Actonel (Risedronate Sodium) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 8, 2012

Actonel

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Osteoporosis is a condition characterized by a decrease in the density of bone, decreasing its strength and resulting in fragile bones. Osteoporosis literally leads to abnormally porous bone that is compressible, like a sponge. This disorder of the skeleton weakens the bone and results in frequent fractures (breaks) in the bones. Osteopenia is a condition of bone that is slightly less dense than normal bone but not to the degree of bone in osteoporosis.

Normal bone is composed of protein, collagen, and calcium, all of which give bone its strength. Bones that are affected by osteoporosis can break (fracture) with relatively minor injury that normally would not cause a bone to fracture. The fracture can be either in the form of cracking (as in a hip fracture) or collapsing (as in a compression fracture of the vertebrae of the spine). The spine, hips, ribs, and wrists are common areas of bone fractures from osteoporosis although osteoporosis-...

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Actonel®
(risedronate sodium) Tablets

DRUG DESCRIPTION

Actonel (risedronate sodium) tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Actonel (risedronate sodium) tablet for oral administration contains the equivalent of 5, 30, 35, 75, or 150 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) 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.

Inactive Ingredients

All dose strengths contain: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide. Dose strength-specific ingredients include: 5 mg—ferric oxide yellow, lactose monohydrate; 30 mg—lactose monohydrate; 35 mg—ferric oxide red, ferric oxide yellow, lactose monohydrate; 75 mg—ferric oxide red; 150 mg—FD&C blue #2 aluminum lake.

What are the possible side effects of risedronate (Actonel)?

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 risedronate and call your doctor at once if you have any of these serious side effects:

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; or
jaw pain, numbness, or...

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What are the precautions when taking risedronate sodium (Actonel)?

Before taking risedronate, tell your doctor or pharmacist if you are allergic to it; 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 medication 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 blood calcium levels (hypocalcemia), inability to sit upright or stand for at least 30 minutes, severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: esophagus problems (e.g., esophageal stricture,...

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Last reviewed on RxList: 3/10/2011
This monograph has been modified to include the generic and brand name in many instances.