Amylmetacresol (0.6mg) + Dextromethorphan Hydrobromide (5mg)

Clinical Pharmacologist's Monograph

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

1. Clinical Overview

A fixed-dose combination lozenge used for the symptomatic relief of sore throat and associated dry, non-productive cough. Amylmetacresol is a topical antiseptic and local anesthetic for the throat, while Dextromethorphan is a centrally-acting antitussive. It is a widely used OTC product in India for upper respiratory tract infections.

OnsetDurationBioavailability
Amylmetacresol: Local effect within 2-5 minutes. Dextromethorphan: Systemic effect within 15-30 minutes.Amylmetacresol: Local anesthetic/antiseptic effect lasts 1-2 hours per lozenge. Dextromethorphan: Antitussive effect lasts 5-6 hours.Amylmetacresol: Negligible systemic absorption from oral mucosa. Dextromethorphan: Approximately 11% (extensive first-pass metabolism).

2. Mechanism of Action

Amylmetacresol acts locally on the oropharyngeal mucosa to denature bacterial proteins and fungal cell membranes, providing antiseptic action. It also has a mild local anesthetic effect, soothing throat pain. Dextromethorphan is a sigma-1 receptor agonist and NMDA receptor antagonist that acts centrally on the cough center in the medulla oblongata, raising the threshold for cough reflex.

3. Indications & Uses

  • Symptomatic relief of sore throat
  • Symptomatic relief of dry, non-productive (tickly) cough associated with upper respiratory tract infections (e.g., common cold, pharyngitis)

4. Dosage & Administration

Adult Dosage: One lozenge to be dissolved slowly in the mouth every 2-3 hours. Maximum: 8 lozenges in 24 hours.

Administration: Allow lozenge to dissolve slowly in the mouth. Do not chew or swallow whole. Do not consume food or drink immediately after taking the lozenge to prolong local effect. Use at regular intervals for symptomatic relief.

5. Side Effects

Common side effects may include:

  • Nausea
  • Gastrointestinal discomfort
  • Drowsiness
  • Dizziness
  • Local mouth numbness or irritation

6. Drug Interactions

DrugEffectSeverity
MAO Inhibitors (Phenelzine, Selegiline, Moclobemide)Risk of severe serotonin syndrome, hyperpyrexia, death.Contraindicated
SSRIs, SNRIs, Tricyclic AntidepressantsIncreased risk of serotonin syndrome.Major
Other CNS Depressants (Alcohol, Benzodiazepines, Opioids)Additive sedation and CNS depression.Major
CYP2D6 Inhibitors (Quinidine, Fluoxetine, Paroxetine)Increased Dextromethorphan plasma levels, increased risk of side effects.Moderate
Linezolid, Methylene BluePotential serotonin syndrome.Major

7. Patient Counselling

  • DO allow the lozenge to dissolve slowly in the mouth.
  • DO not exceed the recommended daily dose.
  • DO not use for persistent or chronic cough without consulting a doctor.
  • DO not give to children under 6 without medical advice.
  • DO not use if cough is productive with colored phlegm.
  • DO inform your doctor if you are taking antidepressants.

8. Toxicology & Storage

Overdose: Nausea, vomiting, drowsiness, dizziness, blurred vision, nystagmus, ataxia, respiratory depression, seizures, serotonin syndrome (agitation, hyperreflexia, hyperthermia), coma. In children, overdose can occur with as few as 4-5 lozenges.

Storage: Store below 30°C in a cool, dry place. Protect from light and moisture. Keep in original packaging. Keep out of reach and sight of children. Do not use after the expiry date printed on the pack.