BINOSTO Rx

Indication(s):

Treatment of postmenopausal osteoporosis. To increase bone mass in men with osteoporosis.

Pharmacology:

Alendronate binds to bone hydroxyapatite and specifically inhibits the activity of osteoclasts, the bone-resorbing cells. It reduces bone resorption with no direct effect on bone formation, although the latter process is ultimately reduced because bone resorption and formation are coupled during bone turnover.

Clinical Trials:

Binosto (alendronate sodium) effervescent tablet 70mg is bioequivalent to alendronate sodium tablet 70mg. The fracture reduction efficacy and bone mineral density changes attributed to Binosto are based on clinical trial data of alendronate sodium 10mg daily and alendronate sodium 70mg weekly.

Legal Classification:

Rx

Adults:

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 30 minutes before the first food, drink, or medication of the day. Do not lie down for at least 30 minutes and until after the first food of the day. 70mg once weekly.

Children:

Not recommended.

Contraindication(s):

Esophagus abnormalities which delay esophageal emptying (eg, stricture, achalasia). Inability to stand or sit upright for at least 30 minutes. Increased risk of aspiration. Hypocalcemia.

Warnings/Precautions:

Active upper GI disease; discontinue and reevaluate if signs/symptoms of esophageal reaction occur. Severe renal impairment (CrCl <35mL/min): not recommended. 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. Sodium restriction (including heart failure, hypertension, or other cardiovascular diseases). Consider discontinuing therapy during invasive dental procedures (eg, tooth extraction, implants, boney surgery). History of bisphosphonate exposure: evaluate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Reevaluate periodically. Pregnancy (Cat.C). Nursing mothers.

Interaction(s)

Calcium supplements, antacids, other multivalent cations reduce absorption (separate dosing by at least 30min). Increased upper GI events with aspirin-containing products and alendronate >10mg/day; caution with NSAIDs.

Adverse Reaction(s)

Abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain (may be severe), nausea; esophagitis, esophageal ulcers or erosions; jaw osteonecrosis, atypical femur fractures; rarely: gastric or duodenal ulcer.

How Supplied:

Tabs—4, 12

LAST UPDATED:

10/31/2012