Vagifem諾舒芬

Vagifem

estradiol

Manufacturer:

Novo Nordisk

Distributor:

Firma Chun Cheong
/
DKSH
Concise Prescribing Info
Contents
Estradiol
Indications/Uses
Vag atrophy due to oestrogen deficiency in postmenopausal women. May be used in women w/ or w/o an intact uterus.
Dosage/Direction for Use
Intravaginal Initial dose: 1 vag tab daily for 2 wk. Maintenance dose: 1 vag tab twice wkly.
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, pulmonary embolism; known thrombophilic disorders eg, protein C, protein S or antithrombin deficiency; active or previous arterial thromboembolic disease eg, angina, MI; acute liver disease, or history of liver disease as long as LFTs have failed to return to normal; porphyria.
Special Precautions
Treat vag infections before starting therapy. 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. Caution in patients w/ 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; ischaemic stroke. 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. 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. Intravaginal applicators may cause minor local trauma, especially in women w/ serious vag atrophy. Not indicated during pregnancy & lactation. Women >65 yr.
Adverse Reactions
Headache, abdominal pain, vag haemorrhage, discharge & discomfort.
Drug Interactions
Increased metabolism w/ CYP450 inducers (eg, phenobarb, phenytoin, carbamazepine, rifampicin, rifabutin, nevirapine, efavirenz); ritonavir, nelfinavir; 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
Vagifem vag tab 10 mcg
Packing/Price
(w/ applicator) 18's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in