Residron

Residron

risedronic acid

Manufacturer:

Mega Lifesciences

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Risedronate sodium.
Description
Each film-coated tablet of Residron contains risedronate sodium hemipenta hydrate 40.17 mg equivalent to risedronate sodium 35 mg.
It also contains the following excipients: Pregelatinised starch, microcrystalline cellulose, crospovidone, magnesium stearate, opadry white IH (titanium dioxide, lactose monohydrate, macrogol 4000, hypromellose), ethanol 96%, purified water.
Risedronate sodium is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. The empirical formula for risedronate sodium hemi-pentahydrate is C7H10NO7P2Na 2.5 H2O. Risedronate sodium is [1-hydroxy-2-(3-pyridinyl) ethylidene] bis (phosphonic acid) monosodium salt.
Molecular Weight: Anhydrous: 305.1. Hemi-pentahydrate: 350.13.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Risedronate sodium is a pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption. The bone turnover is reduced while the osteoblast activity and bone mineralisation is preserved.
Pharmacokinetics: Absorption: Absorption is relatively rapid [time to maximum concentration (Tmax)] of approximately 1 hr for immediate release and is independent of dose. Mean oral bioavailability is 0.63%. Dosing for the immediate-release tablet either 30 min prior to breakfast or 2 hrs after dinner reduces the extent of absorption to 55%. Absorption is reduced by food, especially by product containing calcium or other polyvalent cations. The pharmacokinetic of risedronate are dose-proportional after a single oral dose.
Distribution: In animal studies, approximately 60% of the dose is distributed to bone, with the mean steady-state volume of distribution is 13.8 L/kg. Plasma protein-binding is about 24%.
Metabolism: Risedronate is not metabolized. There is no evidence that supports system metabolism of residronate.
Excretion: Approximately 50% of the absorbed dose is excreted in urine within 24 hrs. Mean renal clearance is 105 mL/min and mean total clearance is 122 mL/min with the difference primarily reflecting nonrenal clearance or clearance caused by adsorption to bone. The renal clearance is not concentration dependent, and there is a linear relationship between renal clearance and creatinine clearance. Unabsorbed drug is eliminated unchanged in feces. The terminal expotential half-life (t½) was 561 hrs.
Indications/Uses
Postmenopausal Osteoporosis: Treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, it reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures.
Osteoporosis in Men: Treatment to increase bone mass in men with osteoporosis.
Dosage/Direction for Use
Recommended Dose: 1 tablet once a week. The tablet should be taken on the same day each week.
Renal Impairment: No dosage adjustment is required for those patients with mild to moderate renal impairment. The use of risedronate sodium is contraindicated in patients with severe renal impairment [creatinine clearance (CrCl) <30 mL/min].
Elderly: No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (>60 years) compared to younger subjects. This has also been shown in the very elderly, ≥75 years postmenopausal population.
Administration: The absorption of risedronate sodium is affected by food, thus to ensure adequate absorption, patients should take risedronate before breakfast at least 30 min before the 1st food, other medicinal product or drink (other than plain water) of the day. If a patient forgets to take the risedronate tablet 35 mg in the morning, inform him/her not to take it later in the day. Take only 1 risedronate 35 mg tablet the next morning and continue the usual schedule of 35 mg (1 tablet on a chosen day of the week). Two (2) tablets should not be taken on the same day.
The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach, risedronate is to be taken while in an upright (standing or sitting) position with a glass of plain water (≥120 mL). Patients should not lie down for 30 min after taking the tablet.
Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate.
Overdosage
No specific information is available on the treatment of overdose with risedronate sodium. Decreases in serum calcium following substantial overdose may be expected. Signs and symptoms of hypocalcaemia may also occur in some of these patients.
Milk or antacids containing magnesium, calcium or aluminium should be given to bind risedronate and reduce absorption of risedronate sodium. In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed risedronate sodium.
Contraindications
Hypersensitivity to risedronate sodium or to any of the excipients of Residron. Hypocalcaemia.
Use in Pregnancy & Lactation: There are no adequate data from the use of risedronate sodium in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Studies in animal indicate that a small amount of risedronate sodium pass into breast milk. Risedronate sodium must not be used during pregnancy or by breastfeeding women.
Severe renal impairment (CrCl <30 mL/min).
Special Precautions
