The chemical structure is:. The chemical evista and alcohol is methanone, [6-hydroxy 4-hydroxyphenyl benzo [b]thienyl]-[4-[2- 1- piperidinyl ethoxy]phenyl]- hydrochloride, evista and alcohol. Raloxifene Evista and alcohol is an offwhite to pale-yellow solid that is very slightly soluble in water. EVISTA is indicated for the reduction in risk of invasive breast cancer evista and alcohol postmenopausal women with osteoporosis [see Clinical Studies ].
EVISTA is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see Clinical Studies ]. The effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.
Twenty-seven percent of the participants received drug for 5 years. Among the factors included in the modified Gail model are the following: Currently, no single clinical finding or test result can quantify evista and alcohol of breast cancer with certainty.
After an assessment of the risk of developing breast cancer, the decision regarding therapy with EVISTA should be based upon an individual assessment of the benefits and risks. For the indications in risk of invasive breast cancer the evista and alcohol duration of treatment is not known [see Clinical Studies ]. Total daily intake of calcium above mg has not demonstrated additional bone benefits while daily intake above mg has been associated with increased risk of adverse effects, including hypercalcemia and kidney stones.
The recommended intake of vitamin D is IU daily. Patients at increased risk for vitamin D insufficiency e. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of hydroxyvitamin D should be considered. They are available as follows:. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to EVISTA in patients who were enrolled in placebocontrolled trials, including exposed for 1 year and for at least 3 years.
The safety evista and alcohol raloxifene in the treatment of osteoporosis was assessed in a large patients multinational, placebo-controlled trial. The incidence of all-cause mortality was similar among groups: Therapy was discontinued due to an adverse reaction in During an average of study-drug exposure of 2. Hot flashes occurred in about one evista and alcohol 10 patients on EVISTA and were most commonly evista and alcohol during the first 6 months of treatment and were not different from placebo thereafter.
The safety of raloxifene has been assessed primarily in 12 Phase 2 and Phase 3 studies with placebo, estrogenand estrogen- progestin therapy control groups.
Common adverse reactions considered to be drug-related were hot flashes and leg cramps. The first occurrence of hot flashes was most commonly reported during the first 6 months of treatment.
Adverse reactions are shown without attribution of causality. The majority of adverse reactions occurring during the studies were mild and generally did not require discontinuation of therapy. EVISTA was compared with estrogen-progestin therapy in three evista and alcohol trials for prevention of osteoporosis. Across all placebo-controlled trials, evista and alcohol, EVISTA was indistinguishable from placebo with evista and alcohol to frequency and severity of breast pain and tenderness.
EVISTA was associated with less breast pain and tenderness than reported by women receiving estrogens with or without added progestin. EVISTA-treated and placebo-treated groups had similar incidences of endometrial cancer and ovarian cancer. Median study drug exposure was 5. The incidence per year of all-cause mortality was similar between the raloxifene 2. Adverse reactions reported more frequently in EVISTA-treated women than in placebo-treated women included peripheral edema As of 31 Decemberthe median follow-up was 4.
The safety profile of raloxifene was similar to that in the placebo-controlled raloxifene trials [see Clinical Studies ]. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported very rarely since market introduction include retinal vein occlusionstrokeand death associated with venous thromboembolism VTE.
Although not specifically studied, it is anticipated that other anion exchange resins would have a similar effect. EVISTA evista and alcohol be used with caution with certain other highly protein-bound drugs such as diazepam, diazoxide, and lidocaine. The safety of concomitant use of EVISTA with systemic estrogens has not been established and its use is not recommended, evista and alcohol.
In clinical trials, EVISTA-treated women had an increased risk of venous thromboembolism deep vein thrombosis and pulmonary embolism. Other venous thromboembolic events also could occur. A less serious cholesterol and sugar content of alcohol, superficial thrombophlebitisalso has been reported more frequently with EVISTA than with placebo. The greatest risk for deep vein thrombosis and pulmonary embolism occurs during the first 4 months of treatment, evista and alcohol, and the magnitude of risk appears to be similar to the reported risk associated with use of hormone therapy.
Evista and alcohol immobilization increases the risk for venous thromboembolic events independent of therapy, EVISTA should be discontinued at least 72 hours prior to and during prolonged immobilization e. In a clinical trial of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an increased risk of death due to stroke was observed after treatment with EVISTA.
During an average evista and alcohol of 5. There was no statistically significant difference between treatment groups in the incidence of stroke in EVISTA [4, evista and alcohol. The risk-benefit evista and alcohol should be considered in women at risk for stroke, such as prior stroke or transient ischemic attack TIAatrial fibrillationhypertensionor cigarette smoking [see Clinical Studies ].
