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Indications:

Hormone replacement therapy for estrogen deficiency symptoms. Prevention of osteoporosis in postmenopausal women at high risk of future fractures, who are intolerant of, or contraindicated for, other medicinal products approved for prevention of osteoporosis.

Contraindications:

Known, past or suspected breast cancer. Known or suspected estrogen-dependent malignant tumours. Undiagnosed genital bleeding. Untreated endometrial hyperplasia. Previous idiopathic or current VTE. Active or recent arterial thromboembolic disease. Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal. Porphyria. Pregnancy & lactation.

Adverse reactions:

Vag bleeding, breast pain/tenderness, irregular menstruation, menorrhagia, vag candidiasis, vaginitis, fluid retention, depression, headache, migraine, nausea, abdominal pain/distension/discomfort, leg cramps, back pain, breast oedema/enlargement, uterine fibroids, peripheral oedema, wt gain, hypersensitivity, nervousness, thrombophlebitis, flatulence, bloating, alopecia, hirsutism, acne, pruritus, urticaria, endometrial hyperplasia, dysmenorrhea, pulmonary embolism.

Interactions:

Reduced effect w/ metabolizing enzyme inducers: Anticonvulsants (phenobarbital, phenytoin, carbamazepine); anti-infectives (rifampicin, rifabutin, nevirapine, efavirenz); St John’s wort; ritonavir & nelfinavir when used concomitantly w/ steroid hormones. Increase effect w/ ketoconazole.

Warnings:

Leiomyoma, endometriosis. A history of, or risk factors for, thromboembolic disorders. Risk factors of estrogen-dependent tumour. HTN; DM; liver disorders; cholelithiasis; migraine or severe headache; SLE; history of endometrial hyperplasia, epilepsy; asthma; otosclerosis. Limited experience of treating women > 65 yr. pregnancy: Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

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