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

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May 26, 2012

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Paget's Disease »

What is Paget's disease?

Paget's disease is a chronic condition of bone characterized by disorder of the normal bone remodeling process. Normal bone has a balance of forces that act to lay down new bone and take up old bone. This relationship (referred to as "bone remodeling") is essential for maintaining the normal calcium levels in our blood. In bone affected by Paget's disease, the bone remodeling is disturbed and not synchronized. As a result, the bone that is formed is abnormal, enlarged, not as dense, brittle, and prone to breakage (fracture).

Paget's disease affects older skeletal bone of adults. It's estimated that 1% of adults in the U.S. have Paget's disease. There is also an extremely rare form of Paget's disease in children, referred to as juvenile Paget's disease. Paget's disease is also known as osteitis deformans.

What causes Paget's disease?

It is not known what causes Paget's disease. Recently, certain...

Read the Paget's Disease article »

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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.