ALENDRONATE SODIUM
ALENDRONATE SODIUM -- alendronate sodium tablet
REMEDYREPACK INC.
SPL UNCLASSIFIED
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Treatment of Osteoporosis in Postmenopausal Women
1.2 Prevention of Osteoporosis in Postmenopausal Women
1.3 Treatment to Increase Bone Mass in Men with Osteoporosis
1.4 Treatment of Glucocorticoid-Induced Osteoporosis
1.5 Treatment of Paget's Disease of Bone
1.6 Important Limitations of Use
2 DOSAGE AND ADMINISTRATION
2.1 Treatment of Osteoporosis in Postmenopausal Women
2.2 Prevention of Osteoporosis in Postmenopausal Women
2.3 Treatment to Increase Bone Mass in Men with Osteoporosis
2.4 Treatment of Glucocorticoid-Induced Osteoporosis
2.5 Treatment of Paget's Disease of Bone
2.6 Dosing Instructions
2.7 Recommendations for Calcium and Vitamin D Supplementation
2.8 Dosing in Severe Renal Impairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Upper Gastrointestinal Adverse Reactions
5.2 Mineral Metabolism
5.3 Musculoskeletal Pain
5.4 Osteonecrosis of the Jaw
5.5 Atypical Subtrochanteric and Diaphyseal Femoral Fractures
5.6 Renal Impairment
5.7 Glucocorticoid-Induced Osteoporosis
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
7.1 Calcium Supplements/Antacids
7.2 Aspirin
7.3 Nonsteroidal Anti-Inflammatory Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Treatment of Osteoporosis in Postmenopausal Women
14.2 Prevention of Osteoporosis in Postmenopausal Women
14.3 Treatment to Increase Bone Mass in Men with Osteoporosis
14.4 Treatment of Glucocorticoid-Induced Osteoporosis
14.5 Treatment of Paget's Disease of Bone
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Osteoporosis Recommendations, Including Calcium and Vitamin D Supplementation
17.2 Dosing Instructions
*Sections or subsections omitted from the full prescribing information are not listed.
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FULL PRESCRIBING INFORMATION
INDICATIONS & USAGE
1.1 Treatment of Osteoporosis in Postmenopausal Women
Alendronate sodium tablets, USP are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets, USP increase bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies (14.1).]
1.2 Prevention of Osteoporosis in Postmenopausal Women
Alendronate sodium tablets, USP are indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies (14.2)].
1.3 Treatment to Increase Bone Mass in Men with Osteoporosis
Alendronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)].
1.4 Treatment of Glucocorticoid-Induced Osteoporosis
Alendronate sodium tablets, USP are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see Clinical Studies (14.4)].
1.5 Treatment of Paget's Disease of Bone
Alendronate sodium tablets, USP are indicated for the treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease. [See Clinical Studies (14.5).]
1.6 Important Limitations of Use
The safety and effectiveness of alendronate sodium tablets, USP for the treatment of osteoporosis are based on clinical data of four years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.
DOSAGE & ADMINISTRATION
2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
• one 10 mg (alendronate) tablet once daily
or
• one 70 mg (alendronate) tablet once weekly
DOSAGE & ADMINISTRATION
2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:
• one 35 mg (alendronate) tablet once weekly
or
• one 5 mg (alendronate) tablet once daily
DOSAGE & ADMINISTRATION
2.3 Treatment to Increase Bone Mass in Men with Osteoporosis
The recommended dosage is:
• one 70 mg (alendronate) tablet once weekly
or
• one 10 mg (alendronate) tablet once daily
DOSAGE & ADMINISTRATION
2.4 Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg (alendronate) tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg (alendronate) tablet once daily.
DOSAGE & ADMINISTRATION
2.5 Treatment of Paget's Disease of Bone
The recommended treatment regimen is 40 mg once a day for six months.
Re-treatment of Paget’s Disease
Re-treatment with alendronate sodium tablets may be considered, following a six-month post-treatment evaluation period in patients who have relapsed, based on increases in serum alkaline phosphatase, which should be measured periodically. Re-treatment may also be considered in those who failed to normalize their serum alkaline phosphatase.
DOSAGE & ADMINISTRATION
2.6 Dosing Instructions
Alendronate sodium tablets must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only
[see Patient Counseling Information (17.2)]
. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate sodium tablet
[see Drug Interactions (7.1)]
. Waiting less than 30 minutes, or taking alendronate sodium tablets with food, beverages (other than plain water) or other medications will lessen the effect of alendronate sodium tablets by decreasing its absorption into the body.
Alendronate sodium tablets should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, an alendronate sodium tablet should be swallowed with a full glass of water (6-8 oz). Patients should not lie down for at least 30 minutes
and
until after their first food of the day. Alendronate sodium tablets should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences
[see Warnings and Precautions (5.1) and Patient Counseling Information (17.2)]
.
