Oestradiol Benzoate Uses

How do you administer this medicine?
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What is Oestradiol Benzoate?

Oestradiol Benzoate is a form of estrogen, a female sex hormone that regulates many processes in the body.

Some Oestradiol Benzoate products placed directly into the vagina are used for "local" treatment of vaginal menopause symptoms (such as dryness, burning, and irritation). Other vaginal Oestradiol Benzoate products are used for treating vaginal menopause symptoms and symptoms that affect other parts of the body (such as hot flashes). This type of vaginal Oestradiol Benzoate has "systemic" effects, meaning that it can affect parts of the body other than where the medicine is directly applied.

This medication guide provides information about Oestradiol Benzoate for local treatment of vaginal symptoms of menopause (such as dryness, itching, irritation, and pain during sexual intercourse).

Oestradiol Benzoate (local) may also be used for purposes not listed in this medication guide.

Oestradiol Benzoate indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Oestradiol Benzoate is a Hormone Replacement Therapy (HRT). It contains the female hormone Oestradiol Benzoate.

Oestradiol Benzoate is used in postmenopausal women, particularly in women who have had their womb removed (have had a hysterectomy) and therefore do not require combined oestrogen/progestagen therapy.

Oestradiol Benzoate is

Used for: Relief of symptoms occurring after menopause: During the menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (‘hot flushes’). Oestradiol Benzoate alleviates these symptoms after menopause. Oestradiol Benzoate should only be prescribed if the symptoms seriously hinder the patient’s daily life.

Prevention of osteoporosis (thinning of the bones), if the patient is at high risk of future fracture and if unable to take other medications for this purpose.

There is only limited experience of treating women older than 65 years.

How should I use Oestradiol Benzoate?

Use Oestradiol Benzoate spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Oestradiol Benzoate spray.

Uses of Oestradiol Benzoate in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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This medication is a female hormone (estrogen). It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. This medication may also be used by women who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure) and by men to treat prostate cancer.

How to use Oestradiol Benzoate intramuscular

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is injected into a muscle as directed by your doctor, usually every 4 weeks. For the treatment of prostate cancer, this medication is usually given every 1 to 2 weeks. The dosage is based on your medical condition and response to treatment.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. If stored at low temperatures, crystal may form in the liquid. To dissolve these crystals, simply warm the product to room temperature prior to use. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder of when to receive your doses.

Tell your doctor if your condition does not improve or if it worsens.

Oestradiol Benzoate description

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Generally refers to the 17-beta-isomer of Oestradiol Benzoate, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Oestradiol Benzoate-17-beta is the most potent form of mammalian estrogenic steroids. In humans, it is produced primarily by the cyclic ovaries and the placenta. It is also produced by the adipose tissue of men and postmenopausal women. The 17-alpha-isomer of Oestradiol Benzoate binds weakly to estrogen receptors (receptors, estrogen) and exhibits little estrogenic activity in estrogen-responsive tissues. Various isomers can be synthesized.

Oestradiol Benzoate dosage

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.

Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause

Start therapy with 0.025 mg per day applied to the skin once weekly. Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.

Treatment Of Moderate To Severe Symptoms Of Vulvar And Vaginal Atrophy Due To Menopause

Start therapy with 0.025 mg per day applied to the skin once weekly. Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.

Treatment Of Hypoestrogenism Due To Hypogonadism, Castration, Or Primary Ovarian Failure

Start therapy with 0.025 mg per day applied to the skin once weekly. The dose should be adjusted as necessary to control symptoms. Clinical responses (relief of symptoms) at the lowest effective dose should be the guide for establishing administration of the Oestradiol Benzoate transdermal system, especially in women with an intact uterus.

Prevention Of Postmenopausal Osteoporosis

Start therapy with 0.025 mg per day applied to the skin once weekly.

