Proglen™

• Premenstrual syndrome
• Menstrual irregularities through dysovulation or anovulation
• Menopause (in addition to oestrogen treatment) to significantly reduce the risk of endometrial hyperplasia and carcinoma.
• Dysfunctional uterine bleeding (DUB)
• Secondary amenorrhoea
• Luteal support during assisted reproductive techniques (ART)
• Luteal support in in luteal phase defect

• Premenstrual syndrome, menstrual irregularities: The treatment should be started at a dose of 200 to 300 mg per day, 10 days per cycle, usually from the 14th day to until onset of menstruation.
• Menopause (in addition to oestrogen treatment):200 mg per day in the evening for the last 14 days of the oestrogen treatment per cycle (i.e. from day 8 to day 21 for a 28-day cycle; and from day 12 to day 25 for a 30-day cycle).
• DUB: 300 to 400 mg (orally) once daily from the 12th day of the cycle for 10 days.
• Secondary amenorrhoea: May be given as a single daily dose of 400 mg at bedtime for 10 days.
• Luteal support during assisted reproductive techniques:400 mg once a day from the day of embryo transfer till pregnancy is confirmed. If pregnant, it should be continued till the 12th week of pregnancy.
• Luteal support in luteal phase defect: 300 mg from the 17th day of cycle for 10 days. If pregnant, it should be continued till the 12th week of pregnancy.

The tablet is to be administered at bedtime.

Progesterone shows similar action as that of progestin. It binds to the receptor which are present on pituitary, hypothalamus or female reproductive tract. By this progesterone will slow the release of gonadotropin releasing hormone (GnRH). It will cause the development of decidual tissue which is required to increase endometrial receptivity which is required for implantatin of the embryo. It will relax the uterine muscle and stimulation of growth of alveolar tissues in the mammary glands. Progesterone will maintain the pregnancy after embryo implantation in infertile patients.

Absorption

When administered by the oral route, the micronized progesterone is absorbed through the digestive tract. Serum progesterone concentrations are linear and dose-proportional following multiple-dose administration of progesterone. The oral bioavailability of progesterone is increased through micronization.

Distribution

Progesterone is approximately 96 to 99% bound to serum proteins, primarily to serum albumin (50 to 54%) and transcortin (43 to 48%).

Excretion

The glucuronide and sulphate conjugates of pregnanediol and pregnanolone are excreted in the bile and urine. Progesterone metabolites are eliminated mainly by the kidneys. Progesterone metabolites, which are excreted in the bile, may undergo enterohepatic recycling or may be excreted in the faeces.

Micronized progesterone sustained-release tablets should not be used in women with any of the following conditions:

• In patients with a known hypersensitivity to its ingredients.
• Undiagnosed abnormal genital bleeding.
• Known, suspected, or a history of breast cancer
• Active deep vein thrombosis, pulmonary embolism or a history of these conditions.
• Active arterial thromboembolic disease (e.g. stroke and myocardial infarction), or a history of these conditions.
• Known liver dysfunction or disease.

• Natural micronized progesterone in sustained release formulation may cause transient dizziness and drowsiness and should be used with caution when driving a motor vehicle or operating machinery.
• Should be taken as a single daily dose at bedtime.
• The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately.
• Not be used during pregnancy
• Cautiously used in nursing mothers