IBANDRONATE SODIUM 3 mg/3mL
IBANDRONATE SODIUM · INJECTION, SOLUTION · Sun Pharmaceutical Industries, Inc.
IBANDRONATE SODIUM is a injection, solution containing ibandronate sodium at 3 mg/3mL, taken intravenous. Manufactured by Sun Pharmaceutical Industries, Inc..
Key Facts
- Brand Name
- IBANDRONATE SODIUM
- Generic Name
- IBANDRONATE SODIUM
- NDC Code (Product)
62756-218- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Strength
- 3 mg/3mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA090853
- Marketing Start
- 02/15/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. Ibandronate sodium increases bone mineral density (BMD) and reduces the incidence of vertebral fractures. 1.2 Important Limitations of Use Theoptimalduration 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.
Dosage & Administration
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 ) 2.1 Dosage Information The dose of ibandronate sodium tablet is one 150 mg tablet taken once monthly on the same date each month. 2.2 Important Administration Instructions Instruct Patients to do the following: Take ibandronate sodium tablets at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit, (see DRUG INTERACTIONS [7.1] ) . Avoid the use of water with supplements including mineral water because they may have a higher concentration of calcium. Swallow ibandronate sodium tablets whole …
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] ). 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 tablets ( 4 )
Drug 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. Therefore, instruct patients to take ibandronate sodium tablets at least 60 minutes before any oral medications, including medications containing multivalent cations (such as antacids, supplements or vitamins). Also, patients should wait at least 60 minutes after dosing before taking any other oral medications ( see DOSAGE AND ADMINISTRATION [2.3] ). 7.2 Aspirin/Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Because aspirin, NSAIDs, and bisphosphonates are all associated with gastrointestinal irritation, caution should be exercised in the concomitant use of aspirin or NSAIDs with ibandronate sodium tablets. 7.3 H2 Blockers In healthy volunteers, co-administration with ranitidine resulted in a 2…
Adverse Reactions
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 ( 5.6 )] The most common adverse reactions (greater than 5%) are back pain, dyspepsia, pain in extremity, diarrhea, headache, and myalgia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 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. Treatment and Prevention of Postmenopausal Osteoporosis Daily Dosing The safety of ibandronate sodium ta…
Frequently Asked Questions
What is IBANDRONATE SODIUM used for?
IBANDRONATE SODIUM contains IBANDRONATE SODIUM. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is IBANDRONATE SODIUM a controlled substance?
IBANDRONATE SODIUM is not classified as a controlled substance by the DEA.
What is the generic name for IBANDRONATE SODIUM?
The generic name for IBANDRONATE SODIUM is IBANDRONATE SODIUM. There are 6 other brand versions of IBANDRONATE SODIUM.
What is the NDC code for IBANDRONATE SODIUM 3 mg/3mL?
The NDC (National Drug Code) for IBANDRONATE SODIUM 3 mg/3mL is 62756-218, listed by Sun Pharmaceutical Industries, Inc..