Application Of The Oestradiol Benzoate Transdermal System

Site Selection
Application

Removal Of The Oestradiol Benzoate Transdermal System

How supplied

Dosage Forms And Strengths

Oestradiol Benzoate (Oestradiol Benzoate transdermal system), 0.025 mg per day — each 6.5 cm² system contains 2 mg of Oestradiol Benzoate USP Individual Carton of 4 systems NDC 50419-454-04

Oestradiol Benzoate (Oestradiol Benzoate transdermal system), 0.0375 mg per day — each 9.375 cm² system contains 2.85 mg of Oestradiol Benzoate USP Individual Carton of 4 systems NDC 50419-456-04

Oestradiol Benzoate (Oestradiol Benzoate transdermal system), 0.05 mg per day — each 12.5 cm² system contains 3.8 mg of Oestradiol Benzoate USP Individual Carton of 4 systems NDC 50419-451-04

Oestradiol Benzoate (Oestradiol Benzoate transdermal system), 0.06 mg per day — each 15 cm² system contains 4.55 mg of Oestradiol Benzoate USP Individual Carton of 4 systems NDC 50419-459-04

Oestradiol Benzoate (Oestradiol Benzoate transdermal system), 0.075 mg per day — each 18.75 cm² system contains 5.7 mg of Oestradiol Benzoate USP Individual Carton of 4 systems NDC 50419-453-04

Oestradiol Benzoate (Oestradiol Benzoate transdermal system), 0.1 mg per day — each 25 cm² system contains 7.6 mg of Oestradiol Benzoate USP Individual Carton of 4 systems NDC 50419-452-04

Storage And Handling

Store at 20°C to 25°C (66°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Do not store above 86°F (30°C).

Do not store unpouched. Apply immediately upon removal from the protective pouch.

Used transdermal systems still contain active hormone. To discard, fold the sticky side of the transdermal system together, place it in a sturdy child-proof container, and place this container in the trash. Used transdermal systems should not be flushed in the toilet.

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981. Manufactured by 3M Drug Delivery Systems, Northridge, CA 91324. Revised: Oct 2013

Oestradiol Benzoate interactions

See also:
What other drugs will affect Oestradiol Benzoate?

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CYP3A4 Interaction

Oestradiol Benzoate is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A4. Potent inhibitors of CYP3A4 (below) increase the risk of myopathy by reducing the elimination of lovastatin

Pharmacokinetics Itraconazol Ketoconazol Erythromyci Clarithromyci Telithromyci HIV protease inhibitor Nefazodon Cyclosporin Large quantities of grapefruit juice (>1 quart daily

Interactions with lipid-lowering drugs that can cause myopathy when given alone

The risk of myopathy is also increased by the following lipid-lowering drugs that are not potent CYP3A4 inhibitors, but which can cause myopathy when given alone

See WARNINGS, Myopathy/Rhabdomyolysis Gemfibrozi Other fibrate Niacin (nicotinic acid) (=1 g/day

Other drug interaction

Danazol: The risk of myopathy/rhabdomyolysis is increased by concomitant administration of danazol particularly with higher doses of lovastatin

Amiodarone or Verapamil: The risk of myopathy/rhabdomyolysis is increased when either amiodarone or verapamil is used concomitantly with a closely related member of the HMG-CoA reductase inhibitor class

Coumarin Anticoagulants: In a small clinical trial in which lovastatin was administered to warfarin treated patients, no effect on prothrombin time was detected. However, another HMG-CoA reductase inhibitor has been found to produce a less than two-second increase in prothrombin time in healthy volunteers receiving low doses of warfarin. Also, bleeding and/or increased prothrombin time have been reported in a few patients taking coumarin anticoagulants concomitantly with lovastatin. It is recommended that in patients taking anticoagulants, prothrombin time be determined before starting lovastatin and frequently enough during early therapy to insure that no significant alteration of prothrombin time occurs Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on coumarin anticoagulants. If the dose of lovastatin is changed, the same procedure should be repeated. Oestradiol Benzoate therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants

Propranolol: In normal volunteers, there was no clinically significant pharmacokinetic o pharmacodynamic interaction with concomitant administration of single doses of lovastatin and propranolol

Digoxin: In patients with hypercholesterolemia, concomitant administration of lovastatin and digoxin resulted in no effect on digoxin plasma concentrations

Oral Hypoglycemic Agents: In pharmacokinetic studies of MEVACOR in hypercholesterolemic noninsulin dependent diabetic patients, there was no drug interaction with glipizide or with chlorpropamide

Oestradiol Benzoate side effects

See also:
What are the possible side effects of Oestradiol Benzoate?

