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Boniva
Overview
What is Boniva?
BONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(-methyl--pentyl) amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, monohydrate with the molecular formula CHNOPNa•HO and a molecular weight of 359.24. Ibandronate sodium is a white- to off-white powder. It is freely soluble in water and practically insoluble in organic solvents. Ibandronate sodium has the following structural formula:
BONIVA is available as a white, oblong, 150 mg film-coated tablet for once-monthly oral administration. One 150 mg film-coated tablet contains 168.75 mg ibandronate monosodium monohydrate, equivalent to 150 mg free acid. BONIVA also contains the following inactive ingredients: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified stearic acid, colloidal silicon dioxide, and purified water. The tablet film coating contains hypromellose, titanium dioxide, talc, polyethylene glycol 6000, and purified water.
What does Boniva look like?
What are the available doses of Boniva?
Tablets: 150 mg ()
What should I talk to my health care provider before I take Boniva?
BONIVA is not recommended in patients with severe renal impairment (creatinine clearance less than 30 mL/min). (, )
How should I use Boniva?
BONIVA is indicated for the treatment and prevention of osteoporosis in postmenopausal women. BONIVA increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.
The dose of BONIVA is one 150 mg tablet taken once monthly on the same date each month.
What interacts with Boniva?
Sorry No Records found
What are the warnings of Boniva?
Sorry No Records found
What are the precautions of Boniva?
Sorry No Records found
What are the side effects of Boniva?
Sorry No records found
What should I look out for while using Boniva?
BONIVA is contraindicated in patients with the following conditions:
What might happen if I take too much Boniva?
No specific information is available on the treatment of overdosage of BONIVA. However, based on knowledge of this class of compounds, oral overdosage may result in hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, dyspepsia, esophagitis, gastritis, or ulcer. Milk or antacids should be given to bind BONIVA. Due to the risk of esophageal irritation, vomiting should not be induced, and the patient should remain fully upright. Dialysis would not be beneficial.
How should I store and handle Boniva?
Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].Valsartan Tablets, USP are available containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP.The 40 mg tablets are yellow, film-coated, round, scored tablets debossed with on one side of the tablet and above the score and below the score on the other side. They are available as follows:NDC 0378-5807-93bottles of 30 tabletsThe 80 mg tablets are light red, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5813-77bottles of 90 tabletsThe 160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5814-77bottles of 90 tabletsThe 320 mg tablets are dark violet, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5815-77bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Valsartan Tablets, USP are available containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP.The 40 mg tablets are yellow, film-coated, round, scored tablets debossed with on one side of the tablet and above the score and below the score on the other side. They are available as follows:NDC 0378-5807-93bottles of 30 tabletsThe 80 mg tablets are light red, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5813-77bottles of 90 tabletsThe 160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5814-77bottles of 90 tabletsThe 320 mg tablets are dark violet, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5815-77bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Valsartan Tablets, USP are available containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP.The 40 mg tablets are yellow, film-coated, round, scored tablets debossed with on one side of the tablet and above the score and below the score on the other side. They are available as follows:NDC 0378-5807-93bottles of 30 tabletsThe 80 mg tablets are light red, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5813-77bottles of 90 tabletsThe 160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5814-77bottles of 90 tabletsThe 320 mg tablets are dark violet, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5815-77bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Valsartan Tablets, USP are available containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP.The 40 mg tablets are yellow, film-coated, round, scored tablets debossed with on one side of the tablet and above the score and below the score on the other side. They are available as follows:NDC 0378-5807-93bottles of 30 tabletsThe 80 mg tablets are light red, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5813-77bottles of 90 tabletsThe 160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5814-77bottles of 90 tabletsThe 320 mg tablets are dark violet, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5815-77bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Valsartan Tablets, USP are available containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP.The 40 mg tablets are yellow, film-coated, round, scored tablets debossed with on one side of the tablet and above the score and below the score on the other side. They are available as follows:NDC 0378-5807-93bottles of 30 tabletsThe 80 mg tablets are light red, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5813-77bottles of 90 tabletsThe 160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5814-77bottles of 90 tabletsThe 320 mg tablets are dark violet, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5815-77bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Valsartan Tablets, USP are available containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP.The 40 mg tablets are yellow, film-coated, round, scored tablets debossed with on one side of the tablet and above the score and below the score on the other side. They are available as follows:NDC 0378-5807-93bottles of 30 tabletsThe 80 mg tablets are light red, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5813-77bottles of 90 tabletsThe 160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5814-77bottles of 90 tabletsThe 320 mg tablets are dark violet, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5815-77bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Valsartan Tablets, USP are available containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP.The 40 mg tablets are yellow, film-coated, round, scored tablets debossed with on one side of the tablet and above the score and below the score on the other side. They are available as follows:NDC 0378-5807-93bottles of 30 tabletsThe 80 mg tablets are light red, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5813-77bottles of 90 tabletsThe 160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5814-77bottles of 90 tabletsThe 320 mg tablets are dark violet, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5815-77bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Valsartan Tablets, USP are available containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP.The 40 mg tablets are yellow, film-coated, round, scored tablets debossed with on one side of the tablet and above the score and below the score on the other side. They are available as follows:NDC 0378-5807-93bottles of 30 tabletsThe 80 mg tablets are light red, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5813-77bottles of 90 tabletsThe 160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5814-77bottles of 90 tabletsThe 320 mg tablets are dark violet, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5815-77bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Valsartan Tablets, USP are available containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP.The 40 mg tablets are yellow, film-coated, round, scored tablets debossed with on one side of the tablet and above the score and below the score on the other side. They are available as follows:NDC 0378-5807-93bottles of 30 tabletsThe 80 mg tablets are light red, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5813-77bottles of 90 tabletsThe 160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5814-77bottles of 90 tabletsThe 320 mg tablets are dark violet, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5815-77bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Valsartan Tablets, USP are available containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP.The 40 mg tablets are yellow, film-coated, round, scored tablets debossed with on one side of the tablet and above the score and below the score on the other side. They are available as follows:NDC 0378-5807-93bottles of 30 tabletsThe 80 mg tablets are light red, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5813-77bottles of 90 tabletsThe 160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5814-77bottles of 90 tabletsThe 320 mg tablets are dark violet, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5815-77bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Valsartan Tablets, USP are available containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP.The 40 mg tablets are yellow, film-coated, round, scored tablets debossed with on one side of the tablet and above the score and below the score on the other side. They are available as follows:NDC 0378-5807-93bottles of 30 tabletsThe 80 mg tablets are light red, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5813-77bottles of 90 tabletsThe 160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5814-77bottles of 90 tabletsThe 320 mg tablets are dark violet, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5815-77bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Valsartan Tablets, USP are available containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP.The 40 mg tablets are yellow, film-coated, round, scored tablets debossed with on one side of the tablet and above the score and below the score on the other side. They are available as follows:NDC 0378-5807-93bottles of 30 tabletsThe 80 mg tablets are light red, film-coated, capsule-shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5813-77bottles of 90 tabletsThe 160 mg tablets are light orange, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5814-77bottles of 90 tabletsThe 320 mg tablets are dark violet, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-5815-77bottles of 90 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
Non-Clinical Toxicology
BONIVA is contraindicated in patients with the following conditions:See , .
BONIVA, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when BONIVA is given to patients with active upper gastrointestinal problems (such as known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers).
Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue BONIVA and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6-8 oz) of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient . In patients who cannot comply with dosing instructions due to mental disability, therapy with BONIVA should be used under appropriate supervision.
There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Interactions
Interactions
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