Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
RALOXIFENE HYDROCHLORIDE (UNII: 4F86W47BR6) (RALOXIFENE - UNII:YX9162EO3I)
ACETRIS HEALTH, LLC
RALOXIFENE HYDROCHLORIDE
RALOXIFENE HYDROCHLORIDE 60 mg
ORAL
PRESCRIPTION DRUG
Raloxifene hydrochloride tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.1, 14.2)] . Raloxifene hydrochloride tablets, USP are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies (14.3)]. Raloxifene hydrochloride tablets, USP are 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 (
Raloxifene Hydrochloride Tablets USP, 60 mg are white to off-white, elliptical, film-coated tablets debossed with ‘X’ on one side and ‘57’ on other side. Bottles of 100 NDC 52343-137-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.
Abbreviated New Drug Application
RALOXIFENE HYDROCHLORIDE - RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED ACETRIS HEALTH, LLC ---------- MEDICATION GUIDE Raloxifene Hydrochloride Tablets, USP for Oral Use (ral ox' i feen hye'' droe klor' ide) Read the Medication Guide that comes with raloxifene hydrochloride tablets before you start taking them and each time you refill your prescription. The information may have changed. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk with your doctor about raloxifene hydrochloride tablets when you start taking them and at regular checkups. What is the most important information I should know about raloxifene hydrochloride tablets? Serious and life-threatening side effects can occur while taking raloxifene hydrochloride tablets. These include blood clots and dying from stroke: • Increased risk of blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) have been reported with raloxifene hydrochloride tablets. Women who have or have had blood clots in the legs, lungs, or eyes should not take raloxifene hydrochloride tablets. • Women who have had a heart attack or are at risk for a heart attack may have an increased risk of dying from stroke when taking raloxifene hydrochloride tablets. 1. Before starting raloxifene hydrochloride tablets, tell your doctor if you have had blood clots in your legs, lungs, or eyes, a stroke, mini-stroke (transient ischemic attack), or have an irregular heartbeat. 2. Stop taking raloxifene hydrochloride tablets and call your doctor if you have: • leg pain or a feeling of warmth in the lower leg (calf). • swelling of the legs, hands, or feet. • sudden chest pain, shortness of breath, or coughing up blood. • sudden change in your vision, such as loss of vision or blurred vision. 3. Being still for a long time (such as sitting still during a long car or airplane trip or being in bed after surgery) can increase your risk of blood clots. (See “What should I avoid while taking raloxif Przeczytaj cały dokument
RALOXIFENE HYDROCHLORIDE - RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED ACETRIS HEALTH, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RALOXIFENE HYDROCHLORIDE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RALOXIFENE HYDROCHLORIDE TABLETS, USP. RALOXIFENE HYDROCHLORIDE TABLETS, USP 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 Boxed Warning 9/2007 Indications and Usage, Invasive Breast Cancer Risk Reduction (1) 9/2007 Warnings and Precautions, Death Due to Stroke (5.2) 7/2007 Warnings and Precautions, Cardiovascular Disease (5.3) 7/2007 Warnings and Precautions, Renal Impairment (5.8) 7/2007 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 tablets USP are 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) Przeczytaj cały dokument