Each capsule contains 100 mg and 200 mg micronized Progesterone.
Pharmacotherapeutic group: Genito-urinary system and sex hormones. ATC Code: G03DA04.
Pharmacology: Pharmacodynamics: Progesterone is a natural progesterone, 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 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: Micronised progesterone is absorbed by the digestive tract. Pharmacokinetic studies conducted in healthy volunteers have shown that oral administration of 2 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.
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 3a, 5 B-pregnanediol (pregnanediol).
Metabolism: Progesterone is metabolised primarily by the liver. The main plasma metabolites are 20 a hydroxy-4a-prenolone and 5 a-dihydroprogesterone. Some progesterone metabolites are excreted in the bile and these may be deconjugated and further metabolized in the gut via reduction, dehydroxylation and epimerization. The main plasma and urinary metabolites are similar to those found during the physiological secretion of the corpus luteum.
Gynprogest is prescribed for disorder related to a progesterone deficit: By oral route: Menstrual irregularity due to dysovulation.
By vaginal route: During in vitro fertilization cycles (IVF).
For all other Progesterone indications, the vaginal route represents an alternative to the oral route, in case of adverse events due to Progesterone (somnolence, dizziness).
Gynprogest should not be taken more than 200 mg per intake (two 100 mg capsules or one 200 mg capsule), by oral or vaginal route.
On average for progesterone insufficiencies, the daily dose is 200 to 300 mg divided into one or two intakes, 100 mg in the morning, and 100 mg or 200 mg at bedtime. In some case, notably to help pregnancy, doctor may has to increase the dose to 600 mg per day, divided into three intakes.
Treatment may be prescribed continuously or sequentially for some days per month, and possibly associated with estrogen therapy. Two routes of administration are possible, oral and vaginal.
If the medicine is to be administered orally: swallow the capsule(s) with a glass of water far from mealtime, in one to three intakes, following doctor's prescription. If the medicine is to be administered vaginally: insert each capsule deeply in the vagina.
Duration of treatment: The duration of the treatment will be specified by the doctor, according to the case. The duration of treatment may be readjusted by the doctor depending on the indication and efficacy or treatment.
Children: Not applicable.
Symptoms of over dosage may include somnolence, dizziness, euphoria or dysmenorrhoea. Treatment is observation and, if necessary, symptomatic and supportive measures should be provided.
Known allergy or hypersensitivity to progesterone or to any of the excipients. The capsule contain arachis oil (peanut oil) and should never be used by patients allergic to peanuts. Severe hepatic dysfunction, undiagnosed vaginal bleeding, mammary or genital tract carcinoma. Thrombophlebitis, thromboembolic disorder, cerebral hemorrhage, porphyria.
Gynprogest are not a treatment for premature labour.
Prescription of progesterone beyond the first trimester of pregnancy may reveal gravidic cholestasis. Gynprogest are not suitable for use as a contraceptive.
If unexplained, sudden or gradual, partial or complete loss of vision, proptosis or diplopia, papilloedema, retinal vascular lesions or migraine occurs during therapy, the drug should be discontinued and appropriate diagnostic and therapeutic measures instituted.
Gynprogest are intended to be co-prescribed with an estrogen product as HRT. Epidemiological evidence suggests that the use of HRT is associated with an increased risk of developing deep vein thrombosis (DVT) or pulmonary embolism. The prescribing information for the co-prescribed estrogen product should be referred to for information about the risks of venous thromboembolism.
There is suggestive evidence of a small increased risk of breast cancer with estrogen replacement therapy. It is not known whether concurrent progesterone influences the risk of cancer in post-menopausal women taking hormone replacement therapy. The prescribing information for the co-prescribed estrogen product should be referred to for information about the risks of breast cancer.
Prior to taking hormone replacement therapy (and at regular intervals thereafter) each woman should be assessed. A personal and family medical history should be taken and physical examination should be guided by this and by the contraindications and warnings for this product.
Gynprogest should not be taken with food and should be taken at bedtime. Concomitant food ingestion increases the bioavailability of Gynprogest.
Gynprogest should be used cautiously in patients with conditions that might be aggravated by fluid retention (e.g. hypertension, cardiac disease, renal disease, epilepsy, migraine, asthma); in patients with a history of depression, diabetes, mild to moderate hepatic dysfunction, migraine or photosensitivity and in breastfeeding mothers.
Clinical examination of the breasts and pelvic examination should be performed where clinically indicated rather than as a routine procedure. Women should be encouraged to participate in the national breast cancer screening programme (mammography) and the national cervical cancer screening programme (cervical cytology) as appropriate for their age. Breast awareness should also be encouraged and women advised to report any changes in their breasts to their doctor or nurse.
Effects On Ability To Drive And Use Machines: Gynprogest may cause drowsiness and/or dizziness in a minority of patients; therefore caution is advised in drivers and users of machines. Taking the capsules at bedtime should reduce these effects during the day.
Use in Pregnancy: The use of Gynprogest is not contraindicated during pregnancy including the first few weeks.
Use in Lactation: Detectable amounts of progesterone enter the breast milk. There is no indication for prescribing HRT during lactation.
Pregnancy: The use of Gynprogest is not contraindicated during pregnancy including the first few weeks.
Lactation: Detectable amounts of progesterone enter the breast milk. There is no indication for prescribing HRT during lactation.
Somnolence or transient dizziness may occur 1 to 3 hours after intake of the drug. Bedtime dosing and reduction of the dose may reduce these effects.
Shortening of the cycle or breakthrough bleeding may occur if the treatment sequence is initiated too early particularly before cycle day 1. If this occurs, the dose of Gynprogest can be reduced and taken at bedtime from day 1 to day 26 of each therapeutic cycle.
Acne, urticaria, rashes, fluid retention, weight changes, gastro-intestinal disturbances, changes in libido, breast discomfort, premenstrual symptoms, menstrual disturbances; also chloasma, depression, pyrexia, insomnia, alopecia, hirsutism; rarely jaundice. Venous thromboembolism, i.e. deep leg or pelvic venous thrombosis and pulmonary embolism, is more frequent among hormone replacement therapy users than among non-users.
After vaginal administration, local irritation may occur (due to the presence of soya lecithin, peanut oil). The following effects have been reported in associated with soft capsules administered via the oral route.
Common undesirable effects: altered menstrual cycles, amenorrhea, intermenstrual bleeding, and headaches.
Uncommon undesirable effects: drowsiness, transient dizziness, cholestatic jaundice, pruritus, gastrointestinal disorder.
Gynprogest may interfere with the effects of bromocriptine and may raise the plasma concentration of cyclosporine. Gynprogest may affect the results of laboratory tests of hepatic and/or endocrine functions.
Metabolism of Gynprogest is accelerated by rifampicin an antibacterial agent.
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. Therefore ketoconazole may increase the bioavailability of progesterone.
Store below 30⁰C and dry place, protect from the light.
Shelf-life: 36 months from manufacturing date.
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Gynprogest softcap 100 mg
2 × 15's
Gynprogest softcap 200 mg
1 × 15's
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