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

The FDA has approved Actonel withCalcium (risedronate sodium with calciumcarbonate tablets, USP) for the treatmentand prevention of osteoporosis inpostmenopausal women. Although Actonelalone is currently available, the additionof calcium tablets makes this thefirst prescription osteoporosis medicationto include calcium supplementation,a crucial part of osteoporosis pharmacotherapy.¹

The formulation of Actonel withCalcium was prompted by the SurgeonGeneral's 2004 Report on Bone Healthand Osteoporosis, which found that theaverage adult consumes about 700 mgof elemental calcium daily—significantlyless than the recommended dailyallowance of 1200 mg for women overage 50. Actonel with Calcium may providethe additional 500 mg of elementalcalcium that may be missing from manyadults' diets.²

In addition, the report summons allAmericans—both the public and thehealth care community—to take the initiativein preventing and treating osteoporosis.Health care workers are encouragedto watch for red flags, such as multiplefractures in a patient under age 50or health conditions that can lead tobone loss. Currently, 10 million Americansover age 50 have osteoporosis, and34 million others are at risk for developingthe condition.³

Actonel with Calcium consists of aonce-weekly 35-mg risedronate tabletand six 1250-mg calcium carbonatetablets (500 mg of elemental calcium) tobe taken on the remaining days of theweek. It is packaged as a 28-day therapyand aims to increase patient compliancewith calcium supplementation.¹ Actonelwith Calcium is marketed by the Alliancefor Better Bone Health, a joint effortbetween Procter & Gamble Pharmaceuticalsand Aventis Pharmaceuticals.²

Pharmacology

Risedronate is a pyridinyl bisphosphonatethat acts as an antiresorptive agent.By inhibiting osteoclast activity, risedronatereduces bone turnover, resultingin increased bone mass. Calcium is amajor component in bone mineralizationand also has an antiresorptive effect onbone.¹

Contraindications,Warnings,and Precautions

Actonel with Calcium is contraindicatedin patients with aknown hypersensitivity toeither component, aninability to remain uprightfor at least 30 minutes, orwith hypo-or hypercalcemia.Patients should be aware thatActonel with Calcium might cause uppergastrointestinal disorders such as dysphagia,esophagitis, and ulcers. Osteonecrosis,especially in the jaw, has beenreported with bisphosphonate use. Itsuse should be avoided in patients with acreatinine clearance of less than 30mL/min.¹ The most common side effectshave been infection, back pain, andarthralgia.²

Patient Counseling

Pharmacists should instruct patientsusing Actonel with Calcium to followthese directions carefully:

• Take the orange Actonel tablet onthe same day of each week (eachSunday, for example)
• Take Actonel when getting up inthe morning
• Take Actonel with at least 6 to 8 oz ofwater
• Do not crush, chew, or suck on thetablets
• Do not eat or drink anything besideswater before the Actonel dose
• Remain upright for at least 30 minutesafter the Actonel dose
• Do not eat or drink anything (includingmedications and vitamins) for atleast 30 minutes after the Actoneldose
• Consult a physician if stomach upsetoccurs (difficulty swallowing orheartburn)
• Take 1 blue calcium tablet on theother non-Actonel days of the week
• Take the calcium tablet withfood^1,4

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

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