Phenazone/ Procaine/ Potassium Hydroxyquinoline Sulphate

Registered South African indications:

• Otitis media 
• Infection or inflammation of the ear

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

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Wherever possible, children with earache should be taken to a doctor

Cautions

Route of application

• For external use only

Response to therapy

• If the earache does not respond quickly to treatment, the patient should consult a doctor, as ear infections can be dangerous

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

Otitis media
Infection of the ear
Inflammation of the ear

Phenazone/ Procaine/ Potassium hydroxyquinoline sulphate
50/10/1 (mg/1g)

• Otic (dro): 2-3 drops into the affected ear(s), 4hrly 

Not established for use in children 

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• FDA Pregnancy Category C (Phenazone, Procaine)

Breastfeeding

• Caution; not recommended (Phenazone) 

Renal Impairment

• Caution; dose adjustment recommended (Procaine)

Hepatic Impairment

• Caution; dose adjustment recommended (Procaine)

Elderly

• Caution; dose adjustment recommended (Procaine)

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

Phenazone 

Skin and Subcutaneous Tissue Disorders

• Skin eruptions

Immune disorders

• Hypersensitivity reactions

Procaine

Central Nervous System Disorders

• Nervousness
• Dizziness
• Tremors
• Seizures 
• Myasthenia gravis 

Cardiovascular Disorders

• Hypertension
• Bradycardia
• Ventricular arrhythmias 
• Cardiac arrest 

Gastrointestinal Disorders

• Nausea and vomiting

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Oedema 

Sensory Disorders

• Blurred vision

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

Phenazone

• No information available 

Procaine

• Buproprion
• Donepezil 
• Hyaluronidase 
• St John's wort
• Sulphonamides

None routine 

Phenazone
Thought to act primarily in the central nervous system, increasing the pain threshold by inhibiting cyclooxygenase, involved in prostaglandin synthesis. 

Procaine
Procaine is an ester type local anaesthetic, which stabilises the neuronal membranes and prevents initiation and transmission of nerve impulses, by decreasing the transient increase in permeability to sodium through the inhibition of voltage-gated sodium channels. 

Potassium hydroxyquinoline sulphate
This ingredient has no pharmacological effect. 

COMBINATION PREPARATIONS

Phenazone/ Procaine/ Potassium hydroxyquinoline sulphate

Ear drops (per g) 50mg/10mg/1mg

• Universal Earache (Litha) originator