Rx Item-Risedronate 35Mg Tab 4 By Apotex Pharma

Clinical Information
Gen. Code and Des.
50364 risedronate sodium ORAL TABLET 35 MG
GCN and Des.
17378 risedronate sodium ORAL TABLET 35 MG
Strength
35MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
92240000 BONE RESORPTION INHIBITORS
Active Ingredients
7621 risedronate sodium 115436721
Inactive Ingredients
2432 lactose 64044515
2537 povidone 9003398




RISEDRONATE SODIUM- risedronate sodium tablet, film coated
Apotex Corp.
INDICATIONS AND USAGE

1.1 Postmenopausal Osteoporosis


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 reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1, 14.2)].

1.2 Osteoporosis in Men
Risedronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis.

1.3 Glucocorticoid-Induced 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.

1.4 Paget's Disease
Risedronate sodium tablets, USP are indicated for treatment of Paget's disease of bone in men and women.
DOSAGE AND ADMINISTRATION

2.1 Treatment of Postmenopausal Osteoporosis
[see Indications and Usage (1.1) ]

The recommended regimen is:

one 5 mg tablet orally, taken daily
or

one 35 mg tablet orally, taken once-a-week
or

one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month
or

one 150 mg tablet orally, taken once-a-month
Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate; and to take calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations at a different time of the day as they interfere with the absorption of risedronate sodium tablets.

RX ITEM-Risedronate 35Mg Tab 4 By Apotex
NDC 00093-5509-44 UPC/GTIN No.3-00935-50944-0 Mfg.Part No.550944

Risedronate 35Mg Tab 4 By Apotex Pharma
BRAND: RISEDRONATE NDC: 00093-5509-44,93550944 UPC: 3-00935-50944-0,300935509440

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