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Fosamax®
(alendronate sodium tablets and oral
solution)
See also: Foasmax Plus
D
Drug Uses
Fosamax is indicated for treatment and prevention
of osteoporosis in postmenopausal women. For the treatment of osteoporosis,
Fosamax increases bone mass and reduces the incidence of fractures, including
those of the hip and spine. It is also indicated for the prevention of
osteoporosis, treatment to increase bone mass in men with osteoporosis,
treatment of glucocorticoid. It is used to treat 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, treatment of
Paget's disease of bone in men and women.
How Taken
Fosamax comes as a tablet to take by mouth. It
should be taken once a day in the morning on an empty stomach. Fosamax should be
taken with a full glass (6-8 ounces) of plain water. Wait at least 30 minutes
after taking Fosamax before you eat, drink, or take other medications. Do not
take Fosamax with mineral water, coffee, orange juice, milk, or other dairy
products. Do not suck or chew the tablet; swallow the tablet whole. Do not lie
down for at least 30 minutes after taking Fosamax. Standing or sitting upright
helps you get the full dose and decreases heartburn or the risk of injury to
your esophagus.
Warnings/Precautions
Before taking Fosamax, tell your doctor if you
have a problem swallowing, such as a narrowing of the esophagus; have esophageal
ulcers or an esophageal disease; have a condition that causes low levels of
calcium in the body; have kidney disease; have stomach ulcers or other stomach
or digestive problems; or are unable to stand or sit upright for at least 30
minutes. You may not be able to take Fosamax, or you may require a dosage
adjustment or special monitoring during treatment if you have any of the
conditions listed above. Fosamax is in the FDA pregnancy category C. This means
that it is not known whether Fosamax will be harmful to an unborn baby. Do not
take Fosamax without first talking to your doctor if you are pregnant or could
become pregnant during treatment. It is not known whether Fosamax passes into
breast milk. Do not take Fosamax without first talking to your doctor if you are
breast-feeding a baby.
Missed Dose
If you take Fosamax every day and you miss a
dose, skip that dose and take the next regularly scheduled dose the following
day. Missing one dose will not affect your treatment. Do not take two tablets at
the same time. If you take a Fosamax once a week and you miss a dose, take the
missed dose on the morning after you remember. Do not take two tablets on the
same day. Return to taking one tablet once a week, as originally scheduled on
your chosen day.
Possible Side Effects
Stop taking Fosamax if you experience any of the
following serious side effects: an allergic reaction (difficulty breathing;
closing of the throat; swelling of the lips, tongue, or face; or hives); Seek
emergency or talk to your doctor if you have difficulty or pain when swallowing;
chest pain; pain or burning under the ribs or in the back; or new or worsening
heartburn. Other, less serious side effects may be more likely to occur.
Continue to take Fosamax and talk to your doctor if you experience abdominal
discomfort; stomach upset, nausea, vomiting, diarrhea, or constipation;
headache; muscle, bone, or joint soreness or aches; eye pain; a rash; or an
altered sense of taste. Side effects other than those listed here may also
occur. Talk to your doctor about any side effect that seems unusual or that is
especially bothersome.
Storage
Store in a well-closed container at room
temperature, 15-30°C (59-86°F).
Overdose
Hypocalcemia, hypophosphatemia, and upper
gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis,
gastritis, or ulcer, may result from oral over dosage. If you do think that an
overdose has occurred, call an emergency room or poison control center.
More Information
Follow you doctor's recommendations about
drinking alcohol and smoking. These activities are related to decreased bone
density. Antacids and other medicines taken by mouth may decrease the effects of
Fosamax. Do not take any other medicines within 30 minutes after a dose of
Fosamax. Talk to your doctor before taking any other medicines during treatment
with Fosamax.
FOSAMAX (alendronate sodium) is a bisphosphonate that acts as a specific
inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic
analogs of pyrophosphate that bind to the hydroxyapatite found in bone.
Alendronate sodium is chemically described as
(4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.
The empirical formula of alendronate sodium is C4H12NNaO7P2•3H2O and its formula
weight is 325.12.
Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble
in water, very slightly soluble in alcohol, and practically insoluble in
chloroform.
Tablets FOSAMAX for oral administration contain 6.53, 13.05, 45.68, 52.21 or
91.37 mg of alendronate monosodium salt trihydrate, which is the molar
equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the
following inactive ingredients: microcrystalline cellulose, anhydrous lactose,
croscarmellose sodium, and magnesium stearate. Tablets FOSAMAX 10 mg also
contain carnauba wax.
Each bottle of the oral solution contains 91.35 mg of alendronate monosodium
salt trihydrate, which is the molar equivalent to 70 mg of free acid. Each
bottle also contains the following inactive ingredients: sodium citrate
dihydrate and citric acid anhydrous as buffering agents, sodium saccharin,
artificial raspberry flavor, and purified water. Added as preservatives are
sodium propylparaben 0.0225% and sodium butylparaben 0.0075%.
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