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In the U.S.—

Fosamax

In Canada—

Fosamax

• Bone resorption inhibitor

Alendronate (a-LEN-dro-nate) is used to prevent or treat osteoporosis (thinning of the bone) in women after menopause and to treat osteoporosis in men. It may also be used to treat Paget's disease of bone and osteoporosis (thinning of the bone) caused by glucocorticoid treatment.

Alendronate is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For alendronate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to alendronate. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet—Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet. Your doctor may recommend that you eat a balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products).

Pregnancy—Alendronate has not been studied in pregnant women. However, studies in animals have shown that alendronate causes birth defects and other pregnancy problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether alendronate passes into breast milk. However, this medicine has been reported to pass into the milk of lactating rats.

Children—Studies on this medicine have been done only in adult patients and there is no specific information comparing use of alendronate in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking alendronate, it is especially important that your health care professional know if you are taking the following:

• Aspirin or products that contain aspirin—Use with alendronate may cause or make esophagus, intestine, or stomach problems worse

Other medical problems—The presence of other medical problems may affect the use of alendronate. Make sure you tell your doctor if you have any other medical problems, especially:

• Digestion problems—Taking alendronate may be harmful to the esophagus, intestine, or stomach

• Esophagus problems or
• Intestine problems or
• Stomach problems—Alendronate may make these conditions worse

• Kidney problems—The effects of alendronate may be increased

Take alendronate with a full glass (6 to 8 ounces) of plain water on an empty stomach. It should be taken in the morning at least 30 minutes before any food, beverage, or other medicines. Food and beverages, such as mineral water, coffee, tea, or juice, will decrease the amount of alendronate absorbed by the body. Waiting longer than 30 minutes will allow more of the drug to be absorbed. Medicines such as antacids or calcium or vitamin supplements will also decrease the absorption of alendronate.

Do not lie down for 30 minutes after taking alendronate . This will help alendronate reach your stomach faster. It will also help prevent irritation to your esophagus.

Your doctor may recommend that you eat a balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products). However, do not take any food, beverages, or calcium or vitamin supplements within 30 minutes or longer of taking alendronate. To do so may keep this medicine from working properly.Waiting longer than 30 minutes will allow more of the drug to be absorbed.

Dosing—

The dose of alendronate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of alendronate. If your dose is different, do not change it unless your doctor tells you to do so.

• For treatment of Paget's disease of bone:
  • Adults—40 milligrams (mg) once a day in the morning, taken at least thirty minutes before the first food, beverage, or medication. You should take alendronate with six to eight ounces of plain water. Your treatment may continue for six months. Your doctor may repeat the treatment.
  • Children—Use and dose must be determined by your doctor.
• For treatment of osteoporosis in men (thinning of bone):
  • Adults—10 mg once a day in the morning, taken at least thirty minutes before the first food, beverage, or medication. You should take alendronate with six to eight ounces of plain water.
• For treatment of postmenopausal osteoporosis (thinning of bone):
  • • Adults—10 mg once a day in the morning or 70 mg once a week, taken at least thirty minutes before the first food, beverage, or medication. You should take alendronate with six to eight ounces of plain water.
• For prevention of postmenopausal osteoporosis (thinning of bone):
  • Adults—5 mg once a day in the morning or 35 mg once a week, taken at least thirty minutes before the first food, beverage, or medication. You should take alendronate with six to eight ounces of plain water.
• For treatment of osteoporosis (thinning of bone) caused by glucocorticoid treatment:
  • Adults—5 mg once a day in the morning, taken at least thirty minutes before the first food, beverage, or medication. In postmenopausal women not receiving estrogen, the dose is 10 mg once a day in the morning, taken at least thirty minutes before the first food, beverage, or medication. You should take alendronate with six to eight ounces of plain water.

Missed dose—

If you miss a dose of this medicine, do not take it later in the day. Resume your usual schedule the next morning. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Abdominal pain 
  
  

• Less common
  • Difficulty in swallowing;  heartburn ;  irritation or pain of the esophagus;  muscle pain 
  
  

• Rare
  • Skin rash 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• Less common
  • Constipation;  diarrhea;  full or bloated feeling;  gas;  headache;  nausea 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 01/06/1997

Revised: 01/10/2001