Foods, drinks (other than plain water) and medicinal products containing polyvalent cations (eg, calcium, magnesium, iron and aluminium) interfere with the absorption of bisphosphonates and should not be taken at the same time as risedronate. In order to achieve the intended efficacy, strict adherence to dosing recommendations is necessary.
Efficacy of bisphosphonates in the treatment of osteoporosis is related to the presence of low bone mineral density and/or prevalent fracture.
High age or clinical risk factors for fracture alone are not sufficient reasons to initiate treatment of osteoporosis with a bisphosphonate.
The evidence to support efficacy of bisphosphonates including risedronate in the very elderly (>80 years) is limited.
Bisphosphonates have been associated with oesophagitis, gastritis, oesophageal ulcerations and gastroduodenal ulcerations.
Thus caution should be used in patients who have a history of oesophageal disorders which delay oesophageal transit or emptying eg, stricture or achalasia; in patients who are unable to stay in the upright position for at least 30 min after taking the tablet; if risedronate is given to patients with active or recent oesophageal or upper gastrointestinal problems.
Physicians should emphasize to patients the importance of paying attention to the dosing instructions and be alert to any signs and symptoms of possible oesophageal reaction. The patients should be instructed to seek timely medical attention if they develop symptoms of oesophageal irritation eg, dysphagia, pain on swallowing, retrosternal pain or new/worsened heartburn. Hypocalcaemia should be treated before starting risedronate therapy. Other disturbances of bone and mineral metabolism (ie, parathyroid dysfunction, hypovitaminosis D) should be treated at the time of starting risedronate therapy.
Osteonecrosis of the jaw generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily IV administered bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (eg, cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Effects on the Ability to Drive or Operate Machinery: No effects on ability to drive and use machines have been observed.
Use in Children: Safety and efficacy of risedronate 35 mg have not been established in children and adolescents.
Use In Pregnancy & Lactation
There are no adequate data from the use of risedronate sodium in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Studies in animal indicate that a small amount of risedronate sodium pass into breast milk. Risedronate sodium must not be used during pregnancy or by breastfeeding women.
Adverse Reactions
More than 10%: Cardiovascular: Hypertension (11%).
Central Nervous System: Headache (3-18%).
Dermatologic: Rash (8-12%).
Endocrine and Metabolic: Increased serum parathyroid hormone (PTH) levels (<30%).
Gastrointestinal: Diarrhea (5-20%); nausea (4-13%); constipation (3-13%); abdominal pain (2-12%); dyspepsia (4-11%).
Genitourinary: Urinary tract infection (11%).
Neuromuscular and Skeletal: Arthralgia (7-33%); back pain (6-28%).
Miscellaneous: Infection (≤31%).
1-10%: Cardiovascular: Peripheral edema (8%); chest pain (5-7%); arrhythmia (2%).
Central Nervous System: Depression (7%); dizziness (3-7%).
Endocrine and Metabolic: Hypocalcemia (≤5%); hypophosphatemia (<3%).
Gastrointestinal: Vomiting (2-5%); gastritis (3%); duodenitis (≤1%); glossitis (≤1%).
Genitourinary: Prostatic hyperplasia (5%); nephrolithiasis (3%).
Neuromuscular and Skeletal: Joint disorder (7%); myalgia (2-7%); neck pain (5%); muscle spasm (1-2%).
Ocular: Cataract (7%).
Respiratory: Bronchitis (3-10%); pharyngitis (6%); rhinitis (6%); dyspnea (4%).
Miscellaneous: Flu-like syndrome (10%); acute phase reaction (includes fever, influenza-like illness) (≤8%).
Less than 1%: Limited to Important or Life-Threatening: Diaphyseal femur fracture, dysphagia, esophageal cancer, esophageal ulcer, esophagitis, gastric ulcer, hypersensitivity reaction, musculoskeletal pain (rarely severe or incapacitating), osteonecrosis (primarily of the jaw), subtrochanteric femur fracture (<1%).
Drug Interactions
Antacids or Mineral Supplements Containing Divalent Cations (eg, Aluminium, Calcium, Magnesium): Pharmacokinetic interaction (decreased risedronate absorption). Administer risedronate at least 30 min before an antacid or mineral supplements containing divalent cations are taken.
Drug Affecting Hepatic Microsomal Enzymes: Risedronate does not induce or inhibit cytochrome P-450 (CYP) isoenzymes and is not metabolized. Pharmacokinetic interaction unlikely.
Nonsteroidal Anti-Inflammatory Agents (NSAIDs): No evidence of increased adverse upper gastrointestinal effects. The levels/effects of risedronate may be decreased by NSAIDs.
Histamine H2 Receptor Antagonists, Proton Pump Inhibitors: No evidence of increased adverse upper gastrointestinal effects.
Phosphate Supplements: Risedronate may increase the levels/effects of phosphate supplements.
Aminoglycosides: The levels/effects of risedronate may be decreased by aminoglycosides.
Storage
Store below 30°C. Protect from light and moisture.
Shelf-Life: 4 years.
ATC Classification
M05BA07 - risedronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Presentation/Packing
FC tab 35 mg x 4's.
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