Alendronate Sodium

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Uses

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 optimal duration of use has not been determined. The safety and effectiveness of alendronate sodium for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

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Other Information

Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.

Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.

The empirical formula of alendronate sodium is C4H12NNaO7P2•3H2O and its formula weight is 325.12. The structural formula is:

Alendronate sodiumis a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.

Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch.

Sources

Alendronate Sodium Manufacturers

Cipla Usa Inc.

Alendronate Sodium | Cipla Usa Inc.

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:

one 70 mg tablet once weekly

or

one 10 mg tablet once daily
2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:

• one 35 mg tablet once weekly

or

• one 5 mg tablet once daily
2.3 Treatment to Increase Bone Mass in Men with Osteoporosis
The recommended dosage is:

• one 70 mg tablet once weekly

or

• one 10 mg tablet once daily
2.4 Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
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.
2.6 Important Administration Instructions
Instruct patients to do the following:
Take alendronate sodium tabletsat 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 tablets[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. Take alendronate sodium tablets 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 ounces). Patients should not lie down for at least 30 minutesand 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)] . 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Administration Instructions for Missed Doses
If a once-weekly dose of alendronate sodium tablets is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall
Golden State Medical Supply, Inc.

Alendronate Sodium | Golden State Medical Supply, Inc.

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
• one 70 mg (alendronate) tablet once weekly
or • one 10 mg (alendronate) tablet once daily 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 weekly 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 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 which the recommended dosage is one 10 mg (alendronate) tablet once daily.
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.
2.6 Important Administration Instructions
Instruct patients to do the following:
• Take alendronate sodium tablets 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 tablets [ 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 by decreasing its absorption into the body. • Take alendronate sodium tablets 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 to 8 ounces). 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)]. 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Administration Instructions for Missed Doses
If a once-weekly dose of alendronate sodium tablets is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall
Sun Pharma Global Fze

Alendronate Sodium | Publix Super Markets Inc

• do not take more than directed (see overdose warning)
adults and children 12 years and over
• take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours
children under 12 years

do not use

No Recall
Cobalt Laboratories Inc.

Alendronate Sodium | Cobalt Laboratories Inc.

Alendronate sodium tablets, USP must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only (see PRECAUTIONS, Information for Patients). Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate sodium tablets (see PRECAUTIONS, Drug Interactions). 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, PRECAUTIONS, Information for Patients).

Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate (see PRECAUTIONS, General).

No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). Alendronate sodium tablets are not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience.
Treatment of osteoporosis in postmenopausal women
(see INDICATIONS AND USAGE)

The recommended dosage is:
one 70 mg tablet once weekly
          or one 10 mg tablet once daily Treatment to increase bone mass in men with osteoporosis
The recommended dosage is:
one 70 mg tablet once weekly
               or one 10 mg tablet once daily Prevention of osteoporosis in postmenopausal women
(see INDICATIONS AND USAGE)

The recommended dosage is:
one 35 mg tablet once weekly
          or one 5 mg tablet once daily
The safety of treatment and prevention of osteoporosis with alendronate sodium tablets has been studied for up to 7 years.
Treatment of glucocorticoid-induced osteoporosis in men and women
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
Paget's disease of bone in men and women
The recommended treatment regimen is 40 mg once a day for six months.
Retreatment of Paget's disease
In clinical studies in which patients were followed every six months, relapses during the 12 months following therapy occurred in 9% (3 out of 32) of patients who responded to treatment with alendronate sodium tablets. Specific retreatment data are not available, although responses to alendronate sodium tablets were similar in patients who had received prior bisphosphonate therapy and those who had not. Retreatment 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. Retreatment may also be considered in those who failed to normalize their serum alkaline phosphatase.

No Recall
Dispensing Solutions Inc.

Alendronate Sodium | Dispensing Solutions Inc.

Alendronate sodium tablets, USP must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only (see PRECAUTIONS, Information for Patients). Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate sodium tablets (see PRECAUTIONS, Drug Interactions). 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, PRECAUTIONS, Information for Patients).

Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate (see PRECAUTIONS, General).

