Product Information
Registration Status: ActiveSIN14582P
ALENDRONATE SANDOZ FILM COATED TABLET 70MG is approved to be sold in Singapore with effective from 2014-11-08. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN14582P.
This product contains Alendronic Acid 70mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by Lek Pharmaceuticals d.d. in SLOVENIA.
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
Alendronic acid (alendronate) is a nitrogen-containing, second generation bisphosphonate. Bisphosphonates were first used to treat Paget’s disease in 1971. This class of medications is comprised of inorganic pyrophosphate analogues that contain non-hydrolyzable P-C-P bonds. Similar to other bisphosphonates, alendronate has a high affinity for bone mineral and is taken up during osteoclast resorption. Alendronate inhibits farnesyl pyrophosphate synthetase, one of the enzymes in the mevalonic acid pathway involved in producing isoprenoid compounds that are essential for post-translational modification of small guanosine triphosphate (GTP)-binding proteins, such as Rho, Ras and Rab. Inhibition of this process interferes with osteoclast function and survival. Alendronate is used for the treatment of osteoporosis and Paget’s disease.
Indication
For the treatment and prevention of osteoporosis in women and Paget's disease of bone in both men and women.
Mechanism of Action
The action of Alendronate on bone tissue is based partly on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Alendronate 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
- Relative to an intravenous (IV) reference dose, the mean oral bioavailability of alendronate in women was 0.7% for doses ranging from 5 to 40 mg when administered after an overnight fast and two hours before a standardized breakfast. Oral bioavailability of the 10 mg tablet in men (0.59%) was similar to that in women (0.78%) when administered after an overnight fast and 2 hours before breakfast.
- Distribution
- * 28 L
- Metabolism
- There is no evidence that alendronate is metabolized in humans or animals.
- Elimination
Clearance
*
Toxicity
Alendronate can damage the esophagus both by toxicity from the medication itself and by nonspecific irritation secondary to contact between the pill and the esophageal mucosa, similar to other cases of "pill esophagitis."
Active Ingredient/Synonyms
(4-amino-1-hydroxybutane-1,1-diyl)bis(phosphonic acid) | (4-amino-1-hydroxybutylidene)bisphosphonic acid | 4-amino-1-hydroxybutane-1,1-diphosphonic acid | ABDP | Acide Alendronique | Acido Alendronico | Acidum Alendronicum | Alendronate | Alendronic acid |
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.