RISEDRONATE SODIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RISEDRONATE SODIUM HEMI-PENTAHYDRATE (UNII: HU2YAQ274O) (RISEDRONIC ACID - UNII:KM2Z91756Z), RISEDRONATE SODIUM MONOHYDRATE (UNII: F67L43UT5C) (RISEDRONIC ACID - UNII:KM2Z91756Z)

Available from:

Actavis Pharma, Inc.

INN (International Name):

RISEDRONATE SODIUM HEMI-PENTAHYDRATE

Composition:

RISEDRONATE SODIUM ANHYDROUS 4.3 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Risedronate sodium tablets is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets 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 is indicated for treatment to increase bone mass in men with osteoporosis. Risedronate sodium tablets is 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 is 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 of

Product summary:

Risedronate sodium tablets is available as follows: 5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other. NDC 0591-2102-30 bottle of 30 30 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other. NDC 0591-2109-30 bottle of 30 35 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other. NDC 0591-2075-04 dose pack of 4 NDC 0591-2075-39 dose pack of 12 75 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other. NDC 0591-2067-02 dose pack of 2 150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other. NDC 0591-2044-54 dose pack of 1 NDC 0591-2044-03 dose pack of 3 Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

Actavis Pharma, Inc.
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MEDICATION GUIDE
Medication Guide
Risedronate Sodium Tablets
(ris-ed-ro-nate so-di-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 muscles
•

Summary of Product characteristics

RISEDRONATE SODIUM- RISEDRONATE SODIUM TABLET, FILM COATED
ACTAVIS PHARMA, 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 tablets 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, 30, 35, 75, 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
Atelvia should not be treated with risedronate sodium
tablets (5.1)
_Upper Gastrointesti