Binosto
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Uses
BINOSTO effervescent tablet 70 mg is indicated for the treatment of osteoporosis in postmenopausal women. For the treatment of osteoporosis, alendronate sodium increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies (14.1).]
BINOSTO is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.2)].
The optimal duration of use has not been determined. The safety and effectiveness of BINOSTO 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.
BINOSTO effervescent tablet 70 mg is indicated for the treatment of osteoporosis in postmenopausal women. For the treatment of osteoporosis, alendronate sodium 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 Treatment to Increase Bone Mass in Men With OsteoporosisBINOSTO is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.2)].
1.3 Important Limitations of UseThe optimal duration of use has not been determined. The safety and effectiveness of BINOSTO 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.
History
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Other Information
BINOSTO (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 molecular formula of alendronate sodium is C4H12NNaO7P2 • 3H2O and its molecular weight is 325.12. The structural formula of alendronate sodium is
Alendronate sodium is a white or almost white crystalline powder that is soluble in water, very slightly soluble in methanol, and practically insoluble in methylene chloride.
BINOSTO for oral administration is an effervescent tablet formulation that must be dissolved in water before use. Each individual tablet contains 91.37 mg of alendronate sodium, which is equivalent to 70 mg of free alendronic acid. Each tablet also contains the following inactive ingredients: monosodium citrate anhydrous, citric acid anhydrous, sodium hydrogen carbonate, and sodium carbonate anhydrous as buffering agents, strawberry flavor, acesulfame potassium, and sucralose.
Once the effervescent tablet is dissolved in water, the alendronate sodium is present in a citrate-buffered solution.
Sources
Binosto Manufacturers
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Mission Pharmacal Company
![Binosto (Alendronate Sodium) Tablet, Effervescent [Mission Pharmacal Company]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Binosto | Versapharm Incorporated
Myorisan should be administered with a meal (see PRECAUTIONS: Information for Patients).
The recommended dosage range for Myorisan is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1 mg/kg/day,8 it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects — some of which may be dose related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2 mg/kg/day, as tolerated. Failure to take Myorisan with food will significantly decrease absorption. Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions.
The safety of once daily dosing with Myorisan has not been established. Once daily dosing is not recommended.
If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of Myorisan, even in low doses, has not been studied, and is not recommended. It is important that Myorisan be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Myorisan on bone loss is unknown (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, and Premature Epiphyseal Closure).
Contraceptive measures must be followed for any subsequent course of therapy (see PRECAUTIONS).
Table 4 Myorisan Dosing by Body Weight (Based on Administration With Food) * See DOSAGE AND ADMINISTRATION: the recommended dosage range is 0.5 to 1 mg/kg/day.Body Weight
Total mg/day
kilograms
pounds
0.5 mg/kg
1 mg/kg
2 mg/kg*
40
88
20
40
80
50
110
25
50
100
60
132
30
60
120
70
154
35
70
140
80
176
40
80
160
90
198
45
90
180
100
220
50
100
200
INFORMATION FOR PHARMACISTSAccess the iPLEDGE system via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654) to obtain an authorization and the "do not dispense to patient after" date. Myorisan must only be dispensed in no more than a 30-day supply.
REFILLS REQUIRE A NEW PRESCRIPTION AND A NEW AUTHORIZATION FROM THE iPLEDGE SYSTEM.
A Myorisan Medication Guide must be given to the patient each time Myorisan is dispensed, as required by law. This Myorisan Medication Guide is an important part of the risk management program for the patient.
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