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Actonel with Calcium

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Actonel with Calcium

Actonel® with Calcium
(risedronate sodium with calcium carbonate) Tablets, USP

Actonel with Calcium

DRUG DESCRIPTION

Actonel® with Calcium (risedronate sodium with calcium carbonate) is a co-package product containing Actonel® (risedronate sodium tablets, 35 mg) for once weekly dosing and calcium carbonate tablets, USP (1250 mg, equivalent to 500 mg elemental calcium) for daily dosing for the remaining 6 days of the week. Each package contains a 28-day course of therapy.

Actonel

Actonel (risedronate sodium tablets) is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Actonel tablet in the Actonel with Calcium (risedronate sodium with calcium carbonate) co-package contains the equivalent of 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C7H10NO7P2Na •2.5 H2O. The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following:

Actonel®
 (risedronate sodium with calcium carbonate) Structural Formula Illustration

Molecular Weight:
Anhydrous: 305.10
Hemi-pentahydrate: 350.13

Risedronate sodium is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents.

Calcium

The empirical formula for calcium carbonate is CaCO3 and the molecular weight is 100.09.

Calcium carbonate is supplied as a calcium carbonate tablet, USP containing 1250 mg calcium carbonate (equivalent to 500 mg elemental calcium). Calcium carbonate is a fine, white, odorless, tasteless powder. It is stable and non-hygroscopic.

Calcium carbonate is formulated per USP standards to meet disintegration or dissolution, weight, purity, and potency requirements.

Inactive Ingredients

Actonel

Crospovidone, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide.

Calcium

Pregelatinized starch, sodium starch glycolate, FD&C Blue #2, magnesium stearate, polyethylene glycol 3350, hypromellose, Opaspray Light Blue, polysorbate 80.

What are the possible side effects of calcium carbonate and risedronate (Actonel with Calcium)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • chest pain;
  • difficulty or pain when swallowing;
  • pain or burning under the ribs or in the back;
  • new or worsening heartburn;
  • severe joint, bone, or muscle pain;
  • new or unusual pain in your thigh or hip; or
  • jaw pain, numbness, or...

Read All Potential Side Effects and See Pictures of Actonel with Calcium »

What are the precautions when taking risedronate sodium with calcium carbonate (Actonel with Calcium)?

Before taking risedronate with calcium, tell your doctor or pharmacist if you are allergic to either of these drugs; or to other bisphosphonates (e.g., alendronate, etidronate, pamidronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This product should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have the following conditions: low or high blood calcium levels (hypocalcemia or hypercalcemia), inability to sit upright or stand for at least 30 minutes, severe kidney disease.

Before using this product, tell your doctor or pharmacist your medical history, especially...

Read All Potential Precautions of Actonel with Calcium »

Last reviewed on RxList: 3/18/2011
This monograph has been modified to include the generic and brand name in many instances.

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Actonel with Calcium - User Reviews

Actonel with Calcium User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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