Actonel (risedronate) is another bisphosphonate prescribed to reduce bone turnover to treat or prevent osteoporosis. It can be taken either daily as 5 mg tablets, or weekly as 35 mg tablets. Like other bisphosphonates, you must be conscientious about following the guidelines listed in Question 57 for taking Fosamax or any bisphosphonate medication. You must take Actonel with PLAIN water on an empty stomach and remain upright (sitting or standing) for 30 minutes. Actonel must be taken prior to the first beverage or food of the day. In other words, nothing should be consumed for 30 minutes after taking Actonel with plain water. Flex dosing (taking Actonel two hours after food or beverage, and at least two hours prior to consuming more food or beverage) is approved in other countries but was not approved by the FDA in the United States because it has the potential to reduce the absorption of the medicine. Do not take calcium and other minerals or milk within 2 hours of taking Actonel.
The FDA recently approved new packaging of weekly Actonel called Actonel with Calcium. This packaging includes a month's supply of medication. There are four packets, one for each week, containing seven pills—one 35 mg tablet of Actonel and six 1,250 mg tablets of calcium carbonate (500 mg of elemental calcium). The manufacturer developed this packaging for individuals taking weekly Actonel to assist them in remembering to take calcium. The directions say to take Actonel one day according to the guidelines described above and to take one calcium tablet with food on each of the other six days of the week. Remember that you must also get adequate Vitamin D so that the calcium is absorbed. On the day you take the Actonel tablet, it is still important to get your RDA of calcium, but you must not take calcium supplements within two hours after taking the Actonel tablet.
Actonel is FDA-approved for the treatment or prevention of postmenopausal osteoporosis in women. It is also approved for the treatment and prevention of glucocorticoid-induced osteoporosis (GIO) in adults who are initiating or continuing oral glucorcorticoid medications at doses of >7.5 mg daily. Actonel has also been approved for the treatment of Paget's disease (see Question 60).
In a recent study that compared the effect of weekly Fosamax on bone mineral density with the effect of weekly Actonel on bone mineral density, Fosamax showed a greater increase in BMD and a greater decrease in bone turnover. But those taking Actonel had fewer fractures than those taking Fosamax. We already know that both Fosamax and Actonel are effective in reducing fracture risk, which is, after all, the point of treating osteoporosis. However, the increase in bone density did not have the expected level of reducing fracture risk in those taking Fosamax. Although Actonel users reported slightly fewer stomach and intestinal (GI) complaints, there was essentially no difference between the GI effects of Actonel and Fosamax.
The above-mentioned study illustrates how important it is for you to work with your clinician to find the best medication for you. For example, both medications mentioned above are effective in decreasing bone turnover, increasing bone mineral density, and reducing fracture risk significantly more than taking a placebo, based on many years of clinical trials. But sometimes people tolerate one medication better than another. And sometimes clinicians feel more strongly about the success of one medication over another. You
An inactive substance that contains no medication or active ingredient to be given to participants in a clinical trial to determine the effectiveness of a specific treatment or medication.
may even be influenced by friends who have taken medication for bone loss and experienced side effects less frequently with one medication over another. The cost of Actonel and Fosamax are about the same. But remember that each person's medical history and bones are different. You and your clinician should make your decision together, whether you choose a bisphosphonate or not.
Like Fosamax, most side effects of Actonel are related to the esophagus (usually causing heartburn), but if you are taking one of these drugs it is important to report chest pain, difficulty swallowing, or severe midline heartburn immediately. If you are taking non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin, or naproxen for pain management, which are known to increase the risk of developing acid stomach or ulcers, together with a bisphosphonate, the risk for gastrointestinal effects can be increased further. Table 9 summarizes information about Actonel.
Also like Fosamax, the long-term effects of Actonel could be a concern after it is discontinued. Although the half-life of Actonel is measured in days instead of years as in the case of Fosamax, it is not clear how a future pregnancy would be affected by the continued effects of Actonel or other bisphosphonates. Actonel is not FDA-approved for use in premenopausal women except those with GIO. If a premenopausal woman had a fragility fracture (see Question 74), a specialist may consider treatment with a bisphospho-nate. This would only be considered if other potential causes for the fracture were ruled out and if she were on a very reliable method of birth control or unable to conceive.
Trade Name (Generic Name) [Manufacturer]
How Supplied Clinical Uses Contraindications
Actonel (risedronate) [Procter & Gamble Pharmaceuticals] 5, 30, 35 mg tablets Actonel with Calcium (risedronate with calcium carbonate)
[The Alliance for Better Bone Health, a collaboration between Procter & Gamble Pharmaceuticals and Aventis Pharmaceuticals]
35 mg risedronate packaged with six calcium carbonate tablets, each 1,250 mg
Prevention and treatment of postmenopausal osteoporosis
Treatment of gluco-
Prevention of osteoporosis in people taking >7.5 mg of glucocorticoids daily Paget's disease
Allergy to bisphosphonates
Low blood calcium Poor kidney function Inability to remain upright (sitting or standing) for 30 minutes
Side Effects and Special
Adverse Reactions Considerations
Bone or muscle pain
Get immediate help for difficulty swallowing, midline chest pain, or severe abdominal pain
Take first thing after rising for the day on an empty stomach with a full glass of plain water, remain upright and take no other food or drink for at least 30 minutes Can be taken weekly
Compliance with medication schedule important for increasing BMD
RDA of calcium and Vitamin D are also important for increasing BMD, both are needed on the day Actonel is taken (at least 2 hours after Actonel) If prescribed by a specialist for women of child-bearing age, they must be on an effective method of birth control and counseled about the unknown long-term effects on future pregnancy In very rare cases could increase the risk for osteonecrosis of the jaw following dental surgery
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