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FOSAMAX

Generic Name: alendronate (a LEN dro nate)
Brand Names: Fosamax

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.

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 (vertebral compression fractures).
  Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture.
- For the prevention of osteoporosis, FOSAMAX 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.
  
  Bone loss is particularly rapid in postmenopausal women younger than age 60. Risk factors often associated with the development of postmenopausal osteoporosis include early menopause; moderately low bone mass (for example, at least 1 standard deviation below the mean for healthy young adult women); thin body build; Caucasian or Asian race; and family history of osteoporosis. The presence of such risk factors may be important when considering the use of FOSAMAX for prevention of osteoporosis.
Treatment to increase 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
- Treatment is indicated in patients with Paget's disease of bone having alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.

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Product description

Safety information

Side Effects

Do not take a Fosamax tablet if you cannot sit upright or stand for at least 30 minutes. Fosamax can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking Fosamax.

Take the Fosamax tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine.

Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water, coffee, tea, or juice) when taking a Fosamax tablet.

For at least the first 30 minutes after taking a Fosamax tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to Fosamax have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using Fosamax. You may need to stop using the medicine for a short time.

Talk with your doctor about the risks and benefits of using Fosamax.

Fosamax is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Product description

Safety information

Side Effects

FOSAMAX, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when FOSAMAX is given to patients with active upper gastrointestinal problems (such as known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers).

Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates including FOSAMAX. In some cases these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue FOSAMAX and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.

The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates including FOSAMAX and/or who fail to swallow oral bisphosphonates including FOSAMAX with the recommended full glass (6-8 oz) of water, and/or who continue to take oral bisphosphonates including FOSAMAX after developing symptoms suggestive of esophageal irritation.

Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient (see DOSAGE AND ADMINISTRATION). In patients who cannot comply with dosing instructions due to mental disability, therapy with FOSAMAX should be used under appropriate supervision. There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials.