Rx Item-Fosamax 70Mg Tab 4 By Merck

FOSAMAX- alendronate sodium tablet
Merck Sharp & Dohme Corp.

1 INDICATIONS AND USAGE

1.1 Treatment of Osteoporosis in Postmenopausal Women
FOSAMAX� is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, FOSAMAX increases 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


FOSAMAX is indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies (14.2)].

1.3 Treatment to Increase Bone Mass in Men with Osteoporosis
FOSAMAX is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)].

1.4 Treatment of Glucocorticoid-Induced Osteoporosis
FOSAMAX is 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
FOSAMAX is 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 FOSAMAX 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.

2 DOSAGE AND ADMINISTRATION

Although alendronate tablets 5 mg, 10 mg, 35 mg, and 40 mg are available in the marketplace, FOSAMAX is no longer marketed in the 5 mg, 10 mg, 35 mg, and 40 mg strengths.

Although an oral solution of alendronate may be available in the marketplace, FOSAMAX oral solution is no longer marketed.

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

one 70 mg tablet once weekly
or
one bottle of 70 mg oral solution 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 bottle of 70 mg oral solution 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 FOSAMAX 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.

RX ITEM-Fosamax 70Mg Tab 4 By Merck
NDC 00006-0031-44 UPC/GTIN No.3-00060-03144-1 Mfg.Part No.3144

Fosamax 70Mg Tab 4 By Merck
BRAND: FOSAMAX NDC: 00006-0031-44,6003144 UPC: 3-00060-03144-1,300060031441 Merck & Co.

ALENDRONATE SODIUM ORAL T
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.