What Is Progesterone Gel?

Progesterone vaginal sustained-release gel for supplemental treatment of progesterone in assisted reproduction technology.

Progesterone vaginal sustained release gel ingredients:

Progesterone The chemical name of progesterone: progesterone-4ene-3,20-dione,
Molecular formula: C ₂₁ H ₃₀ O ₂ ,
Molecular weight: 314.47.
Excipients: glycerin, light liquid paraffin, hydrogenated palm oil glyceride, carbomer 974P, sorbic acid, polycarbophil, sodium hydroxide and pure water.

Progesterone Vaginal Sustained Release Gel Properties:

This product is white or off-white milky viscous body.

Progesterone vaginal sustained-release gel indications:

It is used for supplementary treatment of progesterone in assisted reproduction technology.

Progesterone vaginal sustained release gel specifications:

8% (90mg)

Progesterone vaginal sustained-release gel

For vaginal administration, once a day, 90 mg (one stick). If pregnant, continue treatment until the placenta has autonomous function, reaching 10-12 weeks.
How to use Snow Nursing 1. Remove the dispenser from the sealed bag. Do not remove the screwable cap at this time. (For use at altitudes above 2500 feet, please see the special instructions below.) 2. Hold the thick end of the applicator with your thumb and index finger. Shake vigorously 3-4 times (like a thermometer), making sure to shake the contents to the fine tip of the applicator. 3. Hold the flat part of the thick end of the applicator firmly. Unscrew the thin top cap and discard. Do not squeeze the thick end when screwing the cap, as this may cause the gel to be squeezed out before insertion. 4. Take a sitting or lying position, bend your knees, and insert the applicator into your vagina. Gently insert the thin tip into the vagina. 5. Press the thick end of the applicator and squeeze the gel into the vagina. Remove the applicator and discard it in the trash. Don't worry about the small amount of gel remaining in the applicator, as you have already received the correct and set dose. Special instructions (when used above 2500 feet above sea level) 1. Remove the applicator from the sealed bag. Do not remove the screwable cap at this time. As described above, hold the thick end of the applicator and pierce a small hole in the flat part of the thick end with a lancet or a pin. This will reduce the pressure difference between the internal and external pressure of the applicator due to high altitudes. This will not affect the amount of gel administered, as you will receive the correct and set dose. 2. See step 2 above 3. See step 3 above 4. See step 4 above 5. Place your thumb or index finger at the puncture hole on the thick end of the applicator. Press the thick end of the applicator to squeeze the gel into the vagina. Remove the applicator and discard it in the trash. Don't worry about a small part of the gel remaining in the applicator because you have already received the correct and set dose. Xue Nuo adheres to the inner wall of the vagina and can release progesterone for a long time. A few days after the administration, white microspheres may appear in the vaginal secretions. This phenomenon is very common, if you have any concerns, please discuss with your doctor. If you have forgotten the same dose of snow, please use it as soon as you remember, but do not exceed the recommended daily dose. Xue Nuo should not be used at the same time as other vaginal preparations.

Adverse effects of progesterone vaginal sustained-release gel :

Adverse events with a incidence of 5% or more include:
Whole body: abdominal pain, perineal pain, hypersensitivity (usually manifested as a rash) and other mild medication site reactions Central and peripheral nervous system: headache Digestive system: constipation, abdominal dissection, nausea, vomiting Musculoskeletal system: joint pain mental : Depression, hyposexuality, nervousness, sleepiness female reproductive system: breast enlargement, breast tenderness, difficulty in sexual intercourse, vaginal irritation, itching or burning sensation, spotting bleeding during menstruation (see red)
Urinary system: Adverse events with a incidence of nocturia of <5% include:
Autonomic nervous system: dry mouth, hyperhidrosis, whole body: crying, allergies, allergies, decreased appetite, fatigue, edema, facial edema, fever, hot flashes, flu-like symptoms, water retention, cardiovascular system: syncope central and peripheral nervous system: Migraine, tremor respiratory system: asthma, dyspnea, hyperventilation, rhinitis, pharyngitis,
Sinusitis Digestive system: indigestion, belching, flatulence, gastritis, toothache metabolism and nutrition: thirst urinary system: cystitis, dysuria, frequent urination, urinary tract infections musculoskeletal system: lower limb spasm, lower limb pain, bone pain blood System: Anemia, Purple Scar Tumor: Benign Cyst Female Reproductive System: Dysmenorrhea, Premenstrual Tenseness, Dry Vaginal Skin: Acne, Pruritus, Rash, Seborrhea, Skin Pigment Change, Skin Disease, Urticaria Spirit: Aggressive Reaction, Amnesia, Insomnia eye: conjunctivitis, dry eye

