RALOXIFENE HYDROCHLORIDE tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Aphena Pharma Solutions - Tennessee, LLC

INN (Medzinárodný Name):

RALOXIFENE HYDROCHLORIDE

Zloženie:

RALOXIFENE HYDROCHLORIDE 60 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Raloxifene hydrochloride tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.1, 14.2)] . Raloxifene hydrochloride tablets, USP are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies (14.3) ]. Raloxifene hydrochloride tablets, USP are 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 si

Prehľad produktov:

Raloxifene Hydrochloride Tablets USP, 60 mg are white to off-white, elliptical, film-coated tablets debossed with ‘X’ on one side and ‘57’ on other side.                                    Bottles of 100                                  NDC 52343-137-01                      Store at 20° to 25°C (68° to 77°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.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

RALOXIFENE HYDROCHLORIDE - RALOXIFENE HYDROCHLORIDE TABLET, FILM
COATED
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
Raloxifene Hydrochloride Tablets, USP for Oral Use
(ral ox' i feen hye'' droe klor' ide)
Read the Medication Guide that comes with raloxifene hydrochloride
tablets before you start taking them
and each time you refill your prescription. The information may have
changed. This Medication Guide
does not take the place of talking with your doctor about your medical
condition or treatment. Talk with
your doctor about raloxifene hydrochloride tablets when you start
taking them and at regular checkups.
What is the most important information I should know about raloxifene
hydrochloride tablets?
Serious and life-threatening side effects can occur while taking
raloxifene hydrochloride tablets. These
include blood clots and dying from stroke:
•
Increased risk of blood clots in the legs (deep vein thrombosis) and
lungs (pulmonary embolism)
have been reported with raloxifene hydrochloride tablets. Women who
have or have had blood
clots in the legs, lungs, or eyes should not take raloxifene
hydrochloride tablets.
•
Women who have had a heart attack or are at risk for a heart attack
may have an increased risk of
dying from stroke when taking raloxifene hydrochloride tablets.
1. Before starting raloxifene hydrochloride tablets, tell your doctor
if you have had blood clots in your
legs, lungs, or eyes, a stroke, mini-stroke (transient ischemic
attack), or have an irregular heartbeat.
2. Stop taking raloxifene hydrochloride tablets and call your doctor
if you have:
•
leg pain or a feeling of warmth in the lower leg (calf).
•
swelling of the legs, hands, or feet.
•
sudden chest pain, shortness of breath, or coughing up blood.
•
sudden change in your vision, such as loss of vision or blurred
vision.
3. Being still for a long time (such as sitting still during a long
car or airplane trip or being in bed after
surgery) can increase your risk of blood clots. (See “What should I
avoid

Súhrn charakteristických

RALOXIFENE HYDROCHLORIDE - RALOXIFENE HYDROCHLORIDE TABLET, FILM
COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RALOXIFENE HYDROCHLORIDE TABLETS,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RALOXIFENE HYDROCHLORIDE TABLETS,
USP.
RALOXIFENE HYDROCHLORIDE TABLETS, USP 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
Boxed Warning 9/2007
Indications and Usage, Invasive Breast Cancer
Risk Reduction (1) 9/2007
Warnings and Precautions, Death Due to Stroke (5.2) 7/2007
Warnings and Precautions, Cardiovascular Disease (5.3) 7/2007
Warnings and Precautions, Renal Impairment (5.8) 7/2007
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 tablets USP are 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 (n