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Binosto Generic Name & Formulations
Legal Class
Rx
General Description
Alendronate (as sodium) 70mg; effervescent tabs for oral soln; strawberry-flavor; contains 603mg sodium/tab.
Pharmacological Class
Bisphosphonate.
How Supplied
Tabs—4
Manufacturer
Generic Availability
NO
Binosto Indications
Indications
Treatment of postmenopausal osteoporosis. To increase bone mass in men with osteoporosis.
Limitations of Use
Optimal duration of use has not been determined. For patients at low-risk for fracture: consider drug discontinuation after 3–5yrs.
Binosto Dosage and Administration
Adult
Dissolve one tab in 4oz plain (not mineral) water only; after effervescence stops, wait 5mins and stir soln for 10secs. Take in the AM at least 30mins before the first food, beverage, or medication of the day. Do not lie down for at least 30mins and until after the first food of the day. 70mg once weekly.
Children
Not indicated.
Binosto Contraindications
Contraindications
Esophagus abnormalities which delay esophageal emptying (eg, stricture, achalasia). Inability to stand or sit upright for at least 30mins. Increased risk of aspiration. Hypocalcemia.
Binosto Boxed Warnings
Not Applicable
Binosto Warnings/Precautions
Warnings/Precautions
Active upper GI disease; discontinue and reevaluate if signs/symptoms of esophageal reaction occur. Correct preexisting hypocalcemia or other mineral metabolism disorders (eg, Vit. D deficiency) before starting. Monitor for hypocalcemia during therapy. Ensure adequate Vit. D and calcium intake. Risk of osteonecrosis of the jaw; consider discontinuing therapy during invasive dental procedures (eg, tooth extraction, implants, surgery). History of bisphosphonate exposure: evaluate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Sodium restriction (including heart failure, hypertension, or other cardiovascular diseases). Reevaluate periodically. Severe renal impairment (CrCl <35mL/min): not recommended. Pregnancy. Nursing mothers.
Binosto Pharmacokinetics
See Literature
Binosto Interactions
Interactions
Calcium supplements, antacids, other multivalent cations reduce absorption (separate dosing by at least 30mins). Increased upper GI events with aspirin-containing products and alendronate >10mg/day; caution with NSAIDs. May be antagonized by levothyroxine.
Binosto Adverse Reactions
Adverse Reactions
Abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain (discontinue if severe), nausea; esophagitis, esophageal ulcers or erosions; jaw osteonecrosis, atypical femur fractures; rare: gastric or duodenal ulcer.
Binosto Clinical Trials
See Literature
Binosto Note
Not Applicable
Binosto Patient Counseling
See Literature
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