Product Information
Registration Status: ActiveSIN04948P
ORA-SED JEL is approved to be sold in Singapore with effective from 1990-07-16. It is marketed by INOVA PHARMACEUTICALS (SINGAPORE) PTE LTD, with the registration number of SIN04948P.
This product contains Benzalkonium Chloride 0.1mg/ml, and Choline Salicylate 0.09ml/ml in the form of GEL. It is approved for ORAL use.
This product is manufactured by HAMILTON PHARMACEUTICAL PTY LTD in AUSTRALIA.
It is an Over-the-counter Medicine that can be freely obtained from any retailer
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}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.
Description
Choline salicylate is an anti-inflammatory pain reliever agent that is related to aspirin. It is used to decrease swelling and to treat mild-moderate pain. It is used to treat arthritis in both children and adults. This medicine can also be used for fever [L2129]. Choline Salicylate is the choline salt of salicylic acid, used as an analgesic, antipyretic and antirheumatic. It relieves mild to moderate pain and reduce fever and inflammation or swelling. Choline salicylate is effective in the treatment of gout, rheumatic fever, rheumatoid arthritis and muscle injuries [L2136]. This drug is also a main ingredient in teething gels to relieve pains associated with tooth growth in the infant population [L2134]. The UK government has regulated its use, due to toxicity in those under 16 years of age. Topical oral salicylate gels are no longer indicated for people younger than 16 years for pain associated with infant teething, orthodontic devices, cold sores, or mouth ulcers [L2134].
Indication
The oral gel is indicated for the relief of pain and discomfort of common mouth ulcers, cold sores, denture sore spots, infant teething and mouth ulcers, and sore spots due to orthodontic devices in children [L2135].
Mechanism of Action
Choline salicylate relieves pain by inhibition of prostaglandin synthesis and reduces fever by acting on the hypothalamus heat-regulating center. It also inhibits the generation of impulses through the inhibition of cyclooxygenase enzyme (COX) [L2132], [L2136]. Cyclooxygenase is involved in the production of prostaglandins, in response to injury and after various other stimuli. The prostaglandins promote pain, swelling, and inflammation. The choline salicylate decreases inflammation and pain by reducing the production of these prostaglandins in the area of the mouth it is applied to [L2137].
Pharmacokinetics
- Absorption
- Onset: 1-2 hr after ingestion [L2133] In the oral form, choline salicylate is absorbed across the buccal mucosa. There is a need for caution not to exceed the stated dose and monitor for any signs of suggested salicylism, especially when this drug is used for infants [L2135]. In one study, it was found that this drug was more rapidly absorbed than ASA (absorption t1/2 = 0.1 vs 0.36 h) [L2138].
- Distribution
- 0.15 L/kg (salicylate), and widely distributed throughout extracellular water and most tissues [L2139]
- Metabolism
- The metabolism of salicylic acid is by glycine and phenolic or acyl glucuronate conjugation with small amounts of the drug undergoing hydroxylation [L2139]. Extensively metabolized in the liver; inactive metabolites are excreted by the kidneys [L2142].
- Elimination
Toxicity
LD50, oral in mouse: 2690mg/kg [L2125]. Ld50, subcutaneous in mouse: 1gm/kg [L2125]. Interferes with thyroid function test [L2132]. Gastrointestinal (GI) disorders, fatigue, hypersensitivity reactions, skin eruptions, hemolytic anemia, weakness, dyspnoea; local irritation (rectally); Reye's syndrome. **Potentially Fatal:** Paroxysmal bronchospasm; hepatotoxicity; renal impairment/failure; thrombocytopenia, iron-deficiency anemia, occult bleeding, leukopenia; mild chronic salicylate intoxication [L2132]. Salicylate poisoning is normally associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths due to salicylate poisoning occur in patients whose serum concentrations of salicylate are over 700 mg/L (5.1 mmol/L). Single doses of less than 100 mg/kg are very unlikely to lead to serious poisoning. Patients should be provided with supportive therapy or treatment for salicylate poisoning as necessary. This may include treatment like activated charcoal, urinary alkalinization and, in severe cases, hemodialysis [L2139].
Active Ingredient/Synonyms
Choline salicylate | Choline salicylate |
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.