Osteorise

Risedronate sodium.

Osteorise 5 mg Tablet: Each film coated tablet contains: Risedronate Sodium 5 mg.
Osteorise 35 mg Tablet: Each film coated tablet contains: Risedronate Sodium 35 mg equivalent to 32.5 mg Risedronic Acid.

Pharmacology: Mechanism of Action: At the cellular level, Risedronate Sodium (Osteorise) inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption.
Pharmacokinetics: Absorption: Absorption after an oral dose is relatively rapid (tmax~1 hour) and occurs throughout the upper gastrointestinal tract. The fraction of the dose absorbed is independent of dose over the range studied (single dose, 2.5 to 30 mg; multiple dose, 2.5 to 5 mg). Dosing 1 hour prior to breakfast reduces the extent of absorption by 30% compared to dosing in the fasting state. Dosing either 0.5 hours prior to breakfast or 2 hours after dinner (evening meal) results in a similar extent of absorption. Risedronate Sodium (Osteorise) is effective when administered at least 30 minutes before breakfast.
Distribution: The mean steady-state volume of distribution is 6.3 L/kg in humans. Plasma protein binding of drug is about 24%.
Metabolism: There is no evidence of systemic metabolism of risedronate sodium.
Excretion: Approximately half of the absorbed dose is excreted in urine within 24 hours. Unabsorbed drug is eliminated unchanged in feces. Once risedronate is absorbed, the serum concentration-time profile is multi-phasic, with an initial half-life of about 1.5 hours and a terminal exponential half-life of 480 hours. This terminal half-life is hypothesized to represent the dissociation of risedronate from the surface of bone.
Special populations: Renal insufficiency: Risedronate is excreted unchanged primarily via the kidney. Risedronate Sodium (Osteorise) is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min) because of lack of clinical experience. No dosage adjustment is necessary in patients with a creatinine clearance ≥30 mL/min.
Hepatic insufficiency: No studies have been performed to assess risedronate's safety or efficacy in patients with hepatic impairment. But dosage adjustment is unlikely to be needed in patients with hepatic impairment.

Postmenopausal Osteoporosis: Risedronate Sodium (Osteorise) is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Treatment of Osteoporosis: In postmenopausal women with osteoporosis, Risedronate Sodium (Osteorise) increases BMD and reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures. Osteoporosis may be confirmed by the presence or history of osteoporotic fracture, or by the finding of low bone mass.
Prevention of Osteoporosis: Risedronate Sodium (Osteorise) may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of fracture.
Glucocorticoid-Induced Osteoporosis: Risedronate Sodium (Osteorise) is indicated for the prevention and treatment of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage equivalent to 7.5 mg or greater of prednisone) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
Paget's Disease: Risedronate Sodium (Osteorise) is indicated for treatment of Paget's disease of bone (osteitis deformans) (1) who have a level of serum alkaline phosphatase at least 2 times the upper limit of normal, or (2) who are symptomatic, or (3) who are at risk for future complications from their disease, to induce remission (normalization of serum alkaline phosphatase).

Risedronate Sodium (Osteorise) should be taken at least 30 minutes before the first food or drink of the day other than water.
To facilitate delivery to the stomach, Risedronate Sodium (Osteorise) should be swallowed while patient is in an upright position and with a full glass of plain water (6 to 8 oz). Patients should not lie down for 30 minutes after taking the medication.
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Calcium supplements and calcium-, aluminum-, and magnesium-containing medications may interfere with the absorption of Risedronate Sodium (Osteorise) and should be taken at a different time of the day.
Treatment of Postmenopausal Osteoporosis: The recommended regimen is: One 5-mg tablet orally, taken daily.
One 35-mg tablet orally, taken once a week.
Prevention of Postmenopausal Osteoporosis: The recommended regimen is one 5-mg tablet orally, taken daily.
Alternatively, one 35-mg tablet orally, taken once a week may be considered.
Treatment and Prevention of Glucocorticoid-Induced Osteoporosis: The recommended regimen is: One 5-mg tablet orally, taken daily.
Paget's Disease: The recommended treatment regimen is 30 mg orally once daily for 2 months. Re-treatment may be considered (following post-treatment observation of at least 2 months) if relapse occurs, or if treatment fails to normalized serum alkaline phosphatase. For re-treatment, the dose and duration of therapy are the same as for initial treatment. No data are available on more than 1 course of re-treatment.

Symptoms: Decreases in serum calcium following substantial overdose may be expected in some patients.
Signs and symptoms of hypocalcemia may also occur in some of these patients.
Lethality after single oral doses was seen in female rats at 903 mg/kg and male rats at 1703 mg/kg. The minimum lethal dose in mice and rabbits was 4000 mg/kg and 1000 mg/kg. These values represent 320 to 620 times the 30-mg human dose based on surface area (mg/m²).
Treatment: Administration of milk or antacids containing calcium may be helpful to chelate risedronate and reduce absorption of drug. In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed drug if performed within 30 minutes of ingestion. Standard procedures that are effective for treating hypocalcemia, including the administration of calcium i.v., would be expected to restore physiologic amounts of ionized calcium and to relieve signs and symptoms of hypocalcemia.

