RISEDRONATE SODIUM tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

RISEDRONATE SODIUM HEMI-PENTAHYDRATE (UNII: HU2YAQ274O) (RISEDRONIC ACID - UNII:KM2Z91756Z)

Dostupné s:

Sun Pharmaceutical Industries, Inc.

INN (Mezinárodní Name):

RISEDRONATE SODIUM HEMI-PENTAHYDRATE

Složení:

RISEDRONATE SODIUM 5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Risedronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1, 14.2) ]. Risedronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis. Risedronate sodium tablets are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D. Risedronate sodium tablets are indicated for treatment of Paget's disease of bone in men and women. The optimal duration of use has not been determined. The safety and effectiveness

Přehled produktů:

Risedronate sodium tablets, USP are available as follows: 5 mg film-coated, round, yellow tablets debossed ‘5’ on one side and ‘S’ on other side. Bottles of 30 with Child-resistant Cap, DC 47335-666-83 Bottles of 100 with Child-resistant Cap, NDC 47335-666-88 Bottles of 100, NDC 47335-666-08 Bottles of 1000, NDC 47335-666-18 30 mg film-coated, round, white tablets debossed ‘667’ on one side and ‘S’ on other side. Bottles of 30 with Child-resistant Cap, NDC 47335-667-83 Bottles of 100 with Child-resistant Cap, NDC 47335-667-88 Bottles of 100, NDC 47335-667-08 Bottles of 1000, NDC 47335-667-18 35 mg film-coated, round, brown tablets debossed ‘668’ on one side and ‘S’ on other side. Unit-dose blister package of 4……………………..… NDC 47335-668-68 Unit-dose blister package of 12……………………… NDC 47335-668-62 75 mg film-coated, round, pink tablets debossed ‘727’ on one side and ‘S’ on other side. Unit-dose blister package of 2…………………..…… NDC 47335-727-98 150 mg film-coated, round, blue tablets debossed ‘928’ on one side and ‘S’ on other side. Unit-dose blister package of 1..………………………  NDC 47335-928-60 Unit-dose blister package of 3..………………………  NDC 47335-928-67 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers as defined in USP.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Risedronate Sodium
(RIS-e-DROE-nate SOE-dee-um)Tablets, USP
Read the Medication Guide that comes with risedronate sodium tablets
before you start taking it and each
time you get a refill. There may be new information. This Medication
Guide does not take the place of
talking with your doctor about your medical condition or your
treatment. Talk to your doctor if you have
any questions about risedronate sodium tablets, there may be new
information about it.
What is the most important information I should know about risedronate
sodium tablets?
Risedronate sodium tabletscan cause serious side effects including:
1.
Esophagus problems
2.
Low calcium levels in your blood (hypocalcemia)
3.
Severe jaw bone problems (osteonecrosis)
4.
Bone, joint, or muscle pain
5.
Unusual thigh bone fractures
1. Esophagus problems.
Some people who take risedronate sodium tabletsmay develop problems in
the esophagus (the tube that
connects the mouth and the stomach). These problems include
irritation, inflammation, or ulcers of the
esophagus which may sometimes bleed.
•
It is important that you take risedronate sodium tablets exactly as
prescribed to help lower your
chance of getting esophagus problems. (See the section “How should I
take risedronate sodium
tablets?”)
•
Stop taking risedronate sodium tablets and call your doctor right away
if you get chest pain, new
or worsening heartburn, or have trouble or pain when you swallow.
2. Low calcium levels in your blood (hypocalcemia).
Risedronate sodium tablets may lower the calcium levels in your blood.
If you have low blood calcium
before you start taking risedronate sodium tablets, it may get worse
during treatment. Your low blood
calcium must be treated before you take risedronate sodium tablets.
Most people with low blood calcium
levels do not have symptoms, but some people may have symptoms. Call
your doctor right away if you
have symptoms of low blood calcium such as:
•
Spasms, twitches, or cramps in your muscles

Charakteristika produktu

RISEDRONATE SODIUM - RISEDRONATE SODIUM TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RISEDRONATE SODIUM
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RISEDRONATE SODIUM
TABLETS.
RISEDRONATE SODIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Risedronate sodium is a bisphosphonate indicated for:
Treatment and prevention of postmenopausal osteoporosis (1.1)
Treatment to increase bone mass in men with osteoporosis (1.2)
Treatment and prevention of glucocorticoid-induced osteoporosis (1.3)
Treatment of Paget's disease (1.4)
Limitations of Use
Optimal duration of use has not been determined. For patients at
low-risk for fracture, consider drug
discontinuation after 3 to 5 years of use. (1.5)
DOSAGE AND ADMINISTRATION
Treatment of Postmenopausal Osteoporosis: 5 mg daily, 35 mg
once-a-week, 75 mg two consecutive days
each month, 150 mg once-a-month (2.1)
Prevention of Postmenopausal Osteoporosis: 5 mg daily, 35 mg
once-a-week (2.2)
Men with Osteoporosis: 35 mg once-a-week (2.3)
Glucocorticoid-Induced Osteoporosis: 5 mg daily (2.4)
Paget's Disease: 30 mg daily for 2 months (2.5)
Instruct patients to:
Swallow tablet whole with 6 to 8 ounces of plain water, at least 30
minutes before the first food,
beverage, or medication of the day
Avoid lying down for 30 minutes (2)
Take supplemental calcium and vitamin D if dietary intake is
inadequate (2.7)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 30 mg, 35 mg, 75 mg, and 150 mg (3)
CONTRAINDICATIONS
Abnormalities of the esophagus which delay esophageal emptying such as
stricture or achalasia (4,
5.1)
Inability to stand or sit upright for at least 30 minutes (4, 5.1)
Hypocalcemia (4, 5.2)
Known hypersensitivity to any component of this product (4, 6.2)
WARNINGS AND PRECAUTIONS
_Products Containing Same Active Ingredient:_ Patients receiving
risedronate sodium delayed-release
tablets should not be treated with r