Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
RALOXIFENE HYDROCHLORIDE (UNII: 4F86W47BR6) (RALOXIFENE - UNII:YX9162EO3I)
A-S Medication Solutions
ORAL
PRESCRIPTION DRUG
Raloxifene hydrochloride is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.1, 14.2)] . Raloxifene hydrochloride is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies (14.3)] . Raloxifene hydrochloride is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see Clinical Studies (14.4)] . 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 4.3 years [see Clinical Studies (14.4)] . Twenty-seven percent of the participants received drug for 5 years. The long-term effects and the recommended length of treatment are not known. High risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (LCIS) or atypical hyperpl
Product: 50090-6177 NDC: 50090-6177-1 90 TABLET, COATED in a BOTTLE
Abbreviated New Drug Application
RALOXIFENE HYDROCHLORIDE - RALOXIFENE HYDROCHLORIDE TABLET, COATED A-S MEDICATION SOLUTIONS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RALOXIFENE HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE TABLETS 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 TABLETS (5.1). WOMEN WITH ACTIVE OR PAST HISTORY OF VENOUS THROMBOEMBOLISM SHOULD NOT TAKE RALOXIFENE HYDROCHLORIDE TABLETS (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 Contraindications, Pregnancy (4.2) 06/2018 Warnings and Precautions, Premenopausal Use (5.4) 06/2018 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 throm Прочетете целия документ