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estradiol

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Overview

What is Vagifem?

Vagifem 10 mcg (estradiol vaginal inserts) are small, white, film-coated inserts containing 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. Vagifem 25 mcg (estradiol vaginal inserts) are small, white, film-coated inserts containing 25.8 mcg of estradiol hemihydrate equivalent to 25 mcg of estradiol. Each insert of Vagifem 10 mcg and 25 mcg contains the following excipients: hypromellose, lactose monohydrate, maize starch and magnesium stearate. The film coating contains hypromellose and polyethylene glycol. Each Vagifem insert is 6 mm in diameter and is placed in a disposable applicator. Each insert-filled applicator is packaged separately in a blister pack. Vagifem inserts are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina.

Estradiol hemihydrate is a white, almost white or colorless crystalline solid, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is CHO • ½ HO with a molecular weight of 281.4.

The structural formula is:



What does Vagifem look like?



What are the available doses of Vagifem?

Vagifem is a small, white, round, film-coated, bi-convex vaginal insert containing 10 mcg or 25 mcg of estradiol. Each vaginal insert is 6 mm in diameter and is administered in a disposable applicator.

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

How should I use Vagifem?

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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 a 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.


What interacts with Vagifem?

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What are the warnings of Vagifem?

Sorry No Records found


What are the precautions of Vagifem?

Sorry No Records found


What are the side effects of Vagifem?

Sorry No records found


What should I look out for while using Vagifem?

Vagifem should not be used in women with any of the following conditions:


What might happen if I take too much Vagifem?

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 Vagifem therapy with institution of appropriate symptomatic care.


How should I store and handle Vagifem?

Store at 25ºC (77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). Do not refrigerate.[See USP Controlled Room Temperature.]Store at 25ºC (77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). Do not refrigerate.[See USP Controlled Room Temperature.]2.5 mg, Nitroglycerin Extended-Release (Pink and Clear capsules imprinted TCL-1221) in bottles of 60's, 100's6.5 mg, Nitroglycerin Extended-Release (Blue and Yellow capsules imprinted TCL-1222) in bottles of 60's, 100's9 mg, Nitroglycerin Extended-Release (Green and Yellow capsules imprinted TCL-1223) in bottles of 60's, 100'sRx only2.5 mg, Nitroglycerin Extended-Release (Pink and Clear capsules imprinted TCL-1221) in bottles of 60's, 100's6.5 mg, Nitroglycerin Extended-Release (Blue and Yellow capsules imprinted TCL-1222) in bottles of 60's, 100's9 mg, Nitroglycerin Extended-Release (Green and Yellow capsules imprinted TCL-1223) in bottles of 60's, 100'sRx only2.5 mg, Nitroglycerin Extended-Release (Pink and Clear capsules imprinted TCL-1221) in bottles of 60's, 100's6.5 mg, Nitroglycerin Extended-Release (Blue and Yellow capsules imprinted TCL-1222) in bottles of 60's, 100's9 mg, Nitroglycerin Extended-Release (Green and Yellow capsules imprinted TCL-1223) in bottles of 60's, 100'sRx only2.5 mg, Nitroglycerin Extended-Release (Pink and Clear capsules imprinted TCL-1221) in bottles of 60's, 100's6.5 mg, Nitroglycerin Extended-Release (Blue and Yellow capsules imprinted TCL-1222) in bottles of 60's, 100's9 mg, Nitroglycerin Extended-Release (Green and Yellow capsules imprinted TCL-1223) in bottles of 60's, 100'sRx only


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Clinical Information

Chemical Structure

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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 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
Vagifem should not be used in women with any of the following conditions:

Drug Interactions

Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary,

Vagifem is intended only for vaginal administration. Systemic absorption occurs with the use of Vagifem. The warnings, precautions, and adverse reactions associated with the use of systemic estrogen-alone therapy should be taken into account.

The following serious adverse reactions are discussed elsewhere in the labeling:

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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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Interactions

Interactions

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