RALOXIFENE HYDROCHLORIDE tablet, coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

RALOXIFENE HYDROCHLORIDE (UNII: 4F86W47BR6) (RALOXIFENE - UNII:YX9162EO3I)

Pieejams no:

Modavar Pharmaceuticals LLC

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Raloxifene hydrochloride is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.1, 14.2)] .  Raloxifene hydrochloride is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies (14.3)] . Raloxifene hydrochloride is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see Clinical Studies (14.4)] . The effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see Clinical Studies (14.4)] . Twenty-seven percent of the participants received drug for 5 years. The long-term effects and the recommended length of treatment are not known. High risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (LCIS) or atypical hyperpl

Produktu pārskats:

Raloxifene hydrochloride tablets, USP are white to off-white, oval shaped film coated tablet debossed with “C79” on one side and plain on the other side. They are available as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

RALOXIFENE HYDROCHLORIDE - RALOXIFENE HYDROCHLORIDE TABLET, COATED
MODAVAR PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RALOXIFENE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
RALOXIFENE HYDROCHLORIDE TABLETS.
RALOXIFENE HYDROCHLORIDE TABLETS 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 TABLETS (5.1). WOMEN WITH
ACTIVE OR PAST
HISTORY OF VENOUS THROMBOEMBOLISM SHOULD NOT TAKE RALOXIFENE
HYDROCHLORIDE TABLETS
(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
Contraindications, Pregnancy (4.2) 06/2018
Warnings and Precautions, Premenopausal Use (5.4) 06/2018
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 th