Dydrogesterone

Fetched label is 'Nalvee 10 mg film-coated tablets' (UK SPC). INDICATION-SPECIFIC REGIMENS as stated in §4.2 — Progesterone insufficiencies: dysmenorrhoea 10 mg twice a day from day 5 to 25 of the cycle; endometriosis 10 mg two to three times daily from day 5 to 25 of the cycle, or continuously; irregular menstrual cycles 10 mg twice a day from day 11 to 25 of the cycle; pre-menstrual syndrome 10 mg twice a day from day 12 to 26 of the cycle, with the dosage increased if necessary. Hormone replacement therapy (as supplement to estrogen treatment in non-hysterectomised women with symptoms due to natural or surgically induced menopause) — continuous sequential therapy: continuous use of an estrogen with sequential supplementation of 10 mg dydrogesterone during the last 14 days of each 28-day cycle; cyclical treatment: cyclic use of an estrogen with a treatment-free period (usually 21 days on and 7 days off), with 10 mg dydrogesterone supplemented for the last 12-14 days of estrogen use; depending on the clinical response, the dosage may be adjusted to 20 mg dydrogesterone daily in the course of treatment. Dysfunctional uterine bleeding — to arrest a bleeding episode: 10 mg twice a day for five to seven days; for continuous treatment: 10 mg twice a day from day 11 to day 25 of the cycle (withdrawal bleeding occurs if the endometrium has been adequately primed with endogenous or exogenous estrogen). Secondary amenorrhoea: 10 mg twice a day from day 11 to 25, to produce optimum secretory transformation of an endometrium that has been adequately primed with endogenous or exogenous estrogen. METHOD: when taking 1 film-coated tablet daily it is recommended to always take the daily dose at the same time of day (e.g. always in the morning or always in the evening); when taking 2 film-coated tablets daily it is recommended to take one in the morning and one in the evening. Note this product is not authorised for use in pregnancy (see pregnancy field) — it does not carry a threatened/recurrent miscarriage indication, so no such regimen has been extracted. Paediatric (non per-kg, so not expressed as a mg/kg dose): there is no relevant use for dydrogesterone before menarche; the safety and efficacy of dydrogesterone in adolescents aged 12-18 years has not been established and no recommendation on a posology can be made. Verify any under-18 use against a children's formulary.