Risedronate Sodium

Trade Names:
Actonel
- Tablets 5 mg
- Tablets 30 mg
- Tablets 35 mg
- Tablets 75 mg
- Tablets 150 mg

Pharmacology

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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. Protein binding is about 24%.

Steady-state Vd is 13.8 L/kg.

Metabolism

No evidence of system metabolism.

Elimination

Eliminated in urine (about 50%) in 24 h. Mean renal Cl is 105 mL/min. Mean total Cl is 122 mL/min. Terminal exponential half-life is about 561 h.

Special Populations

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

Pharmacokinetics have not been studied.

Indications and Usage

Treatment and prevention of osteoporosis in postmenopausal women; 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

PO 30 mg once daily for 2 mo.

PO 5 mg daily.

PO 5 mg daily, 35 mg once a week, 75 mg on 2 consecutive days each month, or 150 mg once a month.

PO 35 mg once weekly.

General Advice

• To be taken at least 30 min before the first food or drink of the day other than water.
• To facilitate delivery to the stomach, medication should be swallowed while the patient is in an upright position (with a full glass of water).
• Patient should not lie down for 30 min after taking the medication.

Storage/Stability

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

Drug Interactions

May decrease risedronate absorption, which may decrease activity.

Laboratory Test Interactions

Interferes with bone-imaging agents.

Adverse Reactions

Cardiovascular

Hypertension (11%); arrhythmia (2%).

CNS

Headache (18%); depression, dizziness (7%); asthenia, insomnia (5%).

Dermatologic

Rash (12%); bullous skin reactions, generalized rash (postmarketing).

EENT

Cataract (7%); pharyngitis (6%); iritis, uveitis (postmarketing).

GI

Diarrhea (20%); constipation (13%); abdominal pain (12%); dyspepsia, nausea (11%); gastritis (3%); upper GI irritation including esophagitis and esophageal or gastric ulcer (postmarketing).

Genitourinary

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

Hypersensitivity

Allergic reactions (4%); angioedema (postmarketing).

Lab Tests

Increased serum parathyroid hormone (less than 30%); hypocalcemia (5%); decreased serum phosphate (less than 3%).

Metabolic-Nutritional

Peripheral edema (8%).

Musculoskeletal

Arthralgia (33%); back pain (28%); arthritis (10%); traumatic bone fracture (9%); joint disorder, myalgia (7%); bone pain, neck pain (5%); incapacitating bone, joint, and muscle pain; osteonecrosis of the jaw (postmarketing).

Respiratory

Bronchitis (10%); sinusitis (9%); increased cough, rhinitis (6%).

Miscellaneous

Infection (31%); accidental injury (17%); pain (14%); flu-syndrome (11%); chest pain (7%).

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, esophageal ulcer, esophagitis, 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, because 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 one risedronate 75 mg dose is missed during the month 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, instruct the patient to take one risedronate 75 mg tablet in the morning after the day it is remembered and then the second tablet on the next consecutive morning. Instruct the patient to return to the original schedule and not to take more than two 75 mg tablets within 7 days.
• Instruct the patient that if a dose of 150 mg once-a-month is missed and the next month's dose is more than 7 days away, to take the missed dose in the morning after the day it is remembered. Instruct patients to return to taking their once-a-month dose as originally scheduled. Advise patients to not take more than one 150 mg tablet within 7 days. If the once-a-month dose is missed, and the next month's dose is within 7 days instruct patients to wait until their next month's scheduled dose and then continue taking the once-a-month dose as originally scheduled.
• Instruct patient that if one or both risedronate 75 mg doses are missed on 2 consecutive days of the month, 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 supplemental calcium and vitamin B if dietary intake is inadequate.
• 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, to take 35 mg on the morning after they remember and return to taking 35 mg weekly, as originally scheduled on their chosen day. Advise patients not to 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.

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