Raloxifene hydrochloride 60 mg/1
Raloxifene hydrochloride · TABLET, COATED · Modavar Pharmaceuticals LLC
Raloxifene hydrochloride is a tablet, coated containing raloxifene hydrochloride at 60 mg/1, taken oral. Manufactured by Modavar Pharmaceuticals LLC.
Key Facts
- Brand Name
- Raloxifene hydrochloride
- Generic Name
- Raloxifene hydrochloride
- NDC Code (Product)
72241-010- Manufacturer
- Modavar Pharmaceuticals LLC
- Strength
- 60 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA211324
- Marketing Start
- 12/30/2017
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 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 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 ) 1.1 Treatment and Prevention of Osteoporosis in Postmenopausal Women Raloxifene hydrochloride tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.1 , 14.2) ] . 1.2 Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis Raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies (14.3) ] . 1.3 Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Ris…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 60 mg tablet orally once daily. (2.1) 2.1 Recommended Dosing The recommended dosage is one 60 mg raloxifene hydrochloride tablet 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. Total daily intake of calcium above 1500 mg has not demonstrated additional bone benefits while daily intake above 2000 mg has been associated with increased risk of adverse effects, including hypercalcemia and kidney stones. The recommended intake of vitamin D is 400 to 800 IU daily. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, or chronically ill) may need additional vitamin D supplements. Patients with gastrointestinal malabsorption synd…
Contraindications
4 CONTRAINDICATIONS Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. (4.1) Pregnancy (4.2 , 8.1) 4.1 Venous Thromboembolism 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) ] . 4.2 Pregnancy Raloxifene hydrochloride is contraindicated for use in pregnancy, as it may cause fetal harm [see Use in Specific Populations (8.1) ] .
Drug Interactions
7 DRUG INTERACTIONS Cholestyramine : Use with raloxifene hydrochloride is not recommended. Reduces the absorption and enterohepatic cycling of raloxifene. (7.1 , 12.3) Warfarin : Monitor prothrombin time when starting or stopping raloxifene hydrochloride. (7.2 , 12.3) Highly Protein-Bound Drugs : Use with raloxifene hydrochloride with caution. Highly protein-bound drugs include diazepam, diazoxide, and lidocaine. Raloxifene hydrochloride is more than 95% bound to plasma proteins. (7.3 , 12.3) 7.1 Cholestyramine Concomitant administration of cholestyramine with raloxifene hydrochloride is not recommended. Although not specifically studied, it is anticipated that other anion exchange resins would have a similar effect. Raloxifene hydrochloride should not be co-administered with other anion exchange resins [see Clinical Pharmacology (12.3) ] . 7.2 Warfarin If raloxifene hydrochloride is given concomitantly with warfarin or other warfarin derivatives, prothrombin time should be monitored more closely when starting or stopping therapy with raloxifene hydrochloride [see Clinical Pharmacology (12.3) ] . 7.3 Other Highly Protein-Bound Drugs Raloxifene hydrochloride should be used with caut…
Adverse Reactions
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 Northstar Rx LLC at 1-800-206-7821 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. The data described below reflect exposure to raloxifene hydrochloride in 8429 patients who were enrolled in placebo-controlled trials, including 6666 exposed for 1 year and 5685 for at least 3 years. Osteoporosis Treatment Clinical Trial (MORE) — The safety of raloxifene in the treatment of osteoporosis was assessed in a large (7705 patients) multinational, placebo-controlled trial. Duration of treatment was 36 months, and 5129 postmenopausal women were exposed to raloxifene hydrochloride (2557 received 60 mg/day, and 2572 received 120 mg/day). The incidence of all-cause mortality was similar …
Frequently Asked Questions
What is Raloxifene hydrochloride used for?
Raloxifene hydrochloride contains Raloxifene hydrochloride. It is a tablet, coated taken oral. Consult your doctor for specific uses.
Is Raloxifene hydrochloride a controlled substance?
Raloxifene hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Raloxifene hydrochloride?
The generic name for Raloxifene hydrochloride is Raloxifene hydrochloride. There are 7 other brand versions of Raloxifene hydrochloride.
What is the NDC code for Raloxifene hydrochloride 60 mg/1?
The NDC (National Drug Code) for Raloxifene hydrochloride 60 mg/1 is 72241-010, listed by Modavar Pharmaceuticals LLC.