Medication info
Premarin Tablets 0.3mg (Conjugated Estrogens)

Premarin Tablets 0.3mg (Conjugated Estrogens)

Prescription medicationTablet
Ingredient · strength
Conjugated Estrogens›0.3mg / 1 tablet
Manufacturer / importer
Darim Biotech Co., Ltd.
Appearance
Green oval film-coated tablet
Packaging
For domestic use: 30 tablets (30 tablets/PTPX1), for export: 21 tablets (21 tablets/PTPX1), 30 tablets (30 tablets/PTPX1)
Approval status
Active

MFDS item code 200710607 · Notified 2007.09.18 · Insurance code 664601060

Summary

Main use
Treatment and relief of hormonal disorders (e.g., menopausal symptoms), bleeding, osteoporosis, and cancer (e.g., breast cancer)
Who uses it
Adults · Children
Adult dosage
1. Hypoestrogenism due to hypogonadism, oophorectomy, or ovarian failure - Hypogonadism: The usual adult dose is 0.3 ~ 0.625mg of conjugated estrogens daily for 3 weeks, followed by 1 week without treatment. Adjust the dose for each patient to achieve the optimal response, based on symptom severity and endometrial response. - Oophorectomy and ovarian failure: Administer 1.25mg of this drug daily for 3 weeks, followed by 1 week without treatment. Adjust the dose according to symptom severity and patient response. Use the minimum effective dose for maintenance. 2. Atrophic vaginitis, vulvar atrophy, menopausal symptoms - The usual adult dose is 0.3-1.25mg of this drug daily, starting on day 5 of the menstrual cycle, either cyclically (3 weeks of treatment followed by 1 week without treatment) or continuously. Repeat until symptoms improve. 3. Functional uterine bleeding : The usual adult dose is 0.625-3.75mg of this drug daily in divided doses until bleeding stops; then continue the same dose for 20 days. 4. Osteoporosis : The usual adult dose is 0.625-1.25mg of this drug daily, starting on day 5 of the menstrual cycle, either cyclically (3 weeks of treatment followed by 1 week without treatment) or continuously. Repeat until symptoms improve. 5. Postmenopausal breast cancer (for palliation) : The usual adult dose is 10mg per dose 3 times daily for at least 3 months. 6. Inoperable advanced prostate cancer (for palliation) : The usual adult dose is 1.25-2.5mg per dose 3 times daily. (Injection) 1. Adults : Inject 20-25mg of conjugated estrogens slowly intravenously or intramuscularly per dose. Intravenous injection is more useful because a faster response can be expected. If necessary, repeat the dose after 6-12 hours. Other appropriate treatments may be available in addition to use of this drug. Usual precautions for intravenous injection are required; inject slowly to prevent flushing. Infusion of this drug together with other drugs is generally not recommended. In an emergency, if an infusion has already been started, injection into the end of the infusion set tubing is appropriate. However, consider the possibility of solution mixing.
Children's dosage
(Injection) 2. Children : Inject 5-10mg of this drug per dose.

Ingredients

Manufacturer
Darim Biotech Co., Ltd.

Efficacy & effects

Treatment and relief of hormonal disorders (e.g., menopausal symptoms), bleeding, osteoporosis, and cancer (e.g., breast cancer)

  • Hypogonadism
  • hypoestrogenism due to oophorectomy and ovarian failure
  • atrophic vaginitis
  • vulvar atrophy
  • menopausal disorders
  • dysfunctional uterine bleeding
  • osteoporosis
  • postmenopausal breast cancer
  • advanced prostate cancer
  • dysfunctional uterine bleeding due to hormonal imbalance
  • bleeding during or after surgery
View approved original text

This medication is used to treat hypoestrogenism due to hypogonadism, oophorectomy, and ovarian failure. It also alleviates symptoms caused by atrophic vaginitis and vulvar atrophy, and improves the discomfort of menopausal disorders. It helps in the treatment of dysfunctional uterine bleeding and osteoporosis, and is used to relieve symptoms of postmenopausal breast cancer and advanced prostate cancer. As an injectable form, it is utilized to prevent and treat dysfunctional uterine bleeding caused by hormonal imbalance and to manage bleeding during or after surgery. It is effectively used for various hormone-related conditions.

