CYCLOGEST

Trade name: Cyclogest®
Active ingredient (INN): progesterone
Dosage form: pessaries for vaginal and rectal use
Compound:
Each pessary contains:
active substance: progesterone – 200 mg or 400 mg.
excipients: solid fatty base.
Description: torpedo-shaped pessaries, almost white, about 30 mm long, about 10 mm in diameter.
Pharmacotherapeutic group: sex hormones and modulators of the reproductive system. Progestogens. Derivatives of pregnene. Progesterone
ATX code: G03DA04

By stimulating protein lipase, it increases fat reserves and increases glucose utilization. By increasing the concentration of basal and stimulated insulin, 
it promotes the accumulation of glycogen in the liver and increases the production of gonadotropic hormones 
of the pituitary gland; reduces azotemia, increases nitrogen excretion in urine.
Pharmacokinetics
Absorption occurs quickly, a high concentration of progesterone is observed 1 hour after administration. 
Cmax of progesterone in blood plasma is achieved 2-6 hours after administration.
 When the drug is administered at a dose of 100 mg 2 times a day, the average concentration remains at 9.7 ng/ml for 24 hours. 
When administered in doses of more than 200 mg/day,
 the concentration of progesterone corresponds to the first trimester of pregnancy.

Plasma protein binding is 90%. Progesterone accumulates in the uterus.
Metabolized to form predominantly 3-alpha, 5-beta-pregnanediol. The concentration of 5-beta-pregnanolone in the blood plasma does not increase.
It is excreted in the urine in the form of metabolites, the main part being 3-alpha, 5-beta-pregnanediol (pregnandione). This is confirmed by a constant 
increase in its concentration (Cmax 142 ng/ml after 6 hours).

Indications for use
Progesterone deficiency conditions in women:
-menopausal hormonal therapy in case of progesterone deficiency with non-functioning (absent) ovaries (egg donation);

 prevention (prevention) of premature birth in women at risk (with shortening of the cervix and/or anamnestic data of 
premature birth and/or premature rupture of the membranes);
-support of the luteal phase during preparation for in vitro fertilization;
- support of the luteal phase in the spontaneous or induced menstrual cycle;
-premature menopause;
-menopausal hormone therapy (in combination with estrogen-containing drugs);
- infertility due to luteal insufficiency;
- threatened abortion or prevention of habitual abortion due to progesterone deficiency.

Directions for use and doses
Pessaries are administered intravaginally or rectally at 200 mg to 400 mg twice daily.
Prevention (prophylaxis) of preterm birth in women at risk (with shortening of the cervix and/or history of preterm labor and/or premature rupture of membranes): 
the usual dose is 200 mg at bedtime, from the 22nd to the 34th week pregnancy.

Complete absence of progesterone in women with non-functioning (absent) ovaries (egg donation): against the background of estrogen therapy, 
100 mg/day on the 13th and 14th days of the cycle, then 100 mg 2 times/day from the 15th to On the 25th day of the cycle, from the 26th day and 
if pregnancy is detected, the dose increases by 100 mg/day every week, reaching a maximum of 600 mg/day, divided into 3 doses. The indicated dose is usually used for 60 days.
Support of the luteal phase during the in vitro fertilization cycle: it is recommended to use from 200 to 600 mg/day, starting from the day of
 human chorionic gonadotropin injection during the first and second trimesters of pregnancy.

Support of the luteal phase in a spontaneous or induced menstrual cycle, in case of infertility associated with dysfunction of the corpus luteum: 
it is recommended to use 200-300 mg/day, starting from the 17th day of the cycle for 10 days, in case of delayed menstruation and diagnosis
 of pregnancy, treatment should to be continued.
In cases of threatened abortion or in order to prevent habitual abortion occurring against the background of progesterone deficiency: 200-400 mg/day 
in 2 divided doses daily in the first and second trimesters of pregnancy.

Drug interactions
The interaction of progesterone with other drugs when administered intravaginally or rectally has not been evaluated. 
The simultaneous use of other drugs administered intravaginally or rectally should be avoided to avoid interfering with the release and absorption of progesterone.

Release form
5 pessaries are placed in contour packages made of polyvinyl chloride/polyethylene film.
3 contour packages together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard pack.

Storage conditions
Store in original packaging, protected from light at a temperature not exceeding 30 °C.
Keep out of the reach of children.

Best before date
4 years.
Do not take after the expiration date stated on the package.

Conditions for dispensing from pharmacies
On prescription.

Manufacturer
Accord-UK Ltd.
Barnstaple, EX32 8NS, UK,
under license from L.D. Collins & Co. Ltd.”
1st Floor, Gallery Court, 28 Arcadia Avenue, London, N3 2FG, UK.