No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). Alendronate sodium tablets are not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience.
Treatment of osteoporosis in postmenopausal women
(see INDICATIONS AND USAGE)

The recommended dosage is:
one 70 mg tablet once weekly
          or one 10 mg tablet once daily Treatment to increase bone mass in men with osteoporosis
The recommended dosage is:
one 70 mg tablet once weekly
               or one 10 mg tablet once daily Prevention of osteoporosis in postmenopausal women
(see INDICATIONS AND USAGE)

The recommended dosage is:
one 35 mg tablet once weekly
          or one 5 mg tablet once daily
The safety of treatment and prevention of osteoporosis with alendronate sodium tablets has been studied for up to 7 years.
Treatment of glucocorticoid-induced osteoporosis in men and women
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
Paget's disease of bone in men and women
The recommended treatment regimen is 40 mg once a day for six months.
Retreatment of Paget's disease
In clinical studies in which patients were followed every six months, relapses during the 12 months following therapy occurred in 9% (3 out of 32) of patients who responded to treatment with alendronate sodium tablets. Specific retreatment data are not available, although responses to alendronate sodium tablets were similar in patients who had received prior bisphosphonate therapy and those who had not. Retreatment 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. Retreatment may also be considered in those who failed to normalize their serum alkaline phosphatase.

No Recall
Rebel Distributors Corp

Alendronate Sodium | Rebel Distributors Corp

Alendronate sodium tablets, USP must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only (see PRECAUTIONS, Information for Patients). Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate sodium tablets (see PRECAUTIONS, Drug Interactions). 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, PRECAUTIONS, Information for Patients).

Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate (see PRECAUTIONS, General).

No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). Alendronate sodium tablets are not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience.
Treatment of osteoporosis in postmenopausal women
(see INDICATIONS AND USAGE)

The recommended dosage is:
one 70 mg tablet once weekly
          or one 10 mg tablet once daily Treatment to increase bone mass in men with osteoporosis
The recommended dosage is:
one 70 mg tablet once weekly
               or one 10 mg tablet once daily Prevention of osteoporosis in postmenopausal women
(see INDICATIONS AND USAGE)

The recommended dosage is:
one 35 mg tablet once weekly
          or one 5 mg tablet once daily
The safety of treatment and prevention of osteoporosis with alendronate sodium tablets has been studied for up to 7 years.
Treatment of glucocorticoid-induced osteoporosis in men and women
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
Paget's disease of bone in men and women
The recommended treatment regimen is 40 mg once a day for six months.
Retreatment of Paget's disease
In clinical studies in which patients were followed every six months, relapses during the 12 months following therapy occurred in 9% (3 out of 32) of patients who responded to treatment with alendronate sodium tablets. Specific retreatment data are not available, although responses to alendronate sodium tablets were similar in patients who had received prior bisphosphonate therapy and those who had not. Retreatment 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. Retreatment may also be considered in those who failed to normalize their serum alkaline phosphatase.

No Recall
Watson Laboratories, Inc.

Alendronate Sodium | Watson Laboratories, Inc.

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 PRECAUTIONS, Information for Patients). Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate sodium tablets (see PRECAUTIONS, Drug Interactions). 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 to 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, PRECAUTIONS, Information for Patients).

Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate (see PRECAUTIONS, General).

No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). Alendronate sodium tablets are not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience.

Treatment of osteoporosis in postmenopausal women (see INDICATIONS AND USAGE)

The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily
Treatment to increase bone mass in men with osteoporosis

The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily
Prevention of osteoporosis in postmenopausal women (see INDICATIONS AND USAGE)

The recommended dosage is:
one 35 mg tablet once weekly
or
one 5 mg tablet once daily
The safety of treatment and prevention of osteoporosis with alendronate sodium has been studied for up to 7 years.

Treatment of glucocorticoid-induced osteoporosis in men and women:

The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.

Paget's disease of bone in men and women

The recommended treatment regimen is 40 mg once a day for six months.

Retreatment of Paget's disease:

In clinical studies in which patients were followed every six months, relapses during the 12 months following therapy occurred in 9% (3 out of 32) of patients who responded to treatment with alendronate sodium tablets. Specific retreatment data are not available, although responses to alendronate sodium tablets were similar in patients who had received prior bisphosphonate therapy and those who had not. Retreatment 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. Retreatment may also be considered in those who failed to normalize their serum alkaline phosphatase.

