Dextromethorphan/ Benzocaine/ Cetylpyridinium

Registered South African indications: 

• Cough
• Sore throat

Registered South African contraindications

• Hypersensitivity or known idiosyncrasy to the active ingredient or any of the excipients in this combination product
• Patients with low plasma cholinesterase concentrations (Benzocaine)
• Patients receiving anticholinesterases (Benzocaine)

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

South African recommendations

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly

Severe sore throat

• Advise patients to consult a doctor if sore throat is severe, accompanied by high fever, headache, nausea, vomiting, or persists more than two days

Use in children

• Not for use in children under 6 years

Contains sucrose

• Not suitable for patients with hereditary conditions like fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency

Diabetes mellitus

• Sucrose and anhydrous liquid glucose in the product may affect glycaemic control in diabetic patients

Dextromethorphan

General warning

• Not for patients with or at risk of respiratory failure. Can cause severe reactions with monoamine oxidase inhibitors, including hyperpyrexia and fatalities
• Subject to abuse but no evidence of morphine-type dependence

Benzocaine

Benzocaine should be given cautiously to

• Elderly
• Children
• Epilepsy
• Patients with impaired cardiac conduction or respiratory function
• Shock
• Liver damage
• Patients with myasthenia gravis are particularly sensitive to the effects of local anaesthetics

Forms avail. in SA and covered in this monograph: loz

South African registered indications and dosages

Cough
- For rapid and continuous relief of coughs due to colds
Sore throat
- To alleviate and soothe sore throats irritated by continual coughing and inflammation caused by colds and other throat irritations associated with dust, allergy, smoke, etc.

Dextromethorphan/ Benzocaine/ Cetylpyridinium
4.98/1.25/0.5 (mg)

• Oral: (loz): 2 discs, 3hrly dissolved in the mouth one at a time

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Do not exceed the recommended dose

Paed. forms avail. in SA and covered in this monograph: loz

South African registered indications and dosages

Cough
- For rapid and continuous relief of coughs due to colds
Sore throat
- To alleviate and soothe sore throats irritated by continual coughing and inflammation caused by colds and other throat irritations associated with dust, allergy, smoke, etc.

Dextromethorphan/ Benzocaine/ Cetylpyridinium
4.98/1.25/0.5 (mg)

• Younger than 6 years: Not established for use
• Between 6-12 years: Oral (loz): 1 disc, 3hrly dissolved in the mouth
• Older than 12 years: See adult dosage

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Do not exceed the recommended dose

Pregnancy 

South African recommendations

• Caution; no information available

Breastfeeding

South African recommendations

• Caution; no information available

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no dose adjustment recommended
  Benzocaine should be given cautiously to patients with liver damage

South African recommendations

• Caution; no dose adjustment recommended
  Benzocaine should be given cautiously to the elderly

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Dextromethorphan/ Benzocaine/ Cetylpyridinium

Blood and the Lymphatic System Disorders

Frequency not specified

• Methemoglobinemia

Dextromethorphan Hydrobromide

Gastrointestinal Disorders

Very occasionally

• Gastrointestinal disturbances

Nervous System Disorders

Very occasionally

• Drowsiness
• Dizziness
• Excitation

Benzocaine

Nervous System Disorders

Frequency not specified

• Excitation of the central nervous system (manifested by yawning, restlessness, excitement, nervousness, dizziness, tinnitus, blurred vision, nystagmus, nausea and vomiting, muscle twitching and tremors and convulsions)
• Depression with drowsiness, respiratory failure, and coma (following excitation)
• Numbness of the tongue and perioral regions (early sign of systemic toxicity)

Cardiac Disorders

Frequency not specified

• Myocardial depression
• Peripheral vasodilation (resulting in hypotension)
• Bradycardia
• Arrhythmias
• Cardiac arrest

Immune System Disorders

Frequency not specified

• Allergic reactions
• Idiosyncratic reactions

General Disorders and Administration Site Conditions

Frequency not specified

• Impaired swallowing
• Increased risk of aspiration (when used in the mouth or throat)

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Dextromethorphan

• Monoamine oxidase inhibitors

Benzocaine

• Anticholinesterases

Cetylpyridinium

• No information available

None routine 

Dextromethorphan
Dextromethorphan hydrobromide is a non-narcotic antitussive agent which is believed to inhibit the cough reflex by acting on the cough centre in the medulla. Clinical studies in patients with both acute and chronic cough have demonstrated significant cough suppression. It has a relatively long antitussive action lasting from 6 to 8 hours.

Benzocaine
Benzocaine has a mild local anaesthetic action which helps to alleviate sore or irritated throats.

Cetylpyridinium
Laboratory studies show that cetylpyridinium chloride has a marked bactericidal action against a wide range of bacteria and is effective against pathogenic organisms which are associated with sore throats due to colds. It also has antifungal properties. By lowering surface tension (detergent action) it spreads over the oral and pharyngeal mucosa to loosen and disperse bacterial laden mucous in the mouth and throat.

COMBINATION PREPARATIONS

Dextromethorphan/ Benzocaine/ Cetylpyridinium

Lozenges 4.98mg/1.25mg/1.25mg 

• Cepacol Sore Throat And Cough Relief Discs (Adcock) originator