Estrofem

Estrofem

estradiol

Manufacturer:

Novo Nordisk

Distributor:

Firma Chun Cheong
/
DKSH
Concise Prescribing Info
Contents
Estradiol
Indications/Uses
HRT in postmenopausal women, particularly in women who have had hysterectomy. 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
1 tab daily w/o interruption. Initiation & continuation of treatment of menopausal symptoms Use the lowest effective dose for the shortest duration.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Known, past or suspected breast cancer; known, past or suspected oestrogen-dependent malignant tumours eg, endometrial cancer; undiagnosed genital bleeding; untreated endometrial hyperplasia; previous or current VTE eg, DVT or pulmonary embolism; known thrombophilic disease disorders eg, protein C, protein S or antithrombin deficiency; active or recent arterial thromboembolic disease eg, angina, MI; acute or history of liver disease as long as LFTs have failed to return to normal; porphyria.
Special Precautions
HRT should only be initiated for postmenopausal symptoms that adversely affect quality of life. Careful appraisal of risks & benefits should be undertaken at least annually. Limited evidence regarding risks associated w/ HRT in the treatment of premature menopause. Before initiating or reinstituting HRT, a complete personal & family medical history should be taken. During treatment, periodic check-ups are recommended of a frequency & nature adapted to the individual woman. May recur or be aggravated during treatment w/ Estrofem: leiomyoma (uterine fibroids) or endometriosis; risk factors for thromboembolic disorders; risk factors for 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 treatment discontinuation in case of jaundice or deterioration in liver function; significant increase in BP; new onset of migraine-type headache; pregnancy. Risk of endometrial hyperplasia & carcinoma; breast cancer; ovarian cancer. Associated w/ risk of developing VTE, more likely in the 1st yr of HRT. Temporarily stopping HRT 4-6 wk earlier is recommended if prolonged immobilisation is to follow elective surgery. Risk of ischaemic stroke. May cause fluid retention. Closely monitor women w/ pre-existing hypertriglyceridaemia during HRT. Increased thyroid-binding globulin, other binding proteins (ie, corticoid-binding globulin, sex-hormone-binding globulin), & other plasma proteins (angiotensin/renin substrate, α-1-antitrypsin & ceruloplasmin). HRT use does not improve cognitive function. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Not indicated during pregnancy & lactation. Limited experience in women >65 yr.
Adverse Reactions
Depression; headache; abdominal pain, nausea; leg cramps; breast pain, tenderness or enlargement; oedema; increased wt.
Drug Interactions
Increased metabolism w/ substances known to induce drug-metabolising enzymes (specifically CYP450 enzymes) eg, anticonvulsants (eg, phenobarb, phenytoin, carbamazepine) & anti-infectives (eg, rifampicin, rifabutin, nevirapine, efavirenz); ritonavir & nelfinavir; herbal prep containing St. John's wort.
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
Estrofem tab 1 mg
Packing/Price
28's
Form
Estrofem tab 2 mg
Packing/Price
28's
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