Femoston 2/10: 14 brick red tab each containing 17β-estradiol hemihydrate 2 mg, 14 yellow tab each containing 17β-estradiol hemihydrate 2 mg, dydrogesterone 10 mg. Femoston 1/10: 14 white tab each containing 17β-estradiol hemihydrate 1 mg, 14 grey tab each containing 17β-estradiol hemihydrate 1 mg, dydrogesterone 10 mg. Femoston Conti 1/5: Each salmon-coloured tab contains 17β-estradiol hemihydrate 1 mg, dydrogesterone 5 mg
Indications/Uses
HRT for oestrogen deficiency symptoms in postmenopausal women w/ uterus at least 6 mth (Femoston 2/10 & Femoston 1/10) or 12 mth (Femoston Conti 1/5) since last menses. Prevention of osteoporosis in postmenopausal women w/ uterus, at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for prevention of osteoporosis (Femoston 1/10 & Femoston Conti 1/5).
To be taken continuously w/o a break between packs. Femoston 2/10 tab Continuous sequential: Oestrogen is dosed continuously. The progestogen is added for the last 14 days of every 28 day cycle in a sequential manner. Commence treatment w/ 1 brick red tab daily for the 1st 14 days followed by 1 yellow tab daily for the next 14 days. Femoston 1/10 tab Continuous sequential: Oestrogen is dosed continuously. The progestogen is added for the last 14 days of every 28 day cycle in a sequential manner. Commence treatment w/ 1 white tab daily for the 1st 14 days followed by 1 grey tab daily for the next 14 days. Femoston Conti 1/5 tab Continuous combined: 1 tab daily for a 28 day cycle. The oestrogen & progestogen are given daily w/o interruption. Use only in postmenopausal women >12 mth after menopause.
Hypersensitivity. Known or suspected breast cancer; oestrogen-dependent malignant tumours (eg, endometrial cancer); progestogen-dependent neoplasms (eg, meningioma). Undiagnosed genital bleeding. Untreated endometrial hyperplasia. Previous or current VTE (DVT, pulmonary embolism). Known thrombophilic disorders (eg, protein C, protein S or antithrombin deficiency). Active or recent arterial thromboembolic disease (eg, angina, MI). Acute liver disease or history of liver disease; LFTs have failed to return to normal. Porphyria.
Obtain a complete personal & family medical history before initiating or re-instituting HRT. Leiomyoma (uterine fibroids) or endometriosis; risk factors for thromboembolic disorders & oestrogen-dependent tumours (eg, 1st-degree heredity for breast cancer); HTN; liver disorders (eg, liver adenoma); DM w/ or w/o vascular involvement; cholelithiasis; migraine or severe headache; SLE; history of endometrial hyperplasia; epilepsy; asthma; otosclerosis. Immediate w/drawal of therapy upon occurrence of jaundice or deterioration in liver function; significant increase in BP; new onset of migraine-type headache; pregnancy. Increased risk of endometrial hyperplasia & carcinoma in prolonged oestrogen therapy; breast cancer in combined oestrogen-progestogen therapy or oestrogen-only HRT. Possible slightly increased risk of ovarian cancer in oestrogen-only or combined oestrogen-progestogen HRT which becomes apparent w/in 5 yr of use & diminishes over time after stopping. Discontinue use if VTE develops. Risk of CAD & ischemic stroke. May cause fluid retention; carefully observe patients w/ cardiac or renal dysfunction. Pre-existing hypertriglyceridemia. May induce or exacerbate symptoms of hereditary & acquired angioedema w/ exogenous estrogens. Oestrogens increase thyroid binding globulin leading to increased circulating total thyroid hormone; may elevate other binding & plasma proteins. Does not improve cognitive function. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Contains lactose monohydrate. Not a contraceptive. Possible ALT elevations when co-administered w/ ombitasvir/paritaprevir/ritonavir w/ or w/o dasabuvir & also glecaprevir/pibrentasvir. Not indicated during pregnancy & lactation. No relevant indication for paed population. Women >65 yr.
Metabolism may be increased by anticonvulsants (eg, phenobarb, carbamazepine, phenytoin) & anti-infectives (eg, rifampicin, rifabutin, nevirapine, efavirenz). Exhibit inducing properties w/ ritonavir & nelfinavir. Metabolism may be induced by herbal prep containing St. John's wort. Increase metabolism may lead to decreased effect & changes in uterine bleeding profile. Possible ALT elevations when co-administered w/ ombitasvir/paritaprevir/ritonavir w/ or w/o dasabuvir & also glecaprevir/pibrentasvir. May interfere w/ the metabolism of tacrolimus & cyclosporine A, fentanyl, theophylline.
G03FB08 - dydrogesterone and estrogen ; Belongs to the class of progestogens and estrogens in sequential preparations. G03FA14 - dydrogesterone and estrogen ; Belongs to the class of progestogens and estrogens in fixed combinations.
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