Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
Raloxifene hydrochloride (UNII: 4F86W47BR6) (Raloxifene - UNII:YX9162EO3I)
Avera McKennan Hospital
Raloxifene hydrochloride
Raloxifene hydrochloride 60 mg
PRESCRIPTION DRUG
New Drug Application Authorized Generic
RALOXIFENE HYDROCHLORIDE - RALOXIFENE HYDROCHLORIDE TABLET AVERA MCKENNAN HOSPITAL ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RALOXIFENE HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RALOXIFENE HYDROCHLORIDE. RALOXIFENE HYDROCHLORIDE TABLET FOR ORAL USE INITIAL U.S. APPROVAL: 1997 WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ INCREASED RISK OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM HAVE BEEN REPORTED WITH RALOXIFENE HYDROCHLORIDE (5.1). WOMEN WITH ACTIVE OR PAST HISTORY OF VENOUS THROMBOEMBOLISM SHOULD NOT TAKE RALOXIFENE HYDROCHLORIDE (4.1). INCREASED RISK OF DEATH DUE TO STROKE OCCURRED IN A TRIAL IN POSTMENOPAUSAL WOMEN WITH DOCUMENTED CORONARY HEART DISEASE OR AT INCREASED RISK FOR MAJOR CORONARY EVENTS. CONSIDER RISK-BENEFIT BALANCE IN WOMEN AT RISK FOR STROKE (5.2, 14.5). RECENT MAJOR CHANGES None . INDICATIONS AND USAGE Raloxifene hydrochloride 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 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. (1.3) DOSAGE AND ADMINISTRATION 60 mg tablet orally once daily. (2.1) DOSAGE FORMS AND STRENGTHS Tablets (not scored): 60 mg (3) CONTRAINDICATIONS Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. (4.1) Pregnancy, women who may become pregnant, and nursing mothers. (4.2, 8.1, 8.3) WARNINGS AND PRECAUTIONS _Venous Thromboembolism_: Increased risk of deep vein thr Olvassa el a teljes dokumentumot