Rx Item-Alendronate 35mg Tab 3X4 By Virtus Pharma

Clinical Information
Gen. Code and Des.
47381 alendronate sodium ORAL TABLET 35 MG
GCN and Des.
12389 alendronate sodium ORAL TABLET 35 MG
Strength
35MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
92240000 BONE RESORPTION INHIBITORS
Active Ingredients
5057 alendronate sodium 121268175




ALENDRONATE SODIUM- alendronate sodium tablet
INDICATIONS AND USAGE
1.1 Treatment of Osteoporosis in Postmenopausal Women
Alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets increase bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures) [see Clinical Studies ].
1.2 Prevention of Osteoporosis in Postmenopausal Women
Alendronate sodium tablets are indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies ].
1.3 Treatment to Increase Bone Mass in Men With Osteoporosis
Alendronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies ].
1.4 Treatment of Glucocorticoid-Induced Osteoporosis
Alendronate sodium tablets are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see Clinical Studies ].
1.5 Treatment of Paget?s Disease of Bone
Alendronate sodium tablets 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 ].
2 DOSAGE AND ADMINISTRATION
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 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 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 day for six months
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 info. (17.2) ]. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate sodium tablets [see 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
?
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 full glass of water o 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 and Patient Counseling info. (17.2)].

Rx Item-Alendronate 35mg Tab 3X4 By Virt
NDC No. 69543-0130-12 69543-130-12 UPC/GTIN No. 3-69543-13012-5 MPN No. 13004 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist,

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Virtus Pharmaceuticals Llc

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

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