No Recall
Physicians Total Care, Inc.

Alendronate Sodium | Physicians Total Care, Inc.

Alendronate sodium tablets USP must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only (see PRECAUTIONS, Information for Patients). Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate sodium tablets USP (see PRECAUTIONS, Drug Interactions). Waiting less than 30 minutes, or taking alendronate sodium tablets USP with food, beverages (other than plain water) or other medications will lessen the effect of alendronate sodium tablets USP by decreasing its absorption into the body.

Alendronate sodium tablets USP 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 USP should be swallowed with a full glass of water (6 to 8 oz). Patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate sodium tablets USP 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; PRECAUTIONS, Information for Patients).

Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate (see PRECAUTIONS, General).

No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). Alendronate sodium tablets USP are not recommended for patients with more severe renal insufficiency (creatinine clearance < 35 mL/min) due to lack of experience.
Treatment of Osteoporosis in Postmenopausal Women
(See INDICATIONS AND USAGE.)

The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily Treatment to Increase Bone Mass in Men With Osteoporosis
The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily Prevention of Osteoporosis in Postmenopausal Women
(See INDICATIONS AND USAGE.)

The recommended dosage is:
one 35 mg tablet once weekly
or
one 5 mg tablet once daily
The safety of treatment and prevention of osteoporosis with alendronate sodium tablets USP has been studied for up to 7 years.
Treatment of Glucocorticoid-Induced Osteoporosis in Men and Women
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
Paget’s Disease of Bone in Men and Women
The recommended treatment regimen is 40 mg once a day for six months.
Retreatment of Paget’s Disease
In clinical studies in which patients were followed every six months, relapses during the 12 months following therapy occurred in 9% (3 out of 32) of patients who responded to treatment with alendronate sodium tablets USP. Specific retreatment data are not available, although responses to alendronate sodium tablets USP were similar in patients who had received prior bisphosphonate therapy and those who had not. Retreatment with alendronate sodium tablets USP 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. Retreatment may also be considered in those who failed to normalize their serum alkaline phosphatase.

No Recall
American Health Packaging

Alendronate Sodium | American Health Packaging

Alendronate sodium tablets, USP must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only (see PRECAUTIONS, Information for Patients). Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate sodium tablets (see PRECAUTIONS, Drug Interactions). 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, PRECAUTIONS, Information for Patients).

Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate (see PRECAUTIONS, General).

No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). Alendronate sodium tablets are not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience.

Treatment of osteoporosis in postmenopausal women
(see INDICATIONS AND USAGE)

The recommended dosage is:
one 70 mg tablet once weekly
or one 10 mg tablet once daily
Treatment to increase bone mass in men with osteoporosis

The recommended dosage is:
one 70 mg tablet once weekly
or one 10 mg tablet once daily
Prevention of osteoporosis in postmenopausal women
(see INDICATIONS AND USAGE)

The recommended dosage is:
one 35 mg tablet once weekly
or one 5 mg tablet once daily
The safety of treatment and prevention of osteoporosis with alendronate sodium tablets has been studied for up to 7 years.

Treatment of glucocorticoid-induced osteoporosis in men and women

The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.

Paget's disease of bone in men and women

The recommended treatment regimen is 40 mg once a day for six months.

Retreatment of Paget's disease

In clinical studies in which patients were followed every six months, relapses during the 12 months following therapy occurred in 9% (3 out of 32) of patients who responded to treatment with alendronate sodium tablets. Specific retreatment data are not available, although responses to alendronate sodium tablets were similar in patients who had received prior bisphosphonate therapy and those who had not. Retreatment 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. Retreatment may also be considered in those who failed to normalize their serum alkaline phosphatase.

