Medication info
Preda Tablet 1mg (Estradiol Hemihydrate)

Preda Tablet 1mg (Estradiol Hemihydrate)

Prescription medicationTablet경구
Ingredient · strength
Estradiol Hemihydrate›1.03mg / 1 tablet
Manufacturer / importer
(주)다림바이오텍
Appearance
Red round film-coated tablet
Packaging
Domestic: 28 tablets (28 tablets/PTPX1), 30 tablets (30 tablets/PTPX1), Export: 21 tablets (21 tablets/PTPX1), 30 tablets (30 tablets/PTPX1)
Approval status
Active

MFDS item code 200612351 · Notified 2006.12.13 · Insurance code 664601040

Summary

Main use
Improvement of estrogen deficiency symptoms (hot flashes, sleep disorders) and prevention of postmenopausal osteoporosis.
Who takes it
Adults
Adult dose
This medication is administered orally as 1 to 2 mg of estradiol once daily without interruption. If any adverse reactions occur with the 2 mg dosage, 1 mg should be administered instead. The gel form should be applied to a large skin area excluding the breasts and vulva in the morning or evening; a single dose corresponds to 0.75 mg of estradiol (gel amount of 1.25 g). On average, 1.5 mg (two doses) of estradiol should be applied daily for 24 to 28 days.

Ingredients

Manufacturer
(주)다림바이오텍

Efficacy & effects

Improvement of estrogen deficiency symptoms (hot flashes, sleep disorders) and prevention of postmenopausal osteoporosis.

  • Symptoms of estrogen deficiency
  • menopausal disorders
  • hot flashes
  • sleep disturbances
  • emotional disorders
  • urogenital atrophy
  • loss of bone tissue.
View approved original text

This medication is used primarily to relieve symptoms of estrogen deficiency that occur after menopause or surgical menopause, such as hot flashes, sleep disturbances, emotional disorders, and urogenital atrophy. It also helps prevent osteoporosis after menopause. While there may be slight differences based on the formulation and concentration, all are effective in improving menopause-related symptoms and maintaining bone health. Patients can improve their menopausal symptoms and protect their bone health through this medication.

How to take

Adult dose

This medication is administered orally as 1 to 2 mg of estradiol once daily without interruption. If any adverse reactions occur with the 2 mg dosage, 1 mg should be administered instead. The gel form should be applied to a large skin area excluding the breasts and vulva in the morning or evening; a single dose corresponds to 0.75 mg of estradiol (gel amount of 1.25 g). On average, 1.5 mg (two doses) of estradiol should be applied daily for 24 to 28 days.

Precautions

This medication may increase the risk of endometrial hyperplasia and endometrial cancer in postmenopausal women. Women who have not undergone hysterectomy are advised to take progestogens under a doctor's guidance to reduce the risk of endometrial cancer. Regular check-ups are necessary for long-term use. There may be a slight increase in the risk of breast cancer with prolonged use of this medication for more than 5 years, so regular breast examinations and self-checks are necessary. Patients with breast cancer or metastatic disease should be cautious, as serious side effects like hypercalcemia can occur while taking this medication. Women with breast cancer, endometrial cancer, liver diseases, thrombosis, cardiovascular diseases, cerebrovascular diseases, and pregnant women should not take this medication. Patients with specific conditions such as leiomyoma, fibroids, hypertension, diabetes, migraines, systemic lupus erythematosus, epilepsy, asthma, or those with a past medical history of these conditions need careful management by a doctor. While taking this medication, if symptoms such as increased blood pressure, headaches, abnormal bleeding, or liver function deterioration occur, consult a doctor immediately. If surgery is planned or if immobilization for a long time is expected, it may be necessary to temporarily stop this medication 4 to 6 weeks before the operation, so consult a doctor. This medication can interact with several other drugs, so be sure to inform your doctor or pharmacist if you are taking other medications. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication, and it should be stopped immediately if pregnancy is confirmed during use. In case of overdose, symptoms such as nausea, vomiting, and breast tenderness may occur, and since there is no specific antidote, treatment should be provided based on symptoms. This medication should be kept out of reach of children, stored in its original container, and kept at a temperature below 25 degrees Celsius. This medication is not a contraceptive and should not be used for pregnancy prevention. During use, regular check-ups of the breasts and uterus should be done to continuously assess health status. After applying this medication, wash hands thoroughly and especially avoid contact with the skin of children or men. This medication's components can decompose when exposed to ultraviolet light, so it should be applied to areas not exposed to sunlight and covered by clothing.

Side effects and when to seek care immediately

Serious side effects

Urticaria, edema, rash, severe allergic reactions, severe swelling (edema), significant increase in blood pressure accompanied by severe edema, breast cancer, endometrial cancer, stroke, thromboembolism, venous thrombosis, myocardial infarction, congestive heart failure, gallbladder disease, vascular purpura, chest tightness, difficulty breathing, exacerbation of asthma, epilepsy, seizures, confusion, visual disturbances, paralysis, jaundice, cholestatic jaundice, liver abnormalities, hypercalcemia, angioedema, anaphylaxis.

Mild side effects

  • Breast tenderness
  • breast pain
  • abdominal pain
  • headaches
  • vision disturbances
  • dyspepsia
  • vomiting
  • bloating
  • abdominal distension
  • gallstones
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  • leg cramps
  • leg pain
  • weight gain
  • diarrhea
  • alopecia
  • increased blood pressure
  • insomnia
  • decreased libido
  • signs of dementia
  • gas
  • nausea
  • increased blood pressure
  • thrombosis
  • palpitations
  • thrombophlebitis
  • vulvar pruritus
  • subcutaneous bleeding
  • discharge
  • vulvar swelling
  • irregular bleeding
  • persistent heat sensation
  • intermenstrual bleeding
  • vaginal.

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

Storage

This medication should be stored in a sealed container to prevent air from entering, and care must be taken to avoid freezing. Additionally, it is best to store it in a cool, dry place away from direct sunlight at a temperature below 25 degrees Celsius.

Appearance and packaging

Appearance

Red round film-coated tablet

Package unit

Domestic: 28 tablets (28 tablets/PTPX1), 30 tablets (30 tablets/PTPX1), Export: 21 tablets (21 tablets/PTPX1), 30 tablets (30 tablets/PTPX1)

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.