Patient's question:
Why is it that sometimes my period doesn't come, and the doctor says I need to get a progesterone injection? Is it effective to inject progesterone for irregular periods?Doctor's answer:
Generic Name: Progesterone InjectionFormer Names:
English Name: PROGESTERONEINJECTION
Pinyin Name: HUANGTITONGZHUSHEYE
Drug Category: Estrogen and Progestogen Class
Indications: Used for menstrual disorders such as amenorrhea and functional uterine bleeding, luteal insufficiency, threatened abortion and habitual abortion (due to luteal insufficiency), and treatment of premenstrual tension syndrome;
Characteristics: This product is a clear, colorless or pale yellow oily liquid.
Pharmacology and Toxicology: This product is a progestogen with general progestogen effects. In the late stage of the menstrual cycle, it induces secretory changes in the endometrium, providing favorable conditions for implantation of the fertilized egg. After implantation, the placenta forms, reducing uterine excitability and allowing the fetus to grow safely. In combination with estrogen, it promotes breast development, preparing for lactation. This product can inhibit the release of luteinizing hormone from the anterior lobe of the pituitary through negative feedback on the hypothalamus, preventing the maturation of follicles and inhibiting the ovulation process.
Pharmacokinetics: After intramuscular injection of the oil solution, it is rapidly absorbed. It is metabolized in the liver, with approximately 12% metabolized to progesterone aldehyde, which is then conjugated with glucuronic acid and excreted in the urine. After injecting 100mg, blood drug concentrations reach 68 μg/kg within 6-8 hours and gradually decline, with a duration of action of 48 hours and complete disappearance within 72 hours.
Dosage and Administration: Intramuscular Injection: 1) Threatened abortion: Generally 10-20mg, continued until pain and bleeding cease; 2) History of habitual abortion: 10-20mg once, 2-3 times per week starting from the beginning of pregnancy; 3) Functional uterine bleeding: When hemoglobin is below 7mg, 10mg per day for 5 days, or 20mg per day for 3-4 days; 4) Amenorrhea: 10mg daily for 5 days starting 8-10 days before the expected menstrual period, or 20mg daily for 3-4 days; 5) Premenstrual tension syndrome: 10-20mg injected 12 days before the expected menstrual period, continued for 10 days.
Adverse Reactions: Occasionally nausea, dizziness, headache, fatigue, urticaria, breast swelling, reduced menstrual flow or amenorrhea, abnormal liver function, edema, and weight gain may occur with prolonged use.
Contraindications: Contraindicated in patients with severe liver damage (may worsen symptoms).
Precautions: 1) Use with caution in patients with kidney disease, edema due to heart disease, or hypertension. 2) The existence of progesterone deficiency in premenstrual tension syndrome is not yet definitive, so the use of progesterone for treatment is controversial. 3) Comprehensive examinations should be conducted before administering to patients other than those with early abortion to confirm luteal insufficiency before use.
Use in Pregnancy and Lactation:
Use in Children:
Use in Elderly Patients:
Drug Interactions:
Overdose:
Storage: Store in a dark, airtight container.
Progesterone Injection
Pinyin Name: HUAGTITOGZHUSSHYE
English Name: PROGESTERONEINJECTION
Source (Molecular Formula) and Standard: This product is a sterile oil solution of progesterone. It contains progesterone (C21H30O2) at 93.0-107.0% of the labeled amount.
Characteristics: This product is a clear, colorless or pale yellow oily liquid.
Tests: Should meet the relevant requirements for injectables (Appendix I B).
Identification: Take an appropriate amount of the product (about equivalent to 50mg of progesterone), add 30ml of petroleum ether (boiling range 60-90°C), shake well, and add 30ml of 2-nitrobenzaldehyde solution (prepare by dissolving 0.5g of 2,4-dinitrobenzaldehyde in 5ml of hydrochloric acid and 95ml of anhydrous ethanol, shaking to dissolve, standing overnight, and filtering). Shake for 5 minutes to mix the two liquid layers, heat under a water bath with reflux and occasional shaking for 5-10 minutes, and allow to stand for 2 hours before filtering. Wash the precipitate successively with petroleum ether, hydrochloric acid-ethanol (6:94), and ethanol, dry at 105°C, and determine the melting point (Appendix VI C). The melting point is 267-275°C, with decomposition occurring during melting.
Assay: Determine by high-performance liquid chromatography (Appendix V D).
Chromatographic Conditions and System Suitability Test: Use 8C18 silica gel as the packing material; methanol-water (66:33) as the mobile phase, with a detection wavelength of 254nm. The theoretical plate count calculated for the progesterone peak should be no less than 600, and the resolution between the progesterone peak and the internal standard peak should meet the requirements.
Preparation of Internal Standard Solution: Accurately weigh about 18mg of estrone, dissolve in methanol, and dilute to the mark in a 25ml volumetric flask. Shake well.
Determination Method: Accurately weigh about 25mg of progesterone reference standard, dissolve in methanol, and dilute to the mark in a 25ml volumetric flask. Shake well. Accurately measure 5ml of the reference solution and 5ml of the internal standard solution, and dilute to the mark with methanol in a 25ml volumetric flask. Shake well. Inject 5-10μl into the liquid chromatograph and record the chromatogram. Using a volumetric pipette, accurately measure an appropriate amount of the product (about equivalent to 50mg of progesterone), wash the inside of the pipette with ether several times, and add the washings to the volumetric flask. Dilute with ether to the mark and shake well. Accurately measure 5ml into a stoppered centrifuge tube, and allow the ether to evaporate in a warm water bath. Shake with methanol 4 times (5ml each for the first 3 times, 3ml for the fourth time), shaking for 10 minutes each time and centrifuging for 15 minutes. Using a dropper, transfer the methanol solution to a 25ml volumetric flask, combine the extracts, add 5ml of the internal standard solution, dilute with methanol to the mark, and shake well. Inject 5-10μl into the liquid chromatograph and calculate the peak area by the internal standard method.
Category: Same as progesterone.
Dosage: Intramuscular injection, 10-20mg per dose.
Specifications: (1) 1ml: 10mg (2) 1ml: 20mg
Storage: Store in a dark, airtight container.