No Recall
Ascend Laboratories, Llc

Alendronate Sodium | Ascend Laboratories, Llc

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
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
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
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.
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.
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)].
2.7 Recommendations for Calcium and Vitamin D Supplementation
Patients should receive supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.
Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Dosing in Severe Renal Impairment
Alendronate sodium tablets is not recommended for patients with creatinine clearance <35 mL/min due to lack of experience in this population [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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
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
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
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.
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.
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)].
2.7 Recommendations for Calcium and Vitamin D Supplementation
Patients should receive supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.
Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Dosing in Severe Renal Impairment
Alendronate sodium tablets is not recommended for patients with creatinine clearance <35 mL/min due to lack of experience in this population [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

No Recall
Remedyrepack Inc.

Alendronate Sodium | Remedyrepack Inc.

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

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

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

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.

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.

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)]

.

2.7 Recommendations for Calcium and Vitamin D Supplementation

Patients should receive supplemental calcium if dietary intake is inadequate

[see Warnings and Precautions (5.2)]

. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

2.8 Dosing in Severe Renal Impairment

Alendronate sodium tablets is not recommended for patients with creatinine clearance <35 mL/min due to lack of experience in this population

[see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]

.

No Recall
Sun Pharma Global Inc.

Alendronate Sodium | Sun Pharma Global Inc.

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily 2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 35 mg tablet once weekly
or
one 5 mg tablet once daily 2.3 Treatment to Increase Bone Mass in Men with Osteoporosis
The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily 2.4 Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
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.
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 tablets [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 to 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)].
2.7 Recommendations for Calcium and Vitamin D Supplementation
Patients should receive supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Dosing in Severe Renal Impairment
Alendronate sodium tablets are not recommended for patients with creatinine clearance <35 mL/min due to lack of experience in this population [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

No Recall
Blu Pharmaceuticals, Llc

Alendronate Sodium | Blu Pharmaceuticals, Llc

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
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
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
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.
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.
2.6 Important Administration Instructions
Instruct patients to do the following:

Take alendronate sodium tablets 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.
Take alendronate sodium tablets 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) ].
2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2) ]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.
Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Administration Instructions for Missed Doses
If a once-weekly dose of alendronate sodium tablet is missed, instruct patients to take one dose on the morning after they remember. That should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall
Medvantx, Inc.

Alendronate Sodium | Medvantx, Inc.

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
• one 70 mg tablet once weekly
or
• one 10 mg tablet once daily 2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:
• one 35 mg tablet once weekly
or
• one 5 mg tablet once daily 2.3 Treatment to Increase Bone Mass in Men With Osteoporosis
The recommended dosage is:
• one 70 mg tablet once weekly
or
• one 10 mg tablet once daily 2.4 Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
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.
2.6 Important Administration Instructions
Instruct patients to do the following:
• Take alendronate sodium tablets 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 tablets [ 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 • Take alendronate sodium tablets 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 ounces). 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)]. 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Administration Instructions for Missed Doses
If a once-weekly dose of alendronate sodium tablets is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall
Jubilant Cadista Pharmaceuticals Inc.

Alendronate Sodium | Rite Aid

to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

No Recall
Apotex Corp.

Alendronate Sodium | Baxter Healthcare Corporation

2.1 Intravenous Dosing
MESNEX may be given on a fractionated dosing schedule of three bolus intravenous injections as outlined below.

MESNEX injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage weight by weight (w/w) at the time of ifosfamide administration and 4 and 8 hours after each dose of ifosfamide. The total daily dose of MESNEX is 60% of the ifosfamide dose. The recommended dosing schedule is outlined below in Table 1.
Table 1. Recommended Intravenous Dosing Schedule * The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is increased or decreased, the ratio of MESNEX to ifosfamide should be maintained.

0 Hours

4 Hours

8 Hours

Ifosfamide

1.2 g/m2

–

–

MESNEX Injection*

240 mg/m2

240 mg/m2

240 mg/m2
2.2 Intravenous and Oral Dosing
MESNEX may be given on a fractionated dosing schedule of a single bolus injection followed by two oral administrations of MESNEX tablets as outlined below.

MESNEX injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage (w/w) at the time of ifosfamide administration. MESNEX tablets are given orally in a dosage equal to 40% of the ifosfamide dose 2 and 6 hours after each dose of ifosfamide. The total daily dose of MESNEX is 100% of the ifosfamide dose. The recommended dosing schedule is outlined in Table 2.
Table 2. Recommended Intravenous and Oral Dosing Schedule * The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is increased or decreased, the ratio of MESNEX to ifosfamide should be maintained.

