RALOXIFENE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr.Reddy’s Laboratories Inc

INN (International Name):

Raloxifene hydrochloride

Composition:

Raloxifene hydrochloride 60 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Raloxifene hydrochloride tablets, USP 60 mg tablets are white to off-white, oval, biconvex, film coated tablets, debossed with ‘SG’ on one side and ‘306’ on other side. They are available as follows: Bottle (count) NDC Number 30’s               NDC 43598-505-30 100’s             NDC 43598-505-01 1000’s           NDC 43598-505-10 Store at controlled room temperature, 20° to 25°C (68° to 77°F) [ see USP]. 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RALOXIFENE HYDROCHLORIDE- RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED
Dr.Reddy’s Laboratories Inc
----------
Medication Guide
RALOXIFENE (ral.ox.i.fene) Hydrochloride Tablets,
USP 60 mg for oral use
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 hydro

Summary of Product characteristics

RALOXIFENE HYDROCHLORIDE- RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED
DR.REDDY’S LABORATORIES INC
----------
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 ( 5.1). WOMEN WITH ACTIVE OR PAST HISTORY OF
VENOUS
THROMBOEMBOLISM SHOULD NOT TAKE RALOXIFENE ( 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 tablets, 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 tablets, USP 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.
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. ( 4.