HRT for oestrogen deficiency symptoms in postmenopausal women.
Dosage/Direction for Use
Min effective dose: 1.25 g of gel daily for 21-28 days each mth. Ave dose: 2.5 g of gel daily. Apply either in the morning or evening, preferably after washing, after the same time each day on the forearms, arms &/or shoulders or any other large area of unbroken skin.
Contraindications
Known hypersensitivity. Past history of/or suspected breast cancer; known or suspected malignant oestrogen-dependent tumours eg, endometrial cancer; vag bleeding of unknown aetiology; untreated endometrial hyperplasia; current or previous idiopathic venous thromboembolic accidents (DVT, pulmonary embolism); recent or ongoing arterial thromboembolic illnesses eg, angina pectoris & MI; acute hepatic disorder or a past history of hepatic conditions, until such time as the hepatic function tests return to normal; porphyria. Known or suspected pregnancy.
Special Precautions
Immediately discontinue in case of icterus or deterioration of hepatic function; a significant increase in BP; recurrence of headaches of the migraine type; pregnancy or suspected pregnancy; hypercalcemia; sudden partial or complete loss of vision or a sudden onset of proptosis, diplopia. Carry out physical exam in particular of the pelvic area & breasts. Closely monitor for leiomyoma (uterine fibroma) or endometriosis; thromboembolic risk factors or a history thereof; oestrogen-dependent tumours eg, 1st-degree heredity for breast cancer; arterial HTN; hepatic function disorders eg, hepatic adenoma; sugar diabetes w/ or w/o vascular symptoms; biliary lithiasis; migraine & severe headache; SLE; past history of endometrial hyperplasia; epilepsy; asthma; otosclerosis. Risk of CV, coronary &/or cerebrovascular conditions, in cases of HTN &/or smoking. Endometrial hyperplasia & cancer. Breast cancer. Patients who have a past history of VTE or thrombophilia. Coronary artery disease. Ovarian cancer. Closely monitor patients suffering from terminal renal insufficiency; thyroid function. Hypocalcemia. Dementia. Increased risk of gallbladder disease requiring surgery in postmenopausal women. Elevations of plasma triglycerides leading to pancreatitis or other complications. May exacerbate asthma, DM, epilepsy, migraine, porphyria, SLE, & hepatic haemangiomas. Not indicated during lactation.
Increased metabolism w/ concomitant use of enzyme inducers, in particular of the cytochrome P450 enzyme eg, anticonvulsants (phenobarb, phenytoin, carbamazepine, meprobamate, phenylbutazone) & anti-infective agents (eg, rifabutin, nevirapine, efavirenz). Ritonavir & nelfinavir act as inducers when used concomitantly w/ steroid hormones. St John's wort can stimulate the metabolism of oestrogens & progestational agents. Increase in metabolism of oestrogens & progestational agents can lead to a decrease in the therapeutic effect & to changes to uterine bleeding.
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