Procter & Gamble Pharmaceuticals' and Aventis Pharmaceuticals' Actonel with Calcium (risedronate sodium with calcium carbonate tablets, USP)

Monica Holmberg, PharmD
Published Online: Thursday, June 1, 2006

The FDA has approved Actonel with Calcium (risedronate sodium with calcium carbonate tablets, USP) for the treatment and prevention of osteoporosis in postmenopausal women. Although Actonel alone is currently available, the addition of calcium tablets makes this the first prescription osteoporosis medication to include calcium supplementation, a crucial part of osteoporosis pharmacotherapy.1

The formulation of Actonel with Calcium was prompted by the Surgeon General's 2004 Report on Bone Health and Osteoporosis, which found that the average adult consumes about 700 mg of elemental calcium daily—significantly less than the recommended daily allowance of 1200 mg for women over age 50. Actonel with Calcium may provide the additional 500 mg of elemental calcium that may be missing from many adults' diets.2

In addition, the report summons all Americans—both the public and the health care community—to take the initiative in preventing and treating osteoporosis. Health care workers are encouraged to watch for red flags, such as multiple fractures in a patient under age 50 or health conditions that can lead to bone loss. Currently, 10 million Americans over age 50 have osteoporosis, and 34 million others are at risk for developing the condition.3

Actonel with Calcium consists of a once-weekly 35-mg risedronate tablet and six 1250-mg calcium carbonate tablets (500 mg of elemental calcium) to be taken on the remaining days of the week. It is packaged as a 28-day therapy and aims to increase patient compliance with calcium supplementation.1 Actonel with Calcium is marketed by the Alliance for Better Bone Health, a joint effort between Procter & Gamble Pharmaceuticals and Aventis Pharmaceuticals.2

Pharmacology

Risedronate is a pyridinyl bisphosphonate that acts as an antiresorptive agent. By inhibiting osteoclast activity, risedronate reduces bone turnover, resulting in increased bone mass. Calcium is a major component in bone mineralization and also has an antiresorptive effect on bone.1

Contraindications,Warnings, and Precautions

Actonel with Calcium is contraindicated in patients with a known hypersensitivity to either component, an inability to remain upright for at least 30 minutes, or with hypo-or hypercalcemia. Patients should be aware that Actonel with Calcium might cause upper gastrointestinal disorders such as dysphagia, esophagitis, and ulcers. Osteonecrosis, especially in the jaw, has been reported with bisphosphonate use. Its use should be avoided in patients with a creatinine clearance of less than 30 mL/min.1 The most common side effects have been infection, back pain, and arthralgia.2

Patient Counseling

Pharmacists should instruct patients using Actonel with Calcium to follow these directions carefully:

  • Take the orange Actonel tablet on the same day of each week (each Sunday, for example)
  • Take Actonel when getting up in the morning
  • Take Actonel with at least 6 to 8 oz of water
  • Do not crush, chew, or suck on the tablets
  • Do not eat or drink anything besides water before the Actonel dose
  • Remain upright for at least 30 minutes after the Actonel dose
  • Do not eat or drink anything (including medications and vitamins) for at least 30 minutes after the Actonel dose
  • Consult a physician if stomach upset occurs (difficulty swallowing or heartburn)
  • Take 1 blue calcium tablet on the other non-Actonel days of the week
  • Take the calcium tablet with food1,4

Dr. Holmberg is a pharmacist with Phoenix Children's Hospital, Phoenix, Ariz.

For a list of references, send a stamped, self-addressed envelope to: References Department, Attn. A. Stahl, Pharmacy Times, 241 Forsgate Drive, Jamesburg, NJ 08831; or send an e-mail request to: astahl@ascendmedia.com.


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