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Risedronate Sodium

Pronouncation: (RIS-e-DROE-nate SO-dee-um)
Class: Bisphosphonate

Trade Names:
Actonel
- Tablets 5 mg
- Tablets 30 mg
- Tablets 35 mg
- Tablets 75 mg

Pharmacology

Feedback for Risedronate Sodium

As a treatment for...	Avg User Ratings [?]
Osteoporosis	1 comments Rate it!	10
Prevention of Osteoporosis	Be the first to rate it 0 comments
Paget's Disease	Be the first to rate it 0 comments

Compare with other drugs.

Inhibits normal and abnormal bone resorption.

Pharmacokinetics

Absorption

Relatively rapid and occurs in upper GI tract (oral). T _max is about 1 h. Steady state is about 57 days. Bioavailability is 0.63%.

Distribution

60% of dose is distributed to bone. Vd is 6.3 L/kg. Protein binding is about 24%.

Elimination

Eliminated in urine (about 40%); unabsorbed drug is eliminated in feces. Mean renal Cl is 105 mL/min. Mean total Cl is 122 mL/min. Initial t _½ is about 1.5 h. Terminal exponential t _½ is about 480ߙh.

Special Populations

Renal Function Impairment

Cl decreased about 70% with CrCl 30 mL/min. Not recommended for use in patients with severe renal function impairment.

Indications and Usage

Treatment of osteoporosis in postmenopausal women; prevention of osteoporosis in postmenopausal women at risk of developing osteoporosis; prevention and treatment of glucocorticoid-induced osteoporosis in men and women; treatment of Paget disease of the bone in men and women; treatment to increase bone mass in men with osteoporosis.

Contraindications

Hypocalcemia; inability to stand or sit upright for at least 30 min; hypersensitivity to any component of the product.

Dosage and Administration

Paget Disease
Adults

PO 30 mg once daily for 2ߙmo.

Treatment and Prevention of Glucocorticoid-Induced Osteoporosis
Adults

PO 5 mg daily.

Treatment and Prevention of Postmenopausal Osteoporosis
Adults

PO 5 mg daily, 35 mg once a wk, or 75 mg on 2 consecutive days each mo.

Treatment to Increase Bone Mass in Men With Osteoporosis
Adults

PO 35 mg once weekly.

Storage/Stability

Store at controlled room temperature (68° to 77°F).

Drug Interactions

Antacids, calcium supplements, oral medicines containing divalent cations

Decrease risedronate absorption, which may decrease activity.

Laboratory Test Interactions

Interferes with bone-imaging agents.

Adverse Reactions

The overall adverse reaction profile is similar to placebo.

Cardiovascular

Hypertension (10%); angina pectoris, CV disorder (3%); arrhythmia, syncope, vasodilatation (2%).

CNS

Headache (18%); depression, dizziness (7%); insomnia (5%); anxiety, neuralgia (4%); vertigo (3%); fatigue, hypertonia, paresthesia, sciatica (2%).

Dermatologic

Rash (12%); pruritus (3%); skin carcinoma (2%); bullous skin reactions, generalized rash (postmarketing).

EENT

Cataracts, pharyngitis, rhinitis (6%); nasopharyngitis (5%); amblyopia, conjunctivitis, dry eye, otitis media, tinnitus (3%); eye inflammation, including iritis and uveitis (postmarketing).

GI

Diarrhea (20%); constipation (13%); abdominal pain (12%); nausea (11%); dyspepsia (9%); upper abdominal pain (6%); flatulence (5%); gastroenteritis (4%); belching, colitis, dry mouth, gastritis, GI disorder, vomiting (3%); rectal disorder, tooth disorder (2%).

Genitourinary

UTI (11%); benign prostatic hyperplasia (5%); cystitis (4%); nephrolithiasis (3%).

Hematologic-Lymphatic

Ecchymosis (4%); anemia (2%).

Metabolic-Nutritional

Peripheral edema (8%); hypercholesterolemia (2%)

Musculoskeletal

Arthralgia (33%); back pain (26%); joint disorder, myalgia, pain in extremities (7%); traumatic bone fracture (6%); bone pain, neck pain (5%); arthritis, bone disorder, leg cramps (4%); bursitis, muscle spasm, myasthenia, osteoarthritis, shoulder pain, tendon disorder (3%); joint and muscle pain, osteonecrosis of jaw (postmarketing).

Respiratory

Bronchitis, sinusitis (5%); dyspnea, upper respiratory tract infection (4%); increased cough, pneumonia (3%).

Miscellaneous

Infection (30%); pain (14%); accidental injury (11%); flu syndrome (10%); chest pain (7%); influenza (6%); asthenia, fall (5%); allergic reaction, hernia, neoplasm (3%); angioedema (postmarketing).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Renal Function

Not recommended in patients with CrCl less than 30 mL/min.

Hormone status

Before beginning therapy for prevention or treatment of glucocorticoid-induced osteoporosis, determine the hormonal status and consider appropriate replacement.

Hypocalcemia

Effectively treat hypocalcemia and other disturbances of bone and mineral metabolism prior to starting risedronate.

Musculoskeletal pain

Severe and incapacitating bone, joint, and muscle pain have been reported.

Osteonecrosis

Osteonecrosis, primarily of the jaw, has been reported in patients receiving bisphosphonates.

Upper GI disorders

Bisphosphonates may cause upper GI disorders such as dysphagia, esophagitis, esophageal ulcer, and gastric ulcer.

Overdosage

Symptoms

Hypocalcemia, hypophosphatemia.

Patient Information

Advise patient to read the patient information leaflet before using product the first time and with each refill.
Instruct patient to take the medication exactly as directed, as clinical benefits may be negatively affected by failure to take the drug according to instructions.
Instruct patient to take in an upright position with a full 8 oz glass of water 30 min or more before the first food or liquid of the day.
Remind patient to avoid lying down for 30 min after taking this medication.
Instruct patient that if 1 risedronate 75 mg dose is missed during the mo and the next month's scheduled doses are more than 7 days away, to take the missed dose in the morning after the day it is remembered. If both tablets are missed, the patient should take 1 risedronate 75 mg tablet in the morning after the day it is remembered and then the second tablet should be taken on the next consecutive morning. The patient should then return to the original schedule. No more than two 75 mg tablets should be taken within 7 days.
Instruct patient that if 1 or both risedronate 75 mg doses are missed on 2 consecutive days of the mo, and the next scheduled doses are within 7 days, to wait until the next month's scheduled doses and continue taking the product as originally scheduled.
Instruct patient to take any supplement containing calcium or antacids containing magnesium or aluminum 1 h or more before or 2 h after taking risedronate tablets to prevent interference with absorption.
Instruct patient to report any symptoms of esophageal disease (eg, difficulty or pain upon swallowing; retrosternal pain; severe, persistent, or worsening heartburn) to health care provider before continuing treatment.
Instruct patient that if a dose of risedronate 35 mg weekly is missed, they should take 35 mg on the morning after they remember and return to taking 35 mg weekly, as originally scheduled on their chosen day. Patients should not take two 35 mg tablets on the same day.
Warn breast-feeding women that a decision to use the drug or continue breast-feeding should be made in collaboration with their primary health care provider.