Progesterone vaginal sustained release gel contraindications:

Known allergy to this product (progesterone or any other component) Vaginal bleeding of unknown origin Liver dysfunction or liver disease Known or possible progesterone-sensitive malignant tumor Acute porphyria , Thromboembolic disease, or patients with a history of hormone-related thrombophlebitis or thromboembolic disease, cerebral hemorrhage, or a related medical history

Progesterone vaginal sustained release gel notes:

Physicians should be aware of the earliest symptoms of thromboembolic disease (thrombophlebitis, cerebrovascular disease, pulmonary embolism, and retinal thrombosis). Once these symptoms occur or are suspected, medication should be stopped immediately.
Persons with severe liver dysfunction should be used with caution Before treatment, special attention should be paid to check the breast and pelvic organs, and perform cervical smear cell smear examination.
When breakthrough bleeding and irregular vaginal bleeding occur, non-functional causes should be considered as with all unconventional vaginal bleeding. When vaginal bleeding of unknown origin occurs, you should seek medical treatment in time.
Since progesterone treatment may cause a certain degree of fluid retention, the diseases and symptoms (such as epilepsy, migraine, asthma, heart or kidney insufficiency) should be closely monitored.
When submitting relevant samples, the pathologist should be informed about the treatment of progesterone.
Patients with a history of mental depression should be closely observed when using this product. If severe depression recurs, the drug should be discontinued immediately.
In patients taking estrogen-progesterone combination, a small number of patients were observed to have impaired glucose tolerance. The mechanism by which this occurs is unknown. Therefore, diabetics should be closely observed when receiving luteal therapy.
Drivers and machine operators should be warned that using this product may cause dizziness or sleepiness.
Not applicable to threatened abortion. Treatment should be discontinued when a delayed abortion occurs.
Although the risk of thromboembolism is related to estrogen, the link between progesterone and thrombosis remains unclear. Therefore, women with common risk factors for thrombotic events, such as women with a personal or family history, can be further increased by treatment with Crinone. In these women, the benefits and risks of Crinone administration need to be weighed. However, it should be noted that pregnancy itself leads to an increased risk of thromboembolic events.
Avoid simultaneous use with other intravaginal preparations.
Sorbic acid can cause local skin reactions (such as contact dermatitis) or vaginal irritation.

Progesterone vaginal sustained release gel for pregnant and lactating women:

Medication during pregnancy: If the corpus luteum is deficient, this product can be used in the first 3 months of pregnancy.
Medication during lactation: Do not use this product during lactation.

Progesterone vaginal sustained release gel for children:

Not applicable.

Progesterone vaginal sustained-release gel for the elderly:

Not applicable.

Progesterone Vaginal Extended Release Gel Drug Interactions:

There is no interaction between Snow Nuo® and other drugs.
This product should not be used concurrently with other topical vaginal preparations. If other topical vaginal preparations are used at the same time, use them 6 hours before or after Xue Nuo Tong® administration.

Progesterone vaginal sustained release gel overdose:

If overdose, this product should be discontinued, and patients should be treated with symptomatic treatment and related support.

