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CELVISTA (RALISTA) INDICATIONS

Celvista (Raloxifene hydrochloride) is a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. Raloxifene's biological actions are largely mediated through binding to estrogen receptors. This binding results in activation of certain estrogenic pathways and blockade of others. Thus, raloxifene is a selective estrogen receptor modulator (SERM).

CELVISTA (RALISTA) INSTRUCTIONS

The recommended dosage is one 60-mg Celvista tablet daily, which may be administered any time of day without regard to meals.

CELVISTA (RALISTA) STORAGE

Use the medicine as prescribed by your doctor.

If you miss a dose of Celvista, skip the missed dose and go back to the regular dosing schedule. Do not take 2 doses at once.

CELVISTA (RALISTA) STORAGE

Store Celvista at 77 degrees F (25 degrees C), in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Celvista out of the reach of children and away from pets.

CELVISTA (RALISTA) MORE INFO:



Active Ingredient: Raloxifene

Raloxifene decreases resorption of bone and reduces biochemical markers of bone turnover to the premenopausal range. These effects on bone are manifested as reductions in the serum and urine levels of bone turnover markers, decreases in bone resorption based on radiocalcium kinetics studies, increases in bone mineral density (BMD) and decreases in incidence of fractures. Raloxifene also has effects on lipid metabolism. Raloxifene decreases total and LDL cholesterol levels but does not increase triglyceride levels. It does not change total HDL cholesterol levels. Preclinical data demonstrate that raloxifene is an estrogen antagonist in uterine and breast tissues. Clinical trial data (through a median of 42 months) suggest that raloxifene lacks estrogen-like effects on the uterus and breast tissue.

Warnings/Precautions


Celvista is contraindicated in lactating women or women who are or may become pregnant. It may cause fetal harm when administered to a pregnant woman. Celvista is also contraindicated in women with active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis and in women known to be hypersensitive to raloxifene or other constituents of the tablets.

Venous Thromboembolism

Endometrium

Breast

History of Breast Cancer

Renal Insufficiency

Hepatic Dysfunction

Pregnancy

Lactation

Pediatric Use

Use in elderly

Use in Men

The safety of raloxifene in the treatment of osteoporosis was assessed in a large (7705 patients) multinational placebo-controlled trial. Common adverse events considered to be related to raloxifene therapy were hot flashes and leg cramps. The majority of adverse events occurring during the study were mild and generally did not require discontinuation of therapy. These adverse events included infection, migraine, nausea, myalgia, insomnia, rash, conjunctivitis, vaginitis.

More Information

Incidents of overdose in humans have not been reported. In an 8-week study of 63 postmenopausal women, a dose of raloxifene HCl 600 mg/day was safely tolerated. No mortality was seen after a single oral dose in rats or mice at 5000 mg/kg (810 times the human dose for rats and 405 times the human dose for mice based on surface area, mg/m 2) or in monkeys at 1000 mg/kg (80 times the AUC in humans). There is no specific antidote for raloxifene.



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