国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
RALOXIFENE HYDROCHLORIDE (UNII: 4F86W47BR6) (RALOXIFENE - UNII:YX9162EO3I)
Camber Pharmaceuticals Inc
RALOXIFENE HYDROCHLORIDE
RALOXIFENE HYDROCHLORIDE 60 mg
ORAL
PRESCRIPTION DRUG
Raloxifene hydrochloride tablets, USP are indicated for the treatment of osteoporosis in postmenopausal women [see Clinical Studies (14.1)]. 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)]. Raloxifene hydrochloride tablets are contraindicated in pregnancy, in women who may become pregnant, and in nursing mothers [see Use in Specific Populations (8.1, 8.3)]. Raloxifene hydrochloride tablets may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. In rabbit studies, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred in rabbits at doses ≥0.1 mg/kg (≥0.04 times the human dose based on surface area, mg/m2 ), and hydrocephal
Raloxifene hydrochloride tablets, USP 60 mg are white film coated round biconvex, de-bossed with IG on one side and 256 on the other, Supplied in bottles of 30 (NDC 31722-256-30), bottle of 100 (31722-256-01) and bottle of 1000 (NDC 31722-256-10) Store at controlled room temperature, 20º to 25ºC (68º to 77ºF) [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 20º to 25ºC (68º to 77ºF); that results in a mean kinetic temperature calculated to be not more than 25ºC; and that allows for excursions between 15º and 30ºC (59º and 86ºF) that are experienced in pharmacies, hospitals, and warehouses.
Abbreviated New Drug Application
RALOXIFENE HYDROCHLORIDE- RALOXIFENE HYDROCHLORIDE TABLET Camber Pharmaceuticals Inc ---------- MEDICATION GUIDE RALOXIFENE HYDROCHLORIDE TABLETS, USP FOR ORAL USE Read the Medication Guide that comes with raloxifene hydrochloride tablets before you start taking it 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 it 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 if I am taking raloxifene hydrochloride tablets?”) What is raloxife 完全なドキュメントを読む
RALOXIFENE HYDROCHLORIDE- RALOXIFENE HYDROCHLORIDE TABLET CAMBER PHARMACEUTICALS INC ---------- 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 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 Boxed Warning 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 tablet, USP is an estrogen agonist/antagonist indicated for: Treatment of osteoporosis in postmenopausal women. (1.1) 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 thrombosis, pulmonary embolism, and retinal vein thrombosis. Discontinue use 72 hours prior to and during prolonged immobilization. (5.1, 6.1) _Death Due to Stroke: _Increased risk of de 完全なドキュメントを読む