Dufaston (dydrogesterone) coated tablets 10 mg. №14

Description

Dufaston №14 Composition
active substance: dydrogesterone;

1 tablet contains dydrogesterone 10 mg;

Dufaston №14 excipients:

tablet core – lactose monohydrate, hypromellose; starch corn silica colloidal magnesium dioxide stearate

Dufaston №14 shell:

macrogol 400, hypromellose, titanium dioxide (E 171).

Dosage form
Film-coated tablets.

Basic physical and chemical properties: round, biconvex, film-coated, white tablet with a beveled edge, with a break line and marking “155” on one side on either side of the break line. Diameter – 7 mm.

The break line is for swallowing only and does not split the tablet into equal parts.

Pharmacotherapeutic group
Gonadal hormones and drugs used in the pathology of the reproductive system. Gestagens. Derivatives of pregnadiene. ATX code G03D B01.

Pharmacodynamics
Mechanism of action

Dydrogesterone is a selective progestogen that replaces some of the functions of progesterone.

As a gestagen, dydrogesterone exclusively affects only the endometrium, vaginal mucosa and cervical canal.

Dydrogesterone does not inhibit ovulation. This means that the possibility of egg fertilization in non-pregnant women remains with dydrogesterone.

Dydrogesterone and its metabolites have no thermogenic properties.

In postmenopausal women with a preserved uterus, estrogen replacement therapy is associated with an increased risk of endometrial hyperplasia and endometrial cancer. The addition of progestogens can prevent excessive risks.

Cyclic addition of dydrogesterone to women in whom the endometrium has been stimulated by estrogen puts it in the secretion phase.

Dydrogesterone has no virilizing or virilizing properties. Dydrogesterone has no anabolic or corticoid properties.

Clinical efficacy and safety

A double-blind, double-masked, randomized, multicenter study involving two parallel groups to compare the efficacy, safety and tolerability of oral dydrogesterone at a dose of 30 mg per day and intravaginal micronized progesterone in capsules at a dose of 600 mg per day to maintain the luteal phase when using in vitro fertilization technologies (LOTUS I).

A randomized, open-label, multicenter study involving two parallel groups to compare the efficacy, safety and tolerability of oral dydrogesterone at a dose of 30 mg per day and intravaginal progesterone in the form of 8% gel (Crinone) at a dose of 90 mg per day to maintain the luteal phase when using in vitro fertilization technologies (LOTUS II).

Clinical studies of LOTUS I and LOTUS II have confirmed the following.

The main objective of the studies – to prove that dydrogesterone is less effective than intravaginal micronized progesterone in terms of the presence of heart contractions in the fetus at 12 weeks of gestation (10 weeks of gestation) – has been achieved.

Indications
Irregular menstrual cycles;
endometriosis;
dysmenorrhea;
infertility caused by luteal insufficiency;
support of the luteal phase with the use of assisted reproductive technologies (ART);
threatening and habitual miscarriage associated with progesterone deficiency.
Dufaston® can be used as a cyclic addition to estrogen therapy in women with an intact uterus:

to prevent endometrial hyperplasia during menopause;
with dysfunctional uterine bleeding;
with secondary amenorrhea.

Contraindications
Undiagnosed vaginal bleeding;
have serious liver disease or have had a history of serious liver disease if liver function tests have not returned to normal;
contraindications for estrogens should be considered if they are used in combination with progestogens such as dydrogesterone;
established hypersensitivity to the active substance or to any other component of the drug;
established or suspected progestogenic neoplasms (eg meningioma).
Treatment to support the luteal phase with assisted reproductive technologies (ART) should be discontinued if abortion / miscarriage is diagnosed.