Raloxifene: uses, dosing, side effects & brands

Adverse reactions (>2% and more common than with placebo) include: hot flashes, leg cramps, peripheral edema, flu syndrome, arthralgia, sweating. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Exelan Pharmaceuticals, Inc at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience 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 raloxifene hydrochloride tablets in 8429 patients who were enrolled in placebo-controlled trials, including 6666 exposed for 1 year and 5685 for at least 3 years. Osteoporosis Treatment Clinical Trial (MORE) — The safety of raloxifene in a treatment of osteoporosis was assessed in a large (7705 patients) multinational, placebo-controlled trial. Duration of treatment was 36 months, and 5129 postmenopausal women were exposed to raloxifene hydrochloride (2557 received 60 mg/day, and 2572 received 120 mg/day). The incidence of all-cause mortality was similar among groups: 23 (0.9%) placebo, 13 (0.5%) raloxifene hydrochloride tablets-treated (raloxifene HCl 60 mg), and 28 (1.1%) raloxifene HCl 120 mg women died. Therapy was discontinued due to an adverse…

Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. ( 4.1 ) Pregnancy ( 4.2 , 8.1 ) 4.1 Venous Thromboembolism Raloxifene hydrochloride tablets are contraindicated in women with active or past history of venous thromboembolism (VTE), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis [see Warnings and Precautions (5.1) ]. 4.2 Pregnancy Raloxifene hydrochloride tablets are contraindicated in pregnancy, as it may cause fetal harm [see Use in Specific Populations (8.1) ] .

Cholestyramine: Use with raloxifene hydrochloride tablets is not recommended. Reduces the absorption and enterohepatic cycling of raloxifene. ( 7.1 , 12.3 ) • Warfarin: Monitor prothrombin time when starting or stopping Raloxifene hydrochloride tablets. ( 7.2 , 12.3 ) • Highly Protein-Bound Drugs: Use with Raloxifene hydrochloride tablets with caution. Highly protein-bound drugs include diazepam, diazoxide, and lidocaine. Raloxifene hydrochloride is more than 95% bound to plasma proteins. ( 7.3 , 12.3 ) 7.1 Cholestyramine Concomitant administration of cholestyramine with raloxifene hydrochloride tablets is not recommended. Although not specifically studied, it is anticipated that other anion exchange resins would have a similar effect. Raloxifene hydrochloride tablets should not be co-administered with other anion exchange resins [see Clinical Pharmacology (12.3) ]. 7.2 Warfarin If raloxifene hydrochloride tablets are given concomitantly with warfarin or other warfarin derivatives, prothrombin time should be monitored more closely when starting or stopping therapy with raloxifene hydrochloride tablets [see Clinical Pharmacology (12.3) ]. 7.3 Other Highly Protein-Bound Drugs Raloxifene hydrochloride tablets should be used with caution with certain other highly protein-bound drugs such as diazepam, diazoxide, and lidocaine. Although not examined, raloxifene hydrochloride tablets might affect the protein binding of other drugs. Raloxifene is more than 95% bound to plasma proteins [see Clinical Pharmacology (12.3) ]. 7.4 Systemic Estrogens The safety of concomitant use of raloxifene hydrochloride tablets with systemic estrogens has not been established and its use is not recommended. 7.5 Other Concomitant Medications Raloxifene hydrochloride tablets can be concomitantly administered with ampicillin, amoxicillin, antacids, corticosteroids, and digoxin [see Clinical Pharmacology (12.3) ]. The concomitant use of raloxifene hydrochloride tablets and lipid-lowering agents has not been studied.