Dosage and Administration

Adult dosage

1. Hypoestrogenism due to hypogonadism, oophorectomy, or ovarian failure - Hypogonadism: The usual adult dose is 0.3 ~ 0.625mg of conjugated estrogens daily for 3 weeks, followed by 1 week without treatment. Adjust the dose for each patient to achieve the optimal response, based on symptom severity and endometrial response. - Oophorectomy and ovarian failure: Administer 1.25mg of this drug daily for 3 weeks, followed by 1 week without treatment. Adjust the dose according to symptom severity and patient response. Use the minimum effective dose for maintenance. 2. Atrophic vaginitis, vulvar atrophy, menopausal symptoms - The usual adult dose is 0.3-1.25mg of this drug daily, starting on day 5 of the menstrual cycle, either cyclically (3 weeks of treatment followed by 1 week without treatment) or continuously. Repeat until symptoms improve. 3. Functional uterine bleeding : The usual adult dose is 0.625-3.75mg of this drug daily in divided doses until bleeding stops; then continue the same dose for 20 days. 4. Osteoporosis : The usual adult dose is 0.625-1.25mg of this drug daily, starting on day 5 of the menstrual cycle, either cyclically (3 weeks of treatment followed by 1 week without treatment) or continuously. Repeat until symptoms improve. 5. Postmenopausal breast cancer (for palliation) : The usual adult dose is 10mg per dose 3 times daily for at least 3 months. 6. Inoperable advanced prostate cancer (for palliation) : The usual adult dose is 1.25-2.5mg per dose 3 times daily. (Injection) 1. Adults : Inject 20-25mg of conjugated estrogens slowly intravenously or intramuscularly per dose. Intravenous injection is more useful because a faster response can be expected. If necessary, repeat the dose after 6-12 hours. Other appropriate treatments may be available in addition to use of this drug. Usual precautions for intravenous injection are required; inject slowly to prevent flushing. Infusion of this drug together with other drugs is generally not recommended. In an emergency, if an infusion has already been started, injection into the end of the infusion set tubing is appropriate. However, consider the possibility of solution mixing.

Children's dosage

(Injection) 2. Children : Inject 5-10mg of this drug per dose.

Precautions

This medication is a hormonal preparation used for alleviating menopausal symptoms and preventing osteoporosis. Caution is needed when using this medication since it may increase the risk of certain cancers and cardiovascular diseases. In particular, women with a uterus may be at increased risk of endometrial cancer if this medication is used alone. There may also be an increased risk of cardiovascular diseases, such as stroke, deep vein thrombosis, pulmonary embolism, and myocardial infarction, so patients with a history of thrombotic disease should be monitored more closely. This medication may cause various side effects in some women, including uterine bleeding, breast pain, breast cancer, liver dysfunction, increased blood pressure, etc. It should not be used during pregnancy as it may harm the fetus, and it is advisable not to use it while breastfeeding. Furthermore, it is contraindicated or should be used with caution in patients with certain diseases, so medical advice and instruction must be strictly followed. Regular health check-ups and gynecological examinations are necessary for long-term use of this medication, and any unusual symptoms during treatment should be reported immediately to healthcare professionals. Lastly, this medication may interact with other medications, so it is essential to inform about any other medications being taken.

Side effects

  • Destructive bleeding
  • dripping bleeding
  • abnormal skeletal bleeding
  • change in menstrual volume
  • irregular menstruation
  • premenstrual syndrome
  • amenorrhea
  • increase in uterine fibroid size
  • vaginitis including Candida infection
  • cervical erosion
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  • changes in cervical secretion
  • cystitis syndrome
  • endometrial cancer
  • endometrial hyperplasia
  • uterine cancer
  • hepatic hemangioma enlargement
  • abnormal uterine bleeding
  • vaginal discharge
  • pelvic pain
  • breast pain
  • breast cancer
  • breast fullness
  • tenderness
  • enlargement
  • galactorrhea
  • gynecomastia
  • discharge
  • fibrocystic breast changes
  • nausea
  • vomiting
  • abdominal cramps
  • abdominal bloating
  • cholestatic jaundice
  • pancreatitis
  • abdominal pain
  • gallbladder disease
  • ischemic colitis
  • liver spots
  • acanthosis nigricans
  • polymorphic erythema
  • erythema nodosum
  • hemorrhagic rash
  • hair loss
  • hirsutism
  • male-pattern hirsutism
  • itching
  • rash
  • corneal steepening
  • contact lens hypersensitivity
  • retinal vascular thrombosis
  • headache
  • migraine
  • dizziness
  • depression
  • chorea
  • fatigue
  • anxiety
  • hyperreactivity
  • cerebrovascular disease
  • stroke
  • worsening epilepsy
  • increased triglycerides
  • elevated blood pressure
  • superficial thrombophlebitis
  • pulmonary embolism
  • cerebral thrombosis
  • venous thromboembolism
  • myocardial infarction
  • liver dysfunction (elevated AST, ALT)
  • weight gain or loss
  • worsening porphyria
  • edema
  • changes in libido
  • leg cramps
  • decreased glucose tolerance
  • elevated blood glucose levels
  • arthralgia
  • mood disorders
  • hypersensitivity
  • hypocalcemia
  • worsening asthma
  • anaphylactic reaction
  • urticaria
  • angioedema
  • ovarian cancer
  • enhanced growth of benign meningioma
  • nausea
  • vomiting
  • breast tenderness
  • dizziness
  • abdominal pain
  • drowsiness
  • fatigue
  • skeletal bleeding

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 exposure, and it is best kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

Green oval film-coated tablet

Package unit

For domestic use: 30 tablets (30 tablets/PTPX1), for export: 21 tablets (21 tablets/PTPX1), 30 tablets (30 tablets/PTPX1)

Same-ingredient medicines

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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.

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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.