黄体酮胶囊, Huangtitong Jiaonang, Progesterone Capsules, 20Capsules

Drug Name

Progesterone Capsules
Huangtitong Jiaonang

Active Ingredient

The active ingredient is progesterone.
Chemical Name: Pregn-4-ene-3,20-dione
Molecular Formula: C₂₁H₃₀O₂
Molecular Weight: 314.5

Description

This product is a hard capsule containing white or off-white powder.

Indications/Therapeutic Uses

• Threatened miscarriage and habitual miscarriage
• Premenstrual syndrome
• Anovulatory dysfunctional uterine bleeding and anovulatory amenorrhea
• Combined with estrogen for the treatment of menopausal syndrome

Dosage and Administration

1. Combined Use with Estrogen (e.g., conjugated estrogens, Premarin):
   • Premarin Tablets: 1.25 mg orally once daily for 22 days.
   • Starting from day 13 of Premarin use, administer this product: 200 mg (4 capsules) twice daily for 10 days.
2. For Threatened Miscarriage, Habitual Miscarriage, Premenstrual Syndrome, Anovulatory Dysfunctional Uterine Bleeding, and Anovulatory Amenorrhea:
   • Standard dose: 200–300 mg (4–6 capsules) daily, administered once or twice daily.
   • Maximum single dose: 200 mg (4 capsules).
   • Administer away from meal times.

Adverse Reactions

• Breakthrough bleeding, vaginal spotting
• Weight changes (gain or loss)
• Cervical ectropion, changes in cervical discharge
• Breast tenderness, nausea, dizziness, headache
• Fatigue, fever, insomnia
• Allergic reactions (with or without pruritus), chloasma, melasma
• Obstructive jaundice, abnormal liver function

Contraindications

• Hypersensitivity to progesterone or any excipients in this product
• Unexplained vaginal bleeding
• History or presence of thromboembolic disorders (e.g., thrombophlebitis, cerebrovascular accident, pulmonary embolism, retinal thrombosis)
• Breast or genital tract tumors

Precautions

• Use with caution in patients with nephropathy, cardiac edema, or hypertension.
• Discontinue immediately if signs of thromboembolic disease (e.g., thrombophlebitis, cerebrovascular events, retinal thrombosis) occur.
• Discontinue immediately if sudden vision loss, diplopia, or migraine develops.

Special Population Guidelines

Pediatric Use: Not established.

Pregnancy and Lactation:

• No adverse fetal effects observed in animal studies; use only under medical supervision during pregnancy.
• Small amounts of progesterone are excreted in breast milk; use only under medical supervision during lactation.

Geriatric Use: Not established.

Drug Interactions

• Inducers of CYP450 Enzymes (e.g., phenobarbital, phenytoin, rifampin): May reduce progesterone efficacy.
• CYP450 Inhibitors (e.g., ketoconazole): May increase progesterone blood levels.

Pharmacological Actions

Progesterone is a steroid hormone secreted by the ovaries, placenta, and adrenal glands. In the presence of adequate estrogen, progesterone transforms the endometrium from proliferative to secretory, facilitating embryo implantation and maintaining pregnancy by reducing uterine excitability. It also supports mammary gland development for lactation. Progesterone exerts negative feedback on the hypothalamus, inhibiting pituitary luteinizing hormone release, thereby suppressing follicular development and ovulation.

Storage

Store in a cool, dry place, protected from light and sealed tightly.

Specifications

50 mg per capsule.

Packaging

Aluminum-plastic blister packs.
Pack Size: 10 capsules per blister, 2 blisters per box.

Expiration

24 months.