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Each capsule contains 200 mg of progesterone.
Excipients with known effect: GynProgest contains 298 mg of peanut oil per soft capsule.
Excipients/Inactive Ingredients: GynProgest: peanut oil and soy lecithin.
Body of the capsule: gelatin, glycerol, titanium dioxide.
Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progestogens. ATC code: G03DA04.
Pharmacology: Pharmacodynamics: Mechanism of action: Progesterone is a natural progestogen, the main hormone of the corpus luteum and the placenta. It acts on the endometrium by converting the proliferating phase to the secretory phase. GynProgest Vaginal 200 mg Capsules have all the properties of endogenous progesterone with induction of a full secretory endometrium and in particular gestagenic, antiestrogenic, slightly anti-androgenic and antialdosterone effects.
Pharmacokinetics: Absorption: Following oral administration, micronized progesterone is absorbed by the digestive tract. Pharmacokinetic studies conducted in healthy volunteers have shown that after oral administration of two 100 mg capsules (200 mg), plasma progesterone levels increased to reach the Cmax of 13.8 ng/ml +/- 2.9 ng/ml in 2.2 +/-1.4 hours. The elimination half-life observed was 16.8 +/-2.3 hours.
Although there were inter-individual variations, the individual pharmacokinetic characteristics were maintained over several months, indicating predictable responses to the drug.
Following vaginal administration, micronized progesterone is absorbed rapidly and achieves stable plasma levels in the range of 4-12 ng/ml, depending on the daily dose, with much less inter-subject variation than following oral administration.
Distribution: Progesterone is approximately 96%-99% bound to serum proteins, primarily to serum albumin (50%-54%) and transcortin (43%-48%).
Elimination: Urinary elimination is observed for 95% in the form of glycuroconjugated metabolites, mainly 3 α, 5 β-pregnanediol (pregnandiol).
Biotransformation: Progesterone is metabolized primarily by the liver.
Following oral administration, the main plasma metabolites are 20 α hydroxy-Δ 4 α-prenolone and 5 α-dihydroprogesterone. Some progesterone metabolites are excreted in the bile and these may be deconjugated and further metabolised in the gut via reduction, dihydroxylation and epimerisation. The main plasma and urinary metabolites are similar to those found during the physiological secretion of the corpus luteum.
Following vaginal administration, only low plasma levels of pregnanolone and 5 α-dehydroprogesterone are detected, due to the lack of first-pass metabolism.
Toxicology: Preclinical safety data: Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology and toxicity.
GynProgest Vaginal 200 mg Capsules is indicated in women for supplementation of the luteal phase during Assisted Reproductive Technology (ART) cycles.
Threatened miscarriage or prevention of habitual miscarriage due to luteal phase deficiency up to the 12th week of pregnancy.
Preterm labour.
Posology: Supplementation of the luteal phase during ART cycles: The recommended dosage is 600 mg/day, in three divided doses, from the day of embryo transfer until at least the 7th week of pregnancy and not later than the 12th week of pregnancy.
Threatened miscarriage or prevention of habitual miscarriage due to luteal phase insufficiency: the recommended dosage is from 200 to 400 mg/day in two divided doses up until the 12th week of pregnancy.
Preterm labour: Women with a history of preterm labour: 100 mg/day until 36th week of pregnancy. Women with cervix shorter than 15 mm detected at 22-26 weeks: 200 mg daily until the 36th week of pregnancy.
Paediatric population: There is no relevant use of GynProgest Vaginal 200 mg Capsules in the paediatric population.
Older people: There is no relevant use of GynProgest Vaginal 200 mg Capsules in older people.
Method of Administration: Vaginal.
Each capsule of GynProgest Vaginal 200 mg must be inserted deep into the vagina.
For dosage, national and local treatment guidelines should be taken into account.
Symptoms of overdosage may include somnolence, dizziness, euphoria or dysmenorrhoea. Treatment is observation and, if necessary, symptomatic and supportive measures should be provided.
Hypersensitivity to the active substance or to any of the excipients listed in Description, Severe hepatic dysfunction, Undiagnosed vaginal bleeding, Mammary or genital tract carcinoma, Thrombophlebitis, Thromboembolic disorders, Cerebral haemorrhage, Porphyria, Missed abortion.
GynProgest Vaginal 200 mg Capsules should only be used during the first three months of pregnancy and must only be administrated by vaginal route. Prescription of progesterone beyond the first trimester of pregnancy may reveal gravidic cholestasis.
GynProgest Vaginal 200 mg Capsules are not suitable as a contraceptive.
Treatment should be discontinued upon diagnosis of a missed abortion.
GynProgest Vaginal 200 mg Capsules contains soya lecithin and may cause hypersensitivity reactions (urticarial and anaphylactic shock in hypersensitive patients). As there is a possible relationship between allergy to soya and allergy to peanut, patients with peanut allergy should avoid using GynProgest Vaginal 200mg Capsules.
Effects on ability to drive and use machines: GynProgest Vaginal Capsules has negligible influence on the ability to drive and use machines.
Pregnancy: No association has been found between the maternal use of natural progesterone in early pregnancy and foetal malformations.
Breastfeeding: GynProgest Vaginal 200 mg Capsules is not indicated during breast-feeding.
Detectable amounts of progesterone enter the breast milk.
Fertility: As this medicinal product is indicated to support luteal deficiency in subfertile or infertile women, there is no deleterious known effect on fertility.
Post-Marketing experience: The information given as follows is based on extensive post marketing experience from vaginal administration of progesterone.
Adverse effects have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data). (See table.)
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GynProgest Vaginal 200 mg Capsules may interfere with the effects of bromocriptine and may raise the plasma concentration of ciclosporin. GynProgest Vaginal 200 mg Capsules may affect the results of laboratory tests of hepatic and/or endocrine functions.
Metabolism of GynProgest Vaginal 200mg Capsules is accelerated by rifamycin medicines (such as rifampicin) and antibacterial agents.
The metabolism of progesterone by human liver microsomes was inhibited by ketoconazole (IC50 <0.1 μM). Ketoconazole is a known inhibitor of cytochrome P450 3A4. These data therefore suggest that ketoconazole may increase the bioavailability of progesterone. The clinical relevance of the in vitro findings is unknown.
Incompatibilities: Not applicable.
Special precautions for disposal and other handling: Any unused product or waste material should be disposed of in accordance with local requirements.
Store in the original package.
Shelf life: 3 years.
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
GynProgest 200 mg vag soft cap 200 mg
1 × 15's
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