Oestrogel

Oestrogel

estradiol

Manufacturer:

Besins Healthcare

Distributor:

Metro Drug
Concise Prescribing Info
Contents
Estradiol hemihydrate
Indications/Uses
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of or contraindicated for other medicinal products approved for the prevention of osteoporosis.
Dosage/Direction for Use
Menopausal symptoms 2.5 g (single ruler measure) once daily, may be increased to a max of 5 g (2 ruler measures) daily if effective relief is not obtained after 1 mth treatment. Prevention of osteoporosis 2.5 g once daily.
Contraindications
Hypersensitivity. Known, past or suspected breast cancer; known or suspected estrogen-dependent malignant tumours (eg, endometrial cancer); undiagnosed genital bleeding; untreated endometrial hyperplasia; previous idiopathic or current venous thromboembolism (DVT, pulmonary embolism); active or recent arterial thromboembolic disease (eg, angina, MI, stroke); acute liver disease or history of liver disease as long as liver function tests have failed to return to normal; porphyria.
Special Precautions
Periodic check-ups are recommended during treatment. Investigations, including mammography, should be carried out in accordance w/ currently accepted screening practices, modified to the clinical needs of the individual. Discontinue therapy if jaundice or deterioration in liver function, significant increase in BP, new onset of severe migraine-type headache & pregnancy occurs; VTE develops. Leiomyoma (uterine fibroids) or endometriosis, risk factors for thromboembolic disorders & estrogen 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. Increased risk of CV morbidity in the 1st yr of use, venous thrombosis & pulmonary embolism; breast cancer; endometrial hyperplasia & carcinoma on prolonged periods; ovarian cancer in hysterectomised women on long-term use. Temporarily stop 4-6 wk earlier if prolonged immobilisation is liable following elective surgery, particularly abdominal or orthopaedic surgery to the lower limbs. Breakthrough bleeding & spotting may occur during the 1st mth of treatment. Fluid retention. Preexisting hypertriglyceridemia. Observe diabetic patients closely or those w/ predisposition to diabetes. Patients known to have residual endometriosis post-hysterectomy. Abnormal vag bleeding. Monitor BP & thyroid function. Not indicated during pregnancy & lactation.
Adverse Reactions
Irritation, reddening of the skin, mild & transient erythema at the site of application; headache, migraine, mood changes; nausea; increase in the size of uterine fibromyomata, excessive production of cervical mucus; breast pain, enlargement & secretion.
Drug Interactions
May reduce plasma conc w/ CYP3A4 inducers eg, St. John's wort prep, phenobarb, carbamazepine, efavirenz & rifampicin. May increase plasma conc w/ CYP3A4 inhibitors eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir & grapefruit juice.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03CA03 - estradiol ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
Presentation/Packing
Form
Oestrogel transdermal gel 600 mcg/g
Packing/Price
80 g x 1's
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