RISEDRONATE SODIUM

Bisphosphonate

Brand names: RISEDRONATE SODIUM

Oral

Mechanism of Action

12.1 Mechanism of Action Risedronate has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, risedronate inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption (for example, lack of ruffled border). Histomorphometry in rats, dogs, and minipigs showed that risedronate treatment reduces bone turnover (activation frequency, that is, the rate at which bone remodeling sites are activated) and bone resorption at remodeling sites.

Indications

See full prescribing information

Contraindications

• Warnings and Precautions (5.2) ] 3. Hypocalcemia [ see Warnings and Precautions (5.3) ] 4. Known hypersensitivity to any component of this product. Angioedema
• generalized rash
• bullous skin reactions
• Stevens-Johnson syndrome and toxic epidermal necrolysis
• have been reported [ see Adverse Reactions (6.2) ] • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (4

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Products Containing Same Active Ingredient : Patients receiving Actonel should not be treated with risedronate sodium delayed-release tablets (5
The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended 4 ounces of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation
There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials
Known risk factors for osteonecrosis of the jaw include invasive dental procedures (for example, tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (for example, chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (for example, periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures)

Known Side Effects

10 documented side effects by frequency

Joint Pain

1-10%

Drug Not Working

1-10%

Nausea

1-10%

Fatigue

1-10%

Shortness of Breath

1-10%

Vomiting

1-10%

Diarrhea

1-10%

Headache

1-10%

General Unwellness

1-10%

Limb Pain

1-10%

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Compare With

3 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral