risedronate sodium

risedronate sodium

(rah sed' dro nate)

Actonel

Pregnancy Category C

Drug class

Bisphosphonate

Therapeutic actions

Affects osteoclast activity by reducing the enzymatic and transport processes that lead to resorption of the bone and by inhibiting the osteoclast protein pump, leading to a rate of bone turnover near normal in patients with Paget's disease.

Indications

·        Treatment of Paget's disease of bone in patients with alkaline phosphatase at least two times the upper limit of normal, those who are symptomatic, those at risk for future complications

·        Treatment and prevention of osteoporosis in postmenopausal women

·        Treatment and prevention of glucocorticoid-induced osteoporosis

Contraindications and cautions

·        Contraindicated with allergy to bisphosphonates; severe renal disease, hypocalcemia, inability to stand or sit upright for at least 30 min.

·        Use cautiously with renal dysfunction, lactation, pregnancy.

Available forms

Tablets—5, 30, 35 mg

Dosages

ADULTS

·        Treatment and prevention of osteoporosis: 5 mg PO once daily taken in an upright position with 6–8 oz of water at least 30 min before or after any other beverage or food. For postmenopausal osteoporosis, may switch to 35-mg tablet taken PO once per wk.

·        Treatment of prevention of glucocorticoid osteoporosis: 5 mg/day PO.

·        Paget's disease: 30 mg PO once daily for 2 mo taken in an upright position with 6–8 oz of plain water at least 30 min before or after any other beverage or food; may retreat after at least a 2-mo posttreatment period if indicated.

PEDIATRIC PATIENTS

Safety and efficacy not established.

PATIENTS WITH RENAL IMPAIRMENT

Not recommended with creatinine clearance < 30 mL/min; no dosage adjustment is needed if creatinine clearance > 30 mL/min.

Pharmacokinetics

Route	Onset	Peak
Oral	Rapid	1 hr

Metabolism: Not metabolized; T_1/2: Initial half-life: 1.5 hr; terminal half-life: 48 hr

Distribution: Crosses placenta; may enter breast milk

Excretion: Urine

Adverse effects

·        CNS: Headache, paresthesia, dizziness

·        CV: Chest pain, edema, hypertension

·        EENT: Glaucoma, conjunctivitis, cataract

·        GI: Nausea, diarrhea, dyspepsia, abdominal pain, anorexia

·        Skeletal: Increased or recurrent bone pain

·        Other: Arthralgia, bone pain, leg cramps, rash

Interactions

Drug-drug

·        Absorption of risedronate decreased by calcium, aspirin, aluminum, magnesium; avoid these drugs for 2 hr before to 2 hr after taking risedronate

Nursing considerations

Assessment

·        History: Allergy to bisphosphonates, renal failure, hypocalcemia, pregnancy, lactation

·        Physical: Muscle tone, bone pain; bowel sounds; eye examination; urinalysis, serum calcium; orientation, affect

Interventions

·        WARNING: Administer with a full glass of plain (not mineral) water, at least 30 min before or after any other beverage, food, or medication; have patient remain in an upright position for at least 30 min to decrease the incidence of GI effects. Patients taking weekly dose should mark calendar as a reminder.

·        Monitor serum calcium levels before, during, and after therapy.

·        WARNING: Ensure at least a 2-mo rest period after 2‑mo course of treatment if retreatment is required for Paget's disease.

·        Ensure adequate vitamin D and calcium intake.

·        Provide comfort measures if bone pain returns.

Teaching points

·        Take this drug with a full glass of water (plain water, not mineral water), at least 30 minutes before or after any other beverage, foods, or medication; remain in an upright position for at least 30 minutes to decrease the GI side effects of the drug. If taking a once-weekly dose, mark calendar as a reminder.

·        Maintain adequate vitamin D and calcium intake while you are using this drug.

·        You may experience these side effects: Nausea, diarrhea; bone pain, headache (analgesics may be available to help); rash (appropriate skin care will be suggested).

·        Report twitching, muscle spasms, dark-colored urine, edema, bone pain, rash.

Adverse effects in Italic are most common; those in Bold are life-threatening.