risedronate sodium


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risedronate sodium

Actonel, Atelvia

Pharmacologic class: Bisphosphonate

Therapeutic class: Calcium regulator

Pregnancy risk category C

Action

Inhibits osteoclast-mediated bone resorption. Also exerts antiresorptive effect, probably by directly inhibiting mature osteoclast activity or indirectly inhibiting osteoblasts.

Availability

Tablets: 5 mg, 30 mg, 35 mg, 150 mg

Tablets (delayed-release): 35 mg

Indications and dosages

Prevention of postmenopausal osteoporosis

Adults: 5 mg P.O. daily or 35 mg P.O. weekly (immediate-release)

Treatment of postmenopausal osteoporosis

Adults: 5 mg P.O. daily, or 35 mg P.O. weekly, or 150 mg P.O. monthly (immediate-release). Or, 35 mg P.O. weekly (delayed-release).

Osteoporosis in men

Adults: 35 mg (immediate-release) P.O. weekly

Glucocorticoid-induced osteoporosis

Adults: 5 mg (immediate-release) P.O. daily

Paget's disease

Adults: 30 mg (immediate-release) P.O. daily for 2 months. If indicated, may retreat with same dosage after post-treatment observation period of at least 2 months.

Off-label uses

• Hypercalcemia of malignancy

• Primary hyperparathyroidism

Contraindications

• Hypersensitivity to drug, its components, or other bisphosphonates

• Hypocalcemia

• Inability to stand or sit upright for at least 30 minutes

• Esophageal abnormalities that delay esophageal emptying, such as stricture or achalasia

Precautions

Use cautiously in:

• hypotension, upper GI disorders, difficulty swallowing

• severe renal impairment with creatinine clearance less than 30 ml/minute (not recommended)

• pregnant or breastfeeding patients

• children (use not indicated)

Administration

• Be aware that hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting drug.

• Give immediate-release tablets with 6 to 8 oz of water 30 minutes before first food or beverage of day (other than water).

• Give delayed-release tablets in the morning immediately after breakfast with at least 4 oz of plain water.

Make sure patient stays upright for at least 30 minutes after taking.

• Be aware that patient with poor dietary intake may need calcium and vitamin D supplements.

• Give calcium, magnesium, or aluminum supplements or antacids at different time of day so they don't interfere with risedronate absorption.

Adverse reactions

CNS: headache, anxiety, depression, dizziness, vertigo, syncope, asthenia

CV: hypertension, vasodilation, angina, chest pain, cardiovascular disorder, peripheral edema

EENT: cataract, conjunctivitis, dry eyes, otitis media, rhinitis, sinusitis, pharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, gastroenteritis, colitis, esophageal irritation, dry mouth, anorexia, esophageal stricture or perforation (rare)

GU: urinary tract infection

Hematologic: anemia

Musculoskeletal: bone, back, or joint pain; bone fracture; bursitis; myalgia; arthritis; leg and muscle cramps; jaw osteonecrosis

Respiratory: crackles, cough, bronchitis, pneumonia

Skin: rash, pruritus, ecchymosis, skin cancer

Other: accidental injury, infection, neck pain, flulike symptoms, allergic reactions, neoplasm, hypersensitivity reactions including angioedema (rare)

Interactions

Drug-drug. Antacids, aspirin, calcium-or magnesium-based supplements or laxatives, iron preparations: decreased risedronate absorption

Nonsteroidal anti-inflammatory drugs, salicylates: increased GI irritation

Drug-diagnostic tests. Bone-imaging diagnostic agents: interference with test agents

Calcium, phosphorus: decreased levels

Drug-food. Any food: decreased drug absorption

Patient monitoring

• Watch for difficulty swallowing and signs and symptoms of esophageal irritation. Discontinue drug if new or worsening symptoms occur.

• Assess skin for unusual findings that may indicate skin cancer.

• Monitor patient for severe bone, joint, or muscle pain; consider discontinuing drug if symptoms are severe

Patient teaching

• Advise patient to read patient information insert before starting therapy.

Stress importance of taking immediate-release tablets with a full glass (6 to 8 oz) of water at least 30 minutes before first food or drink of day and delayed-release tablets in the morning immediately after breakfast with at least 4 oz of plain water. Tell patient to stay upright for at least 30 minutes afterward.

Instruct patient to stop drug and notify prescriber if difficulty or pain on swallowing, midline chest pain, or severe, persistent heartburn occurs.

• Tell patient that chewing or sucking tablet may cause mouth irritation.

• Tell patient to report signs and symptoms of colitis.

• Advise patient taking calcium-, magnesium-, or aluminum-based supplements or antacids to take them at least 2 hours after risedronate.

• Advise patient to promptly report leg cramps or bone, joint, or jaw pain.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.

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References in periodicals archive ?
Therefore the market size of risedronate sodium is expected to keep expanding fast in the next few years in China.
According to the company, Risedronate sodium tablets are used to treat or prevent osteoporosis in women after menopause; to treat or prevent osteoporosis in either men or women who are taking corticosteroid medicines; to treat Paget's disease of the bone; as well as to treat and prevent postmenopausal osteoporosis.
Adachi, "In vitro disintegration studies of weekly generic and branded risedronate sodium formulations available in Canada," Current Medical Research and Opinion, vol.
Material and Methods: Eighty-five postmenopausal women with primer osteoporosis who had uninterrupted risedronate sodium (A) (35 mg/week), strontium ranelate (P) (2 g/day) and calcium (1000 mg/day)--vitamin D (880 IU/day) supplementation for 3 years were included in our retrospective study.
Among the leading Rx brands that Warner Chilcott receives are Asacol HD (mesalamine) delayed-release tablets for ulcerative colitis, Actonel (risedronate sodium) for osteoporosis and copromotion rights to Enablex (darifenacin) for treatment of overactive bladder.
Commonly used bisphosphonates, include risedronate sodium (Actonel) and alendronic acid (Fosamax), both are taken once a week and act on the mechanisms that maintain bone to encourage the formation of denser bones and thereby reduce the risk of both hip and spinal fracture.
("Ajinomoto", President and CEO: Norio Yamaguchi, Headquarters: Tokyo) and Takeda Pharmaceutical Company Limited ("Takeda", President: Yasuchika Hasegawa, Headquarters: Osaka) are pleased to announce that the Ministry of Health, Labour and Welfare approved today "Actonel(R) 17.5 mg tablets" and "Benet(R) 17.5 mg tablets", a once-weekly formulation of risedronate sodium hydrate (generic name) for the treatment of osteoporosis.
AFI: Actonel is also known as risedronate sodium. It is a member of the class of drugs called biphosphonates.
Data from a McMaster University, Toronto, Ontario, endoscopy study published recently in Gastroenterology and presented at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) showed that risedronate sodium (Actonel) reduced the incidence of gastric ulcers in healthy, postmenopausal women relative to another osteoporosis therapy, alendronate sodium.
Risedronate sodium (brand name Actonel[R]) is approved for the prevention and treatment of osteoporosis in postmenopausal women and for the prevention and treatment of glucocorticoid-induced osteoporosis in both men and women.
Tenders are invited for Tablet/Capsule Risedronate Sodium 150Mg.