Alendronate Sodium (Generic Fosamax) - Product information and Uses
Alendronic acid or alendronate sodium which is marketed as Fosamax by Merck is a bisphosphonate drug used for osteoporosis and several other bone diseases. It is marketed alone as well as in combination with vitamin D under the name Fosamax+D .
As with all potent bisphosphonates, the systemic bioavailability after oral dosing is low, averaging only 0.6â€“0.7% in women and in men under fasting conditions. Intake together with meals and beverages other than water further reduces the bioavailability. The absorbed drug rapidly partitions, with approximately 50% binding to the exposed bone surface; the remainder is excreted unchanged by the kidneys. Treatment of post-menopausal women with Fosamax has demonstrated normalization of the rate of bone turnover, significant increase in BMD (bone mineral density) of the spine, hip, wrist and total body, and significant reductions in the risk of vertebral (spine) fractures, wrist fractures, hip fractures, and all non-vertebral fractures. In the women with the highest risk of fracture (by virtue of pre-existing vertebral fractures) in the Fracture Intervention Trial, treatment with Fosamax 5 mg/day for two years followed by 10 mg/day for the third year (plus calcium and vitamin D) resulted in approximately 50% reductions in fractures of the spine, hip, and wrist compared with the control group taking placebos plus calcium and vitamin D.
Fosamax is used for Prophylaxis and treatment of female osteoporosis, Treatment of male osteoporosis, Prevention and treatment of corticosteroid-associated osteoporosis together with supplements of calcium and vitamin D as well as treatment of Paget's disease
Alendronate Sodium - Availability And Packaging
Alendronate is available as Generic Fosamax which is packaged in 10 mg and 70 mg tablets.
Contraindications and Precautions of Alendronate Sodium (Generic Fosamax)
The contraindications of Generic Fosamax are
Acute inflammations of the gastrointestinal tract (esophagitis, gastritis, ulcerations)
Clinically manifest osteomalacia
Certain malformations and malfunctions of the esophagus (strictures, achalasia)
Inability to stand, walk, or sit for 30 minutes after oral administration
Renal impairment with a creatinine clearance below 30ml/min
Hypersensitivity to alendronate or any inactive ingredient present in Generic Fosamax.
Pregnancy and breastfeeding.
Patients below 18 yrs. of age, as no clinical data exists.
Side Effects of Alendronate Sodium (Generic Fosamax)
Below are mentioned the side effects of Generic Fosamax (Alendronate Sodium)
Gastrointestinal tract: ulceration of the esophagus; this may require hospitalization and intensive treatment. Gastric and duodenal ulceration may also occur. December 31, 2008, the FDA reported alendronate and related drugs may carry an increased risk for esophageal cancer. General: infrequent cases of skin rash, rarely manifesting as Stevens-Johnson syndrome and toxic epidermal necrolysis, eye problems (uveitis, scleritis) and generalized muscle, joint, and bone pain (rarely severe) have been seen. In laboratory tests decreased calcium and phosphate values may be obtained but reflect action of the drug and are harmless. Osteonecrosis of the Jaw - Deterioration of the Temporomandibular Joint (TMJ) may occur while on this drug, if dental work of any kind is carried out. Although osteonecrosis is uncommon, it occurs primarily in patients being administered intravenous biphosphonates, with most cases being reported in cancer patients. Neurological: Rare instances of auditory hallucinations and visual disturbances have been associated with alendronate and other bisphosphonates. Bone: Alendronate has been linked in long-term users to the development of low-impact femoral fractures. Further, studies suggest that users of alendronate have an increase in the numbers of osteoclasts and develop giant, more multinucleated osteoclasts; the significance of this development is unclear. People who have taken Fosamax has been linked to a rare type of leg fracture that cuts straight across the upper thigh bone after little or no trauma. (Subtrochanteric fractures). This is because Fosamax makes the thigh bone more brittle and stops the cells in the body that remodel the bone. Studies are showing that people who have taken Fosamax for more than five years are at risk for developing these kind of fractures. In some cases, patients have reported that, after weeks or months of unexplained aching, their thigh bones simply snapped while they were walking or standing.
Alendronate Sodium (Generic Fosamax) - Interactions
Below are listed the interactions of Alendronate Sodium (Generic Fosamax)
Milk, diet, and drugs containing high amounts of calcium, magnesium or aluminium (antacids): the resorption of alendronate is decreased. At least half an hour should pass after intake of alendronate before taking the supplement or drug.
Highly active vitamin D analogues or fluorides: no data is available. Concomitant treatment should be avoided.
The additional beneficial effect of HRT (hormone replacement therapy) with estrogens/progestins or raloxifene in postmenopausal women remains to be elucidated, but no interactions have been seen. The combination is therefore possible.
Intravenous ranitidine increases the oral bioavailability of alendronate. No clinical consequences are known.
The combination of NSAIDs and alendroate may increase the risk of gastric ulcers. Both these drugs have the potential to irritate the upper gastro-intestinal mucosa.
Generic Fosamax - Dosage
The dosage of generic fosamax to treat various indications are listed below:
Prophylaxis of osteoporosis in women: 5-10 mg daily or 35-70 mg weekly.
Therapy of osteoporosis in women and men : 10 mg daily or 70 mg weekly.
Osteoporosis under corticosteroids: 5-10 mg daily or 35-70 mg weekly in men and premenopausal women or those receiving concomitant HRT. In postmenopausal women not receiving HRT, the recommended dose is 10 mg daily or 70 mg weekly.
Paget's Disease: 40 mg daily for 6 months.
The drug is to be taken only upon rising for the day with water, not to exceed 6-8 oz. Stand, walk, or sit, and remain fasting for 30-45 minutes afterwards, then eat breakfast.
Additional Info: Prescribing Information
Considerable portions of the text here is from http://en.wikipedia.org/wiki/Alendronic_acid and is reproduced here under the Creative Commons Attribution-ShareAlike License