Dydrogesterone/ Estradiol

Registered South African indications:

• Hormone replacement therapy
• Prevention of postmenopausal osteoporosis

Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Hepatic impairment
• Known, past or suspected breast cancer
• Known or suspected oestrogen-dependent malignant tumours
• Known or suspected progestogen-dependent neoplasms
• Undiagnosed genital bleeding
• Untreated endometrial hyperplasia
• Previous or current venous thromboembolism
• Known thrombophilic disorders
• Active or recent arterial thromboembolic disease
• Porphyria

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Elderly
• Leiomyoma 
• Endometriosis
• Risk factors for thromboembolic disorders 
• Risk factors for oestrogen-dependent tumours
• Hypertension
• Diabetes mellitus 
• History of hepatic disorders
• Cholelithiasis
• Migraine or headache
• Systemic lupus erythematosus
• History of endometrial hyperplasia 
• Epilepsy
• Asthma
• Otosclerosis
• Risk factors for thrombophilic states
• Coronary artery disease
• Pre-existing hypertriglyceridaemia
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption 

Forms avail. in SA and covered in this monograph: tab

Hormone replacement therapy
- In women with an intact uterus
Prevention of postmenopausal osteoporosis
- In women with an intact uterus

Oestradiol
1mg

• Oral (tab): 1 tab, dly, for 14 days

THEN

Oestradiol/ Dydrogesterone
1/10 (mg)

• Oral (tab): 1 tab, dly, for 14 days

If the patient is still menstruating, it is advisable to start the treatment on the first day of menstruation

Treatment can commence at any time in the case of post-menopausal patients

If a dose has been forgotten, it should be taken as soon as possible. When more than 12 hours have elapsed, it is recommended to continue with the next dose without taking the forgotten tablet

Oestradiol/ Dydrogesterone
1/5 (mg)

• Oral (tab): 1 tab, dly, for 28 days

Femoston-conti should be used only in women more than 12 months post-menopause

For surgically induced menopause, treatment may start immediately

If a dose has been forgotten, it should be taken as soon as possible. When more than 12 hours have elapsed, it is recommended to continue with the next dose without taking the forgotten tablet

Not indicated for use in children

Pregnancy

• FDA Pregnancy Category Not Rated (NR)

Breastfeeding

• Caution; not recommended

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Contraindicated

Elderly

• Caution; no information available

Central Nervous System Disorders

• Headache
• Migraine
• Dizziness
• Depression
• Nervousness
• Asthenia

Cardiovascular Disorders

• Myocardial infarction
• Hypertension
• Peripheral vascular disease
• Varicose veins
• Venous thromboembolism

Gastrointestinal Disorders

• Abdominal pain
• Nausea and vomiting
• Flatulence
• Dyspepsia

Hepatobiliary Disorders

• Abnormal hepatic function
• Gall bladder disorder

Genitourinary Disorders

• Vaginal candidiasis
• Cystitis-like syndrome
• Influence on libido
• Breast pain/tenderness
• Menstrual disorders 
• Pelvic pain
• Cervical discharge
• Breast enlargement
• Premenstrual syndrome

Endocrine and Metabolic Disorders

• Change in weight

Musculoskeletal Disorders

• Back pain

Skin and Subcutaneous Tissue Disorders

• Allergic skin reactions 
• Angioedema
• Vascular purpura
• Peripheral oedema

Immune, Blood and Lymphatic System Disorders

• Increase in size of leiomyoma
• Hypersensitivity

• St John's Wort
• CYP450 inducers
• CYP450 inibitors
• CYP3A4 substrates

• Breast examination
• Gynaecological examination

Specific cases may require

• Mammogram

Dydrogesterone
Dydrogesterone is an orally-active selective progestative substance, which belongs to the C21-steroids. The progestative effects of dydrogesterone are almost exclusively exercised on the endometrium, the vagina and the cervical mucous. Dydrogesterone and its metabolites are not thermogenic. Dydrogesterone, when cyclically administered to women with an oestrogen-activated endometrium, brings the uterus epithelium into the secretion phase which decreases the risk of oestrogen induced hyperplasia and/or carcinoma of the endometrium. Dydrogesterone has no androgenous, oestrogenic, anabolic or corticoid properties.

Oestrogen
The active component oestradiol is chemically and biologically identical to the natural human sex hormone oestradiol. Oestradiol is the most important oestrogen and the most active of the ovarian hormones. Oestrogens affect the release of gonadotrophins by the pituitary gland, contributing to the occurrence of the ovarian cycle. Oestrogens cause cyclical changes in the uterus, cervix and vagina and ensure the retention of tone and elasticity in the urogenital tract. Oestradiol plays an important part in maintaining bone mass, and has a preventative effect on the incidence of osteoporotic fractures. Oestrogens have a beneficial effect on the metabolism of lipids and lipoproteins.

COMBINATION PREPARATIONS

Fixed combination preparations

Oestradiol/ Dydrogesterone

Tablet 0.5mg/2.5mg

• Femoston Conti 0.5mg/2.5mg (Abbott) originator

Oestradiol/ Dydrogesterone

Tablet 1mg/5mg

• Femoston Conti (Abbott) originator

Sequential preparations

Oestradiol/ Dydrogesterone

Tablet 1mg/10mg

• Femoston 1/10 (Abbott) originator