RISEDRONATE SODIUM tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

RISEDRONATE SODIUM (UNII: OFG5EXG60L) (RISEDRONIC ACID - UNII:KM2Z91756Z)

Disponible des:

Macleods Pharmaceuticals Limited

Designació comuna internacional (DCI):

RISEDRONATE SODIUM

Composición:

RISEDRONATE SODIUM 5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Risedronate sodium tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets, USP reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1, 14.2) ]. Risedronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis. Risedronate sodium tablets, USP 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, USP are indicated for treatment of Paget's disease of bone in men and women. The optimal duration of use has not been determined. T

Resumen del producto:

Risedronate sodium tablets, USP are available as follows: 5 mg yellow coloured, circular, biconvex, film-coated tablet debossed with "CL 90" on one side and plain on other side. NDC 33342-107-07 bottle of 30 NDC 33342-107-49 bottle of 2000 NDC 33342-107-06 Unit dose tablets pack of 30 (3 x 10) 30 mg white to off white, circular, biconvex, film-coated tablet debossed with "CL 91" on one side and plain on other side. NDC  33342-108-07 bottle of 30 NDC 33342-108-15 bottle of 500 NDC 33342-108-06 Unit dose tablets pack of 30 (3 x 10) 35 mg orange coloured, circular, biconvex, film-coated tablet debossed with "CL 92" on one side and plain on the other side. NDC 33342-109-37 dose pack of 4 NDC 33342-109-50 dose pack of 12 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Macleods Pharmaceuticals Limited
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SPL MEDGUIDE SECTION
Risedronate Sodium tablets, USP
(RIS-e-DROE-nate SOE-dee-um)
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 tablets can 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 tablets may 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 musc

Fitxa tècnica

RISEDRONATE SODIUM - RISEDRONATE SODIUM TABLET, FILM COATED
MACLEODS PHARMACEUTICALS LIMITED
----------
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, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Risedronate sodium tablet, USP 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 (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, 30, 35 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
Atelvia should not be treated with
risedronate sodium tablets (5.1)
•