverse reactions have been reported with estrogen and/or progestin therapy.

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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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Professional

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. 315.72
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Tips

Tips

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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).