Ibandronate Sodium

Ibandronate Sodium Tablets are a bisphosphonate indicated for the treatment and prevention of post-menopausal osteoporosis. ( 1.1 ) Limitations of Use The optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. ( 1.2 ).

1.1Treatment and Prevention of Postmenopausal Osteoporosis Ibandronate Sodium

Tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Ibandronate sodium increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

1.2Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of Ibandronate Sodium Tablets for the treatment of osteoporosis are based on clinical data of three 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.

Ibandronate sodium is contraindicated in patients with the following conditions:

• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (see Warnings and Precautions [ 5.1 ])
• Inability to stand or sit upright for at least 60 minutes (see Dosage and Administration [2.2], and Warnings and Precautions [ 5.1 ])
• Hypocalcemia (see Warnings and Precautions [ 5.2 ])
• Known hypersensitivity to ibandronate sodium tablets or to any of its excipients. Cases of anaphylaxis have been reported. (see Adverse Reactions [6.2]) .
• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia ( 4 , 5.1 )
• Inability to stand or sit upright for at least 60 minutes ( 4 , 5.1 )
• Hypocalcemia ( 4 )
• Hypersensitivity to ibandronate sodium ( 4 )

• Upper gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions and discontinue use if new or worsening symptoms occur. ( 5.1 )