RALOXIFENE HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE
(ra-lox'i-feen)
Evista
Classifications: hormone; selective estrogen receptor antagonist/agonist;
Therapeutic: osteoporosis prophylactic

Prototype: Tamoxifen
Pregnancy Category: X

Availability

60 mg tablets

Action

Tamoxifen analog that exhibits selective estrogen receptor antagonist activity on uterus and breast tissue. Prevents tissue proliferation in both sites. Decreases bone resorption and increases bone density.

Therapeutic Effect

Effectiveness indicated by increased bone mineral density.

Uses

Prevention and treatment of osteoporosis in postmenopausal women.

Contraindications

Active thromboembolic event; hypersensitivity to raloxifene; pregnancy (category X), lactation, children.

Cautious Use

Concurrent use of raloxifene and estrogen hormone replacement therapy and lipid-lowering agents; hyperlipidemia; hepatic impairment.

Route & Dosage

Prevention or Treatment of Osteoporosis
Adult: PO 60 mg q.d.

Administration

Oral
  • Discontinue 72 h before and during prolonged immobilization.
  • Store at 15°–30° C (59°–86° F) in a tightly closed container and protect from light.

Adverse Effects (≥1%)

Body as a Whole: Infection, flu-like syndrome, leg cramps, fever, arthralgia, myalgia, arthritis. CNS: Migraine headache, depression, insomnia. CV: Hot flashes, chest pain, peripheral edema, decreased serum cholesterol. GI: Nausea, dyspepsia, vomiting, flatulence, GI disorder, gastroenteritis, weight gain. Respiratory: Sinusitis, pharyngitis, cough, pneumonia, laryngitis. Skin: Rash, sweating. Urogenital: Vaginitis, UTI, cystitis, leukorrhea, endometrial disorder, breast pain, vaginal bleeding.

Interactions

Drug: Use of estrogens not recommended; absorption reduced by cholestyramine; use with warfarin or other coumarin derivatives may result in changes in prothrombin time (PT).

Pharmacokinetics

Absorption: 60% absorbed, absolute bioavailability 2%. Metabolism: Extensive first-pass metabolism in liver. Elimination: Primarily in feces. Half-Life: 27.7–32.5 h.

Nursing Implications

Assessment & Drug Effects

  • Lab tests: Periodically monitor bone density, liver function, and plasma lipids; with concurrent oral anticoagulants, carefully monitor PT and INR.
  • Monitor carefully for and immediately report S&S of thromboembolic events.
  • Do not give drug concurrently with cholestyramine; however, if unavoidable, space the two drugs as widely as possible.

Patient & Family Education

  • Contact physician immediately if unexplained calf pain or tenderness occurs.
  • Avoid prolonged restriction of movement during travel.
  • Drug does not prevent and may induce hot flashes.
  • Do not take drug with other estrogen-containing drugs.
  • Tell prescriber if you are taking drugs to lower your cholesterol.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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