Raloxifene Hydrochloride
Generic Name: raloxifene hydrochloride
Brand Names:
Raloxifene Hydrochloride
11 DESCRIPTION Raloxifene HCl, USP is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is: The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[ b ]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene HCl, USP has the molecular formula C 28 H 27 NO 4 S•HCl, which corresponds to a molecular weight of 510.05.
Overview
11 DESCRIPTION Raloxifene HCl, USP is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is: The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[ b ]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene HCl, USP has the molecular formula C 28 H 27 NO 4 S•HCl, which corresponds to a molecular weight of 510.05.
Uses
1 INDICATIONS AND USAGE Raloxifene HCl tablets, USP are 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 HCl 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.
Dosage
2 DOSAGE AND ADMINISTRATION 60 mg tablet orally once daily. (2.1) 2.1 Recommended Dosing The recommended dosage is one 60 mg raloxifene HCl tablet, USP 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 osteoporosis treatment or prevention, supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate. Postmenopausal women require an average of 1500 mg/day of elemental calcium.
Side Effects
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 AvKARE at 1-855-361-3993; email drugsafety@avkare.com; 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 directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Interactions
7 DRUG INTERACTIONS Cholestyramine: Use with raloxifene HCl is not recommended. Reduces the absorption and enterohepatic cycling of raloxifene. (7.1, 12.3) Warfarin: Monitor prothrombin time when starting or stopping raloxifene HCl. (7.2, 12.3) Highly Protein-Bound Drugs: Use with raloxifene HCl with caution. Highly protein-bound drugs include diazepam, diazoxide and lidocaine. Raloxifene HCl is more than 95% bound to plasma proteins. (7.3, 12.3) 7.1 Cholestyramine Concomitant administration of cholestyramine with raloxifene HCl is not recommended. Although not specifically studied, it is anticipated that other anion exchange resins would have a similar effect. Raloxifene HCl should not be co-administered with other anion exchange resins [see Clinical Pharmacology (12.3) ] .
Warnings
WARNING--INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene HCl (5.1) . Women with active or past history of venous thromboembolism should not take raloxifene HCl (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. 5 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 death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. No increased risk of stroke was seen in this trial. Consider risk-benefit balance in women at risk for stroke. (5.2, 14.5) Cardiovascular Disease: Raloxifene HCl should not be used for the primary or secondary prevention of cardiovascular disease. (5.3, 14.5) Premenopausal Women: Use is not recommended. (5.4) Hepatic Impairment: Use with caution. 4 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.
Pregnancy
8.1 Pregnancy Pregnancy Category X. Raloxifene HCl should not be used in women who are or may become pregnant [see Contraindications (4.2) ] .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Raloxifene HCl tablets, USP, 60 mg, are supplied as white to off-white, elliptical shaped, film–coated tablets debossed with “AN057” on one side and plain on the other side. They are available as follows: NDC 50268-694-15 (10 tablets per card, 5 cards per carton) Dispensed in Unit Dose Package. For Institutional Use Only.
Frequently Asked Questions
What is Raloxifene Hydrochloride used for?▼
1 INDICATIONS AND USAGE Raloxifene HCl tablets, USP are 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 HCl 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.
What are the side effects of Raloxifene Hydrochloride?▼
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 AvKARE at 1-855-361-3993; email drugsafety@avkare.com; 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 directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Can I take Raloxifene Hydrochloride during pregnancy?▼
8.1 Pregnancy Pregnancy Category X. Raloxifene HCl should not be used in women who are or may become pregnant [see Contraindications (4.2) ] .
What are the important warnings for Raloxifene Hydrochloride?▼
WARNING--INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene HCl (5.1) . Women with active or past history of venous thromboembolism should not take raloxifene HCl (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. 5 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 death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. No increased risk of stroke was seen in this trial. Consider risk-benefit balance in women at risk for stroke. (5.2, 14.5) Cardiovascular Disease: Raloxifene HCl should not be used for the primary or secondary prevention of cardiovascular disease. (5.3, 14.5) Premenopausal Women: Use is not recommended. (5.4) Hepatic Impairment: Use with caution. 4 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.