Ibandronate is a bisphosphonate sold in the U.S. under 2 brand and generic names, for postmenopausal osteoporosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Ibandronate Sodium (application ANDA090853). Other ibandronate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
3 mg every 3 months administered intravenously over a period of 15 to 30 seconds ( 2.2 ) Dosing Instructions: Only administer intravenously by a health care professional. ( 2.1 ) Do not mix with calcium-containing solutions or other intravenously administered drugs. ( 2.1 ) Do not administer more frequently than once every 3 months. ( 2.2 ) Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate 2.1 Important Administration Instructions Ibandronate sodium injection must be administered intravenously only by a health care professional. Care must be taken not to administer intra-arterially or paravenously as this could lead to tissue damage [see Warnings and Precautions ( 5.4 )] . Appropriate medical support and monitoring measures should be readily available when ibandronate sodium injection is administered. If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment [see Warnings and Precautions ( 5.2 )]. Visually inspect the liquid in the vial for particulate matter and discoloration before administration. Do not use vials with particulate matter or discoloration. Discard any unused portion. Do not mix with calcium-containing solutions or other intravenously administered drugs. Vials are for single use only. 2.2 Dosage…
The following clinically significant adverse drug reactions are described elsewhere in the labeling: Hypocalcemia and Mineral Metabolism [see Warnings and Precautions ( 5.1 ) ] Anaphylactic Reaction [see Warnings and Precautions ( 5.2 )] Renal Impairment [see Warnings and Precautions ( 5.3 )] Tissue Damage Related to Inappropriate Drug Administration [see Warnings and Precautions ( 5.4 )] Osteonecrosis of the Jaw [see Warnings and Precautions ( 5.5 )] Musculoskeletal [see Warnings and Precautions ( 5.6 )] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions ( 5.7 )] The most frequently reported adverse reactions (>5%) are arthralgia, back pain, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Quarterly Intravenous Injection – In a 1-year, double-blind, multicenter study comparing ibandronate sodium injection administered intravenously as 3 mg every 3 months to ibandronate sodium tablets 2.5 mg (ibandronate) daily oral tablet in women…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Tablet | Generic | $3 | View → | |
| 2 | Not yet rated | Prescription | Injectable | Generic | $3 | View → |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| R575 | 150 mg | white | capsule | — |
| X;78 | 150 mg | white | capsule | — |
| APO;IBA150 | 150 mg | white | oval | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Ibandronate sodium injection is contraindicated in patients with the following conditions: Hypocalcemia [see Warnings and Precautions ( 5.1 )] Known hypersensitivity to ibandronate sodium injection or to any of its excipients. Cases of anaphylaxis, including fatal events, have been reported. [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.2 )] Hypocalcemia ( 4 ) Hypersensitivity to ibandronate sodium injection ( 4 )
Melphalan/Prednisolone Intravenous ibandronate (6 mg) did not interact with intravenous melphalan (10 mg/m 2 ) or oral prednisolone (60 mg/m 2 ). [See Clinical Pharmacology ( 12.3 )] 7.2 Tamoxifen There was no interaction between oral 30 mg tamoxifen and intravenous 2 mg ibandronate. [See Clinical Pharmacology ( 12.3 )] 7.3 Bone Imaging Agents Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with ibandronate sodium injection have not been performed.