OSTOMAX

Alendronic acid is a second generation bisphosphonate that is used for the treatment of some forms of osteoperosis and Paget's disease Label 1, 5.

It functions by preventing resorption of bone Label 1.

Alendronic acid is indicated for the treatment and prevention of osteoporosis in men and postmenopausal women, treatment of glucocorticoid-induced osteoporosis, and Paget's disease of bone Label 1, 2.

However, alendronic acid is not indicated for use in pediatric populations or patients with a creatinine clearance <35 mL/min Label.

Alendronic acid tablets have a very low oral bioavialability Label 2.

After administration it distributes into soft tissue and bone or is excreted in the urine Label.

Alendronic acid does not undergo metabolism

Mean oral bioavailability of alendronic acid in women is 0.64% and in men is 0.59% Label 2.

Bioavailability of alendronic acid decreases by up to 40% if it is taken within an hour of a meal Label.

Urinary excretion is the sole method of elimination of alendronic acid and no metabolites are detected upon urine collection 2.

Administration of radiolabeled alendronic acid results in 50% recovery in urine within 72 hours Label 4.

No alendronic acid is recovered in the feces Label 2, 3.

Men excrete less alendronic acid than women, though race and advanced age do not affect elimination Label.

Due to alendronic acid being incorporated into the skeleton, the terminal half life is estimated to be over 10 years Label.

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In clinical studies, ≥3% of patients experience abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, and nausea Label.

No information for treatment of overdose is available, however patients should be given milk or antacids to bind alendronic acid and vomiting should not be induced Label.

Patients may experience hypocalcemia, hypophosphatemia, and upper gastrointestinal events.

There are currently no studies for safety and efficacy in pregnancy, though studies in pregnant rats show fetal and maternal complications at 4 times the clinical dose and pregnant rabbits do not show complications at as high as 10 times the clincal dose Label.

Excretion in breast milk, and therefore safety in lactation, is unknown Label.

Alendronic acid has been studied for use in pediatric patients Label.

The oral bioavailability is similar to that in adult patients, but an increase in the portion of patients experiencing vomiting Label.

There is no significant difference in efficacy or safety of alendronic acid in geriatric populations, though there is potential for even greater sensitivity in patients at a further advanced age than those in the study Label.

Alendronic acid is not recommended for patients with creatinine clearance <35 mL/min, but no dosage adjustment is necessary in hepatic impairment Label.

For external use only.

Do not use more than one acne product at a time.

After area is wet with

Blemfree™ Cleansing Wash Concentrate has foamed, tap Blemfree™ Cleansing Spheres with fingertips and massage in small circles for 60 seconds.

Proceed to rinse step.