Duphaston

Duphaston is applied already more than 30 years, and its pharmacological effects are well studied. In early researches on animals and in clinical tests it was demonstrated, that Duphaston:

• by progestagenic activity is 10-30-fold more active, than a peroral progesterone;
• does not cause androgenic effects (acne rash, roughening of voice, hirsutism) at women;
• does not cause masculinization of genitals of a female fetus;
• does not influence the activity of pituitary-adrenal system and does not cause an atrophy of adrenal glands;
• does not render estrogenic influence on a vagina and uterus and on genitals of a male fetus;
• does not essentially influence coagulability of blood;
• in the usual therapeutic dozes, apparently, does not suppress ovulation. There is various data about conception during reception of dydrohesteron, especially at treatment of endometriosis and sterility.

Duphaston is effectively enough applied at androgenic lack of progesterone in an organism, expressed by sterility with lutein insufficiency, premenstrual syndrome, dysmenorrhoea, irregular menstruations, dysfunctional vaginal and uterine bleedings, at threat of premature interruption of pregnancy.

Active substance of Duphaston favourably differs from many other artificial prostagens by the biggest similarity with natural progesterone, not possessing anabolic, glucocorticoid, androgenic, estrogenic and thermogenic activity.

Collateral action

In rare cases: breaking uterine bleedings (which can be warned by increase of a doze).

During clinical application of Duphaston other collateral actions (including virilising effect) have not been revealed.

Contra-indications

• the Dubin-Johnson syndrome;
• the Rotor’s syndrome;
• the raised sensitivity to the components of a preparation.

Pregnancy and lactation

Application of Duphaston is possible at pregnancy under indications.

Dydrohesterone is released with breast milk. If application of a preparation during a lactation is necessary it is recommended to consider the problem on the termination of breast feeding.

Special instructions

Before the beginning of carrying out of replacement therapy it is necessary to conduct medical examination and gynecologic survey. A regular mammography is recommended. Abnormal bleedings and the pathological changes revealed at gynecologic survey, can form the basis to research endometrium. It is necessary to appoint Duphaston carefully in a combination with estrogen to patients with infringements of function of kidneys, cardiovascular diseases, diabetes, epilepsy, migraine.

Common uses

Duphaston is an orally active progestogen which acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, Duphaston has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum. Furthermore, Duphaston is non-androgenic, non-estrogenic, non-corticoid, non-anabolic and is not excreted as pregnanediol.

Before using

Irregular duration of cycles and irregular occurrence and duration of periods caused by progesterone deficiency.

Combined with an estrogenic substance, Duphaston can be applied in secondary amenorrhoea, dysfunctional uterine bleeding and post-menopausal complaints where endogenous progesterone deficiency is implicated.

Directions

In general

The dosage schemes below are meant as general recommendations. For optimal therapeutic effect, the dosages are to be adapted to the nature and severity of the disorder.

In irregular cycles due to endogenous progesterone deficiency

Duphaston 5 to 10 mg is recommended especially in irregular cycles due to shortened luteal phase (ie pre-menopause). Treatment should be repeated for several cycles.

In secondary amenorrhoea

Administration of Duphaston in combination with an estrogen is usually recommended as in these conditions endogenous progesterone deficiency is nearly always accompanied by estrogen deficiency. 0,05 mg ethinylestradiol is administered each day from the 1st to the 25th day of the cycle, and 5 mg Duphaston is added twice daily from the 11th to the 25th day. Five days after the subsequent withdrawal bleeding, the same is repeated to imitate a natural cycle.

In dysfunctional uterine bleeding

The symptomatic treatment is aimed at stopping the bleeding and including a subsequent withdrawal bleeding.

To stop bleeding: Duphaston 10 mg together with 0,10 mg ethinylestradiol twice daily for 5 to 7 days.

To prevent heavy bleedings: Duphaston 5 mg twice daily from day 11 to day 25 of the cycle, if necessary, combined with an estrogen during the first half of the cycle.

In post-menopausal complaints

If for the symptomatic treatment of post-menopausal complaints estrogens are used (hormone replacement therapy HRT), Duphaston 10 mg is used to counteract the effects of unopposed estrogens on the endometrium. A subsequent withdrawal bleeding is induced.

If on continuous estrogen therapy: Duphaston 10 mg twice daily during the first 12 to 14 days of each calendar month.

If on cyclic estrogen therapy: Duphaston 10 mg twice daily during the last 12 to 14 days of the treatment.

Cautions

Duphaston should not be given to patients with undiagnosed vaginal bleeding nor to those with a history of thromboembolic disorders.

Duphaston should be used with caution in patients with cardiovascular, renal or hepatic impairment, diabetes mellitus, asthma, epilepsy and migraine. It should be used with care in persons with a history of mental depression.

Store in a dry, dark place at temperatures not exceeding 25°C. Keep out of reach of children.

Possible side effects

Side effects of Duphaston may include gastro-intestinal disturbances, allergic skin rashes or urticaria, changes in libido, acne, fluid retention, mass gain, mental depression and breast changes, which may include discomfort or gynaecomastia. Alterations in liver function tests have been reported and less frequently jaundice.

In a small percentage of the treated cases, breakthrough bleeding may occur, which can be prevented by increasing the dosage. During the clinical application of Duphaston, no virilising side effects were observed.

If you take too much

See"Possible side effects" and"Cautions". Treatment is symptomatic and supportive.

Drug interactions

Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Some medicines or medical conditions may interact with this medicine. Inform your doctor or pharmacist of all prescription and over-the-counter medicine that you are taking.

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.