RALOXIFENE HYDROCHLORIDE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Raloxifene hydrochloride (UNII: 4F86W47BR6) (Raloxifene - UNII:YX9162EO3I)

Disponible depuis:

Avera McKennan Hospital

DCI (Dénomination commune internationale):

Raloxifene hydrochloride

Composition:

Raloxifene hydrochloride 60 mg

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

New Drug Application Authorized Generic

Résumé des caractéristiques du produit

RALOXIFENE HYDROCHLORIDE - RALOXIFENE HYDROCHLORIDE TABLET
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RALOXIFENE HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RALOXIFENE
HYDROCHLORIDE.
RALOXIFENE HYDROCHLORIDE TABLET FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM
STROKE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM HAVE
BEEN REPORTED WITH RALOXIFENE
HYDROCHLORIDE (5.1). WOMEN WITH ACTIVE OR PAST HISTORY OF VENOUS
THROMBOEMBOLISM SHOULD NOT TAKE
RALOXIFENE HYDROCHLORIDE (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.
CONSIDER RISK-BENEFIT BALANCE
IN WOMEN AT RISK FOR STROKE (5.2, 14.5).
RECENT MAJOR CHANGES
None .
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 is 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)
DOSAGE AND ADMINISTRATION
60 mg tablet orally once daily. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets (not scored): 60 mg (3)
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. (4.2,
8.1, 8.3)
WARNINGS AND PRECAUTIONS
_Venous Thromboembolism_: Increased risk of deep vein thr