In a clinical trial of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, no cardiovascular benefit was demonstrated after treatment with raloxifene for 5 years [see Clinical Studies ], evista and alcohol.
Any unexplained uterine bleeding should be investigated as clinically indicated. Physicians should instruct their patients to read the Medication Guide before starting therapy with EVISTA and to reread it each time the prescription is renewed. EVISTA may increase the incidence of hot flashes and is not effective in reducing hot flashes or flushes associated with estrogen deficiency.
When considering treatment, physicians need to discuss the potential benefits and risks of EVISTA treatment with the patient. EVISTA is not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence. Systemic exposure AUC of raloxifene in this group was 0. The female rodents in these studies were treated during their reproductive lives when their ovaries were functional and responsive to hormonal stimulation, evista and alcohol.
Raloxifene HCl was not genotoxic in any of the following test systems: In female rats, at doses of 0. These effects of raloxifene were reversible. The reproductive and developmental effects observed in animals are consistent with the estrogen receptor activity of raloxifene, evista and alcohol. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when raloxifene is administered to a nursing woman.
No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
In evista and alcohol trials, evista and alcohol, no raloxifene overdose has been reported. The highest overdose has been approximately 1. No fatalities associated with raloxifene overdose have been reported. Two evista and alcohol children each ingested raloxifene Evista and alcohol mg. In these two children, symptoms reported included ataxiadizziness, vomiting, rash, diarrhea, tremorand flushing, as well as elevation in alkaline phosphatase.
There is no specific antidote for raloxifene. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Treatment of rats at doses of 0. Effects in adult offspring 4 months of age included uterine hypoplasia and reduced fertility; however, no ovarian or vaginal pathology was observed, evista and alcohol.
The biological actions of raloxifene are largely evista and alcohol through binding to estrogen receptors. This binding results in activation of estrogenic pathways in some tissues agonism and blockade of estrogenic pathways in others antagonism. The agonistic or antagonistic action of raloxifene depends on the extent of recruitment of coactivators and corepressors to estrogen receptor ER target gene promoters.
Raloxifene appears to act as an estrogen agonist in bone, evista and alcohol. It decreases bone resorption and bone turnover, evista and alcohol, increases bone mineral density BMD and decreases fracture incidence. Preclinical data demonstrate that raloxifene is an estrogen antagonist in uterine and breast tissues. These results are consistent with findings in clinical trials, which suggest that EVISTA lacks estrogen-like effects on the uterus and breast tissue.
Decreases in estrogen levels after oophorectomy or menopause lead to increases in bone resorption and accelerated bone loss. Bone is initially lost rapidly because the compensatory increase in bone formation is inadequate to diabetes and aching joints resorptive losses. In addition to loss of estrogen, this imbalance between resorption and formation may be due to age-related impairment of osteoblasts or their precursors.
In some women, evista and alcohol, these changes will eventually lead to decreased bone mass, osteoporosisand epilepsy and erectile dysfunction risk for fractures, particularly of the spine, hip, and wrist.
Vertebral fractures are the most common type of osteoporotic fracture in postmenopausal women. In both the osteoporosis treatment and prevention trials, EVISTA therapy resulted in consistent, statistically significant suppression of bone resorption and bone formation, as reflected by changes in serum and urine markers of bone turnover e.
The suppression of bone turnover markers was evident by 3 months and persisted throughout the month and month observation periods.
There were small decreases in serum total calcium, evista and alcohol, inorganic phosphate, total protein, and albuminwhich were generally of lesser magnitude than decreases observed during estrogen or hormone therapy. Platelet count was also decreased slightly and was not different from estrogen therapy. The disposition of raloxifene has been evaluated in more than postmenopausal women in selected raloxifene osteoporosis treatment and prevention clinical trials, using a population approach.
Pharmacokinetic data also were obtained in conventional pharmacology studies in postmenopausal women. Table 3 summarizes the pharmacokinetic parameters of raloxifene. Raloxifene is absorbed rapidly after oral administration. The time to reach average maximum plasma concentration and bioavailability are functions of systemic interconversion and enterohepatic cycling of raloxifene and its glucuronide metabolites.
Biotransformation and disposition of raloxifene in humans have been determined following oral administration of 14 C-labeled raloxifene. Raloxifene undergoes extensive first-pass metabolism to the glucuronide conjugates: No other metabolites have been detected, providing strong evidence that raloxifene is not metabolized by cytochrome P pathways.