0 Hours

2 Hours

6 Hours

Ifosfamide

1.2 g/m2

–

–

MESNEX injection*

240 mg/m2

–

–

MESNEX tablets

–

480 mg/m2

480 mg/m2

The efficacy and safety of this ratio of intravenous and oral MESNEX has not been established as being effective for daily doses of ifosfamide higher than 2 g/m2.

Patients who vomit within two hours of taking oral MESNEX should repeat the dose or receive intravenous MESNEX.
2.3 Monitoring for Hematuria
Maintain adequate hydration and sufficient urinary output, as required for ifosfamide treatment, and monitor urine for the presence of hematuria. If severe hematuria develops when MESNEX is given according to the recommended dosage schedule, dosage reductions or discontinuation of ifosfamide therapy may be required.
2.4 Preparation for Intravenous Administration and Stability
Preparation

Determine the volume of MESNEX injection for the intended dose.

Dilute the volume of MESNEX injection for the dose in any of the following fluids to obtain a final concentration of 20 mg/mL:
• 5% Dextrose Injection, USP • 5% Dextrose and 0.2% Sodium Chloride Injection, USP • 5% Dextrose and 0.33% Sodium Chloride Injection, USP • 5% Dextrose and 0.45% Sodium Chloride Injection, USP • 0.9% Sodium Chloride Injection, USP • Lactated Ringer’s Injection, USP
Stability

The MESNEX injection multidose vials may be stored and used for up to 8 days after initial puncture.

Store diluted solutions at 25°C (77°F). Use diluted solutions within 24 hours.

Do not mix MESNEX injection with epirubicin, cyclophosphamide, cisplatin, carboplatin, and nitrogen mustard.

The benzyl alcohol contained in MESNEX injection vials can reduce the stability of ifosfamide. Ifosfamide and MESNEX may be mixed in the same bag provided the final concentration of ifosfamide does not exceed 50 mg/mL. Higher concentrations of ifosfamide may not be compatible with MESNEX and may reduce the stability of ifosfamide.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Any solutions which are discolored, hazy, or contain visible particulate matter should not be used.

No Recall
Remedyrepack Inc.

Alendronate Sodium | Remedyrepack Inc.

Treatment of osteoporosis in postmenopausal women and in men: 10 mg daily or 70 mg (tablet) once weekly. (2.1, 2.3) Prevention of osteoporosis in postmenopausal women: 5 mg daily or 35 mg once weekly. (2.2) Glucocorticoid-induced osteoporosis: 5 mg daily; or 10 mg daily in postmenopausal women not receiving estrogen. (2.4) Paget's disease: 40 mg daily for six months. (2.5) Instruct patients to: (2.6) Swallow tablets whole with 6 to 8 ounces plain water at least 30 minutes before the first food, drink, or medication of the day. Not lie down for at least 30 minutes after taking alendronate sodium tablets and until after food.

The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily

The recommended dosage is:
one 35 mg tablet once weekly
or
one 5 mg tablet once daily

The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily

The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.

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.

Instruct patients to do the following:
Take alendronate sodium tablets 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 tablets [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 Take alendronate sodium tablets 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 ounces). 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)].

Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

If a once-weekly dose of alendronate sodium tablets is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall
Remedyrepack Inc.

Alendronate Sodium | Remedyrepack Inc.

Treatment of osteoporosis in postmenopausal women and in men: 10 mg daily or 70 mg (tablet) once weekly. (2.1, 2.3) Prevention of osteoporosis in postmenopausal women: 5 mg daily or 35 mg once weekly. (2.2) Glucocorticoid-induced osteoporosis: 5 mg daily; or 10 mg daily in postmenopausal women not receiving estrogen. (2.4) Paget's disease: 40 mg daily for six months. (2.5) Instruct patients to: (2.6) Swallow tablets whole with 6 to 8 ounces plain water at least 30 minutes before the first food, drink, or medication of the day. Not lie down for at least 30 minutes after taking alendronate sodium tablets and until after food.

