地屈孕酮片, Dydrogesterone Tablets, Diqu Yuntong Pian, 20tablets

Drug Name

Dydrogesterone Tablets
(Generic Name: Dydrogesterone Tablets; Pinyin: Diqu Yuntong Pian)

Active Ingredient

The active ingredient is dydrogesterone.
Chemical Name: 9β,10α-Pregn-4,6-diene-3,20-dione
Molecular Formula: C₂₁H₂₈O₂
Molecular Weight: 312.85
Excipients: Lactose monohydrate, corn starch, colloidal silicon dioxide, magnesium stearate, hypromellose, and film-coating premix (gastric soluble).

Description

This product is a white film-coated tablet that appears white after the coating is removed.

Indications/Therapeutic Uses

Dydrogesterone is used to treat diseases caused by endogenous progesterone deficiency, including:

• Dysmenorrhea (painful menstruation)
• Endometriosis
• Secondary amenorrhea (absence of menstruation)
• Irregular menstrual cycles
• Dysfunctional uterine bleeding
• Premenstrual syndrome
• Threatened miscarriage or habitual miscarriage due to progesterone deficiency
• Infertility caused by luteal phase deficiency
• Luteal support in assisted reproductive technology (ART)

Dosage and Administration

Dysmenorrhea:
Administer orally, 1 tablet (10 mg) twice daily from day 5 to day 25 of the menstrual cycle.

Endometriosis:
Administer orally, 1 tablet (10 mg) two to three times daily from day 5 to day 25 of the menstrual cycle.

Functional Uterine Bleeding:

• Hemostasis: 1 tablet (10 mg) twice daily for 5–7 days.
• Bleeding Prevention: 1 tablet (10 mg) twice daily from day 11 to day 25 of the menstrual cycle.

Amenorrhea:
Administer estradiol once daily from day 1 to day 25 of the menstrual cycle. Combine with dydrogesterone (10 mg) twice daily from day 11 to day 25.

Premenstrual Syndrome:
Administer 1 tablet (10 mg) twice daily from day 11 to day 25 of the menstrual cycle.

Irregular Menstrual Cycles:
Administer 1 tablet (10 mg) twice daily from day 11 to day 25 of the menstrual cycle.

Threatened Miscarriage:
Initial dose: 4 tablets (40 mg) orally, followed by 1 tablet (10 mg) every 8 hours until symptoms resolve.

Habitual Miscarriage:
Administer 1 tablet (10 mg) twice daily until the 20th week of pregnancy.

Infertility Due to Luteal Phase Deficiency:
Administer 1 tablet (10 mg) daily from day 14 to day 25 of the menstrual cycle. Treatment should continue for at least 6 consecutive cycles. Follow the dosage for habitual miscarriage or as directed by a physician during early pregnancy.

(Refer to the package insert for additional dosing instructions.)

Adverse Reactions

(Refer to the package insert for details.)

Contraindications

• Hypersensitivity to dydrogesterone or any excipients.
• Known or suspected hormone-dependent tumors.
• Known or suspected hormone-related malignancies.
• Unexplained vaginal bleeding.
• Severe hepatic impairment, history of severe liver disease, or elevated liver enzymes; liver tumors (current or past), Dubin-Johnson syndrome, Rotor syndrome, jaundice.
• Pregnancy-related conditions or symptoms worsened by sex hormones (e.g., severe pruritus, obstructive jaundice, herpes gestationis, porphyria, otosclerosis).
• Discontinue use in confirmed or suspected spontaneous or induced abortion.
• Contraindications to combined therapy with estrogens and progestins (e.g., dydrogesterone).

Precautions

(Refer to the package insert for details.)