Dosing & Uses
Dosage Forms & Strengths
400 mg PO qDay for 3 months
ClCr< 30 mL/min: Not recommended
Not removed by dialysis
Take with 6-8 oz plain water
2 hours before or after food
Other Indications & Uses
Safety & efficacy not established
400 mg PO qDay for 3 months
Serious - Use Alternative
Significant - Monitor Closely
Frequency Not Defined
Inability to stand or sit upright for at least 30 minutes
Abnormalities of the esophagus which delay emptying such as stricture or achalasia
Risk of esophageal adverse effects, including esophagitis, esophageal ulceration/erosion, or esophageal bleeding with strictures or perforation
Following therapy, allow 3 months interval to assess response
Not recommended in severe renal failure (CrCl <30 mL/min)
Take with plain water only-NOT coffee, juice or mineral water; sit or stand upright for at least 30 minutes after administration
Risk of osteonecrosis of jaw
Food reduces bioavailability
Risk of severe bone, joint &/or muscle pain
Avoid concurrent multivalent cation-containing medicines or food
Esophageal cancer risk (July 21, 2011 FDA safety communication)
- Conflicting findings exist from studies evaluating the risk of esophageal cancer with oral bisphosphonates
- Esophagitis and other esophageal events have been reported, particularly in patients who do not follow the specific directions for use of oral bisphosphonates (eg, sit up or stand after administration, take with full glass of water)
- An ongoing review of data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus is currently being conducted by the FDA
- The FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer
- There are insufficient data to recommend endoscopic screening of asymptomatic patients
- FDA will continue to evaluate all available data supporting the safety and effectiveness of bisphosphonate drugs and will update the public when more information becomes available
- Instruct patients to contact their healthcare provider if they develop symptoms of esophagitis (eg, swallowing difficulties, chest pain, new or worsening heartburn, trouble or pain when swallowing)
Pregnancy & Lactation
Pregnancy Category: C
Lactation: not known if crosses in to breast milk, use caution
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Bisphosphanate that inhibits bone resorption via actions on osteoclast activity, leading to an indirect increase in bone formation
Half-Life: 50 (single dosing) -150 hr (repeated dosing)
Onset: 2 days -1 month
Peak Effect: 3 month
Duration: 3-6 months after completion (multiple doses)
Peak plasma time: 2 hr
Bioavailability: 6%; food reduces bioavailability by up to 90%
Protein bound: 90%
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Select a box to add or remove a plan.
Select a class to view formulary status for similar drugs