See WARNINGS and Boxed Warning regarding the potential adverse effects on the fetus, the induction of malignant neoplasms, gallbladder disease, cardiovascular disease, elevated blood pressure, and hypercalcemia.

Skin irritation: In controlled clinical studies with Oestradiol Benzoate (Oestradiol Benzoate transdermal), the most commonly reported adverse events were topical reactions of erythema and/or pruritus at the application site. In general these reactions caused patients little or no discomfort, and led to premature discontinuation of treatment in 0.9% (3/317) of patients in these trials. The rate of application site reactions, based on 8,135 applications of the 0.025, 0.05, and 0.1 Oestradiol Benzoate (Oestradiol Benzoate transdermal) systems in these trials was 6.1 per 100 applications (4.9, 5.4, 10.7 for the 3 Oestradiol Benzoate (Oestradiol Benzoate transdermal) doses respectively) compared to 6.2 in the placebo treated patients (2,014 applications).

In a placebo-controlled trial of Oestradiol Benzoate (Oestradiol Benzoate transdermal) 0.025, 0.05, and 0.1 conducted in 196 patients in the US, the adverse events reported by at least 5% of patients in 1 or more of the treatment groups are shown in Table 5.

Table 5: Incidence of Adverse Events >5% in a Placebo-Controlled Study of Oestradiol Benzoate Data Are Expressed as % of Treatment Group

Placebo

Oestradiol Benzoate

Oestradiol Benzoate

Oestradiol Benzoate

Adverse Event

0.025 mg/day

0.05 mg/day

0.1 mg/day

(N=54)

(N=48)

(N=47)

(N=47)

Breast Pain

3.7

25.0

44.7

46.8

Headache

22.2

18.8

8.5

6.4

Infection

7.4

10.4

10.6

8.5

Injury Accident

3.7

10.4

4.3

2.1

Anxiety

0

8.3

2.1

0

Emotional Lability

1.9

8.3

2.1

6.4

Arthralgia

1.9

6.3

2.1

4.3

Flu Syndrome

7.4

6.3

6.4

8.5

Joint Disorder

0

6.3

0

0

Pruritus

1.9

6.3

12.8

0

Rhinitis

1.9

6.3

4.3

4.3

Abdominal Pain

9.3

4.2

10.6

2.1

General Edema

1.9

4.2

6.4

6.4

Monilia Vagina

5.6

4.2

8.5

4.3

Nausea

1.9

4.2

10.6

8.5

Peripheral Edema

0

4.2

2.1

6.4

Sinusitis

7.4

4.2

2.1

4.3

Asthenia

1.9

2.1

10.6

6.4

Back Pain

3.7

2.1

2.1

6.4

Diarrhea

1.9

2.1

8.5

0

Dysmenorrhea

0

2.1

2.1

6.4

Enlarged Abdomen

0

2.1

2.1

6.4

Enlarged Breast

0

2.1

2.1

8.5

Rash

5.6

2.1

4.3

2.1

Anemia

0

0

6.4

4.3

Gastroenteritis

1.9

0

0

6.4

Hyperlipemia

5.6

0

0

2.1

Leukorrhea

0

0

12.8

0

Paresthesia

1.9

0

6.4

0

Urogenital Adverse Events : In the US placebo-controlled study, 72 patients were included who had intact uteri. As expected, after 12-13 weeks of continuous unopposed therapy, findings of endometrial hyperplasia (diagnosed either by endometrial biopsy and/or ultrasonography) were increased with increasing doses of Oestradiol Benzoate (placebo: 0/18 patients; Oestradiol Benzoate (Oestradiol Benzoate transdermal) 0.025: 1/14 (7.1%); Oestradiol Benzoate (Oestradiol Benzoate transdermal) 0.05: 12/22 (54.5%); Oestradiol Benzoate (Oestradiol Benzoate transdermal) 0.1: 10/18 (55.6%). In the 86 patients who had not previously undergone a total hysterectomy, vaginal bleeding was also increased with increasing doses of Oestradiol Benzoate [placebo: 2/21 patients (9.5%); Oestradiol Benzoate (Oestradiol Benzoate transdermal) 0.025: 6/19 (31.6%); Oestradiol Benzoate (Oestradiol Benzoate transdermal) 0.05: 14/25 (56.0%); Oestradiol Benzoate (Oestradiol Benzoate transdermal) 0.1: 12/21 (57.1%)].

