Duphaston 10mg

In cases where there is or is suspected a deficiency in endogenous progesterone or where the specific action of Duphaston 10mg has been clinically demonstrated eg, in infertility, threatened abortion, habitual abortion, dysmenorrhoea, endometriosis and irregular cycles. Moreover, combined with an oestrogenic substance, Duphaston 10mg can be applied in secondary amenorrhoea and dysfunctional bleedings.

Dosages, treatment schedule and duration of treatment may be adapted to the severity of the dysfunction and the clinical response.

Symptomatic relief of mild to moderate vasomotor symptoms associated with menopause; prevention of postmenopausal osteoporosis; Continuous Sequential Therapy: An oestrogen is dosed continuously and one tablet of 10 mg Duphaston 10mg is added for the last 14 days of every 28 day cycle, in a sequential manner.

Cyclic Therapy: When an oestrogen is dosed cyclically with a treatment-free interval, usually 21 days on and 7 days off. One tablet of 10 mg Duphaston 10mg is added for the last 12-14 days of oestrogen therapy.

If ultrasound or endometrial biopsies would reveal inadequate progestational response, 20 mg Duphaston 10mg should be prescribed.

Dysmenorrhoea: 10 mg twice daily from day 5 to day 25 of the menstrual cycle.

Endometriosis: 10 mg two or three times daily from day 5 to day 25 of the cycle or continuously.

Dysfunctional Bleeding (To Arrest Bleeding): 10 mg twice daily for five to seven days. Duphaston 10mg should be given with oestrogen.

Dysfunctional Bleeding (To Prevent Bleeding): 10 mg twice daily from day 11 to day 25 of the cycle. Duphaston 10mg should be given with oestrogen.

Amenorrhoea: An oestrogen once daily from day 1 to day 25 of the cycle, together with 10 mg Duphaston 10mg twice daily from day 11 to day 25 of the cycle.

Irregular Cycles: 10 mg twice daily from day 11 to day 25 of the cycle.

Threatened Abortion: 40 mg at once, then 10 mg every eight hours until symptoms remit.

Habitual Abortion: 10 mg twice daily until the twentieth week of pregnancy.

Infertility Due to Luteal Insufficiency: 10 mg daily from day 14 to day 25 of the cycle. The treatment should be continued for at least 6 consecutive cycles. It is advisable to continue this treatment during the first months of any pregnancy using the doses stated with respect to habitual abortion.

There is no relevant use of Duphaston 10mg before menarche. The safety and efficacy of Duphaston 10mg in adolescents aged 12 to 18 years has not been established. Currently available data are described in Adverse Reactions and

Pharmacology: Pharmacodynamics under Actions, but no recommendation on a posology can be made.

Administration: For oral use.

For administration of higher dosages, the tablets should be taken evenly distributed over the day.

Known hypersensitivity to the active substance or to any of the excipients.

Known or suspected progestogen dependent neoplasms (e.g. meningioma).

Undiagnosed vaginal bleeding.

Contraindications for the use of estrogens when used in combination with Duphaston 10mg.

Existence of serious liver disorders, or serious liver disorders in the medical history as long as the liver function values have not normalised.

Duphaston 10mg is used to treat conditions associated with low levels of female hormone progesterone such as painful menstrual periods (dysmenorrhea), endometriosis problems with menstrual cycle abnormal bleeding from vagina (dysfunctional uterine bleeding). It is also used in patients with recurrent abortion due to progesterone deficiency, Infertility (due to luteal insufficiency, the lining of the uterus is unable to prepare for pregnancy). Duphaston 10mg is also used in combination with estrogen hormone drugs as a hormone replacement therapy in females at menopause (the time in a woman’s life when her menstrual periods stop). It is used in post-menopausal conditions, hot flushes (sudden reddening with increased heat in face, neck and chest), prevention of thinning and weakening of bones (osteoporosis).

In vitro data show that the major metabolic pathway generating the main pharmacologically active metabolite 20α dihydrodydrogesterone (DHD) is catalyzed by aldo-keto reductase 1C (AKR 1C) in human cytosol. Next to the cytosolic metabolism there are metabolic transformations by cytochrome P450 isoenzymes (CYPs), nearly exclusively via CYP3A4, resulting in several minor metabolites. The main active metabolite DHD is substrate for metabolic transformation by CYP3A4.

Therefore, the metabolism of Duphaston 10mg and DHD may be increased by concomitant use of substances known to induce these CYP enzymes such as anticonvulsants (e.g. Phenobarbital, phenytoin, carbamazepine), anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz) and herbal preparations containing e.g. St John’s Wort (Hypericum perforatum), sage, or gingko biloba.

Ritonavir and nelfinavir, although known as strong cytochrome enzyme inhibitors, by contrast exhibit enzyme-inducing properties when used concomitantly with steroid hormones.

Clinically, increased metabolism of Duphaston 10mg may lead to a decreased effect and changes in the bleeding pattern.

In vitro studies have shown that Duphaston 10mg and DHD do not inhibit or induce CYP drugmetabolizing enzymes at clinically relevant concentrations.

The most commonly reported adverse drug reactions of patients treated with Duphaston 10mg in clinical trials of indications without oestrogen treatment are migraines/headache, nausea, menstrual disorders and breast pain/tenderness.

The following undesirable effects have been observed with the frequencies indicated as follows during clinical trials using Duphaston 10mg (n=3,483 in indications without oestrogen treatment and from spontaneous reporting.

Undesirable Effects in Adolescent Population: Based on spontaneous reports and limited clinical trial data, the adverse reaction profile in adolescents is expected to be similar to that seen in adults.

Undesirable Effects that are Associated with an Oestrogen-Progestogen Treatment : Breast cancer, endometrial hyperplasia, endometrial carcinoma, ovarian cancer.

Venous thromboembolism.

Myocardial infarction, coronary artery disease, ischemic stroke.

Each tablet contains 10 mg Duphaston 10mg.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Excipients/Inactive Ingredients: Core: Lactose monohydrate, hypromellose, maize starch, colloidal anhydrous silica, magnesium-stearate.

Film-Coating: Hypromellose, macrogol 400, titanium dioxide (E171).