INDICATIONS

Fosamax is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Fosamax slows bone loss while increasing bone mass, which may prevent bone fractures.

INSTRUCTIONS

Take Fosamax exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Fosamax tablets are taken either once each day or once each week.

Take the Fosamax tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take a Fosamax tablet only once a week, take it on the same day each week and always first thing in the morning.

Take each Fosamax tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a tablet. Do not crush, chew, or suck the Fosamax tablet. Swallow the pill whole.

After taking a Fosamax tablet, carefully follow these instructions:
Do not lie down or recline for at least 30 minutes after taking Fosamax.
Do not eat or drink anything other than plain water.
Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking Fosamax. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

To be sure Fosamax is helping your condition, your bone mineral density will need to be tested on a regular basis. Visit your doctor regularly.

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

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.

If you take Fosamax tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.

If you take Fosamax tablets once a week: If you forget to take Fosamax on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.

DOSAGE

Treatment of Osteoporosis in Postmenopausal Women

The recommended dosage is:
one 70 mg tablet once weekly 
one bottle of 70 mg oral solution once weekly 
one 10 mg tablet once daily

Prevention of Osteoporosis in Postmenopausal Women

The recommended dosage is:
one 35 mg tablet once weekly 
one 5 mg tablet once daily

Treatment to Increase Bone Mass in Men with Osteoporosis

The recommended dosage is:
one 70 mg tablet once weekly 
one bottle of 70 mg oral solution once weekly 
one 10 mg tablet once daily

Treatment of Glucocorticoid-Induced Osteoporosis

The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.

Treatment of Paget's Disease of Bone

The recommended treatment regimen is 40 mg once a day for six months.

STORAGE 

Store at room temperature away from moisture and heat.

SAFETY INFORMATION

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 this medication.

You should not take Fosamax if you are allergic to alendronate, or if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

To make sure you can safely take Fosamax, tell your doctor if you have any of these other conditions:

• trouble swallowing;
• a vitamin D deficiency;
• a dental problem;
• kidney disease; or
• an ulcer or other problem in your stomach or esophagus.

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 dental surgery or pre-existing dental problems.

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

FDA pregnancy category C. It is not known whether Fosamax will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether alendronate passes into breast milk or if it could harm a nursing baby. Do not use Fosamax without telling your doctor if you are breast-feeding a baby.

SIDE EFFECTS

Get emergency medical help if you have any of these signs of an allergic reaction to Fosamax: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Fosamax and call your doctor at once if you have any of these serious side effects:

• chest pain;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• severe heartburn, burning pain in your upper stomach, or coughing up blood;
• new or worsening heartburn;
• fever, body aches, flu symptoms;
• severe joint, bone, or muscle pain;
• new or unusual pain in your thigh or hip;
• jaw pain, numbness, or swelling.

Less serious Fosamax side effects may include:

• mild heartburn, bloating;
• mild nausea, vomiting, or stomach pain;
• diarrhea, gas, or constipation;
• mild joint pain or swelling;
• swelling in your hands or feet; or
• dizziness, eye pain, headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.