The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily

The recommended dosage is:
one 35 mg tablet once weekly
or
one 5 mg tablet once daily

The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily

The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.

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.

Instruct patients to do the following:
Take alendronate sodium tablets 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 tablets [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 Take alendronate sodium tablets 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 ounces). 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)].

Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

If a once-weekly dose of alendronate sodium tablets is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall
Aidarex Pharmaceuticals Llc

Alendronate Sodium | Aidarex Pharmaceuticals Llc

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily 2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 35 mg tablet once weekly
or
one 5 mg tablet once daily 2.3 Treatment to Increase Bone Mass in Men With Osteoporosis
The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily 2.4 Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
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.
2.6 Important Administration Instructions
Instruct patients to do the following:
Take alendronate sodium tablets 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 tablets [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 Take alendronate sodium tablets 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 ounces). 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)]. 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Administration Instructions for Missed Doses
If a once-weekly dose of alendronate sodium tablets is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall
Mylan Pharmaceuticals Inc.

Alendronate Sodium | Mylan Pharmaceuticals Inc.

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
• one 70 mg tablet once weekly
or • one 10 mg tablet once daily 2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:
• one 35 mg tablet once weekly
or • one 5 mg tablet once daily 2.3 Treatment to Increase Bone Mass in Men with Osteoporosis
The recommended dosage is:
• one 70 mg tablet once weekly
or • one 10 mg tablet once daily 2.4 Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
2.5 Treatment of Paget's Disease of Bone
The recommended treatment regimen is 40 mg once a day for 6 months.
Re-treatment of Paget’s Disease
Re-treatment with alendronate sodium tablets may be considered, following a 6-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.
2.6 Important Administration Instructions
Instruct patients to do the following:
• Take alendronate sodium tablets 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 tablets [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 by decreasing its absorption into the body. • Take alendronate sodium tablets 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 to 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)]. 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Administration Instructions for Missed Doses
If a once-weekly dose of alendronate sodium tablets are missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall
Virtus Pharmaceuticals

Alendronate Sodium | Virtus Pharmaceuticals

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 70 mg (alendronate) tablet once weekly
or
one 10 mg (alendronate) tablet once daily 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 2.3 Treatment to Increase Bone Mass in Men with Osteoporosis
The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily 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.
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.
2.6 Important Administration Instructions
Instruct patients to do the following:
Take alendronate sodium tablets 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 tablets [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 Take alendronate sodium tablets 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)]. 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Administration Instructions for Missed Doses
If a once-weekly dose of alendronate sodium tablet is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall
Aurobindo Pharma Limited

Alendronate Sodium | Aurobindo Pharma Limited

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 70 mg tablet once weekly
                                    or
one 10 mg tablet once daily 2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 35 mg tablet once weekly
                                    or
one 5 mg tablet once daily 2.3 Treatment to Increase Bone Mass in Men with Osteoporosis
The recommended dosage is:
one 70 mg tablet once weekly
                                    or
one 10 mg tablet once daily 2.4 Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
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.
2.6 Important Administration Instructions
Instruct patients to do the following:
Take alendronate sodium tablets 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 tablets [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. Take alendronate sodium tablets 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 to 8 ounces). 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)]. 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Administration Instructions for Missed Doses
If a once-weekly dose of alendronate sodium tablets is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall
Mylan Institutional Inc.

Alendronate Sodium | Mylan Institutional Inc.

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
• one 70 mg tablet once weekly
or • one 10 mg tablet once daily 2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:
• one 35 mg tablet once weekly
or • one 5 mg tablet once daily 2.3 Treatment to Increase Bone Mass in Men with Osteoporosis
The recommended dosage is:
• one 70 mg tablet once weekly
or • one 10 mg tablet once daily 2.4 Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
2.5 Treatment of Paget's Disease of Bone
The recommended treatment regimen is 40 mg once a day for 6 months.
Retreatment of Paget’s Disease
Retreatment with alendronate sodium tablets may be considered, following a 6-month post-treatment evaluation period in patients who have relapsed, based on increases in serum alkaline phosphatase, which should be measured periodically. Retreatment may also be considered in those who failed to normalize their serum alkaline phosphatase.
2.6 Important Administration Instructions
Instruct patients to do the following:
• Take alendronate sodium tablets 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 tablets [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 by decreasing its absorption into the body. • Take alendronate sodium tablets upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a alendronate sodium tablet should be swallowed with a full glass of water (6 to 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)]. 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Administration Instructions for Missed Doses
If a once weekly dose of alendronate sodium tablets are missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall
Aidarex Pharmaceuticals Llc

