Product Information
Registration Status: ActiveSIN14439P
INDRONATE FILM-COATED TABLET 35MG is approved to be sold in Singapore with effective from 2013-11-14. It is marketed by INTEGA PTE LTD, with the registration number of SIN14439P.
This product contains Risedronic Acid 35mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by Pharmathen S.A. in GREECE.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Risedronate is a bisphosphonate used to strengthen bone, treat or prevent osteoporosis, and treat Paget's disease of bone.
Indication
For the treatment of Paget's disease of the bone (osteitis deformans), postmenopausal and glucocorticoid-induced osteoporosis
Mechanism of Action
The action of risedronate on bone tissue is based partly on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Risedronate also targets farnesyl pyrophosphate (FPP) synthase. Nitrogen-containing bisphosphonates (such as pamidronate, alendronate, risedronate, ibandronate and zoledronate) appear to act as analogues of isoprenoid diphosphate lipids, thereby inhibiting FPP synthase, an enzyme in the mevalonate pathway. Inhibition of this enzyme in osteoclasts prevents the biosynthesis of isoprenoid lipids (FPP and GGPP) that are essential for the post-translational farnesylation and geranylgeranylation of small GTPase signalling proteins. This activity inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.
Pharmacokinetics
- Absorption
- Rapid absorption (~1 hr) after an oral dose, occurs throughout the upper gastrointestinal tract
- Distribution
- * 13.8 L/kg
- Metabolism
- No evidence found for metabolization of risedronate in humans or mammals
- Elimination
Clearance
* 122 mL/min * 73 mL/min [osteopenic postmenopausal women]
Toxicity
Side effects include abdominal pain, anxiety, back pain, belching, bladder irritation, bone disorders and pain, bronchitis, bursitis, cataracts, chest pain, colitis, constipation, depression, diarrhea, difficulty breathing, dizziness, dry eyes, eye infection, flu-like symptoms, gas, headache, high blood pressure, infection, insomnia, itching, joint disorders and pain, leg cramps, muscle pain, muscle weakness, nausea, neck pain, nerve pain, pain, pneumonia, rash, ringing in ears, sinus problems, sore throat, stomach bleeding, stuffy or runny nose, swelling, tendon problems, tumor, ulcers, urinary tract infection, vertigo, vision problems, and weakness.
Active Ingredient/Synonyms
Acide risédroniqe | Acido risedronico | Acidum risedronicum | Ridron | Risedronate | Risedronic acid | Risedronsäure | Risedronate |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.