Actonel


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risedronate

(riss-ed-roe-nate) ,

Actonel

(trade name),

Atelvia

(trade name)

Classification

Therapeutic: bone resorption inhibitors
Pharmacologic: biphosphonates
Pregnancy Category: C

Indications

Prevention and treatment of postmenopausal and corticosteroid-induced osteoporosis.Treatment of Paget's disease in men and women.Treatment of osteoporosis in men.

Action

Inhibits bone resorption by binding to bone hydroxyapatite, which inhibits osteoclast activity.

Therapeutic effects

Reversal of the progression of osteoporosis with decreased fractures and other sequelae.
Reduced bone turnover and resorption; normalization of serum alkaline phosphatase with reduced complications of Paget’s disease.

Pharmacokinetics

Absorption: Rapidly but poorly absorbed following oral administration (0.63% bioavailability).
Distribution: 60% of absorbed dose distributes to bone.
Metabolism and Excretion: 40% of absorbed dose is excreted unchanged by kidneys; unabsorbed drug is excreted in feces.
Half-life: Initial—1.5 hr; terminal—220 hr (reflects dissociation from bone).

Time/action profile (effects on serum alkaline phosphatase)

ROUTEONSETPEAKDURATION
POwithin days30 daysup to 16 mo

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Hypocalcemia;Abnormalities of the esophagus, which delay esophageal emptying (i.e., strictures, achalasia);Inability to stand/sit upright for at least 30 min; Lactation: Lactation;Severe renal impairment (CCr <30 mL/min).
Use Cautiously in: History of upper GI disorders;Other disturbances of bone or mineral metabolism (correct abnormalities before initiating therapy);Dietary deficiencies (supplemental vitamin D and calcium may be required);Invasive dental procedures, cancer, receiving chemotherapy or corticosteroids, poor oral hygeine, periodontal disease, dental disease, anemia, coagulopathy, infection, or poorly fitting dentures (may ↑ risk of jaw osteonecrosis); Obstetric / Pediatric: Safety not established; use in pregnancy only if potential benefit justifies potential risks.

Adverse Reactions/Side Effects

Central nervous system

  • weakness (most frequent)

Ear, Eye, Nose, Throat

  • amblyopia
  • conjunctivitis
  • dry eyes
  • eye pain/inflammation
  • tinnitus

Cardiovascular

  • chest pain
  • edema

Gastrointestinal

  • abdominal pain (most frequent)
  • diarrhea (most frequent)
  • belching
  • colitis
  • constipation
  • dysphagia
  • esophagitis
  • esophageal cancer
  • esophageal ulcer
  • gastric ulcer
  • nausea

Dermatologic

  • rash (most frequent)

Musculoskeletal

  • arthralgia (most frequent)
  • musculoskeletal pain (most frequent)
  • femur fractures
  • osteonecrosis (primarily of jaw)

Respiratory

  • asthma exacerbation

Miscellaneous

  • flu-like syndrome

Interactions

Drug-Drug interaction

Concurrent use with NSAIDs or aspirin ↑ risk of GI irritation.Absorption is ↓ by calcium supplements or antacids.Proton pump inhibitors and H2 antagonists may cause a faster release of drug from the delayed-release product that can ↑ drug levels; concurrent use not recommendedFood ↓ absorption (administer at least 30 min before breakfast).

Route/Dosage

Oral (Adults) Postmenopausal Osteoporosis—5 mg daily; or 35 mg once weekly (immediate- or delayed-release); or 75 mg taken on 2 consecutive days for a total of 2 tablets each month; or 150 mg once monthly. Osteoporosis in Men—35 mg once weekly (immediate-release); Glucocorticoid-induced Osteoporosis—5 mg daily; Paget’s disease—30 mg daily for 2 mo; retreatment may be considered after 2 mo off therapy.

Availability

Tablets: 5 mg, 30 mg, 35 mg, 150 mg
Delayed-release tablets (Atelvia): 35 mg
In combination with: calcium carbonate.

Nursing implications

Nursing assessment

  • Osteoporosis: Assess patients via bone density study for low bone mass before and periodically during therapy.
  • Paget’s disease: Assess for symptoms of Paget’s disease (bone pain, headache, decreased visual and auditory acuity, increased skull size).
  • Lab Test Considerations: Osteoporosis: Assess serum calcium before and periodically during therapy. Hypocalcemia and vitamin D deficiency should be treated before initiating alendronate therapy. May cause mild, transient ↑ of calcium and phosphate.
    • Paget’s disease: Monitor alkaline phosphatase prior to and periodically during therapy to monitor effectiveness of therapy.

Potential Nursing Diagnoses

Risk for injury (Indications)

Implementation

  • Oral: Administer Actonel first thing in the morning with 6–8 oz of water, 30 min prior to other medications, beverages, or food. Waiting longer than 30 min will improve absorption. Administer Atelvia right after breakfast with 4 ounces of water. Tablet should be swallowed whole; do not crush, break, or chew.
    • Calcium-, magnesium-, or aluminum-containing agents may interfere with absorption of risedronate and should be taken at a different time of day with food.
    • Avoid administering delayed-release product with proton pump inhibitors or H2 antagonists; may allow a faster release and increased drug level.

