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estradiol
Overview
What is Divigel?
Divigel (estradiol gel) 0.1% is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm) of the thigh in a thin, quick-drying layer. Divigel is available in three doses of 0.25, 0.5, and 1.0 g for topical application (corresponding to 0.25, 0.5, and 1.0 mg estradiol, respectively).
The active component of the topical gel is estradiol.
Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has an empirical formula of CHO and molecular weight of 272.39. The structural formula is:
The remaining components of the gel (carbomer, ethanol, propylene glycol, purified water, and triethanolamine) are pharmacologically inactive.
What does Divigel look like?
What are the available doses of Divigel?
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What should I talk to my health care provider before I take Divigel?
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How should I use Divigel?
Divigel (estradiol gel) 0.1% is indicated in the treatment of moderate to severe vasomotor symptoms associated with menopause.
When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need 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. Patients should be re-evaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see and ). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
Divigel (estradiol gel) 0.1%, at doses of 0.25, 0.5, and 1.0 g/day, is indicated for topical use in the treatment of moderate to severe vasomotor symptoms associated with menopause. Each gram of Divigel contains 1 mg of estradiol.
Patients should be treated with the lowest effective dose of Divigel. Generally, women should be started at 0.25 gram Divigel daily. Subsequent dosage adjustments may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.
Divigel should be applied once daily on the skin of either the right or left upper thigh. The application surface area should be about 5 by 7 inches (approximately the size of two palm prints). The entire contents of a unit dose packet should be applied each day. To avoid potential skin irritation, Divigel should be applied to the right or left upper thigh on alternating days. Divigel should not be applied on the face, breasts, or irritated skin or in or around the vagina. After application, the gel should be allowed to dry before dressing. The application site should not be washed within 1 hour after applying Divigel. Contact of the gel with eyes should be avoided. Hands should be washed after application.
What interacts with Divigel?
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What are the warnings of Divigel?
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What are the precautions of Divigel?
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What are the side effects of Divigel?
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What should I look out for while using Divigel?
Estrogen products, including Divigel (estradiol gel) 0.1%, should not be used in women with any of the following conditions:
See .
What might happen if I take too much Divigel?
Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing drug products by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.
How should I store and handle Divigel?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Divigel (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 1.0 g, corresponding to 1.0 mg estradiol, respectively. NDC 54868-6056-0Keep out of the reach of children. 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.]Manufactured byOrion Corporation Orion PharmaTengströminkatu 8FI-20360 TurkuFinland Distributed byUpsher-Smith Laboratories, Inc.Minneapolis, MN 55447 1-800-654-2299 Product of Finland Revised June 2007Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146 Divigel (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 1.0 g, corresponding to 1.0 mg estradiol, respectively. NDC 54868-6056-0Keep out of the reach of children. 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.]Manufactured byOrion Corporation Orion PharmaTengströminkatu 8FI-20360 TurkuFinland Distributed byUpsher-Smith Laboratories, Inc.Minneapolis, MN 55447 1-800-654-2299 Product of Finland Revised June 2007Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146 Divigel (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 1.0 g, corresponding to 1.0 mg estradiol, respectively. NDC 54868-6056-0Keep out of the reach of children. 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.]Manufactured byOrion Corporation Orion PharmaTengströminkatu 8FI-20360 TurkuFinland Distributed byUpsher-Smith Laboratories, Inc.Minneapolis, MN 55447 1-800-654-2299 Product of Finland Revised June 2007Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146 Divigel (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 1.0 g, corresponding to 1.0 mg estradiol, respectively. NDC 54868-6056-0Keep out of the reach of children. 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.]Manufactured byOrion Corporation Orion PharmaTengströminkatu 8FI-20360 TurkuFinland Distributed byUpsher-Smith Laboratories, Inc.Minneapolis, MN 55447 1-800-654-2299 Product of Finland Revised June 2007Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146 Divigel (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 1.0 g, corresponding to 1.0 mg estradiol, respectively. NDC 54868-6056-0Keep out of the reach of children. 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.]Manufactured byOrion Corporation Orion PharmaTengströminkatu 8FI-20360 TurkuFinland Distributed byUpsher-Smith Laboratories, Inc.Minneapolis, MN 55447 1-800-654-2299 Product of Finland Revised June 2007Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146 Divigel (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 1.0 g, corresponding to 1.0 mg estradiol, respectively. NDC 54868-6056-0Keep out of the reach of children. 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.]Manufactured byOrion Corporation Orion PharmaTengströminkatu 8FI-20360 TurkuFinland Distributed byUpsher-Smith Laboratories, Inc.Minneapolis, MN 55447 1-800-654-2299 Product of Finland Revised June 2007Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146 Divigel (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 1.0 g, corresponding to 1.0 mg estradiol, respectively. NDC 54868-6056-0Keep out of the reach of children. 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.]Manufactured byOrion Corporation Orion PharmaTengströminkatu 8FI-20360 TurkuFinland Distributed byUpsher-Smith Laboratories, Inc.Minneapolis, MN 55447 1-800-654-2299 Product of Finland Revised June 2007Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146 Divigel (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 1.0 g, corresponding to 1.0 mg estradiol, respectively. NDC 54868-6056-0Keep out of the reach of children. 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.]Manufactured byOrion Corporation Orion PharmaTengströminkatu 8FI-20360 TurkuFinland Distributed byUpsher-Smith Laboratories, Inc.Minneapolis, MN 55447 1-800-654-2299 Product of Finland Revised June 2007Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146 Divigel (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 1.0 g, corresponding to 1.0 mg estradiol, respectively. NDC 54868-6056-0Keep out of the reach of children. 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.]Manufactured byOrion Corporation Orion PharmaTengströminkatu 8FI-20360 TurkuFinland Distributed byUpsher-Smith Laboratories, Inc.Minneapolis, MN 55447 1-800-654-2299 Product of Finland Revised June 2007Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146 Divigel (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 1.0 g, corresponding to 1.0 mg estradiol, respectively. NDC 54868-6056-0Keep out of the reach of children. 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.]Manufactured byOrion Corporation Orion PharmaTengströminkatu 8FI-20360 TurkuFinland Distributed byUpsher-Smith Laboratories, Inc.Minneapolis, MN 55447 1-800-654-2299 Product of Finland Revised June 2007Relabeling of "Additional Barcode" byPhysicians Total Care, Inc.Tulsa, OK 74146
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Divigel provides estrogen therapy by delivering estradiol, the major estrogenic hormone secreted by the human ovary, to the systemic circulation following topical application.
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
Estrogen products, including Divigel (estradiol gel) 0.1%, should not be used in women with any of the following conditions:See .
Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Due to a theoretical risk of a pharmacodynamic interaction, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and FROVA within 24 hours of each other should be avoided (see ).
Concomitant use of other 5HT agonists within 24 hours of FROVA treatment is not recommended (see ).
Selective Serotonin Reuptake Inhibitors / Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome
See and .
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Divigel was studied at doses of 0.25, 0.5 and 1.0 g/day in a 12-week, double-blind, placebo-controlled study that included a total of 495 postmenopausal women (86.5% Caucasian). The adverse events that occurred at a rate greater than 5% in any of the treatment groups are summarized in .
In a 12-week placebo-controlled study of Divigel, application site reactions were seen in <1% of subjects.
The following additional adverse reactions have been reported with estrogen and/or progestin therapy.
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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