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risedronate (Rx)Brand and Other Names:Actonel, Atelvia, more...Actonel with Calcium

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 5mg
  • 30mg
  • 35mg
  • 150mg

tablet, delayed release

  • 35mg
more...

Postmenopausal Osteoporosis

Treatment and prevention

5 mg PO once daily or 35 mg PO once weekly or 150 mg PO once monthly

35 mg once-weekly dosing copackaged with calcium carbonate 1250 mg for remaining 6 days of week

Glucocorticoid-Induced Osteoporosis

5 mg/day PO

Paget Disease

30 mg/day PO for 2 months

Monitor serum alkaline phosphatase

Osteoporosis in Men

35 mg PO once weekly

Osteogenesis Imperfecta (Orphan)

Orphan indication sponsor

  • Warner Chilcott Pharmaceuticals; 100 Enterprise Drive; Rockaway, NJ 07866

Dosing Modifications

Renal impairment

  • CrCl >30 mL/min: No dose adjustment necessary
  • CrCl <30 mL/min: Not recommended

Hepatic impairment

  • Safety and efficacy not established
  • No dose adjustment suggested; drug does not undergo hepatic metabolism

Administration

Immediate release

  • Take at least 30 minutes with 6-8 oz water before first food or drink of day
  • Swallow with plain water only, not coffee or juice
  • Stand or sit upright; do not lie down for 30 minutes after taking to avoid esophageal irritation

Delayed release

  • Administer in morning immediately after breakfast; compared with immediate-release risedronate, Atelvia resulted in significantly higher incidence of abdominal pain when administered before breakfast under fasting conditions
  • To facilitate delivery to stomach, swallow whole while in upright position and with ≥4 oz plain water
  • Tablets should not be chewed, cut, or crushed
  • Do not lie down for 30 minutes after taking medication

Safety and efficacy not established

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Interactions

Interaction Checker

risedronate and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Arthralgia (7-33%)

            Diarrhea (5-20%)

            Headache (3-18%)

            Nausea (4-13%)

            Constipation (3-13%)

            Rash (8-12%)

            Abdominal pain (2-12%)

            Hypertension (11%)

            Dyspepsia (4-11%)

            1-10%

            Flulike syndrome (10%)

            Depression (7%)

            Chest pain (5-7%)

            Dizziness (3-7%)

            Pharyngitis (6%)

            Rhinitis (6%)

            Prostatic hyperplasia (5%)

            Hypocalcemia (<5%)

            Dyspnea (4%)

            Gastritis (3%)

            Nephrolithiasis (3%)

            Hypophosphatemia (<3%)

            Arrhythmia (2%)

            <1%

            Diaphyseal femur

            Dysphagia

            Esophageal cancer

            Esophageal ulcer

            Femur fracture

            Gastric and duodenal ulcer

            Osteonecrosis

            Postmarketing Reports

            Hypersensitivity reactions including angioedema, generalized rash and bullous skin reactions, some severe

            Gastrointestinal: Esophagitis, flatulence, bloating, esophageal or gastric ulcers

            Musculoskeletal pain: Bone, joint, or muscle pain, described as severe or incapacitating, have been reported rarely

            Eye inflammation: Iritis, uveitis

            Jaw osteonecrosis

            Stevens-Johnson syndrome

            Toxic epidermal necrolysis

            Pulmonary: Asthma exacerbations

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            Warnings

            Contraindications

            Hypersensitivity; angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported

            Hypocalcemia

            Hypercalcemia from any cause including, but not limited to, hyperparathyroidism, hypercalcemia of malignancy, or sarcoidosis

            Inability to stand or sit upright for at least 30 minutes

            Esophagus abnormalities (eg, stricture, achalasia) that delay esophageal emptying

            Cautions

            Ensure adequate intake of calcium and vitamin D; correct hypocalcemia, if present, before initiating therapy

            Avoid concomitant polyvalent cation-containing medications

            May cause upper GI disorders (eg, dysphagia, esophagitis, esophageal or gastric ulcer); instruct patients to follow dosing instructions; discontinue use if new or worsening symptoms occur

            Severe irritation of upper GI mucosa; discontinue if new or worsening symptoms occur in patients with active upper GI disease

            Osteonecrosis of the jaw, can occur spontaneously and is generally associated with tooth extraction and/or local infection with delayed healing; known risk factors include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders; risk of osteonecrosis of jaw may increase with duration of exposure to bisphosphonates

            Food decreases bioavailability

            Not recommended in severe renal impairment (CrCl <30 mL/min)

            Risk of severe joint, muscle, or bone pain

            Possible increased risk of atypical subtrochanteric and diaphyseal femur fractures; consider periodic reevaluation of need for continued bisphosphonate therapy, particularly if treatment lasts >5 years; patients with new thigh or groin pain should be evaluated to rule out a femoral fracture

            Consider appropriate hormone replacement therapy if necessary

            Administration of calcium has been associated with a slight increase in risk of kidney stones; in patients with a history of kidney stones or hypercalciuria, metabolic assessment to seek treatable causes of these conditions is warranted; if administration of calcium tablets necessary, monitor urinary calcium excretion periodically; patients with achlorhydria may have decreased absorption of calcium; taking calcium with food enhances absorption; concomitant use of calcium-containing antacids should be monitored to avoid excessive intake of calcium

            Esophageal cancer risk (July 21, 2011, FDA safety communication)

            • Conflicting findings exist from studies evaluating the risk of esophageal cancer with oral bisphosphonates
            • Esophagitis and other esophageal events have been reported, particularly in patients who do not follow specific directions for use of oral bisphosphonates (eg, sitting up or standing after administration, taking with full glass of water)
            • Ongoing review of data from published studies to evaluate whether use of oral bisphosphonates is associated with increased risk of cancer of esophagus is currently being conducted by FDA
            • FDA has not concluded that taking oral bisphosphonates increases risk of esophageal cancer
            • Data are insufficient to recommend endoscopic screening of asymptomatic patients
            • FDA will continue to evaluate all available data supporting safety and effectiveness of bisphosphonates and will update public when more information becomes available
            • Instruct patients to contact their healthcare provider if they develop symptoms of esophagitis (eg, swallowing difficulties, chest pain, new or worsening heartburn, trouble or pain when swallowing)
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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Unknown whether drug crosses into breast milk; avoid using

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Bisphosphonate; binds to hydroxyapatite crystals in bone and inhibits osteoclast-mediated bone resorption

            Absorption

            Bioavailability: 0.54-0.75%

            Peak plasma time: 1-3 hr

            Distribution

            Protein bound: 24%

            Vd: 13.8 L/kg

            Metabolism

            Not metabolized

            Elimination

            Half-life: Initial, 1.5 hr; terminal, 480 hr

            Renal clearance: 105 mL/min

            Total body clearance: 122 mL/min

            Excretion: Urine (up to 85%), feces (unabsorbed drug)

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            Administration

            Instructions

            Immediate release

            • Take at least 30 minutes with 6-8 oz water before first food or drink of day
            • Swallow with plain water only, not coffee or juice
            • Stand or sit upright; do not lie down for 30 minutes after taking to avoid esophageal irritation

            Delayed release

            • Administer in morning immediately after breakfast; compared with immediate-release risedronate, Atelvia resulted in significantly higher incidence of abdominal pain when administered before breakfast under fasting conditions
            • To facilitate delivery to stomach, swallow whole while in upright position and with ≥4 oz plain water
            • Tablets should not be chewed, cut, or crushed
            • Do not lie down for 30 minutes after taking medication
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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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