Medication info

Dibigel 0.1% Gel (Estradiol)

Prescription medication경구
Ingredient · strength
Estradiol Hemihydrate›1.033mg / 1g
Manufacturer / importer
현대약품(주)
Appearance
Clear colorless to white soft gel preparation
Packaging
28 grams/packet[(1 gram/packet x 28)]
Approval status
Active

MFDS item code 200110219 · Notified 2001.11.13

Summary

Main use
Improvement of estrogen deficiency symptoms (hot flashes, sleep disorders) and prevention of postmenopausal osteoporosis
Who takes it
Adults
Adult dose
Tablets: Administer 1 or 2 mg of estradiol orally once daily without interruption, and if adverse reactions occur with 2 mg, adjust to 1 mg. Gel: After showering in the morning or evening, apply to a large area of clean skin (abdomen, shoulders, upper arms, thighs) excluding the breasts and vulva; the amount per application corresponds to 0.75 mg of estradiol. On average, administer 1.5 mg daily for 24-28 days.

Ingredients

Importer
현대약품(주)

Efficacy & effects

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

  • Estrogen deficiency symptoms
  • menopausal disorders
  • hot flashes
  • sleep disturbances
  • emotional disorders
  • urogenital atrophy
  • bone tissue loss
View approved original text

This medication improves estrogen deficiency symptoms that occur due to menopause resulting from natural aging or surgical removal, such as hot flashes, sleep disturbances, emotional disorders, and urogenital atrophy. It is also used to prevent osteoporosis that occurs after menopause. Available in various formulations (tablets, gel, transdermal delivery), it can be administered depending on the situation. This drug helps alleviate uncomfortable symptoms caused by menopause and prevent bone tissue loss to maintain a healthy life.

How to take

Adult dose

Tablets: Administer 1 or 2 mg of estradiol orally once daily without interruption, and if adverse reactions occur with 2 mg, adjust to 1 mg. Gel: After showering in the morning or evening, apply to a large area of clean skin (abdomen, shoulders, upper arms, thighs) excluding the breasts and vulva; the amount per application corresponds to 0.75 mg of estradiol. On average, administer 1.5 mg daily for 24-28 days.

Precautions

This medication is used for hormone replacement therapy in postmenopausal women. It may increase the risk of endometrial cancer and breast cancer, so women with a uterus should take another hormone called progestin as directed by their doctor. Regular check-ups are necessary during long-term use, and breast self-examinations and regular breast screenings are recommended due to the potential increased risk of breast cancer. This medication should not be used if there is a history of or suspicion of breast cancer or endometrial cancer, severe liver dysfunction, a history of thrombosis, or cardiovascular diseases. It is also not administered to pregnant women or those who may become pregnant, nor to breastfeeding mothers. Women with certain conditions, such as smooth muscle tumors, endometriosis, hypertension, diabetes, or liver disease, should consult a doctor before use and require careful monitoring during treatment. This medication can cause side effects such as headaches, breast pain, edema, and abdominal pain. Rarely, thrombosis, liver function abnormalities, and skin rashes may occur. If symptoms of thrombosis, such as leg pain or swelling, sudden chest pain, or shortness of breath develop, seek immediate medical attention. This drug may interact with other medications, so inform your doctor about any other medications being taken. Overdosage may result in nausea, vomiting, and breast tenderness, and while there is no specific antidote, treatment should be supportive according to the symptoms. Store this medication out of the reach of children, avoid direct sunlight, and store at room temperature below 25 degrees Celsius. When using, clean the area of application and avoid contact with the eyes, mouth, and mucous membranes, ensuring to wash hands after application. Additionally, this medication is not a contraceptive and should not be used for pregnancy prevention. An increased risk of dementia has been reported, so women over the age of 65 should use it with caution.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash accompanied by fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe overall lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Breast tenderness
  • breast pain
  • abdominal pain
  • headache
  • visual disturbances
  • dyspepsia
  • vomiting
  • bloating
  • abdominal distension
  • gallstones
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  • leg cramps
  • rashes
  • hair loss
  • increased blood pressure
  • insomnia
  • dizziness
  • diarrhea
  • itching
  • melasma
  • polymorphic erythema
  • nodular erythema
  • vascular purpura
  • decreased libido
  • exacerbation of asthma
  • signs of dementia
  • gas retention
  • nausea
  • increased blood pressure
  • palpitations
  • venous thrombosis
  • vulvar itching
  • postcoital bleeding
  • leukorrhea
  • vulvar edema

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is also advisable to store the medication at normal room temperature, avoiding excessively hot or cold places.

Appearance and packaging

Appearance

Clear colorless to white soft gel preparation

Package unit

28 grams/packet[(1 gram/packet x 28)]

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.