Choline Salicylate (8.7% w/w) + Cetalkonium Chloride (0.01% w/w)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

A topical analgesic and anti-inflammatory solution primarily used for the relief of mild to moderate pain and inflammation associated with sore throat, pharyngitis, and tonsillitis. Choline Salicylate is a non-steroidal anti-inflammatory drug (NSAID) derivative of salicylic acid, providing local analgesic and anti-inflammatory effects. Cetalkonium Chloride is a quaternary ammonium compound (quat) antiseptic that provides local antibacterial and antifungal activity, helping to reduce microbial load in the oropharyngeal cavity. This combination is formulated as a mouth paint or gargle solution.

OnsetDurationBioavailability
Topical analgesic effect begins within 2-5 minutes of application.Local analgesic effect typically lasts for 2-4 hours.Systemic absorption of Choline Salicylate from the oral mucosa is minimal and variable, estimated to be less than 10-15% of the applied dose. Cetalkonium Chloride is poorly absorbed systemically.

2. Mechanism of Action

Choline Salicylate exerts its local analgesic and anti-inflammatory effects by inhibiting the enzyme cyclooxygenase (COX), both COX-1 and COX-2, at the site of application. This inhibition reduces the synthesis of prostaglandins, which are mediators of pain, inflammation, and fever. Its choline component may enhance local penetration. Cetalkonium Chloride is a cationic surfactant that disrupts microbial cell membranes, leading to leakage of cellular contents and death of bacteria and fungi. It provides a broad-spectrum antiseptic action, reducing secondary infection risk in inflamed tissues.

3. Indications & Uses

  • Symptomatic relief of pain and inflammation in acute sore throat
  • Symptomatic relief in pharyngitis
  • Symptomatic relief in tonsillitis

4. Dosage & Administration

Adult Dosage: Apply 1 ml of the solution (approx. 20 drops) undiluted to the affected area of the throat using the provided applicator or as a gargle (diluted with equal part water) 3 to 4 times daily, or as directed by the physician. For gargle, use for 30 seconds then spit out. Do not swallow.

Administration: Shake the bottle well before use. Use the calibrated dropper or applicator. Tilt head back, apply solution to the back of the throat. Avoid eating or drinking for at least 15-20 minutes after application. For gargle, dilute with an equal amount of water, gargle for 30 seconds, and spit out completely. Do not swallow the solution. Do not use for more than 5 consecutive days without medical advice.

5. Side Effects

Common side effects may include:

  • Transient local burning or stinging sensation at application site
  • Altered taste perception (bitter/metallic taste)
  • Temporary numbness of tongue or mouth
  • Dryness of mouth

6. Drug Interactions

DrugEffectSeverity
Anticoagulants (Warfarin, Acenocoumarol)Increased risk of bleeding due to additive antiplatelet effect of salicylate.Major
Other NSAIDs (Ibuprofen, Diclofenac)Increased risk of gastrointestinal side effects and reduced antiplatelet effect of aspirin (if used).Moderate
MethotrexateSalicylates can decrease renal clearance of methotrexate, increasing its toxicity.Major
Sulfonylureas (Glibenclamide, Glimepiride)Salicylates may potentiate hypoglycemic effect.Moderate
Valproic AcidSalicylates can displace valproic acid from protein binding sites, increasing its free concentration and toxicity.Moderate
Corticosteroids (e.g., Prednisolone)Increased risk of gastrointestinal ulceration.Moderate
ACE Inhibitors (e.g., Ramipril)Salicylates may reduce the antihypertensive effect.Moderate
DiureticsSalicylates may reduce the efficacy of diuretics in heart failure.Moderate
ProbenecidSalicylates antagonize the uricosuric effect of probenecid.Major

7. Patient Counselling

  • DO shake the bottle well before each use.
  • DO use the exact dose as prescribed, using the provided dropper.
  • DO avoid eating or drinking for at least 15-20 minutes after application.
  • DO spit out the solution after gargling. Do NOT swallow.
  • DO inform your doctor if you are pregnant, planning pregnancy, or breastfeeding.
  • DO inform your doctor about all other medicines you are taking, including OTC drugs and herbal supplements.
  • DON'T use for more than 5 days unless directed by your doctor.
  • DON'T give this medicine to children under 16 years of age without consulting a doctor.
  • DON'T use if you are allergic to aspirin or other salicylates.
  • DON'T drive or operate machinery if you feel dizzy or experience ringing in your ears.

8. Toxicology & Storage

Overdose: Acute overdose is unlikely with topical use but can occur from accidental ingestion of a large volume. Symptoms of salicylate poisoning (salicylism) include: Tinnitus, hearing loss, vertigo, hyperventilation (respiratory alkalosis followed by metabolic acidosis), nausea, vomiting, sweating, tachycardia, hyperpyrexia, restlessness, confusion, seizures, coma, respiratory failure, and cardiovascular collapse. Cetalkonium Chloride ingestion can cause nausea, vomiting, diarrhea, and mucosal irritation.

Storage: Store at room temperature (15-30°C), protected from light and moisture. Keep the bottle tightly closed. Keep out of reach and sight of children. Do not freeze. Do not use after the expiry date printed on the label. Discard any unused medicine properly, do not flush down the toilet or pour into drains.