No

Bisphosphonate Derivative

Paget's disease of the bone; treatment and prevention of glucocorticoid-induced osteoporosis; treatment and prevention of osteoporosis in postmenopausal women

C

Hypersensitivity to risedronate, bisphosphonates, or any component; hypocalcemia; abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia; inability to stand or sit upright for at least 30 minutes

Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophageal ulcer, and gastric ulcer. Use caution in patients with renal impairment; hypocalcemia must be corrected before therapy initiation with alendronate; ensure adequate calcium and vitamin D intake, especially for patients with Paget's disease in whom the pretreatment rate of bone turnover may be greatly elevated.

Seen in patients taking 30 mg/day for Paget's disease:

>10%:

Central nervous system: Headache (18%)

Dermatologic: Rash (11%)

Gastrointestinal: Diarrhea (20%), abdominal pain (11%)

Neuromuscular & skeletal: Arthralgia (33%)

Miscellaneous: Flu-like syndrome (10%)

1% to 10%:

Central nervous system: Chest pain (7%), dizziness (7%)

Cardiovascular: Peripheral edema (8%)

Gastrointestinal: Nausea (10%), constipation (7%), belching (3%), colitis (3%, placebo 3%)

Neuromuscular & skeletal: Weakness (5%), bone pain (5%, placebo 5%), leg cramps (3%, placebo 3%), myasthenia (3%)

Miscellaneous: Neoplasm (3%)

Ocular: Amblyopia (3%, placebo 3%), dry eye (3%)

Otic: Tinnitus (3%, placebo 3%)

Respiratory: Sinusitis (5%), bronchitis (3%, placebo 5%) <1%: Acute iritis

Seen in patient taking 5 mg/day for osteoporosis (events similar to those seen with placebo)

>10%:

Central nervous system: Pain (14%)

Gastrointestinal: Abdominal pain (12%), diarrhea (11%), nausea (11%)

Genitourinary: Urinary tract infection (11%)

Neuromuscular & skeletal: Back pain (26%), arthralgia (24%)

1% to 10%:

Central nervous system: Depression (7%), dizziness (6%), insomnia (5%), anxiety (4%), vertigo (3%)

Cardiovascular: Hypertension (10%), chest pain (5%), cardiovascular disorder (2%), angina (2%)

Dermatologic: Rash (8%), bruising (4%), pruritus (3%), skin carcinoma (2%)

Gastrointestinal: Flatulence (5), gastritis (2%), gastrointestinal disorder (2%), rectal disorder (2%), tooth disorder (2%)

Genitourinary: Cystitis (4%)

Hematologic: Anemia (2%)

Neuromuscular & skeletal: Joint disorder (7%), myalgia (7%), neck pain (5%), asthenia (5%), bone pain (5%), bone disorder (4%), neuralgia (4%), leg cramps (4%), bursitis (3%), tendon disorder (3%), hypertonia (2%), paresthesia (2%)

Ocular: Cataract (6%), conjunctivitis (3%)

Otic: Otitis media (2%)

Respiratory: Pharyngitis (6%), rhinitis (6%), dyspnea (4%), pneumonia (3%)

Miscellaneous: Neoplasm(3%), hernia (3%)

<1%: Duodenitis, glossitis, abnormal liver function tests, iritis

Symptoms of overdose include hypocalcemia, hypophosphatemia; upper GI adverse events (upset stomach, heartburn, esophagitis, gastritis, or ulcer)

Gastric lavage may remove unabsorbed drug; treat with milk or antacids to bind alendronate; dialysis would not be beneficial

Decreased effect: Calcium supplements and antacids interfere with the absorption of risedronate

A bisphosphonate which inhibits bone resorption via actions on osteoclasts or on osteoclast precursors; decreases the rate of bone resorption direction, leading to an indirect decrease in bone formation

Onset of effect: May require weeks

Absorption: Oral: Rapid following oral dose, absolute bioavailability poor

Distribution: V_d: 6.3 L/kg

Protein binding: ~24%

Metabolism: Not metabolized

Bioavailability: ~0.54% to 0.75%

Half-life: Terminal: 220 hours

Elimination: Renal (up to 80%) with unabsorbed drug eliminated in feces

Oral:

Paget's disease of bone: 30 mg once daily for 2 months

Treatment and prevention of postmenopausal osteoporosis or glucocorticoid-induced osteoporosis: 5 mg once daily (efficacy for use longer than 1 year has not been established)

Elderly: No dosage adjustment is necessary

Dosage adjustment in renal impairment: Cl_cr <30 mL/minute: Not recommended

Food may reduce absorption (similar to other bisphosphonates).

Alkaline phosphatase should be periodically measured; serum calcium, phosphorus, and possibly potassium due to its drug class; use of absorptiometry may assist in noting benefit in osteoporosis; monitor pain and fracture rate

Calcium (total): Adults: 9.0-11.0 mg/dL (2.05-2.54 mmol/L), may slightly decrease with aging; phosphorus: 2.5-4.5 mg/dL (0.81-1.45 mmol/L)

May cause dizziness

None reported

No information available to require special precautions

No effects or complications reported

In order to be effective, this drug must be taken exactly as prescribed. Take 30 minutes before first food of the day with 6-8 ounces of water and avoid lying down for 30 minutes after ingestion. You may experience headache (request analgesic); skin rash; or abdominal pain, diarrhea, or constipation (report if persistent). Report unresolved muscle or bone pain or leg cramps; acute abdominal pain; chest pain, palpitations, or swollen extremities; disturbed vision or excessively dry eyes; ringing in the ears; or persistent flu-like symptoms. Also notify healthcare provider if experiencing difficulty swallowing, pain when swallowing, or severe or persistent heartburn. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Tablet, as sodium: 5 mg, 30 mg