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Pharmacologic class: Bisphosphonate
Therapeutic class: Calcium regulator
Pregnancy risk category C
Inhibits osteoclast activity and reduces bone resorption and turnover; in postmenopausal women, reduces elevated bone turnover rate, leading to (on average) net gain in bone mass
Solution for injection: 3 mg/3 ml in single-use prefilled glass syringes
Tablets (film-coated): 2.5 mg, 150 mg
Indications and dosages
➣ Osteoporosis treatment and prevention in postmenopausal women
Adults: 2.5-mg tablet P.O. daily, or 150-mg tablet P.O. once monthly on same date each month
➣ Osteoporosis treatment in postmenopausal women
Adults: 3 mg I.V. injection every 3 months
• Hypersensitivity to drug or its components
• Uncorrected hypocalcemia
• Inability to stand or sit upright for at least 60 minutes (after oral administration)
• Abnormalities of esophagus, such as stricture or achalasia, that delay esophageal emptying (tablets)
Use cautiously in:
• severe renal impairment (not recommended)
• active upper GI disease (such as Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers)
• patients who develop jaw osteonecrosis during therapy
• concurrent use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or other bisphosphonates
• pregnant or breastfeeding patients
• children younger than age 18 (safety and efficacy not established).
• With patient standing or sitting upright, give oral dose with 6 to 8 oz water at least 60 minutes before first food or drink (other than water) of day or before administering other oral drugs or supplements (including calcium, antacids, and vitamins).
• Give with plain water only; some mineral waters may have higher calcium concentration and shouldn't be used.
• Don't let patient chew or suck tablet because this may cause oropharyngeal ulcers.
• Keep patient upright for at least 60 minutes after oral dose to avoid serious esophageal irritation.
• Give parenteral formulation only by I.V. injection over 15 to 30 seconds.
• Don't mix parenteral formulation with calcium-containing solutions or other I.V. drugs.
• If patient misses I.V. dose, give it as soon as possible; thereafter, give dose every 3 months from date of last injection. Don't administer more often than every 3 months.
CNS: insomnia, asthenia, headache, fatigue, dizziness, vertigo, nerve root lesion
GI: constipation, diarrhea, vomiting, abdominal pain, dysphagia, esophagitis, esophageal irritation (tablets), gastric ulcer, dyspepsia, gastritis, esophageal ulcer
GU: urinary tract infection
Metabolic: hypercholesterolemia, hypocalcemia
Musculoskeletal: osteonecrosis (mainly in jaw), localized osteoarthritis and muscle cramp, joint disorder, joint pain, muscle pain, back pain, extremity pain, arthritis
Respiratory: upper respiratory tract infection, bronchitis, pneumonia
Other: tooth disorder, influenza, infection, injection site reaction, allergic reaction
Drug-drug. Aspirin, NSAIDs: additive GI irritation
Drugs containing calcium and other multivalent cations (such as aluminum, iron, magnesium), including antacids, supplements, and vitamins: interference with ibandronate absorption
Drug-diagnostic tests. Alkaline phosphatase, calcium: decreased
Bone-imaging agents: interference with test results
Drug-food. Milk, mineral water, other foods and beverages: interference with ibandronate absorption, reducing drug's bioavailability and effect on bone mineral density (when patient consumes food or beverage less than 60 minutes after ibandronate dose)
• Monitor creatinine clearance in patients with mild or moderate renal impairment.
☞ Monitor for signs and symptoms of GI irritation (including ulcers) after oral administration; discontinue drug if new or worsening symptoms occur.
• Evaluate serum calcium and phosphate levels.
• Monitor for hypocalcemia and other disturbances of bone and mineral metabolism; administer effective treatment before therapy starts.
• Monitor patient for adequate intake of supplemental calcium and vitamin D during therapy, as appropriate.
• Advise patient to read patient information leaflet carefully before starting drug.
• Instruct patient to take drug first thing in morning on empty stomach with 6 to 8 oz of plain water only.
☞ Caution patient not to chew or suck tablet because this may cause throat ulcers.
• Instruct patient not to eat, drink, or take other oral medications for 60 minutes after taking tablet.
☞ Caution patient not to lie down for at least 60 minutes after taking drug.
• Advise patient to take once-monthly tablet (150 mg) on same date each month.
• If patient misses once-monthly dose and next scheduled dose is more than 7 days away, instruct her to take one 150-mg tablet in morning after the day she remembers it and then resume taking one 150-mg tablet every month in morning of chosen day, per original schedule. However, if next scheduled dose is only 1 to 7 days away, tell her to wait until next scheduled dose.
☞ Instruct patient to stop drug and immediately report heartburn, serious vomiting, severe chest or abdominal pain, difficulty swallowing, severe bone, joint, or muscle pain.
• If drug is prescribed for injection, tell patient she will receive it every 3 months.
• Advise patient to take supplemental calcium and vitamin D as prescribed, if dietary intake is inadequate.
• Teach patient to take only those pain relievers recommended by prescriber. Point out that some over-the-counter pain preparations (such as aspirin and NSAIDs) may worsen adverse effects.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.