Raloxifene Hydrochloride

A to Z Drug Facts

 Action Binds to and modulates effects of selected estrogen receptors. This results in estrogen-like effects on bone (increase in bone mineral density) and lipids (decrease in total and LDL cholesterol) but no effect on breast or uterine tissue.

 Indications For the prevention and treatment of osteoporosis in postmenopausal women.

 Contraindications Women who are or may become pregnant; women with active or history of venous thromboembolic events, including deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis; allergy to raloxifene or other constituents of the tablet; coadministration of cholestyramine.

 Route/Dosage

ADULT WOMEN: PO 60 mg qd.

 Interactions

Cholestyramine: Major reduction in absorption and enterohepatic cycling of raloxifene; avoid concurrent use. Warfarin: Raloxifene may decrease anticoagulant effect. Highly protein-bound drugs (eg, clofibrate, indomethacin, naproxen, ibuprofen, diazepam, diazoxide): May displace raloxifene from protein-binding sites, increasing the effects of raloxifene.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Hot flashes. CNS: Migraine; depression; insomnia. DERM: Rash; sweating. EENT: Sinusitis; pharyngitis; laryngitis. GI: Nausea; dyspepsia; vomiting; flatulence; gastroenteritis; abdominal pain. GU: Vaginitis; urinary tract infection; cystitis; leukorrhea; endometrial disorder. RESP: Cough; pneumonia. OTHER: Infection; flu-syndrome; leg cramps; chest pain; fever; weight gain; edema; arthralgia; myalgia; arthritis.

 Precautions

Pregnancy: Category X. Lactation: Undetermined. Children: Safety and efficacy not established. Venous thromboembolic events: Increased risk of thromboembolic events. Hepatic function impairment: Safety and efficacy not evaluated in patients with severe hepatic insufficiency. Premenopausal use: Safety and efficacy not established. Use is not recommended. Concurrent estrogen therapy: Concurrent use with systemic estrogens is not recommended. Lipid metabolism: Raloxifene lowers serum total and LDL cholesterol but does not affect total HDL or triglycerides. Endometrium: Because raloxifene does not affect endometrial proliferation unexplained uterine bleeding should be investigated as clinically indicated. Breast abnormality: Investigate any unexplained breast abnormality during therapy. Prior history of breast cancer: Raloxifene has not been adequately studied in women with prior history of breast cancer. Use in men: Safety and efficacy not established.

 Administration/Storage

• Administer once daily.
• Can be administered any time of the day without regard to meals.
• Store at controlled room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note previous history of thromboembolic disease or breast cancer.
• Ensure that patient has adequate calcium intake via diet or supplement.
• Ensure that medication is discontinued ³ 72 hr prior to and during any event associated with prolonged immobilization.
• Monitor patient for signs of thromboembolic event and notify physician.
• Assess patient for side effects.

 Patient/Family Education

• Advise patient to read package insert before starting therapy and each time the prescription is refilled.
• Teach name, expected action, and potential side effects to patient.
• Advise patient that drug is taken once a day without regard to meals.
• Advise patient that if a dose is missed, to start taking the drug on the normal schedule as soon as possible. Do not make up for the missed dose.
• Advise patient that this drug is for postmenopausal women only. It should not be given to premenopausal women or men to prevent osteoporosis.
• Advise patient that estrogen therapy that comes as a pill, patch, or injection should not be used in conjunction with this drug.
• Advise patient that drug does not reduce hot flashes and may actually cause hot flashes in some women.
• Instruct patient to take supplemental calcium (1500 mg) and vitamin D (400 IU) daily if dietary intake is not adequate.
• Encourage patient to perform weight-bearing exercises and avoid behaviors that promote osteoporosis (eg, alcohol consumption, cigarette smoking).
• Advise patient to avoid prolonged restrictions of movement during travel.
• Advise patient that medication will need to be discontinued at least 72 hr prior to any event that would cause prolonged immobilization (eg, postsurgical recovery) and can only be restarted once patient is fully mobile.
• Instruct patient to report these symptoms to physician: pain in groin or calves, leg swelling, sudden chest pain, shortness of breath or coughing blood, abnormal vaginal bleeding, breast lumps, sudden vision problems.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts