Alovell

Uses

Alendronic acid is used for the-

• Treatment and prevention of osteoporosis in post-menopausal women
• Treatment of osteoporosis, Alendronic acid increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures)
• Prevention of osteoporosis, Alendronic acid may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture
• Treatment toincrease bone mass in men with osteoporosis
• Treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D
• Treatment of Paget’s disease of bone in men and women

Alovell is also used to associated treatment for these conditions: Osteogenesis Imperfecta (OI), Osteoporosis, Osteoporosis caused by glucocorticoid, Paget’s Disease

How Alovell works

Alendronic acid binds to bone hydroxyapatite. Bone resorption causes local acidification, releasing alendronic acid which is that taken into osteoclasts by fluid-phase endocytosis. Endocytic vesicles are acidified, releasing alendronic acid to the cytosol of osteoclasts where they induce apoptosis. Inhibition of osteoclasts results in decreased bone resorption which is shown through decreased urinary calcium, deoxypyridinoline and cross-linked N-telopeptidases of type I collagen.

Dosage

Alovell dosage

Treatment of osteoporosis in post-menopausal women: The recommended dose is one Alendronic acid 70 mg once weekly or 10 mg once daily.

Treatment to increase bone mass in men with osteoporosis:The recommended dose is one Alendronic acid tablet 10 mg once daily. Alternatively, one Alendronic acid 70 mg once weekly may be considered.

Prevention of osteoporosis in post-menopausal women: The recommended dose is 35 mg once weekly or 5 mg once daily. The safety of treatment and prevention of osteoporosis with Alendronic acid has been studied for up to 7 years.

Use for elderly patients: No dosage adjustment is required for elderly patients. Because in clinical study there was no evidence of age related differences in the efficacy or safety profiles of Alendronic acid.

Treatment of glucocorticoid-induced osteoporosis in men and women: The recommended dose is 5 mg once daily, except for post-menopausal women not receiving oestrogen, for whom the recommended dose is 10 mg once daily.

Paget’s disease of bone in men and women: The recommended treatment regimen is 40 mg once a day for six months.

Side Effects

The commonest symptomatic side effects are constipation, diarrhoea, oesophageal ulcer, flatulence, dysphagia, musculoskeletal pain, headache, rarely rash, erythema, transient decrease in serum calcium and phosphate, nausea, vomiting, peptic ulceration, hypersensitivity reactions including urticaria and angio-oedema.

Toxicity

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

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. 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.

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

Alendronic acid has been studied for use in pediatric patients. The oral bioavailability is similar to that in adult patients, but an increase in the portion of patients experiencing vomiting.

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.

Alendronic acid is not recommended for patients with creatinine clearance Label.

Interaction

The incidence of upper gastrointestinal side effects are increased with the concomitant use of non-steroidal anti-inflammatory agents and aspirin. Absorption of Alendronate is reduced in the presence of antacids and calcium supplements.

Volume of Distribution

28L.

Elimination Route

Mean oral bioavailability of alendronic acid in women is 0.64% and in men is 0.59%. Bioavailability of alendronic acid decreases by up to 40% if it is taken within an hour of a meal.

Half Life

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

Clearance

71mL/min.

Elimination Route

Administration of radiolabeled alendronic acid results in 50% recovery in urine within 72 hours. No alendronic acid is recovered in the feces. Men excrete less alendronic acid than women, though race and advanced age do not affect elimination.

Pregnancy & Breastfeeding use

Alendronic acid should not be given to pregnant women or nursing mother.

Contraindication

Hypocalcaemia; Renal impairment; Vitamin D deficiency; Active gastrointestinal problem such as dysphagia, oesophago-duodenitis or ulcer; and Hypersensitivity to any components of the tablet.

Special Warning

Children: Not recommended.

Innovators Monograph

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