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alendronate (Oral route)

Pronunciation

a-LEN-droe-nate

Commonly used brand name(s)

In the U.S.

  • Fosamax

Available Dosage Forms:

  • Tablet
  • Solution
  • Tablet, Effervescent

Therapeutic Class: Calcium Regulator

Chemical Class: Bisphosphonate

Uses For alendronate

Alendronate is used to prevent and treat osteoporosis (thinning of the bone) in women after menopause. alendronate 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.

Slideshow: Flashback: FDA Drug Approvals 2013

alendronate is available only with your doctor's prescription.

Before Using alendronate

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 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.

Pediatric

Use of alendronate is not indicated in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alendronate in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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 alendronate 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 alendronate, 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 alendronate. 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 alendronate

alendronate 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.

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 alendronate from working properly.

Follow your dosing instructions given to you by your doctor closely. It may affect the way alendronate works if you do not. Do not stop using alendronate 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 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.

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 alendronate, 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 alendronate, 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 alendronate

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

alendronate can irritate your esophagus. If you think alendronate has started to damage your esophagus, stop taking alendronate and call your doctor. 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 alendronate.

alendronate 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.

alendronate 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.

alendronate Side Effects

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
  • Abdominal or stomach pain
Less common
  • Difficulty with swallowing
  • heartburn
  • irritation or pain of the esophagus
  • muscle pain
Rare
  • Skin rash
Incidence not known
  • Abdominal or stomach cramps
  • 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
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • swollen joints
  • tingling of the hands or feet
  • tremor
  • 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.

See also: Side effects (in more detail)

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