Product image of Estradiol Transdermal System. (Estradiol) 0.05mg PATCH supplied by GNH India

Estradiol Transdermal System.

Active Ingredient:
Estradiol
Form:
PATCH
Brand:
ESTRADIOL TRANSDERMAL SYSTEM.
Origin:
US

Estradiol Transdermal System. (Estradiol PATCH) 0.05mg

Estradiol, the active ingredient in ESTRADIOL TRANSDERMAL SYSTEM, is an estrogen presented as a 0.05mg patch for transdermal use. It is used to treat menopausal symptoms, estrogen deficiency, and hypoestrogenism in women.

GNH India supplies ESTRADIOL TRANSDERMAL SYSTEM as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide.

Strength

0.05mg

Pack Size

4s

Storage

Ambient

Manufacturer / TM Owner

Sandoz Inc

1
Pack/s
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Indications & Clinical Uses

ESTRADIOL TRANSDERMAL SYSTEM is a hormone replacement therapy used to manage symptoms related to estrogen deficiency.

  • Menopausal symptoms: Reduces moderate to severe vasomotor symptoms such as hot flashes.
  • Vulvar and vaginal atrophy: Alleviates moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
  • Hypoestrogenism: Treats conditions caused by low estrogen levels, such as hypogonadism, castration, or primary ovarian failure.
  • Postmenopausal osteoporosis: Prevents bone loss and reduces the risk of fractures in postmenopausal women at significant risk of osteoporosis.

How It Works

  • Estradiol binds to estrogen receptors (ERα and ERβ) and exerts estrogenic effects on target tissues. This interaction helps to regulate the growth and function of various tissues, including the reproductive system, bones, and cardiovascular system, thereby alleviating symptoms associated with estrogen deficiency.

Side Effects

ESTRADIOL TRANSDERMAL SYSTEM may cause side effects, ranging from common to serious.

Common Side Effects

  • Skin irritation at the application site.
  • Breast tenderness or swelling.
  • Headache.
  • Abdominal bloating or cramps.
  • Nausea.
  • Fluid retention.

Serious or Rare Side Effects

  • Increased risk of blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (PE).
  • Increased risk of endometrial hyperplasia or cancer in women with a uterus who do not use progestin.
  • Increased risk of stroke and heart disease.
  • Increased risk of breast cancer.
  • Gallbladder disease.
  • High blood pressure.

Precautions & Warnings

ESTRADIOL TRANSDERMAL SYSTEM should be used with caution and under medical supervision.

  • Contraindications: Do not use if you have a history of breast cancer, blood clots, liver disease, or unexplained vaginal bleeding.
  • Monitoring: Regularly monitor for signs of blood clots, breast changes, and other serious side effects.
  • Progestin use: Women with a uterus should use progestin to reduce the risk of endometrial cancer.
  • Allergies: Avoid if allergic to estradiol or any components of the patch.
  • Storage: Store at 20 to 25°C (68 to 77°F). Excursions permitted to 15 to 30°C (59 to 86°F). Do not store unpouched. Apply immediately upon removal from the protective pouch.

Avoid Interactions

ESTRADIOL TRANSDERMAL SYSTEM may interact with other medications, potentially altering their effects or increasing the risk of side effects.

Major Interactions (Avoid)

  • Anticoagulants: Increased risk of bleeding.
  • Estrogen-containing products: Increased risk of estrogen-related side effects.
  • CYP3A4 inducers: May decrease the effectiveness of estradiol.

Moderate Interactions (Monitor Closely)

  • Anticonvulsants: May alter the metabolism of estradiol.
  • Antidepressants: May increase the risk of serotonin syndrome.
  • Thyroid hormones: May affect thyroid hormone levels.

Frequently Asked Questions

ESTRADIOL TRANSDERMAL SYSTEM is used to treat menopausal symptoms such as hot flashes, symptoms of vulvar and vaginal atrophy, and conditions caused by low estrogen levels, including hypogonadism and primary ovarian failure. It is also used to prevent postmenopausal osteoporosis in women at significant risk.

Estradiol works by binding to estrogen receptors (ERα and ERβ) in the body. This interaction helps to regulate the growth and function of various tissues, including the reproductive system, bones, and cardiovascular system, thereby alleviating symptoms associated with estrogen deficiency.

The usual dose of ESTRADIOL TRANSDERMAL SYSTEM is determined by a healthcare provider based on the individual's needs and medical history. It is typically applied as a patch twice weekly, but the specific dosage and regimen should be followed as prescribed.

ESTRADIOL TRANSDERMAL SYSTEM is not recommended for use during pregnancy or breastfeeding. Estradiol can affect the development of the fetus and may pass into breast milk. Always consult a healthcare provider for personalized advice.

To order ESTRADIOL TRANSDERMAL SYSTEM from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets and will ask the buyer to confirm trade or institutional credentials. The team will then provide pricing, availability, shipping, and the necessary import paperwork.

ESTRADIOL TRANSDERMAL SYSTEM is a transdermal patch that delivers estradiol through the skin, which can help reduce some of the gastrointestinal side effects associated with oral estrogen therapies. It is generally well-tolerated and provides a steady release of estrogen over a specified period.

ESTRADIOL TRANSDERMAL SYSTEM should be stored at 20 to 25°C (68 to 77°F). Excursions permitted to 15 to 30°C (59 to 86°F). Do not store unpouched. Apply the patch immediately upon removal from the protective pouch to ensure its effectiveness.

ESTRADIOL TRANSDERMAL SYSTEM is administered by applying the patch to a clean, dry area of the lower abdomen or buttocks. The patch should be changed twice weekly, as directed by a healthcare provider. Avoid applying the patch to the breasts.

The most serious risks associated with ESTRADIOL TRANSDERMAL SYSTEM include an increased risk of blood clots, stroke, heart disease, breast cancer, and endometrial cancer in women with a uterus who do not use progestin. Regular monitoring and follow-up with a healthcare provider are essential to manage these risks.

ESTRADIOL TRANSDERMAL SYSTEM should not be used by individuals with a history of breast cancer, blood clots, liver disease, or unexplained vaginal bleeding. It is also not recommended for use during pregnancy or breastfeeding. Always consult a healthcare provider for personalized advice.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

References

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