Raloxifene Hcl (raloxifene HCl)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Raloxifene hydrochloride, a nonsteroidal benzothiophene derivative, is an estrogen agonist-antagonist.
USES: Raloxifene is used by women to prevent and treat bone loss (osteoporosis) after menopause. It slows down bone loss and helps to keep bones strong, making them less likely to break. Raloxifene may also lower the chance of getting a certain type of breast cancer (invasive breast cancer) after menopause.
Raloxifene is not an estrogen hormone, but it acts like estrogen in some parts of the body, like your bones. In other parts of the body (uterus and breasts), raloxifene acts like an estrogen blocker. It does not relieve menopause symptoms such as hot flashes.
Raloxifene belongs to a class of drugs known as selective estrogen receptor modulators-SERMs. This medication should not be used before menopause. It should not be used to prevent heart disease.
Generic name: raloxifene HCl
Pronunciation: (ral-OX-i-feen)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Raloxifene Hcl
Indications
The following indications are listed for Raloxifene Hcl:
- Post-Menopausal Osteoporosis Prevention
- Postmenopausal Osteoporosis
- Prevention Of Breast Cancer In High Risk Women
Also known as: Post-Menopausal Osteoporosis, Postmenopausal Osteoporosis Prophylaxis.
Dosing
Dosage of raloxifene hydrochloride is expressed in terms of the hydrochloride. Raloxifene hydrochloride 60 mg contains 55.71 mg of raloxifene.
Patients receiving raloxifene for prevention or treatment of osteoporosis should receive supplemental calcium and/or vitamin D if their daily dietary intake is inadequate.
Plasma concentrations are higher in individuals with moderate to severe renal impairment compared with individuals with normal renal function. The manufacturer makes no specific recommendations for raloxifene dosage adjustment in patients with renal impairment.
Limited evidence from patients with cirrhosis (Child-Pugh class A) and total serum bilirubin concentrations of 0.6-2 mg/dL indicate that plasma concentrations of raloxifene are 150% higher in such patients relative to plasma concentrations in patients with normal hepatic function. Raloxifene has not been evaluated in patients with hepatic impairment other than Child-Pugh class A. The manufacturer currently makes no specific recommendation for adjustment of raloxifene dosage in patients with hepatic impairment. However, the drug is extensively metabolized in the liver and excreted principally in feces.
Raloxifene is administered orally as a single daily dose. The manufacturer states that the drug may be taken without regard to meals or time of day. Raloxifene may be administered concomitantly with calcium carbonate or aluminum and magnesium hydroxide-containing antacids.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
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There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
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There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
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There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Raloxifene may cause fetal toxicity when administered to pregnant women. Effects on reproductive function are expected because raloxifene is an estrogen agonist-antagonist. Since the risks clearly outweigh any possible benefits in women who are pregnant, raloxifene is contraindicated in such women; the drug also is not indicated for use in women of childbearing potential. If raloxifene is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug, raloxifene should be discontinued and the patient informed of the potential hazard to the fetus.
In reproductive studies in rabbits using raloxifene hydrochloride doses of 0.1 mg/kg or more (at least 0.04 times the recommended dose in humans on a mg/m2 basis), abortion and a low rate of fetal heart anomalies (i.e., ventricular septal defects) were observed, and in rabbits using raloxifene doses of 10 mg/kg or more (at least 4 times the recommended dose in humans on a mg/m2 basis), hydrocephaly was observed in the fetuses. In reproductive studies in rats using raloxifene hydrochloride doses of 1 mg/kg or more (at least 0.2 times the recommended dose in humans on a mg/m2 basis), retardation of fetal development and developmental abnormalities (i.e., wavy ribs, kidney cavitation) were observed.
In studies in rats using raloxifene hydrochloride doses of 0.1-10 mg/kg (0.02-1.6 times the recommended dose in humans on a mg/m2 basis) during gestation and lactation, delayed and disrupted parturition, decreased neonatal survival and altered physical development, sex- and age-specific reductions in growth and changes in pituitary hormone content, and decreased lymphoid compartment size in offspring were observed. Disruption of parturition, which resulted in maternal and progeny morbidity and/or death, was observed in rats given raloxifene hydrochloride 10 mg/kg. While ovarian or vaginal pathology was not observed in adult offspring (4 months of age), uterine hypoplasia and reduced fertility were noted.
It is not known whether raloxifene distributes into human milk or if the drug affects milk production or the nursing infant; however, because raloxifene is an estrogen agonist-antagonist, estrogenic effects on mammary tissue during lactation may be affected.
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ICD codes
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Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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