Patient/Family Teaching

  • Instruct patient on the importance of taking as directed. Risedronate should be taken with 6–8 oz of water (mineral water, orange juice, coffee, and other beverages decrease absorption). If a dose of Actonel 35 is missed, take 1 tablet the morning remembered, then return to the 1 tablet/wk on the originally scheduled day; do not take 2 pills at once. If 1 or both tablets of Actonel 75 are missed and the next month's scheduled doses are more than 7 days away: if both Actonel 75 are missed take 1 the morning remembered and 1 the next morning. If only 1 Actonel 75 tablet is missed: take the missed tablet on the morning of the day after you remember, then return to original schedule. Do not take more than two 75 mg tablets within 7 days. If 1 or both tablets of Actonel 75 are missed and the next month's scheduled doses are within 7 days, omit and return to schedule next month. If 1 or both tablets of Actonel 150 are missed and the next month's scheduled doses are more than 7 days away, take the missed tablet on the morning of the day after you remember, then return to original schedule. Do not take more than two 150-mg tablets within 7 days. If 1 or both tablets of Actonel 75 are missed and the next month's scheduled doses are within 7 days, omit and return to schedule next month. Encourage patient to read the Medication Guide before starting therapy and with each Rx refill in case of changes.
    • Caution patients to remain upright for 30 min following dose to facilitate passage to stomach and minimize risk of esophageal irritation.
    • Advise patient to eat a balanced diet and consult health care professional about the need for supplemental calcium and vitamin D (see ).
    • Inform patient that severe musculoskeletal pain may occur within days, months, or years after starting risendronate. Symptoms my resolve completely after discontinuation or slow or incomplete resolution may occur. Notify health care professional if severe pain occurs.
    • Encourage patient to participate in regular exercise and to modify behaviors that increase the risk of osteoporosis (stop smoking, reduce alcohol consumption).
    • Advise patient to inform health care professional of risedronate therapy prior to dental surgery.
    • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Reversal of the progression of osteoporosis with decreased fractures and other sequelae. For patients at low risk of fracture, discontinue after 3 to 5 yr of use.
  • Decrease in serum alkaline phosphatase and the progression of Paget’s disease.

Actonel

(ăk′tō-nĕl′)
A trademark for the drug risedronate sodium.

Actonel®

Risedronate, see there.
References in periodicals archive ?
A dedicated GP sales team will be maintained with the responsibility for supporting GPs and specialists who prescribe primary care products, including Actonel.
Fosamax and Actonel are the only oral bisphosphonates approved for use in both men and women.
Osteonecrosis (bone death) of the jaw, or ON], is a very rare complication of bisphosphonate drugs (including Actonel, Fosamax, Boniva, and Reclast) which, when it occurs, typically follows a tooth extraction or other trauma to the jaw, says Dr.
Cases of osteochemone- crosis have been found among patients taking nitrogen-based bisphos- phonate medicines, including Fosamax, Actonel and Boniva and the IV cancer drugs Aredia and Zometa.
Preliminary results of laboratory analyses for products from these companies intercepted on their way to the United States have identified counterfeit versions of the following prescription drugs: the cholesterol-lowering agents Lipitor (atorvastatin), Crestor (rosuvastatin), and Zetia (ezetimibe); the antihypertensives Diovan (valsartan) and Hyzaar (losartan-hydrochlorothiazide); Actonel (risedronate), a bisphosphonate for osteoporosis; Nexium (esomeprazole) for gastroesophageal reflux disease; Celebrex (celecoxib) for arthritis-related pain; Arimidex (anastrozole) for breast cancer; and Propecia (finasteride), for male pattern baldness.
El doctor Diaz Salazar, medico especialista en Endocrinologia por el Hospital Universitario de Dulsserdorfd, Alemania, dio a conocer los resultados de un trascendental estudio presentado en el marco de la Reunion Anual de la Sociedad Norteamericana de Menopausia 2005 (NAMS), realizada en San Diego, California, llamado Fosamax Plus Once Weekly Actonel Once a Week Comparison Trial (FACT), en el cual se comparo el efecto de dos medicamentos de la misma clase terapeutica conocidos como bifosfonatos, que estan indicados para el tratamiento de la osteoporosis: Fosamax Plus y Actonel.
Tokyo, Japan, Sept 13, 2005 - (JCNN) - Aventis Pharma, Ajinomoto and Eisai jointly announced on September 12 that the three companies have reached an agreement on the distribution of Actonel Tablet 2.
The FDA has approved Actonel with Calcium, a product that provides the fracture protection of Actonel tablets conveniently packaged with calcium tablets.
Health care sales and earnings were led by the growth of Prilosec OTC, Actonel and double-digit growth in developing markets, primarily in oral care.
I have been placed on Actonel for a year now and am improving.
Bisphosphonates, a class of drugs including Fosamax (alendronate) and Actonel (risedronate) that is used in the treatment of osteoporosis, are at least as effective as hormone therapy for this purpose.