Clinical trial of progesterone vaginal sustained-release gel :

Two clinical trials have been conducted abroad. A multicenter, open-label clinical study (COL1620-F01) was designed to compare the effectiveness and safety of this product with progesterone oral preparations in IVF subjects. A total of 283 subjects were selected. Administration began within 24 hours after transplantation. The progesterone oral preparation group was given 100 mg every morning and 200 mg every night;
The progesterone vaginal sustained-release gel group was administered 90 mg once daily for 30 days. Results: There was no significant difference in pregnancy rates between the two groups (progesterone vaginal sustained-release gel group: 35%, oral progesterone preparation group: 30%, p = 0.31).
The other is a single-center, parallel, randomized, open clinical study (COL1620-007US), which aims to evaluate the induction, promotion and maintenance of POF (premature ovarian failure) or only part of ovarian function in the egg donation cycle. Effectiveness and safety of pregnancy. A total of 90 subjects were enrolled. Progesterone vaginal sustained-release gel 90mg (n = 64) was randomly administered twice daily or intramuscularly 100mg progesterone (n = 26) once daily. The trial consisted of three cycles (preparation cycle, egg donation cycle and treatment period). Results: Twenty-seven cases (54%) of progesterone vaginal sustained-release gel group were chemical pregnancy, of which 24 cases (48%) were clinical pregnancy. Of the 24 subjects with clinical pregnancy, 15 (30%) were persistent pregnancies. There were 4 (31%) chemical pregnancies in the intracorporeal corpus luteum group, and 3 (23%) were clinical pregnancies. Of the 3 subjects with clinical pregnancy, 2 (15%) were persistent pregnancies.
A randomized, open, multicenter, controlled clinical study was conducted in China to evaluate the safety and effectiveness of this product. A total of 238 subjects were selected for the trial, including 117 in the progesterone vaginal sustained-release gel group and 121 in the progesterone injection group. Progesterone vaginal sustained-release gel 90mg once a day, progesterone injection 60mg once a day, continuous use for 60 days. The results showed that there was no statistically significant difference in the hCG-positive rate of blood and the clinical pregnancy rates of 30 and 60 days after embryo transfer.

Progesterone vaginal sustained release gel pharmacology and toxicology

Pharmacological progesterone is a natural steroid hormone secreted by the ovary, placenta and adrenal glands. When there is sufficient estrogen, progesterone can change the endometrium from the proliferative phase to the secretory phase. Progesterone is the main substance in the development of decidual tissues. The effects of progesterone on glandular epithelial cells and mesenchymal differentiation have been extensively studied. Progesterone is an essential component to increase the endometrium's acceptability for implantation of pregnant eggs. After implantation of fertilized eggs, progesterone also plays a role in maintaining pregnancy. Oral estradiol and intramuscular progesterone can cause normal or almost normal endometrial responses in women with functional gonads between the ages of 50 and 60.
Toxicological carcinogenicity, mutagenicity, and fertility impairment No carcinogenicity or mutagenicity of Xue Nuo Tong® has been studied. The effect of Xue Nuo Tong® on fertility has not been evaluated in animals.

Progesterone Vaginal Extended Release Gel Storage

Keep tightly closed at 25 ° C. Keep out of reach of children.

Progesterone Vaginal Extended Release Gel Packaging:

This product is pre-packaged in a disposable white polyethylene applicator. The applicator is designed for vaginal delivery and can be twisted off at the top.
Each applicator can deliver 1.125g of gel containing 8% progesterone (90 mg).
Each dispenser is sealed and packaged individually in paper / coated / polyethylene foil, 15 boxes per box.

Progesterone vaginal sustained release gel expiration date:

36 months

Progesterone vaginal sustained release gel implementation standards:

JX20030101

Progesterone vaginal sustained-release gel import drug registration number:

Import Drug Registration Certificate Number: H20080649

Progesterone vaginal sustained-release gel manufacturers:

Fleet Laboratories Ltd