Generic Name: Progesterone (Vaginal Pessary) 400mg
Company Name: Renata Pharma Ltd
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Indications
Progesterone, a female sex hormone, is present in Microgest 400 Vaginal Pessary. It is used to address problems with menstruation and pregnancy brought on by hormonal imbalance. In order to avoid endometrial hyperplasia, it is also recommended in conjunction with estrogen as part of hormone replacement therapy (thickening of the lining of the uterus).
Pharmacology
Natural endogenous progesterone is physically and physiologically similar to Micronized Progesterone Vaginal Pessary.
Absorption: In healthy women, vaginal administration of 400 mg progesterone every 12 hours has been demonstrated to be successful in swiftly attaining and maintaining serum progesterone concentrations at physiological levels adequate for the ovarian cycle's mid-luteal phase and early pregnancy.
Progesterone is predominantly attached to serum albumin and corticosteroid-binding globulin, with around 96 percent to 99 percent associated with serum proteins.
Progesterone is predominantly processed by the liver, which produces pregnanediol and pregnanolones. Pregnanediols and pregnanolones are converted to glucuronide and sulfate metabolites in the liver. Bile-excreted progesterone metabolites can be deconjugated and subsequently metabolized in the gut through reduction, dehydroxylation, and epimerization.
Progesterone is eliminated by the kidneys and bile ducts.
Dosage & Administration
For luteal phase support as part of an ART treatment: 400 mg was administered vaginally twice a day starting at oocyte retrieval. The administration of Progesterone should be continued for 38 days if pregnancy has been confirmed.
For maintenance of Pregnancy in cases of Threatened or recurrent abortion: 200 to 400 mg per day in divided doses.
For the treatment of premenstrual syndrome and puerperal depression: 200 mg daily to 400mg twice a day, by vaginal or rectal insertion. For premenstrual syndrome commence treatment on day 14 of the menstrual cycle and continue treatment until the onset of menstruation. If symptoms are present at ovulation commence treatment on day 12.
Interaction
Rifampicin, carbamazepine, and phenytoin are examples of drugs that stimulate the hepatic cytochrome-P450-3A4 system, which can increase the clearance rate and hence decrease progesterone bioavailability. Concomitant vaginal products have not been studied for their effect on progesterone exposure from Micronized Progesterone, thus they are not suggested.
Contraindications
Side Effect
The estrogenic, androgenic, and mineralocorticoid actions of micronized progesterone are absent. Mild somnolence has been recorded, as well as other CNS adverse effects such as depression, breast discomfort, and bloating. When using the vaginal method, there are fewer side effects.
Pregnancy & Lactation
Progesterone is known as the “pregnancy hormone.”
Progesterone helps the fertilized egg be implanted in the uterus to establish a pregnancy and help maintain a healthy pregnancy.
Women naturally produce progesterone in the ovaries, the placenta, and the adrenal glands during pregnancy.
During fertility treatments such as IVF (in vitro fertilization), progesterone is often given because the medications used in the process reduce a woman’s natural production of the hormone.
Precautions & Warnings
In the case of a threatening miscarriage, micronized progesterone is not recommended. In the event of a missed miscarriage, treatment should be stopped. If any of the following problems are suspected, micronized progesterone should be stopped: Myocardial infarction, cerebrovascular problems, arterial or venous thromboembolism (pulmonary embolism or venous thromboembolism), thrombophlebitis, or retinal thrombosis are all examples of thromboembolism.
Storage Conditions
Keep the container cold (below 30°C), dry, and dark. Keep out of children's reach.
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