Alendronate Sodium | Aidarex Pharmaceuticals Llc

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily 2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 35 mg tablet once weekly
or
one 5 mg tablet once daily 2.3 Treatment to Increase Bone Mass in Men With Osteoporosis
The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily 2.4 Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
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 USP 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.
2.6 Dosing Instructions
Alendronate sodium tablets USP 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 tablets USP [see Drug Interactions (7.1)]. Waiting less than 30 minutes, or taking alendronate sodium tablets USP with food, beverages (other than plain water) or other medications will lessen the effect of alendronate sodium tablets USP by decreasing its absorption into the body

Alendronate sodium tablets USP should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, alendronate sodium tablets USP should be swallowed with a full glass of water (6 to 8 oz). Patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate sodium tablets USP 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)].
2.7 Recommendations for Calcium and Vitamin D Supplementation
Patients should receive supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Dosing in Severe Renal Impairment
Alendronate sodium tablets USP are not recommended for patients with creatinine clearance < 35 mL/min due to lack of experience in this population [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

No Recall
Aidarex Pharmaceuticals Llc

Alendronate Sodium | Aidarex Pharmaceuticals Llc

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily 2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 35 mg tablet once weekly
or
one 5 mg tablet once daily 2.3 Treatment to Increase Bone Mass in Men With Osteoporosis
The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily 2.4 Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
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 USP 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.
2.6 Dosing Instructions
Alendronate sodium tablets USP 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 tablets USP [see Drug Interactions (7.1)]. Waiting less than 30 minutes, or taking alendronate sodium tablets USP with food, beverages (other than plain water) or other medications will lessen the effect of alendronate sodium tablets USP by decreasing its absorption into the body

Alendronate sodium tablets USP should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, alendronate sodium tablets USP should be swallowed with a full glass of water (6 to 8 oz). Patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate sodium tablets USP 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)].
2.7 Recommendations for Calcium and Vitamin D Supplementation
Patients should receive supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Dosing in Severe Renal Impairment
Alendronate sodium tablets USP are not recommended for patients with creatinine clearance < 35 mL/min due to lack of experience in this population [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

No Recall
Cobalt Laboratories

Alendronate Sodium | Actavis Pharma, Inc.

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily 2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 35 mg tablet once weekly
or
one 5 mg tablet once daily 2.3 Treatment to Increase Bone Mass in Men with Osteoporosis
The recommended dosage is:
one 70 mg tablet once weekly
or
one 10 mg tablet once daily 2.4 Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
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.
2.6 Important Administration Instructions
Instruct patients to do the following:
Take alendronate sodium tablets 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 tablets [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. Take alendronate sodium tablets 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 to 8 ounces). 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)]. 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Administration Instructions for Missed Doses
If a once-weekly dose of alendronate sodium tablets is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall
Preferred Pharmaceuticals, Inc.

Alendronate Sodium | Preferred Pharmaceuticals, Inc.

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
1. one 70 mg tablet once weekly
or 2. one 10 mg tablet once daily
2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:
1. one 35 mg tablet once weekly
or 2. one 5 mg tablet once daily 2.3 Treatment to Increase Bone Mass in Men with Osteoporosis
The recommended dosage is:
1. one 70 mg tablet once weekly
or 2. one 10 mg tablet once daily 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.
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.
2.6 Important Administration Instructions
Instruct patients to do the following:
1. Take alendronate sodium tablets 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 tablets [ 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 by decreasing its absorption into the body. 2. Take alendronate sodium tablets 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 to 8 ounces). 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)]. 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Administration Instructions for Missed Doses
If a once-weekly dose of alendronate sodium tablets is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall
Northstar Rx Llc

