Pronunciation:

a-LEN-droe-nate

Brand Names:

• Fosamax

Dosage Forms:

• Tablet, Effervescent
• Tablet
• Solution

Classifications:

Therapeutic—

Calcium Regulator

Chemical—

Bisphosphonate

Uses of This Medicine:

Alendronate is used to prevent and treat osteoporosis (thinning of the bone) in women after menopause. This medicine may also be used to increase bone mass in men who have osteoporosis, and in men and women to prevent and treat osteoporosis caused by long-term use of corticosteroids (cortisone-like medicine). It may also be used to treat Paget's disease of the bone.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Use of alendronate is not indicated in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alendronate in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Parathyroid Hormone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Dairy Food

Other medical problems—

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

• Anemia or
• Blood clotting problems or
• Cancer or
• Dental or tooth problems or
• Dental procedures (eg, dental implants, tooth extraction) or
• Infection or
• Poor oral hygiene or
• Surgery (eg, dental surgery)—May increase risk for severe jaw problems.

• Esophagus (the tube that runs from your throat to your stomach) problems (eg, achalasia, stricture) or
• Hypocalcemia (low calcium in the blood) or
• Inability to stand or sit upright for at least 30 minutes or
• Kidney problems, severe or
• Trouble with swallowing—Should not be used in patients with these conditions.

• Heart failure, history of or
• Heart or blood vessel problems or
• Hypertension (high blood pressure)—Use with caution. Binosto® contains sodium and may make these conditions worse if you are on a salt-restricted diet.

• Stomach or bowel problems (eg, Barrett's esophagus, duodenitis, gastritis, heartburn, inflammation of the esophagus, or ulcers)—Use with caution. Alendronate may make these conditions worse.

Proper Use of This Medicine:

This medicine comes with a Medication Guide and a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take the medicine on an empty stomach. It should be taken as soon as you get out of bed in the morning and at least 30 minutes before any food, beverage, or other medicines. Food and beverages (eg, 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, calcium, or vitamin supplements will also decrease the absorption of alendronate.

If you are using alendronate oral liquid, drink at least 2 ounces (a quarter of a cup) of water immediately after taking the medicine. This will allow the medicine to reach your intestines and be absorbed by the body more quickly.

Swallow the tablet whole with a full glass (6 to 8 ounces) of plain water. Do not suck or chew on the tablet because it may cause throat irritation.

The effervescent tablet should not be chewed, swallowed whole, or dissolved in the mouth to prevent the risk of mouth or throat irritation.

If you are taking alendronate effervescent tablet, dissolve it in 4 ounces of room temperature plain water only (not mineral water or flavored water). Wait at least 5 minutes after the effervescence stops and then stir the solution for 10 seconds and drink it.

Do not lie down for at least 30 minutes after taking alendronate and before having your first food for the day. This will help alendronate reach your stomach faster. It will also help prevent irritation to your esophagus.

It is important that you eat a well-balanced diet with adequate amounts of calcium and vitamin D (found in milk or other dairy products). However, do not take any foods, beverages, or calcium supplements within 30 minutes or longer after taking the alendronate. To do so may keep this medicine from working properly.

Follow your dosing instructions given to you by your doctor closely. It may affect the way this medicine works if you do not. Do not stop using this medicine suddenly without asking your doctor.

Tell your doctor if you do weight-bearing exercises, smoke or drink excessively. Your doctor will need to take these into consideration in deciding your dose.

Dosing—

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (effervescent tablets):
  • For treatment of osteoporosis in men:
    • Adults—70 milligrams (mg) once a week at least 30 minutes before the first food or drink of the day other than water.
    • Children—Use is not recommended.
  • For treatment of postmenopausal osteoporosis:
    • Adults—70 milligrams (mg) once a week at least 30 minutes before the first food or drink of the day other than water.
    • Children—Use is not recommended.
• For oral dosage forms (liquid or tablets):
  • For treatment of corticosteroid-induced osteoporosis:
    • Adults—5 milligrams (mg) once a day at least 30 minutes before the first food or drink of the day other than water. In postmenopausal women not receiving estrogen, the dose is 10 mg once a day.
    • Children—Use is not recommended.
  • For treatment of Paget's disease of bone:
    • Adults—40 milligrams (mg) once a day for 6 months. Your doctor may tell you to repeat this dose.
    • Children—Use is not recommended.
  • For treatment of osteoporosis in men:
    • Adults—10 milligrams (mg) once a day or 70 mg once a week at least 30 minutes before the first food or drink of the day other than water.
    • Children—Use is not recommended.
  • For treatment of postmenopausal osteoporosis:
    • Adults—10 milligrams (mg) once a day or 70 mg once a week at least 30 minutes before the first food or drink of the day other than water.
    • Children—Use is not recommended. .
  • For prevention of postmenopausal osteoporosis:
    • Adults—5 milligrams (mg) once a day or 35 mg once a week at least 30 minutes before the first food or drink of the day other than water.
    • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For patients taking the medicine each day: If you miss a dose or forget to use your medicine in the morning, skip the missed dose and take your medicine the next morning. Do not take two tablets on the same day. Return to your regular schedule the next day.

If you are on a weekly schedule and miss a dose of this medicine, take it the next morning after you remember. Resume your usual schedule taking the medicine on your chosen day the next week.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Protect the effervescent tablet from moisture and do not remove from the blister pack until you are ready to use it.

Precautions While Using This Medicine:

If you will be taking this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and watch for unwanted effects.

This medicine can irritate your esophagus. Call your doctor right away if you think this medicine has started to damage your esophagus. Some symptoms of damage to the esophagus are heartburn (either new or worse than usual), pain when swallowing, pain in the center of your chest, trouble swallowing, or feeling that food gets stuck on the way to your stomach.

It is important that you tell all of your health care providers that you are taking alendronate. If you are having a dental procedure while taking alendronate, you may have an increased chance of having a severe problem with your jaw.

Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain while using this medicine.

This medicine could lower the amount of calcium in your blood. Call your doctor right away if you develop any signs of low calcium levels, such as muscle spasms or twitching, or numbness or tingling in your fingers, toes, or lips.

This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 immediately if any of the following side effects occur:

More common

Stomach pain

Less common

Difficulty with swallowing

heartburn

irritation or pain of the esophagus

muscle pain

Rare

Skin rash

Incidence not known

Blistering, peeling, or loosening of the skin

bloating or swelling of the face, arms, hands, lower legs, or feet

bone, joint, or muscle pain, severe and occasionally incapacitating

chest pain

chills

confusion

convulsions

cough

diarrhea

difficulty with breathing

difficulty with moving

heartburn

heavy jaw feeling

hives or welts

irregular heartbeats

itching

joint pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loosening of a tooth

muscle aching or cramping

muscle cramps in the hands, arms, feet, legs, or face

numbness and tingling around the mouth, fingertips, or feet

pain or burning in the throat

pain, swelling, or numbness in the mouth or jaw

rapid weight gain

red skin lesions, often with a purple center

red, irritated eyes

redness of the skin

sore throat

sores, ulcers, or white spots on the lips or tongue or inside the mouth

stomach cramps

swollen joints

tingling of the hands or feet

tremor

trouble breathing

unusual tiredness or weakness

unusual weight gain or loss

vomiting

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Constipation

diarrhea

full or bloated feeling

gas

headache

nausea

Incidence not known

Blurred vision or other change in vision

dizziness or lightheadedness

eye pain

feeling of constant movement of self or surroundings

general feeling of discomfort or illness

hair loss or thinning of the hair

sensation of spinning

sensitivity of the eye to light

tearing

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.