Raloxifene hydrochloride is the generic equivalent of the brand-name drug Raloxifene hydrochloride. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Raloxifene hydrochloride through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Raloxifene hydrochloride tablets, USP is an estrogen agonist/antagonist indicated for: Treatment and prevention of osteoporosis in postmenopausal women. ( 1.1 ) Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. ( 1.2 ) Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. ( 1.3 ) Important Limitations: Raloxifene hydrochloride tablets, USP is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer. 1.1 Treatment and Prevention of Osteoporosis in Postmenopausal Women Raloxi…
Adverse Reactions
6 ADVERSE REACTIONS 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 Dr. Reddy’s Laboratories, Inc at 1-888-375-3784 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 dire…
Drug Interactions
7 DRUG INTERACTIONS Cholestyramine : Use with raloxifene is not recommended. Reduces the absorption and enterohepatic cycling of raloxifene. ( 7.1 , 12.3 ) Warfarin : Monitor prothrombin time when starting or stopping raloxifene. ( 7.2 , 12.3 ) Highly Protein-Bound Drugs : Use with raloxifene with caution. Highly protein-bound drugs include diazepam, diazoxide, and lidocaine. Raloxifene is more than 95% bound to plasma proteins. ( 7.3 , 12.3 ) 7.1 Cholestyramine Concomitant administration of cho…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 60 mg tablet orally once daily. ( 2.1 ) 2.1 Recommended Dosing The recommended dosage is one raloxifene hydrochloride tablets, USP 60 mg daily, which may be administered any time of day without regard to meals [see Clinical Pharmacology (12.3) ] . For the indications in risk of invasive breast cancer the optimum duration of treatment is not known [see Clinical Studies (14.3 , 14.4) ] . 2.2 Recommendations for Calcium and Vitamin D Supplementation For either osteoporos…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION See FDA-approved Medication Guide . Physicians should instruct their patients to read the Medication Guide before starting therapy with Raloxifene hydrochloride tablets and to reread it each time the prescription is renewed. 17.1 Osteoporosis Recommendations, Including Calcium and Vitamin D Supplementation For osteoporosis treatment or prevention, patients should be instructed to take supplemental calcium and/or vitamin D if intake is inadequate. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, chronic…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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