IBANDRONATE SODIUM

AbsorptionThe absorption of oral ibandronate occurs in the upper gastrointestinal tract. Plasma concentrations increase in a dose-linear manner up to 50 mg oral intake and increases nonlinearly above this dose. Following oral dosing, the time to maximum observed plasma ibandronate concentrations ranged from 0.5 to 2 hours (median 1 hour) in fasted healthy postmenopausal women. The mean oral bioavailability of 2.5 mg ibandronate was about 0.6% compared to intravenous dosing. The extent of absorp...

14.1 Treatment of Postmenopausal Osteoporosis Daily Dosing The effectiveness and safety of ibandronate sodium tablets were demonstrated in a randomized, double-blind, placebo-controlled, multinational study (Treatment Study) of 2946 women aged 55 to 80 years, who were on average 21 years postmenopause, who had lumbar spine BMD 2 to 5 SD below the premenopausal mean (T-score) in at least one vertebra [L1 to L4], and who had 1 to 4 prevalent vertebral fractures. Ibandronate sodium tablets were evaluated at oral doses of 2.5 mg daily and 20 mg intermittently. The main outcome measure was the occu...

The following clinically significant adverse drug reactions are described elsewhere in the labeling: Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.1 )] Hypocalcemia and Mineral Metabolism [see Warnings and Precautions ( 5.2 )] Musculoskeletal [see Warnings and Precautions ( 5.3 )] Jaw Osteonecrosis [see Warnings and Precautions ( 5.4 )] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions ( 5.5 )] Severe Renal Impairment [see Warnings and Prec...

Ibandronate sodium tablets are 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...

Upper gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions and discontinue use if new or worsening symptoms occur. ( 5.1 ) Hypocalcemia may worsen during treatment. Correct hypocalcemia before use. ( 5.2 ) Severe Bone, Joint, and Muscle Pain may occur. Consider discontinuing use if symptoms develop. ( 5.3 ) Osteonecrosis of the Jaw has been reported. ( 5.4 ) Atypical Fractures including Femoral Fractures have been reported. Patients with new thigh or groi...

7 DRUG INTERACTIONS Calcium supplements, antacids and some oral medications may interfere with absorption of ibandronate. Do not take within 60 minutes of dosing ( 7.1 ) Use caution when co-prescribing aspirin/nonsteroidal anti-inflammatory drugs that may worsen gastrointestinal irritation. ( 7.2 ) 7.1 Calcium Supplements/Antacids Products containing calcium and other multivalent cations (such as ...