RALOXIFENE HYDROCHLORIDE tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Amneal Pharmaceuticals LLC

INN (Tên quốc tế):

RALOXIFENE HYDROCHLORIDE

Thành phần:

RALOXIFENE HYDROCHLORIDE 60 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Raloxifene hydrochloride tablets 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 known. High risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (LCIS) or aty

Tóm tắt sản phẩm:

Raloxifene hydrochloride tablets USP, 60 mg  are supplied as white to off-white, elliptical shaped, film–coated tablets debossed with “AN057” on one side and plain on the other side. They are available as follows: Bottles of 30:                                      NDC 65162-057-03 Bottles of 90:                                      NDC 65162-057-09 Bottles of 100:                                    NDC 65162-057-10 Bottles of 500:                                    NDC 65162-057-50 Bottles of 1000:                                  NDC 65162-057-11 Bottles of 2000:                                  NDC 65162-057-33 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 to 30ºC (59º and 86ºF) that are experienced in pharmacies, hospitals and warehouses. Dispense in tight containers.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

Amneal Pharmaceuticals LLC
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Medication Guide
Raloxifene Hydrochloride (ral ox’ i feen hye” droe klor’ ide)
Tablets, USP for Oral Use
Read the Medication Guide that comes with raloxifene hydrochloride
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 when you start taking it and at regular
checkups.
What is the most important information I should know about raloxifene
hydrochloride?
Serious and life-threatening side effects can occur while taking
raloxifene hydrochloride. 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. Women who have or have
had blood clots in the legs,
lungs, or eyes should not take raloxifene hydrochloride.
•
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.
1.
Before starting raloxifene hydrochloride, 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 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?”)
What is raloxifene hydrochloride?
Raloxifene hydrochloride is a type of prescription medicine called a
Selectiv

Đặc tính sản phẩm

RALOXIFENE HYDROCHLORIDE- RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED
AMNEAL PHARMACEUTICALS LLC
----------
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 HAS 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
Contraindications, Pregnancy (4.2) 06/2018
Warnings and Precautions, Premenopausal Use (5.4) 06/2018
INDICATIONS AND USAGE
Raloxifene hydrochloride tablets are 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 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 (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. (4.2,