Medications and Drugs
Pharmacy Author: Omudhome Ogbru, PharmD
Medical and Pharmacy Editor: Jay W. Marks, MD
GENERIC NAME: alendronate
BRAND NAME: Fosamax
DRUG CLASS AND MECHANISM: Alendronate is in a class of medications
called bisphosphonates. The bisphosphonate class includes etidronate (Didronel),
ibandronate (Boniva),
pamidronate (Aredia), risedronate (Actonel), and
tiludronate (Skelid). Bisphosphonates are used for treating osteoporosis
(reduced density of bone that leads to
fractures) and bone pain from diseases
such as metastatic breast cancer, multiple myeloma, and Paget's disease. Bone is
in a constant state of remodeling. New bone is laid down by cells called
osteoblasts while old bone is removed by cells called osteoclasts.
Bisphosphonates strengthen bone by inhibiting bone removal (resorption) by
osteoclasts. After menopause, there is an increased rate of bone loss leading to
osteoporosis, and alendronate has been shown to increase bone density and
decrease fractures of bones. The FDA approved alendronate in September 1995.
PRESCRIPTION: Yes
GENERIC AVAILABLE: Yes
PREPARATIONS: Tablets: 5, 10, 35, 40, 70 mg. Solution: 70 mg
STORAGE: Tablets and solution should be stored at room temperature,
15-30 C (59-86 F) and not frozen.
PRESCRIBED FOR: Alendronate is used for treating osteoporosis in men
and postmenopausal women. It also is used for Paget's disease of bone and
osteoporosis caused by steroid treatment. Non-FDA approved (off-label) uses
include vitamin D overdose and osteoporosis caused by spinal injury.
DOSING: The recommended dose for treatment of osteoporosis is 5-10 mg
daily or 35-70 mg weekly. Paget's disease is treated with 40 mg once daily for
six months.
Since food, other medications, and vitamins can interfere with the absorption
of alendronate, they should be taken at least 30 minutes before alendronate. In
order to avoid chemical irritation of the esophagus (the swallowing tube that
connects the mouth with the stomach), alendronate should be taken with a full
glass of plain water immediately upon arising in the morning and never chewed or
sucked. It should be avoided by patients with abnormalities of the esophagus
which delay esophageal emptying, such as scarring (stricture) or poor motility
(achalasia). Patients should also not lie down for 30 minutes after swallowing
the tablets. Those patients who are unable to remain upright for at least 30
minutes after taking alendronate should not take it.
DRUG INTERACTIONS: Calcium supplements and antacids reduce the
absorption of alendronate. Therefore, alendronate should be taken at least 30
minutes before calcium and antacids.
Intravenous ranitidine (Zantac) increases blood levels of alendronate. The
importance of this reaction is unknown.
The risk of stomach and intestinal side effects may increase when alendronate
is combined with aspirin or other
nonsteroidal antiinflammatory drugs (NSAIDs).
PREGNANCY: Alendronate has not been studied in
pregnant women.
NURSING MOTHERS: It is not known whether alendronate is secreted in
breast milk.
SIDE EFFECTS: The most common side effect of alendronate is stomach
pain. It also may cause nausea,
vomiting, bloating, constipation, diarrhea,
gas,
black stool (due to intestinal bleeding), change in taste perception, and muscle
or joint pain. Alendronate may irritate the esophagus, causing ulcers and
bleeding. This occurs more often when patients do not drink enough water with
alendronate, wait 30 minutes before lying down, or take alendronate before the
first meal of the day. Rarely, patients may experience jaw problems
(osteonecrosis of the jaw) associated with delayed healing and infection after
tooth extraction.
Bone, joint, and muscle pain also can occur as can femoral fractures.
Reference: FDA Prescribing Information
Last Editorial Review: 7/13/2010
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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