RALOXIFENE HYDROCHLORIDE- raloxifene tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

RALOXIFENE HYDROCHLORIDE

Composition:

RALOXIFENE HYDROCHLORIDE 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies (14.3)]. Raloxifene hydrochloride tablets 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

Product summary:

Raloxifene hydrochloride tablets, USP 60 mg are white film coated round biconvex, de-bossed with IG on one side and 256 on the other, supplied in unit dose packages of 30 (3 x 10) NDC 60687-266-21. Store at controlled room temperature, 20º to 25ºC (68º to 77ºF) [see USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20º to 25ºC (68º to 77ºF); that results in a mean kinetic temperature calculated to be not more than 25ºC; and that allows for excursions between 15º and 30ºC (59º and 86ºF) that are experienced in pharmacies, hospitals, and warehouses. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RALOXIFENE HYDROCHLORIDE- RALOXIFENE TABLET
American Health Packaging
----------
MEDICATION GUIDE
8426621/1120
Raloxifene Hydrochloride Tablets, USP for Oral Use
(ral•ox•i•fene)
Read the Medication Guide that comes with raloxifene hydrochloride
tablets before you start taking it 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 it 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 if I am taking raloxifene
hydrochloride tablets?")

Summary of Product characteristics

RALOXIFENE HYDROCHLORIDE- RALOXIFENE TABLET
AMERICAN HEALTH PACKAGING
----------
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 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 tablet, USP 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
thrombos