Generic Name and Formulations:
Alendronate (as sodium) 70mg; effervescent tabs for oral soln; strawberry-flavor; contains 650mg sodium/tab.

Company:
Mission Pharmacal Company

Indications for BINOSTO:
Treatment of postmenopausal osteoporosis. To increase bone mass in men with osteoporosis. Limitations of use: optimal duration of use has not been determined.

Adult Dose for BINOSTO:
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, drink, 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's Dose for BINOSTO:
Not applicable.

Pharmacological Class:
Bisphosphonate.

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.

Warnings/Precautions:
Active upper GI disease; discontinue and reeva luate 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). Risk of osteonecrosis of the jaw; consider discontinuing therapy during invasive dental procedures (eg, tooth extraction, implants, surgery). History of bisphosphonate exposure: eva luate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Reeva luate periodically. Pregnancy (Cat.C). Nursing mothers.

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.

Adverse Reactions:
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.

Elimination:
Renal.

Generic Availability:
NO

How Supplied:
Tabs—4, 12