Product Overview
Generic name: conjugated estrogen cream
Chinese Pinyin: JieHeCiJiSuRuGao
English name: Conjugated Estrogens Cream
Product name: Red Lilai
Ingredients: Naturally combined estrogen, completely extracted from natural substances.
Properties: White-like cream.
Functions and indications: Postmenopausal women with atrophic vaginitis, dry vulva. Hypo estrogen caused by hypogonadism, castration, or primary ovarian function decline.
Specification: 1g: 0.625mg*14g/box
Usage and dosage: According to the severity of symptoms, 0.5-2 grams per day, intravaginal administration. Try to choose the lowest dose that can improve symptoms. This vaginal ointment should be used short-term and periodically, for example, use it continuously for 3 weeks and stop using it for 1 week.
Adverse reactions: ⒈Changes in the form of vaginal bleeding in the genitourinary system, abnormal withdrawal bleeding, bleeding changes, breakthrough bleeding, spotting bleeding, uterine leiomyoma volume increase; vaginal candidiasis; changes in the volume of cervical secretions.
⒉The breast is tender and enlarged.
⒊Gastrointestinal nausea, vomiting; abdominal cramps, abdominal distension; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis.
⒋Melasma or melasma persists after stopping the drug, erythema multiforme, erythema nodular erythema, hair loss, hirsutism in women.
⒌ Cardiovascular venous thromboembolism, pulmonary embolism.
⒍The curvature of the cornea becomes steep and the tolerance to contact lenses decreases.
⒎ Central nervous system headache, migraine, dizziness, depression, chorea.
⒏ Other weight gain or loss, impaired glucose tolerance, aggravated porphyria, edema, and changes in libido.
Contraindications: 1. Unusually diagnosed abnormal bleeding from reproductive organs.
2. Known, suspected or had breast cancer.
3. Known or suspected estrogen-dependent tumors.
4. Active deep vein thrombosis, pulmonary embolism or a history of such diseases.
5. Active or recent (such as within the past year) arterial thromboembolic disease (such as stroke, myocardial infarction).
6. Liver insufficiency or liver disease that cannot be restored to normal by liver function test.
7. This product cannot be used in patients who are known to have allergic reactions to its ingredients.
8. Known or suspected pregnancy, this product has no indication for pregnant women. Women who accidentally use oral contraceptives containing estrogen and progesterone during pregnancy may not increase or are unlikely to increase the risk of birth defects in their children.
Note: Estrogen/hormone replacement therapy (ERT/HRT) is associated with an increased risk of certain cancers and cardiovascular diseases. Women with intact uterus and women using non-antagonist estrogen are associated with an increased risk of endometrial cancer. The ERT/HRT method should not be used or continued to prevent coronary heart disease.
Drug interactions: Research data on drug interactions combining equine estrogen and medroxyprogesterone acetate show that the two drugs do not change their pharmacokinetic properties when used at the same time. Studies on the interaction of conjugated equine estrogen and other drugs have not been carried out. In vivo and in vitro studies have shown that 17β-estradiol, a component of equine estrogen, is partially metabolized by cytochrome P450 3A4 (CYP3A4), so CYP3A4 is a strong inducer (for example: phenobarbital, phenytoin, rifampicin and dexamethasone) Can reduce the plasma concentration of 17β-estradiol. Lead to reduced estrogen effects and/or changes in the state of uterine bleeding. CYP3A4 inhibitors (for example: cimetidine, erythromycin, and ketoconazole) can increase the plasma concentration of 17β-estradiol and may cause side effects.
Pharmacology and Toxicology: The pharmacological effects of combined estrogen are similar to endogenous estrogen. In target organ tissues (women's genitourinary organs, breasts, hypothalamus, pituitary gland), estrogen enters the cells and is transported to the nucleus, causing specific RNA and protein synthesis.
Pharmacokinetics: Conjugated estrogen is water-soluble and can be absorbed through mucosa after topical administration. Mainly in the liver metabolism and inactivation. Some estrogen is secreted from bile, however, they can be reabsorbed through the liver-intestinal circulation. The water-soluble estrogen mixture is strongly acidic. Therefore, it is ionized in body fluids, and the renal tubules are reabsorbed very little, which is beneficial to excretion through the kidneys.
Medication for pregnant women and lactating women: This product should not be used for pregnant women. The use of estrogen can reduce the quality and quantity of milk. Estrogen can be detected in the milk of mothers taking the drug. Women who are breastfeeding should not use estrogen.
Children's medication: Although estrogen replacement therapy has been used to treat certain adolescents with puberty retardation to induce puberty, the safety and efficacy of children have not been established. Adolescent girls receiving estrogen therapy can also cause premature breast development and vaginal keratinization, and may lead to vaginal bleeding. Because long-term high-dose and repeated administration of estrogen will accelerate bone closure, hormone therapy should not be started before bone closure, so as not to endanger bone growth and development. If the patient uses estrogen before the completion of bone development, it is recommended to monitor its effect on bone maturity and bone center regularly during the medication.
Medication for elderly patients: In the WHI-estrogen alone subgroup study, 46% of the subjects (n=4943) were 65 years old and older, of which 7.1% (n=767) were 75 years old And above. Compared with placebo, conjugated equine estrogen has a higher relative risk of stroke in elderly people less than 75 years old than those over 75 years old. Among all the subjects participating in the WHI combined equine estrogen plus medroxyprogesterone acetate sub-study, 44% (n=7320) of the subjects were between 65-74 years old, and 6.6% of them (n=1095) ) Is 75 years old and above.
Overdose: In adults and children, the symptoms of overdose of estrogen-containing drugs include: nausea, vomiting, breast tenderness, dizziness, drowsiness/fatigue; withdrawal bleeding may occur in women. There is no special antidote, and symptomatic treatment should be taken if necessary.
Storage: shading and airtight.
Packing: 1g: 0.625mg*14g/box.
Validity period: 24 months
Approval number: National Medicine Standard H20051718
Company Name: Xinjiang Xinziyuan Biopharmaceutical Co., Ltd.
