Medication info

Estrevagel (Estradiol Hemihydrate)

Prescription medication경구
Ingredient · strength
Estradiol Hemihydrate›1.0325mg / 1g
Manufacturer / importer
(주)삼오제약
Appearance
A translucent gel that is dispensed in specific amounts from a white, sealed, opaque container
Packaging
50 grams/tube
Approval status
Active

MFDS item code 199806329 · Notified 1998.04.09

Summary

Main use
Improvement of estrogen deficiency symptoms (such as hot flashes, sleep disturbances) and prevention of post-menopausal osteoporosis.
Who takes it
Adults
Adult dose
(Tablets) Administer 1 or 2 mg of estradiol orally once daily without interruption. If adverse reactions occur at a 2 mg dose, reduce to 1 mg. (Gel) The amount applied at one time corresponds to 0.75 mg of estradiol (gel volume 1.25 g); 1.5 mg (2 compressions) is to be administered daily for 24 to 28 days. The dosage can be adjusted based on clinical symptoms. (Estrava gel)

Ingredients

Importer
(주)삼오제약

Efficacy & effects

Improvement of estrogen deficiency symptoms (such as hot flashes, sleep disturbances) and prevention of post-menopausal osteoporosis.

  • Estrogen deficiency symptoms
  • hot flashes
  • sleep disturbances
  • emotional disorders
  • atrophic changes in the urogenital tract
  • and bone tissue loss.
View approved original text

This medication is used to improve estrogen deficiency symptoms arising from natural or surgical menopause, such as hot flashes, sleep disturbances, emotional disorders, atrophic changes in the urogenital tract, and more. It also helps prevent bone tissue loss that may occur after menopause and helps prevent osteoporosis. The formulations include tablets, gels, and transdermal systems, each effective for alleviating symptoms and preventing osteoporosis. This drug plays an important role in improving the overall quality of life of menopausal women. Therefore, it is used for alleviating menopausal symptoms and preventing osteoporosis.

How to take

Adult dose

(Tablets) Administer 1 or 2 mg of estradiol orally once daily without interruption. If adverse reactions occur at a 2 mg dose, reduce to 1 mg. (Gel) The amount applied at one time corresponds to 0.75 mg of estradiol (gel volume 1.25 g); 1.5 mg (2 compressions) is to be administered daily for 24 to 28 days. The dosage can be adjusted based on clinical symptoms. (Estrava gel)

Precautions

This drug may increase the risk of endometrial hyperplasia and endometrial cancer in women post-menopause; thus, if the uterus is still present, progestogens should be taken as directed by a doctor. Moreover, long-term use of this drug for more than five years may slightly increase the risk of breast cancer, making regular breast examinations and self-assessments necessary. Patients with breast cancer or bone metastatic disease may experience severe hypercalcemia if this drug is used, necessitating its discontinuation. This drug should not be used by individuals with specific conditions or diseases such as breast cancer, endometrial cancer, liver disease, cardiovascular disease, thromboembolism, and pregnant women. Before use, it is essential to review personal and family medical histories, and to closely monitor health status through regular check-ups during treatment. This medication may increase the risk of cardiovascular diseases such as thrombosis, stroke, and myocardial infarction, so patients with these risk factors need to be particularly cautious. In case of overdose, symptoms such as nausea, vomiting, and breast tension may occur, and as there is no specific antidote, symptomatic treatment is necessary. This drug should not be administered to women who are pregnant or could become pregnant, or to breastfeeding mothers, as it may harm the fetus during pregnancy. Additionally, this drug may interact with other medications, so anyone taking other drugs should inform their healthcare provider. When applying this medication, skin irritation or allergic reactions may occur, so the application area should be cleaned and hands washed thoroughly after use. If surgery is expected or long periods of immobility are anticipated, it is recommended to discontinue use of this drug 4 to 6 weeks before surgery and to resume after recovery. Hormone replacement therapy should be utilized at the minimum effective dose to relieve symptoms, with a regular assessment of risks and benefits to decide whether to continue treatment. This drug does not serve as a contraceptive and will not prevent pregnancy; if pregnancy is confirmed during treatment, use should be discontinued immediately. Lastly, this drug should be stored out of reach of children, kept in its original container, and maintained at room temperature, below 25 degrees.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • angioedema
  • chest tightness
  • difficulty breathing
  • thromboembolism
  • deep vein thrombosis
  • pulmonary embolism
  • anaphylaxis
  • significant increase in blood pressure
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  • anaphylaxis with purpura and angioedema
  • myocardial infarction
  • stroke
  • jaundice
  • cholestatic jaundice
  • stroke
  • worsening migraines
  • seizures
  • altered consciousness
  • visual disturbances
  • paralysis
  • sudden and severe headache
  • severe edema
  • sudden bleeding.

Mild side effects

  • Depression
  • headache
  • visual disturbances
  • abdominal pain
  • nausea
  • dyspepsia
  • vomiting
  • bloating
  • abdominal distension
  • gallstones
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  • rash
  • leg cramps
  • breast tenderness
  • breast enlargement
  • breast pain
  • weight gain
  • diarrhea
  • dizziness
  • alopecia
  • increased blood pressure
  • melasma
  • polymorphic erythema
  • nodular erythema
  • purpura
  • pruritus
  • vaginal candidiasis
  • insomnia
  • decreased libido
  • signs of dementia
  • gas bloating
  • itching
  • irritation
  • increased blood pressure
  • palpitations
  • breast pain
  • vaginal dryness.

Not everyone experiences these, and they can vary from person to person.

Storage

This drug is sensitive to light; therefore, it should be stored in an opaque container. It is also important to keep it in a sealed container to prevent air exposure while storing it at room temperature. This helps maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

A translucent gel that is dispensed in specific amounts from a white, sealed, opaque container

Package unit

50 grams/tube

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.