Product Information
Registration Status: InactiveTHIS PRODUCT HAS BEEN DEREGISTERED!
BYDUREON POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED PEN 2MG is approved to be sold in Singapore with effective from 2016-10-10. It is marketed by ASTRAZENECA SINGAPORE PTE LTD, with the registration number of SIN15095P.
This product contains Exenatide 2mg in the form of SUBCUTANEOUS INJECTION, POWDER, FOR SUSPENSION, EXTENDED-RELEASE. It is approved for SUBCUTANEOUS use.
This product is manufactured by Amylin Ohio LLC in UNITED STATES.
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.
Description
Exenatide, derived from a compound found in the saliva of the Gila monster, a large lizard native to the southwestern US, is a functional analog of Glucagon-Like Peptide-1 (GLP-1), a naturally occuring peptide.
Indication
Indicated as adjunctive therapy to improve glycemic control in patients with Type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of both, but have not achieved adequate glycemic control.
Mechanism of Action
Exenatide is a functional analog of the human incretin Glucagon-Like Peptide-1 (GLP-1). Incretins enhance glucose-dependent insulin secretion and exhibit other antihyperglycemic actions following their release into the circulation from the gut. The GLP-1 system increases insulin secretion only in the presence of elevated plasma glucose levels, avoiding inappropriately high insulin levels during fasting. The drug also moderates peak serum glucagon levels during hyperglycemic periods following meals, but does not interfere with glucagon release in response to hypoglycemia. Secondary effects of drug administration reduces the rate of gastric emptying and decreases food intake, mitigating the potential severity of hyperglycemic events after meals.
Pharmacokinetics
- Absorption
- Following subcutaneous administration to patients with type 2 diabetes, exenatide reaches median peak plasma concentrations in 2.1 hours.
- Distribution
- * 28.3 L
- Metabolism
- Elimination
Clearance
* Apparent cl=9.1 L/hr
Toxicity
Effects of the overdoses included severe nausea, severe vomiting, and rapidly declining blood glucose concentrations.
Active Ingredient/Synonyms
AC 2993 | AC-2993 | AC002993 | AC2993 | AC2993a | Exenatide | Exenatide synthetic | Synthetic exendin-4 | Exenatide |
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.