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:

Liberty Pharmaceuticals, Inc.

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 of osteoporosis in postmenopausal women [see Clinical Studies (14.1)]. Raloxifene hydrochloride tablets are contraindicated in women with active or past history of venous thromboembolism (VTE), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis [see Warnings and Precautions (5.1)]. Raloxifene hydrochloride tablets are contraindicated in pregnancy, in women who may become pregnant, and in nursing mothers [see Use in Specific Populations (8.1, 8.3)]. Raloxifene hydrochloride tablets may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. In rabbit studies, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred in rabbits at doses ≥0.1 mg/kg (≥0.04 times the human dose based on surface area, mg/m2 ), and hydrocephal

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 bottles of 30 (NDC 76282-256-30), bottle of 100 (NDC 76282-256-01), and bottle of 500 (NDC 76282-256-05). 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RALOXIFENE HYDROCHLORIDE- RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED
Liberty Pharmaceuticals, Inc.
---------- MEDICATION GUIDE RALOXIFENE
HYDROCHLORIDE TABLETS, USP 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.
•
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.
•
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 HYDROCHLORIDE TABLET, FILM COATED
LIBERTY PHARMACEUTICALS, 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
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
Boxed Warning 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 tablet, USP is an estrogen agonist/antagonist
indicated for:
Treatment of osteoporosis in postmenopausal women. (1.1)
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 thrombosis,
pulmonary embolism, and retinal vein thrombosis.
Discontinue use 72 hours prior to and during prolonged immobilization.
(5.1, 6.1)
_Death Due to Stroke: _Increase