Alendronate

Alendronate is a prescription medication used to treat osteoporosis and Paget's disease in men and women. It is also used to prevent osteoporosis in postmenopausal women. Alendronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density.

Alendronate is a prescription medicine used to:

• Treat or prevent osteoporosis in women after menopause. It helps reduce the chance of having a hip or spinal fracture (break). Osteoporosis is a disease where your bones become weaker and are more likely to break.
• Increase bone mass in men with osteoporosis.
• Treat osteoporosis in either men or women who are taking corticosteroid medicines.
• Treat certain men and women who have Paget's disease of the bone. Paget's disease is a condition when your bones grow too large and weak.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Alendronate may be found in some form under the following brand names:

• Fosamax

The most common side effects of alendronate are:

• Stomach area (abdominal) pain
• Heartburn
• Constipation
• Diarrhea
• Upset stomach
• Pain in your bones, joints, or muscles
• Nausea

You may get allergic reactions, such as hives or, in rare cases, swelling of your face, lips, tongue, or throat.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Alendronate may cause serious side effects. See "Drug Precautions."

These are not all the possible side effects of alendronate. For more information, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antacids
• calcium supplements
• aspirin
• nonsteroidal anti-inflammatory drugs (NSAIDS) like ibuprofen (Advil, Motrin) or naproxen (Aleve)

This is not a complete list of alendronate drug interactions. Ask your doctor or pharmacist for more information.

Alendronate can cause serious side effects including:

1. Esophagus problems. It is important that you take alendronate exactly as prescribed to help lower your chance of getting esophagus problems.

• Stop taking alendronate and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow.

2. Low calcium levels in your blood (hypocalcemia).  Alendronate may lower the calcium levels in your blood. If you have low blood calcium before you start taking alendronate, it may get worse during treatment. Your low blood calcium must be treated before you take alendronate. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:

• Spasms, twitches, or cramps in your muscles
• Numbness or tingling in your fingers, toes, or around your mouth

Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take alendronate. Take calcium and vitamin D as your doctor tells you to.

3. Bone, joint, or muscle pain.  Some people who take alendronate develop severe bone, joint, or muscle pain.

 

4. Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take alendronate. Your doctor should examine your mouth before you start alendronate. Your doctor may tell you to see your dentist before you start alendronate. It is important for you to practice good mouth care during treatment with alendronate.

 

5. Unusual thigh bone fractures.

Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.

Call your doctor right away if you have any of these side effects.

Do not take alendronate if you:

• Have certain problems with your esophagus, the tube that connects your mouth with your stomach.
• Cannot stand or sit upright for at least 30 minutes.
• Have low levels of calcium in your blood.
• Are allergic to alendronate or any of its ingredients.
• Do not take alendronate oral solution if you have trouble swallowing liquids.

Always take alendronate on an empty stomach. If taken with food or drink (other than water), the body will not be able to absorb and use this medication.

Alendronate effervescent tablets contain a high amount of salt in each tablet. Avoid eating foods with a high amount of salt if your doctor has told you to limit how much salt you eat.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of alendronate there are no specific foods that you must exclude from your diet when receiving alendronate.

Before you start alendronate, be sure to talk to your doctor if you:

• Have problems with swallowing
• Have stomach or digestive problems
• Have low blood calcium
• Plan to have dental surgery or teeth removed
• Have kidney problems
• Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
• Are pregnant, or plan to become pregnant. It is not known if alendronate can harm your unborn baby.
• Are breastfeeding or plan to breastfeed. It is not known if alendronate passes into your milk and may harm your baby.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Certain medicines may affect how alendronate works.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if alendronate is excreted in human breast milk or if it will harm your nursing baby.

• Take alendronate exactly as your doctor tells you.
• Alendronate works only if taken on an empty stomach.
• Take alendronate after you get up for the day and before taking your first food, drink, or other medicine.
• Take alendronate while you are sitting or standing.
• Do not chew or suck on a tablet of alendronate.
• Do not take alendronate with mineral water, coffee, tea, soda, or juice.
• If you take alendronate daily:
  • Take 1 alendronate tablet one time a day, every day after you get up for the day and before taking your first food, drink, or other medicine.
• If you take alendronate once weekly:
  • Choose the day of the week that best fits your schedule.
  • Tablets:
    • Take 1 dose of alendronate every week with water on your chosen day after you get up for the day and before taking your first food, drink, or other medicine.
  • Oral Solution:
    • Drink your prescribed dose every week on your chosen day after you get up for the day and before taking your first food, drink, or other medicine.
    • Drink at least 2 ounces of plain water after you drink alendronate oral solution.
  • Effervescent tablet:
    • Dissolve one tablet of alendronate in approximately half a glass of plain room temperature water (4 oz). Wait at least 5 minutes after the effervescence stops, stir the solution for approximately 10 seconds and drink the solution.
• After swallowing alendronate tablet, wait at least 30 minutes:
  • Before you lie down. You may sit, stand or walk, and do normal activities like reading.
  • Before you take your first food or drink except for plain water.
  • Before you take other medicines, including antacids, calcium, and other supplements and vitamins.
• Do not lie down for at least 30 minutes after you take alendronate and after you eat your first food of the day.
• If you miss a dose of alendronate, do not take it later in the day. Take your missed dose on the next morning after you remember and then return to your normal schedule. Do not take 2 doses on the same day.
• If you take too much alendronate, call your doctor. Do not try to vomit. Do not lie down.

Take alendronate exactly as your doctor prescribes it. Follow the directions on your prescription label carefully. The recommended once-daily dose ranges from 5 mg to 10 mg. The recommended once-weekly dose ranges from 35 mg to 70 mg. Because alendronate may be used in the treatment of several conditions, your doctor will determine the best dose for you.

If you take too much alendronate, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If alendronate is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store alendronate at room temperature.
• Store alendronate effervescent tablets at 20°C to 25°C (68°F to 77°F)
• Keep alendronate in a tightly closed container.
• Keep alendronate tablets in their original blister pack until you use them.
• Protect alendronate from moisture.
• Keep alendronate and all medicines out of the reach of children.