Vagifem

Vag atrophy due to estrogen deficiency in postmenopausal women.

Administered intravag using the applicator. Initially 1 vag tab daily for 2 wk. Maintenance: 1 vag tab twice a wk. Administration: Open the blister pack at the plunger end. Insert the applicator in the vag until resistance is met (8-10 cm). Release the vag tab by pressing the plunger. W/draw the applicator & discard.

Hypersensitivity. Known, history or suspected breast cancer. Known or suspected estrogen-dependent malignant tumors (eg, endometrial cancer); undiagnosed genital bleeding, untreated endometrial hyperplasia, previous idiopathic or current venous thromboembolism (DVT, pulmonary embolism). Known thromboembolic disorders (eg, protein C, protein S or antithrombin deficiency). Active or previous arterial thromboembolic disease (eg, angina, MI). Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal. Porphyria. Pregnancy & lactation.

For treatment of postmenopausal symptoms, hormone replacement therapy (HRT) should only be initiated for symptoms that adversely affect quality of life. In all cases, carefully appraise the risks & benefits & HRT should only be continued as long as the benefit outweighs the risk. Obtain medical history (before initiating & reinstituting hormone therapy); periodic check-ups (during treatment). Closely supervise patients w/ leiomyoma (uterine fibroids) or endometriosis; risk factors for, thromboembolic disorders; risk factors for estrogen-dependent tumors; HTN; liver disorders; DM w/ or w/o vascular involvement; cholelithiasis; migraine or (severe) headache; SLE; history of endometrial hyperplasia; epilepsy; asthma; otosclerosis. Discontinue if w/ jaundice or deterioration in liver function, significant increase in BP & new onset of migraine-type headache or pregnancy. Increased risk of endometrial hyperplasia & carcinoma, breast cancer, ovarian cancer, venous thromboembolism, CAD, ischemic stroke. Carefully observe patients w/ cardiac or renal dysfunction, pre-existing hypertriglyceridemia. Increased risk in probable dementia in those using continuous combined or estrogen-only HRT after the age of 65. Special care in women w/ intact uterus w/ abnormal bleeding of unknown etiology, or women w/ intact uterus previously treated w/unopposed estrogens. Should not be given >1 yr if w/o another physical exam including gynecological exam.

Breast pain, peripheral edema & postmenopausal bleedings; headache; abdominal pain; vag hemorrhage/discharge/discomfort; vulvovag mycotic infection; nausea; rash; increased wt; hot flush, HTN.

Increased estrogen 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). May antagonize effect w/ strong inhibitors eg, ritonavir & nelfinavir. May induce the metabolism w/ herbal prep containing St. John's wort (Hypericum perforatum).

Oestrogens, Progesterones & Related Synthetic Drugs

G03CA03 - estradiol ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.

Rx