RISEDRONATE SODIUM- risedronate sodium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

RISEDRONATE SODIUM

Composition:

RISEDRONATE SODIUM 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Risedronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate 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 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 of risedronate

Product summary:

Risedronate Sodium Tablets, USP are available containing 5 mg, 30 mg, 35 mg or 150 mg risedronate sodium, USP. The 5 mg tablets are light beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and 44 on the other side. They are available as follows: NDC 0378-4044-93 bottles of 30 tablets NDC 0378-4044-05 bottles of 500 tablets The 30 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 114 on the other side. They are available as follows: NDC 0378-4114-93 bottles of 30 tablets NDC 0378-4114-05 bottles of 500 tablets The 35 mg tablets are light orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and 714 on the other side. They are available as follows: NDC 0378-4714-99 unit of use blister card containing 4 tablets NDC 0378-4714-92 carton of 10 cards each containing 4 tablets NDC 0378-4714-96 unit of use blister card containing 12 tablets NDC 0378-4714-78 carton of 10 cards each containing 12 tablets The 150 mg tablets are light blue, film-coated, round, unscored tablets debossed with M over RE on one side of the tablet and 150 on the other side. They are available as follows: NDC 0378-4150-32 unit of use blister card containing 1 tablet NDC 0378-4150-97 carton of 10 cards each containing 1 tablet NDC 0378-4150-53 unit of use blister card containing 3 tablets NDC 0378-4150-93 carton of 10 cards each containing 3 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RISEDRONATE SODIUM- RISEDRONATE SODIUM TABLET, FILM COATED
Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
RISEDRONATE SODIUM TABLETS, USP
(ris″ e droe′ nate soe′ dee um)
5 mg, 30 mg, 35 mg and 150 mg
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
6.
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.
1.
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?”)
2.
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.
7.
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 ha

Summary of Product characteristics

RISEDRONATE SODIUM- RISEDRONATE SODIUM TABLET, FILM COATED
MYLAN PHARMACEUTICALS 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
RECENT MAJOR CHANGES
Contraindications (4) 03/2015
Warnings and Precautions (5.4) 04/2015
INDICATIONS AND USAGE
Risedronate sodium tablets are a bisphosphonate indicated for:
•
•
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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, 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:
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•
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DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 30 mg, 35 mg and 150 mg (3)
CONTRAINDICATIONS
•
•
•
•
WARNINGS AND PRECAUTIONS
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•
•
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ADVERSE REACTIONS
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)
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)
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)
_Pro