How does this medication work? What will it do for me?
Alendronate belongs to a family of medications known as bisphosphonates. It is used to treat and prevent osteoporosis for postmenopausal women. It is also used to treat osteoporosis for men.
Alendronate may also be used to treat and prevent steroid-induced osteoporosis for men and women (osteoporosis caused by taking corticosteroids such as prednisone for long periods of time). It may also be used to treat Paget's disease of the bone for both men and women.
Alendronate increases the thickness of bone (bone mineral density) by slowing down the cells that usually break down bone (osteoclasts). This allows the cells that build bone (osteoblasts) to work more efficiently. By making bones stronger, alendronate can help to reduce the incidence of osteoporosis-related fractures.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each white, oval-shaped, film-coated biconvex tablet with "P" logo imprinted on one side and "70" on the other, contains sodium alendronate 91.37 mg, which is equivalent to 70 mg of alendronate. Nonmedicinal ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, starch, and hypromellose.
How should I use this medication?
When used for postmenopausal women, the recommended dose of alendronate to treat osteoporosis is one 10 mg tablet daily or 70 mg once weekly. To prevent osteoporosis, the recommended dose is 5 mg once a day.
To treat osteoporosis for men, the recommended dose of alendronate is one 10 mg tablet daily or 70 mg once weekly.
To treat and prevent steroid-induced osteoporosis for men and women, the recommended dose is 5 mg daily, except for postmenopausal women not taking estrogen. For those women, the recommended dose is 10 mg once a day.
When used to treat Paget's disease of the bone for men and women, the recommended dose is 40 mg once a day for 6 months.
The tablet should be taken upon rising for the day, at least 30 minutes before the first food, beverage, or medication of the day. To reduce the risk of irritating the throat or esophagus, take the tablet with a full glass (250 mL) of plain water only.
After swallowing, do not lie down until at least 30 minutes have passed and you have eaten your first food of the day. Swallow the tablets whole. Do not chew or suck on the tablets.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose when taking this medication once a day, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
If you miss a dose when taking this medication once weekly, take the missed dose the morning after you remember. Then return to your weekly dose on the original day of the week. Do not take 2 doses on the same day. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take alendronate if you:
- are allergic to alendronate or any ingredients of the medication
- cannot stand or sit upright for at least 30 minutes
- have an abnormality of the esophagus (passage leading from throat to stomach) that delays the emptying of the esophagus into the stomach
- have low blood calcium
- have severely reduced kidney function
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- abdominal pain
- mild skin rash or redness
- pain in bones, muscles, or joints
Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- severe joint, bone, or muscle pain
- symptoms of low calcium levels such as muscle spasms, and prickling or tingling sensations around the mouth or in the hands or feet
- vision changes or eye pain
Stop taking the medication and seek immediate medical attention if any of the following occur:
- new or unusual pain in the hip or thigh
- signs of a serious allergic reaction (e.g., swelling of face or throat, hives, or difficulty breathing)
- signs of a severe skin reaction (e.g., high fever; rash; sores; painful blisters on the skin, mouth, or eyes; or skin peeling off)
- signs of damage to the esophagus (e.g., pain in the esophagus [throat area] or behind the breastbone, chest pain, difficulty swallowing, pain when swallowing, or new or worsening heartburn)
- symptoms of a stomach or intestinal ulcer (e.g., nausea, vomiting, abdominal pain, loss of weight or appetite, black or bloody stools, or vomiting blood)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
December 19, 2011
Health Canada has issued new restrictions concerning the use of alendronate. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Atypical femur fracture: There is evidence that long term use of this class of medication may contribute to a type of rare fracture of the long bone in the thigh (femur).
If you experience new or unusual pain in the groin, hip, or thigh area, contact your doctor as soon as possible.
Bone, joint, and muscle problems: Rarely, people taking this medication experience severe bone, joint, or muscle pain. This is usually reversed when the medication is stopped.
Calcium and vitamin D: Calcium and vitamin D are important contributors to bone growth and strength. It may be necessary to take calcium or vitamin D supplements to get the best effect from alendronate if you are not getting enough from your diet. Your doctor may test you for low calcium levels or vitamin D deficiency before you start taking alendronate.
Effects on the esophagus: Alendronate may irritate the lining of the esophagus (the passage from the throat to the stomach). Esophagitis, ulcers, and erosions have been reported by people who take alendronate. In some cases, these effects have been severe and have required hospitalization. Contact your doctor at once if you suddenly experience problems swallowing, find it painful to swallow, develop pain behind the sternum (breastbone), or have new or worsening heartburn.
To ease the passage of the medication to the stomach and thus reduce the potential for irritation of the esophagus, swallow alendronate with a full glass of plain water upon arising for the day. Do not lie down until 30 minutes have passed and you have eaten your first food of the day. Do not chew or suck on the tablet, as this may lead to ulcers in the mouth or throat. Do not take alendronate at bedtime or before getting up for the day.
Effects on the stomach and intestines: Rarely, people taking this medication have developed ulcers of the stomach or intestines. If you suffer from stomach problems, such as ulcers and severe indigestion, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Get immediate medical attention if you have symptoms of a stomach or intestinal ulcer, such as nausea, vomiting, abdominal pain, loss of weight or appetite, black or bloody stools, or vomiting blood.
Jaw problems: Rarely, alendronate may cause severe jaw problems associated with delayed healing and infection, especially in people with cancer or after tooth extractions. If you experience any pain in the jaw, especially after having a tooth removed, contact your doctor immediately.
Kidney function: Alendronate is removed from the body by the kidneys. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if alendronate passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children and adolescents: The safety and effectiveness of using this medication have not been established for children under 18 years of age.
What other drugs could interact with this medication?
There may be an interaction between alendronate and any of the following:
- aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
- antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
- ASA and ASA-containing products (when alendronate is taken in doses greater than 10 mg daily) - note that this does not apply to the 70 mg weekly dose
- calcium supplements (wait at least 30 minutes after taking alendronate to take calcium supplements)
- H2 antagonists (e.g., famotidine, ranitidine)
- non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
- proton pump inhibitors (e.g., lansoprazole, omeprazole)
- systemic angiogenesis inhibitors (e.g., axitinib, bevacizumab, lenalidomide, pazopanib, regorafenib, vandetanib)
- supplements containing minerals such as aluminum, calcium, iron, magnesium and phosphate
- other medications given by mouth (wait at least 30 minutes after taking alendronate to take any other medication by mouth)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.