Drospirenone/ Oestradiol

Registered South African indications:

• Prevention of osteoporosis
• Hormone replacement therapy

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Severe renal impairment
• Hepatic impairment
• Undiagnosed vaginal bleeding
• Current, history of or suspected beast cancer
• Current or suspected oestrogen-dependent malignant tumours
• Untreated endometrial hyperplasia
• Previous or current venous thromboembolism
• Current or recent arterial thromboembolic disease
• Thrombophilic disorders
• Porphyria
• Benign or malignant liver tumors

Cautions

• Breastfeeding
• Risk factors for oestrogen dependent tumours
• Hypertension
• Diabetes mellitus with or without vascular involvement
• Cholelithiasis
• Migraine or severe headache
• Systemic lupus erythematosus
• History of endometrial hyperplasia
• Leiomyoma
• Endometriosis
• Epilepsy
• Asthma
• Otosclerosis
• Hypoparathyroidism
• Hereditary angioedema
• Risk factors for venous thromboembolism
• Cardiac dysfunction
• Hypertriglyceridemia
• History of chloasma gravidarum
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption

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

Prevention of osteoporosis in women with intact uterus
Hormone replacement therapy

Drospirenone/ Oestradiol
2/1 (mg)

• Oral (tab): 1 tablet, dly continuously

---

Treatment of postmenopausal symptoms: the lowest effective dose for the shortest duration should be used

---

Take tablets at the same time every day

If a tablet is forgotten it should be taken as soon as possible; If more than 24 hours have elapsed no extra tablet needs to be taken

If several tablets are forgotten, bleeding may occur

Not indicated for use in children

Pregnancy

• FDA Pregnancy Category X

Breastfeeding

• Caution

Renal Impairment

• Severe: Contraindicated

Hepatic Impairment

• Contraindicated

Elderly

• No dose adjustment recommended

Central Nervous System Disorders

• Depression
• Emotional lability
• Nervousness
• Sleep disorder
• Anxiety
• Decreased libido
• Headache
• Paraesthesia
• Impaired concentration
• Dizziness
• Migraine
• Asthenia

Cardiovascular Disorders

• Palpitations
• Embolism
• Venous thrombosis
• Hypertension
• Varicose veins
• Thrombophlebitis
• Generalised oedema
• Chest pain

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders

• Abdominal pain
• Nausea and vomiting
• Enlarged abdomen
• Diarrhoea
• Constipation
• Dry mouth
• Flatulence

Hepatobiliary Disorders

• Abnormal liver function
• Cholelithiasis

Genitourinary Disorders

• Urinary tract disorder
• Urinary tract infection
• Benign breast neoplasm
• Breast carcinoma
• Endometrial hyperplasia
• Benign uterine neoplasm
• Uterine fibroid enlargement
• Benign neoplasm of cervix uteri
• Menstrual disorder
• Vaginal discharge
• Ovarian disorder
• Cervix disorder
• Pelvic pain
• Vulvovaginal disorder
• Vaginal candidiasis
• Vaginitis
• Vagial dryness
• Salpingitis

Endocrine and Metabolic Disorders

• Increased weight
• Decreased weight
• Anorexia
• Increased appetite
• Hyperlipidaemia
• Breast enlargement
• Fibrocystic breast disease
• Galactorhoea
• Breast pain

Musculoskeletal Disorders

• Extremity pain
• Back pain
• Arthralgia
• Muscle cramps
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Acne
• Alopecia
• Pruritus
• Rash
• Hirsutism
• Hair disorder
• Increased sweating

Immune, Blood and Lymphatic System Disorders

• Anaemia

Sensory Disorders

• Vertigo
• Visual disturbances
• Tinnitus
• Taste disturbance

Others

• Chills

• CYP450 inducers
• CYP3A4 inhibitors
• Thyroid replacement therapy
• HIV protease inhibitors
• Non-nucleoside reverse transcriptase inhibitors
• Agents that increase serum potassium
• Antihypertensives

• Pelvic examination
• Breast examination
• Cervical cytology
• Blood pressure

Specific cases may require

• Mammogram
• Endometrial sampling
• Blood glucose
• Lipid profile
• Thyroid function
• Serum potassium

This product contains oestradiol and drospirenone. Synthetic oestradiol is chemically and biologically identical to endogenous human oestradiol. It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms. Drospirenone is a synthetic progestogen and thus counteracts the estrogen-induced risk of endometrial hyperplasia in women with an intact uterus. It also displays aldosterone antagonist activity.

COMBINATION PREPARATIONS

Drospirenone/Oestradiol

Tablet 2mg/1mg

• Angeliq (Bayer) originator