Overview
11 DESCRIPTION Ibandronate sodium is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The drug substance used in ibandronate sodium tablets 150 mg is ibandronate sodium in the form of propylene glycol solvate. The chemical name for ibandronate sodium propylene glycol solvate is monosodium {1-hydroxy-3-[methyl(pentyl) amino]-1-phosphonopropyl} phosphonate...
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The action of ibandronate on bone tissue is based on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass. 12.2 Pharmacodynamics Osteoporosis is characterized by decreased bone mass and increased fracture risk, most commonly at the spine, hip, and wrist. The diagnosis can be confirmed by a finding of low bone mass, evidence of fracture on x-ray, a history of osteoporotic fracture, or height loss or kyphosis indicative of vertebral fracture.
Indications
- 1 INDICATIONS AND USAGE Ibandronate sodium tablet is a bisphosphonate indicated for the treatment and prevention of postmenopausal 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 ). 1.1 Treatment and Prevention of Postmenopausal Osteoporosis Ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Common Doses
- 150 mg
Dosage
2 DOSAGE AND ADMINISTRATION Take one 150 mg tablet once monthly on the same day each month ( 2.1 ) Instruct patient to: ( 2.2 ) Swallow whole tablet with 6 to 8 oz of plain water only, at least 60 minutes before the first food, beverage, or medication of day. Avoid lying down for at least 60 minutes after taking ibandronate sodium tablets. Do not eat, drink (except for water), or take other medication for 60 minutes after taking ibandronate sodium tablets. Take supplemental calcium and vitamin D if dietary intake inadequate ( 2.3 ) 2.
Contraindications
- 4 CONTRAINDICATIONS 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 [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] ).
Side Effects
- 6 ADVERSE REACTIONS 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 Precautions ( 5.
Interactions
- 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 aluminum, magnesium, iron) are likely to interfere with absorption of ibandronate sodium tablets.