In 2 long-term studies involving a total of 488 patients treated for a mean duration of 618 days and up to 3.5 years, the nature and incidence of adverse events did not change with prolonged duration of treatment.

The following additional adverse reactions have been reported with estrogen therapy:

1. Genitourinary System. Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting; increase in size of uterine leiomyomata; vaginal candidiasis; change in amount of cervical secretion.

2. Breasts. Tenderness, enlargement.

3. Gastrointestinal. Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; gallbladder disease.

4. Skin. Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism.

5. Eyes. Steepening of corneal curvature: intolerance to contact lenses.

6. Central Nervous System. Headache, migraine, dizziness; mental depression; chorea.

7. Miscellaneous. Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; changes in libido.

Oestradiol Benzoate contraindications

See also:
What is the most important information I should know about Oestradiol Benzoate?

Oestradiol Benzoate can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

You should not use this medication if you have any of the following conditions: liver disease, a bleeding disorder, unusual vaginal bleeding, a history of breast or uterine cancer, or if you have ever had a heart attack, stroke, or a blood clot.

Oestradiol Benzoate may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin while you are using Oestradiol Benzoate, to help lower this risk. Report any unusual vaginal bleeding right away.

Long-term use of Oestradiol Benzoate may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using Oestradiol Benzoate transdermal long term.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Oestradiol Benzoate transdermal.

Oestradiol Benzoate transdermal should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.



Active ingredient matches for Oestradiol Benzoate:

Estradiol in Ireland, United Kingdom.


List of Oestradiol Benzoate substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Gel; Topical; Estradiol Hemihydrate 0.06% (A. Menarini)
Oestrodose 0.75 mg/1.25 g x 1 Bottle 80 g (A. Menarini)
Oestrodose transdermal gel 600 mcg/g / w/ metering pump 80 g x 1's (A. Menarini)$ 18.55
Gel; Topical; Estradiol 0.06% (Chemech Laboratories Ltd.)
80g (Chemech Laboratories Ltd.)$ 5.10
Oestrogel 0.06 % x 80 g (Chemech Laboratories Ltd.)
Oestrogel 0.06 % x 10 g (Chemech Laboratories Ltd.)
Oestrogel 0.06 % x 30 g (Chemech Laboratories Ltd.)
Oestrogel 0.06 % x 80 g x 1's (Chemech Laboratories Ltd.)
Oestrogel 0.06 % x 1 tube 80 g in thöôùc ño lieàu (Chemech Laboratories Ltd.)
Oestrogel 3mg x 5g GEL / 80g (Chemech Laboratories Ltd.)$ 5.10
Oestrogel 80 gm Gel (Chemech Laboratories Ltd.)$ 0.32
OESTROGEL 0.06% GEL 1 tube / 80 GM gel each (Chemech Laboratories Ltd.)$ 9.52
Oestrogel gel 0.06% 80 g x 1's (Chemech Laboratories Ltd.)
Oestrogel topical gel 0.06 % 80 g x 1's (Chemech Laboratories Ltd.)
OESTROGEL topical gel 3 mg x 5 g x 80g (Chemech Laboratories Ltd.)$ 5.10
Oestrogel 0.06% w/w Gel (Besins Healthcare India Pvt Ltd)$ 10.48
Tablet, Film-Coated; Oral; Estradiol Hemihydrate 1 mg (Solvay)
Tablet, Film-Coated; Oral; Estradiol Hemihydrate 2 mg (Solvay)
Tablets, Film-Coated; Oral; Estradiol Hemihydrate 1 mg (Solvay)
Tablets, Film-Coated; Oral; Estradiol Hemihydrate 2 mg (Solvay)

References

  1. DailyMed. "ESTRADIOL HEMIHYDRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "estradiol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "estradiol". http://www.drugbank.ca/drugs/DB00783 (accessed September 17, 2018).

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The results of a survey conducted on ndrugs.com for Oestradiol Benzoate are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Oestradiol Benzoate. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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