Hypocalcemia; Known hypersensitivity to any component of this product; Inability to stand or sit upright for at least 30 minutes.

General: Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, oesophagitis, oesophageal ulcer and gastric ulcer. In order to facilitate delivery to the stomach and minimize the possibility of gastrointestinal adverse effects, patients should take Risedronate Sodium (Osteorise) while in an upright position (standing or sitting) with a full glass of plain water and should avoid lying down for 30 minutes after taking this medication.
Use in Pregnancy: Pregnancy Category C: Survival of neonates was decreased in rats treated during gestation with oral doses >/=16 mg/kg/day (approximately 5.2 times the 30-mg/day human dose based on surface area, mg/m²).
Similar to other bisphosphonates, treatment during mating and gestation with doses as low as 3.2 mg/kg/day (approximately 1 time the 30-mg/day dose based on surface area, mg/m²) has resulted in periparturient hypocalcemia and mortality in pregnant rats allowed to deliver.
There are no adequate and well-controlled studies of Risedronate Sodium (Osteorise) in pregnant women. Risedronate Sodium (Osteorise) should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Use in Lactation: Risedronate was detected in feeding pups exposed to lactating rats for a 24-hour period post-dosing, indicating a small degree of lacteal transfer. It is not known whether risedronate is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from bisphosphonates, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Use in Elderly: No overall differences in efficacy or safety were observed between these patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.

Pregnancy: Pregnancy Category C: Survival of neonates was decreased in rats treated during gestation with oral doses >/=16 mg/kg/day (approximately 5.2 times the 30-mg/day human dose based on surface area, mg/m²).
Similar to other bisphosphonates, treatment during mating and gestation with doses as low as 3.2 mg/kg/day (approximately 1 time the 30-mg/day dose based on surface area, mg/m²) has resulted in periparturient hypocalcemia and mortality in pregnant rats allowed to deliver.
There are no adequate and well-controlled studies of Risedronate Sodium (Osteorise) in pregnant women. Risedronate Sodium (Osteorise) should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Nursing Mothers: Risedronate was detected in feeding pups exposed to lactating rats for a 24-hour period post-dosing, indicating a small degree of lacteal transfer. It is not known whether risedronate is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from bisphosphonates, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Body as a Whole: Back Pain, Abdominal Pain, Neck Pain, Asthenia, Chest Pain, Neoplasm, Hernia.
Cardiovascular: Hypertension, Cardiovascular Disorder, Angina Pectoris.
Digestive: Nausea, Diarrhea, Flatulence, Gastritis, Gastrointestinal Disorder, Rectal Disorder, Tooth Disorder.
Hemic and Lymphatic: Ecchymosis, Anemia.
Musculoskeletal: Arthralgia, Joint Disorder, Myalgia, Bone Pain, Bone Disorder, Leg Cramps, Bursitis, Tendon Disorder.
Nervous: Depression, Dizziness, Insomnia, Anxiety, Neuralgia, Vertigo, Hypertonia, Paresthesia.
Respiratory: Pharyngitis, Rhinitis, Dyspnea, Pneumonia.
Skin and Appendages: Rash, Pruritus, Skin Carcinoma.
Special Senses: Cataract, Conjunctivitis, Otitis Media.
Urogenital: Urinary Tract Infection, Cystitis.
Laboratory Test Findings: Asymptomatic mild decreases in serum calcium and phosphorus levels have been observed in some patients.

No specific drug-drug interaction studies were performed. Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (Cytochrome P450).
Calcium Supplements/Antacids: Co-administration of Risedronate Sodium (Osteorise) and calcium, antacids, or oral medications containing divalent cations will interfere with the absorption of Risedronate Sodium (Osteorise).
Hormone Replacement Therapy: If considered appropriate, Risedronate Sodium (Osteorise) may be used concomitantly with hormone replacement therapy.
Aspirin/Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Among regular aspirin or NSAID users, the incidence of upper gastrointestinal adverse experiences in Risedronate Sodium (Osteorise)-treated patients is similar to that of placebo.
H2 Blockers and Proton Pump Inhibitors (PPIs): In such patients using PPIs or H2 blockers, the incidence of upper gastrointestinal adverse experiences in the Risedronate Sodium (Osteorise)-treated patients was similar to that in placebo-treated patients.
Drug/Laboratory Test Interactions: Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with Risedronate Sodium (Osteorise) have not been performed.

Store below 30°C. Protect from heat, sunlight and moisture.

Agents Affecting Bone Metabolism

M05BA07 - risedronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.

POM

FC tab 35 mg x 4's.