SANOFI INDIA LTD SANOFI HOUSE, CTS NO 117-B L&T BUSINESS PARK SAKI VIHAR ROAD, POWAI ANDHERI EAST, MUMBAI 400072
Risedronate 35mg fc tablets,
List of Related Indications:
- Post menopausal osteoporosis
List Of Drugs:
- Risedronate - @ -Biophosphonates- (FDC- List )- (1983)
Indication Type Description:
Dosages/ Overdosage Etc
Interaction with Food
Pregnancy and lactation
No specific drug inteaction studies have been performed. Risedronate is not metabolised and does not induce or inhibit hepatic microsoimal drug metabilizing enzymes (cytochrome P450)
Calcium suplements /antacids- Co-admin of risedronate and calcium or oral medications containing divalent cartions will interfere with absorption of risedronate.
Risedronate may be used concomittantly with hormone replacement therapy Incidence of upper gastrointeatinal adverse reactions with risedronate patients was similar to Aspirin or NSAID patients.
Incidence of upper gastrointestinal adverse effects was similar to H2 blocker and Proton pump inhibitors
Drug/ lab interactions- Bispophonates are known to intefere with the use of bone-imaging agents. Specific studies have not been performed with risedronate.
Most adverse raections were either mild or moderate and did not lead to discontinuatioion of therapy
Body as a whole- Infection, back pain, pain, abdominal pain, asthenia, chest pain, hernia
Cardiovadcular system- Hypertension, cardiovascular disorder. angina pectoris
Digestive Nausea, diarrhea, flatulence, gastritis, gastro-intestinal disorder, rectal disorder, tooth disorder Hemic anf lymphatic Ecchymosis, anemia
Musculaoskeletal Arthalgia, joint disorder, myalgia, bone disorder, leg cramps, bursitis, tendon disorder
Nervous Depression, dizziness, insomnia, anxiety, neuralgia, vertigo, hypertonia, paresthesia Respiratory Pharyngitis, rhinitis, dyspepsia, pneumonia
Dosages/ Overdosage Etc:
Treatment and prevention of osteoporosis in post menopausal women
Dose- One 5mg tablet taken orally daily or one 35mg tablet taken once a week.
1. Patients should be informed to pay particular attention to dosing instructions and clinical befefits may be compromised by failure to take the drug according to instructions.
2. Residronate should be taken at least 30 minutes before the first food or drink of the day other than water.
3. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation patients should take resifronate while in an upright position (sitting or standing) with a full glass of plain water
4. Patients should not lie down for 30 minutes after taking the mediaction
5. Patients should not chew or suck the tablet because of a potential for orophageal irritation
6. Patients should be instructed that if they develop sympotoms of esophageal disease (such as difficulty or pain upon swallowing, reosternal or sever persisrent or worsening heartburn) they should consult their physician before continuing the drug.
7. Patients should be instructed that it they a miss a dosae they should take 1 tablet on the morning they remember and return to 1 tablet once a week as originally scheduled.
8. Patients should not take 2 tablets on the same day.
9. Patients should recieve supplemental calcium and viamin D if dietary intake is inaequate.
10. Calcium supplements or calcium ,aluminium and magnesium containing products may interfere with the absorpton of the drug and should be taken at different time of the day as with food
11. Physician should instruct the patients to read Patient information before starting therapy, and read it each time the prescription is renewed
t has an affinity for hydroxyapitite crystals in bone and acts as an antiresorptive agent. At the cellular level resifronate inhibits osateoclasts. The osteoclasts adhere to the bone surface but show evidence of reduced active resorption
Absorption after an oral dose is realtively rapid and occurs through out the upper gastrointerstinal tract. The fraction of the dose absorbed is independent of dose over the range. Dosing 1 hour prior to breakfast reduces the extent of absorption by 30% compared to dosing in the fasting state. Human plasm binding of drug is about 24%. approximately half of the absorbed dose is excreted in urine within 24 hrs.and 85% of an intrevenous dose is receoverdc in the urine over 28 days. Unabsorbed drug is eliminated in the feces.
Interaction with Food:
Dosing 1 hour prior to breakfast reduces the extent of absorption by 30% compared to dosing in the fasting state.
Drug/Lab Interactions- Bisphonates are known to interfere with the use of bone-imaging agents.
Pregnancy and lactation:
Pregnancy- No adequate and well controlled studies of residronate in pregnant women. Residronate should be used in pregnancy only if the potential benefit outweighs the risk to the mother and the fetus.
Nursing women Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from bisphosphonates a decison should be taken whether to discontue nursing or discontinue the drug depending on the importance of drug to the mother.
Pediatric use- Safety and effectivenes in pediatric patients have not been studied.
Geraitric patients- No overall differances in efficay or safety between patients of younger age and older individuals, but greater sensitivity in some older patients cannot be ruled out.
Use in Men- Safety and effectiveness have been demonstrated in clinical studies in men receiving ACTONEL both for Pagets disease and for treatment and prevention of glucocortoid -induced osteoporosis. However the safety and effectiveness in men for osteoporosis due to other causes have not been established,.