Dydrogesterone

Registered South African indications:

• Irregular duration of cycles and duration of periods
• Secondary amenorrhoea
• Dysfunctional uterine bleeding
• Post-menopausal complaints

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Breastfeeding
• 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 idiopathic or current venous thromboembolism
• Known thrombophilic disorders
• Active or recent arterial thromboembolic disease
• Porphyria

Cautions

• Pregnancy
• Renal impairment
• Elderly
• Premature menopause
• Leiomyoma 
• Endometriosis
• Risk factors for thromboembolic disorders
• Risk factors for oestrogen dependent tumours
• Hypertension
• Diabetes mellitus with or without vascular involvement
• Cholelithiasis
• Migraine or headache
• Systemic lupus erythematosus
• A history of endometrial hyperplasia
• Ovarian cancer
• Epilepsy
• Asthma
• Otosclerosis
• Intact uterus
• Cardiac dysfunction
• Coronary artery disease
• Pre-existing hypertriglyceridemia
• Fertile women
• Thyroid disorders
• Galactose intolerance
• Lapp lactase deficiency 
• Glucose-galactose malabsorption 

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

Irregular duration of cycles and duration of periods
- Due to endogenous progesterone deficiency

• Oral (tab): 5-10mg, dly

Secondary amenorrhoea (additional agent required)

• Oral (tab): Day 11-25 of cycle: 5mg, 12hrly

Dysfunctional uterine bleeding (additional agent required)
- To stop bleeding 

• Oral (tab): 10mg, 12hrly; Treatment duration: 5-7 days

- To prevent heavy bleeding

• Oral (tab): Day 11-25 of cycle: 5mg, 12hrly

Post-menopausal complaints where endogenous progesterone deficiency is implicated
- If on continuous oestrogen therapy

• Oral (tab): Day 1-14 of calender month: 10mg, 12hrly

- If on cyclic oestrogen therapy

• Oral (tab): Day 14-28 of cycle: 10mg, 12hrly

Not indicated for use in children

Pregnancy

• FDA Pregnancy Category Not Rated (NR)

Breastfeeding

• Contraindicated

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Contraindicated

Elderly

• Caution; no information available

Porphyria Information

• Probably porphyrinogenic (PRP)

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Depression
• Nervousness
• Influence on libido
• Headache
• Migraine
• Dizziness
• Asthenia

Cardiovascular Disorders

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

Gastrointestinal Disorders

• Abdominal pain
• Nausea and vomiting
• Flatulence
• Dyspepsia

Hepatobiliary Disorders

• Abnormal hepatic function
• Jaundice 
• Gall bladder disorder

Genitourinary Disorders

• Vaginal candidiasis
• Cystitis-like syndrome
• Breast pain or tenderness
• Menstrual disorders 
• Pelvic pain
• Cervical discharge
• Breast enlargement
• Premenstrual syndrome
• Ovarian cancer

Endocrine and Metabolic Disorders

• Change in weight
• Thyroid disorders

Musculoskeletal Disorders

• Back pain

Skin and Subcutaneous Tissue Disorders

• Allergic skin reactions 
• Angioedema
• Vascular purpura

Immune, Blood and Lymphatic System Disorders

• Increase in size of leiomyoma
• Hypersensitivity

• Oestrogens 
• Progestogens 
• CYP450 inducers
• CYP450 inhibitors

• Pelvic examination
• Breast examination

Dydrogesterone is an orally active progestogen which acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, dydrogesterone 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.

Tablet 10mg

• Duphaston (Abbott) originator

COMBINATION PREPARATIONS

Fixed combination preparation

Oestradiol/ Dydrogesterone

Tablet 1mg/5mg

• Femoston Conti (Abbott) originator

Sequential preparations

Oestradiol/ Dydrogesterone

Tablet 1mg/10mg

• Femoston 1/10 (Abbott) originator