Actonel (risedronate) is in a group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Risedronate slows bone loss while increasing bone mass, which may prevent bone fractures.
Actonel is used to treat or prevent osteoporosis in men and women.
Actonel is also used to treat Paget"s disease of bone.
Important information
You should not use Actonel if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.
Do not take a Actonel tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach).
Before taking this medicine
You should not use Actonel if you are allergic to risedronate, or if you have:
Do not take a Actonel tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate 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.
To make sure Actonel is safe for you, tell your doctor if you have:
In rare cases, risedronate may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use Actonel, the more likely you are to develop this condition.
Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.
Talk with your doctor about the risks and benefits of using Actonel.
It is not known whether Actonel will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether risedronate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How should I take Actonel?
Take Actonel exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Actonel tablets come in different strengths (number of milligrams per pill). Some tablets are taken once each day. Some tablets are taken once each week, or only 1 or 2 times each month.
Your dosing schedule will depend on the tablet strength your doctor has prescribed. If you change tablet strengths, you may also need to change your schedule. Follow the directions on your prescription label.
Take the Actonel tablet first thing in the morning with a full glass (6 to 8 ounces) of water, at least 30 minutes before you eat or drink anything or take any other medicine.
Use only plain water (not mineral water) when taking a Actonel tablet.
After taking a Actonel tablet, carefully follow these instructions:
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Do not lie down or recline for at least 30 minutes after taking the tablet.
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Do not eat or drink anything other than plain water.
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Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking Actonel. 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.
Do not take two different strengths of Actonel tablet at the same time.
If you take Actonel only once a week, take it on the same day and time each week.
Do not crush, chew, or suck the tablet. Swallow it whole. The pill has a special coating to protect your stomach. Breaking the pill will damage this coating.
If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using Actonel. You may need to stop using the medicine for a short time.
To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. You may not need to take Actonel for longer than 3 to 5 years if you take it for osteoporosis.
Actonel 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.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
If you take Actonel 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 Actonel tablets once a week, or once or twice per month: If you forget to take Actonel 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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.
Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.
What should I avoid while taking Actonel?
Avoid taking any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking a risedronate tablet. Some medicines can make it harder for your body to absorb risedronate.
Actonel side effects
Get emergency medical help if you have signs of an allergic reaction to Actonel: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Actonel and call your doctor at once if you have:
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chest pain, new or worsening heartburn;
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difficulty or pain when swallowing;
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pain or burning under the ribs or in the back;
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severe or ongoing indigestion;
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severe joint, bone, or muscle pain;
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new or unusual pain in your thigh or hip;
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jaw pain, numbness, or swelling; or
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severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common Actonel side effects may include:
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mild stomach pain or upset stomach;
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flu symptoms, muscle pain;
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diarrhea, constipation;
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mild joint or back pain; or
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headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.
See also: Side effects (in more detail)
Actonel dosing information
Usual Adult Dose for Osteoporosis:
Treatment of Postmenopausal Osteoporosis:
Immediate release:
-5 mg orally once a day or
-35 mg orally once a week or
-75 mg orally on two consecutive days for a total of two tablets each month or
-150 mg orally once a month
Treatment to Increase Bone Mass in Men with Osteoporosis:
Immediate release:
-35 mg orally once a week
Treatment of Glucocorticoid-Induced Osteoporosis:
Immediate release:
-5 mg orally once a day
Comments:
-Refer to administration advice for details on how to take this drug.
-Reevaluate bisphosphonate therapy periodically.
-Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
Uses:
-Treatment to reduce the incidence of vertebral fractures and composite endpoint of nonvertebral osteoporosis-related fractures in postmenopausal women
-Treatment to increase bone mass in men with osteoporosis
-Treatment of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases
Usual Adult Dose for Prevention of Osteoporosis:
Prevention of Postmenopausal Osteoporosis:
-5 mg orally once a day or
-35 mg orally once a week or
-75 mg orally on two consecutive days for a total of two tablets each month or
-150 mg orally once a month
Prevention of Glucocorticoid-Induced Osteoporosis:
-5 mg orally once a week
Comments:
-Refer to administration advice for details on how to take this drug.
-Reevaluate bisphosphonate therapy periodically.
-Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
Uses:
-Prevention of osteoporosis in postmenopausal women
-Prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases
Usual Adult Dose for Paget"s Disease:
-30 mg orally once a day for 2 months
Comments:
-Retreatment may be considered (following post-treatment observation of at least 2 months) if relapse occurs, or if treatment fails to normalize serum alkaline phosphatase.
-For retreatment, the dose and duration of therapy are the same as for initial treatment.
-There is no data available on more than 1 course of retreatment.
Use: Treatment of Paget"s disease of bone in men and women
What other drugs will affect Actonel?
Tell your doctor about all your current medicines and any you start or stop using, especially:
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aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
This list is not complete. Other drugs may interact with risedronate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
