Tetracaine

Registered South African indications:

• Pain
• Inflammation
• Cold sores
• Mouth ulcers
• Denture irritation

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to local anaesthetics of the ester type
• Hypersensitivity to para-aminobenzoic acid and its derivatives
• Low plasma-cholinesterase concentrations or in those receiving anticholinesterases

Cautions

• Pregnancy
• Breastfeeding
• Renal function
• Hepatic function
• Instillation into the middle ear or use in
  procedures which might involve penetration into the middle ear
• Repeated exposure
• Epilepsy

Forms avail in SA and covered in this monograph: oin

Pain 
Inflammation 
Cold sores
Mouth ulcers 
Denture irritation

• Topical (oin): Apply small quantity to the affected area, 5-7hrly; Max: 3 applications/24hrs

When wearing new dental prothesis, the gums, palate and the prosthesis should be covered with a thin layer

No information available

Pregnancy 

• Caution
• There are no adequate data from the use of tetracaine in pregnant women. There are no animal studies to indicate direct or indirect harmful effects with respect to reproductive toxicity
• The rapid hydrolysis of tetracaine by plasma pseudocholinesterase means that it is unlikely to present a significant hazard to the foetus when used as indicated
• As a precautionary measure, it is preferable to avoid the use of tetracaine during pregnancy

Breastfeeding 

• Caution
• It is not known whether tetracaine or its metabolites are secreted in breast milk. A risk to the new-borns/ infants cannot be excluded. Therefore the product is not recommended for use on breastfeeding mothers

Fertility

• There are no clinical data regarding the potential effect of tetracaine on fertility

Renal Impairment

• Caution; no information available

Hepatic Impairment 

• Caution; no information available 

Elderly 

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Non-regulated product
• Non-regulated products are not subjected to rigorous controls to verify its efficacy, safety, nor that the ingredients, dosages and claims listed on the label are indeed accurate, therefore authorities caution athletes against the risk of using these products

Skin and Subcutaneous Tissue Disorders

• Application site reactions
  - Erythema
  - Oedema
  - Pruritus
  - Vesicles
  - Blistering
  - Itching

None known

None routine

Overdose

• Overdosage with tetracaine is unlikely to result from application to intact skin
• If accidentally ingested systemic toxicity may occur, and signs will be similar to those observed after administration of other local anaesthetics
• These signs have been described as: signs of inebriation, tingling, numbness of the tongue, tinnitus, nystagmus, nausea or vomiting, twitching and convulsions
• Oxygen is recommended as the first-line treatment for systemic toxicity

Tetracaine is a local anaesthetic and is believed to act by blocking nerve conduction mainly by inhibiting sodium ion flux across the axon membrane. Tetracaine achieves this by acting upon specific receptors that control gating mechanisms responsible for conductance changes in specialised proteinaceous sodium channels. Blocking sodium ion flux prevents the setting up of an action potential in the nerve axon, thus preventing pain receptors signalling to the central nervous system.

Ointment (per 10g) 50mg

• Dynexan (Restan/Adcock) originator

Also available in the following forms: Cream and eye drop.