Alendronate Sodium | Northstar Rx Llc

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:

one 70 mg tablet once weekly
                                or
one 10 mg tablet once daily 2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:

one 35 mg tablet once weekly
                              or
one 5 mg tablet once daily 2.3 Treatment to Increase Bone Mass in Men with Osteoporosis
The recommended dosage is:

one 70 mg tablet once weekly
                            or
one 10 mg tablet once daily 2.4 Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
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.
2.6 Important Administration Instructions
Instruct patients to do the following:

Take alendronate sodium tablets 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 tablets [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. Take alendronate sodium tablets 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 to 8 ounces). 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)]. 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Administration Instructions for Missed Doses
If a once-weekly dose of alendronate sodium tablets is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall
Teva Pharmaceuticals Usa Inc

Alendronate Sodium | Kremers Urban Pharmaceuticals Inc.

2.1 General Dosing Information
Methylphenidate HCl Extended-Release Tablets should be administered orally once daily in the morning with or without food.

Methylphenidate HCl Extended-Release Tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed [see Patient Counseling Information (17)].
2.2 Patients New to Methylphenidate
The recommended starting dose of Methylphenidate HCl Extended-Release Tablets for patients who are not currently taking methylphenidate or stimulants other than methylphenidate is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults (see Table 1).
TABLE 1. Methylphenidate HCl Extended-Release Tablets Recommended Starting Doses and Dose Ranges Patient Age Recommended Starting Dose Dose Range Children 6-12 years of age 18 mg/day 18 mg - 54 mg/day Adolescents 13-17 years of age 18 mg/day 18 mg - 72 mg/day
not to exceed 2 mg/kg/day Adults 18-65 years of age 18 or 36 mg/day 18 mg - 72 mg/day 2.3 Patients Currently Using Methylphenidate
The recommended dose of Methylphenidate HCl Extended-Release Tablets for patients who are currently taking methylphenidate twice daily or three times daily, at doses of 10 to 60 mg/day is provided in Table 2. Dosing recommendations are based on current dose regimen and clinical judgment. Conversion dosage should not exceed 72 mg daily.
TABLE 2. Recommended Dose Conversion from Methylphenidate Regimens to Methylphenidate HCl Extended-Release Tablets Previous Methylphenidate Daily Dose Recommended Methylphenidate HCl Extended-Release Tablets Starting Dose 5 mg Methylphenidate twice daily or three times daily 18 mg every morning 10 mg Methylphenidate twice daily or three times daily 36 mg every morning 15 mg Methylphenidate twice daily or three times daily 54 mg every morning 20 mg Methylphenidate twice daily or three times daily 72 mg every morning
Other methylphenidate regimens: Clinical judgment should be used when selecting the starting dose.
2.4 Dose Titration
Doses may be increased in 18 mg increments at weekly intervals for patients who have not achieved an optimal response at a lower dose. Daily dosages above 54 mg in children and 72 mg in adolescents have not been studied and are not recommended. Daily dosages above 72 mg in adults are not recommended.

A 27 mg dosage strength is available for physicians who wish to prescribe between the 18 mg and 36 mg dosages.
2.5 Maintenance/Extended Treatment
There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with Methylphenidate HCl Extended-Release Tablets. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods.

The effectiveness of Methylphenidate HCl Extended-Release Tablets for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use Methylphenidate HCl Extended-Release Tablets for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient's functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
2.6 Dose Reduction and Discontinuation
If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.

If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

No Recall
Proficient Rx Lp

Alendronate Sodium | Proficient Rx Lp

2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
• one 70 mg tablet once weekly
or
• one 10 mg tablet once daily 2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:
• one 35 mg tablet once weekly
or
• one 5 mg tablet once daily 2.3 Treatment to Increase Bone Mass in Men With Osteoporosis
The recommended dosage is:
• one 70 mg tablet once weekly
or
• one 10 mg tablet once daily 2.4 Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
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.
2.6 Important Administration Instructions
Instruct patients to do the following:
• Take alendronate sodium tablets 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 tablets [ 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 • Take alendronate sodium tablets 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 ounces). 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)]. 2.7 Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
2.8 Administration Instructions for Missed Doses
If a once-weekly dose of alendronate sodium tablets is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

No Recall