Product Information
Registration Status: ActiveMINIMS TETRACAINE HYDROCHLORIDE EYE DROPS 1% W/V is approved to be sold in Singapore with effective from 1990-12-04. It is marketed by BAUSCH & LOMB (SINGAPORE) PTE LTD, with the registration number of SIN04204P.
This product contains Tetracaine 0.01g/mL in the form of SOLUTION. It is approved for OPHTHALMIC use.
This product is manufactured by LABORATOIRE CHAUVIN SA in FRANCE.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Tetracaine is an ester local anaesthetic currently available in combination with lidocaine as a cream and patch.
Indication
The combination lidocaine and tetracaine patch is indicated for local dermal analgesia for superficial dermatological procedures and superficial venous access. The combination lidocaine and tetracaine cream is intended to provide topical local analgesia for superficial dermatological procedures.
Mechanism of Action
Tetracaine is an ester-type anesthetic and produces local anesthesia by blocking the sodium ion channels involved in initiation and conduction of neuronal impulses.
Pharmacokinetics
- Absorption
- Systemic absorption of anaesthetic from the combination cream is directly related to the duration and surface area of application. Although peak plasma concentrations for lidocaine were measured, plasma levels for tetracaine could not be determined due to low levels (<0.9 ng/mL)
- Distribution
- Tetracaine is rapidly hydrolyzed in the plasma; therefore, volume of distribution could not be determined.
- Metabolism
- Tetracaine is rapidly hydrolyzed by plasma esterases to the following primary metabolites: para-aminobenzoic acid and diethylaminoethanol. The activity of both metabolites is unspecified.
- Elimination
Clearance
Tetracaine is hydrolyzed rapidly in the plasma; therefore, clearance has not been determined.
Toxicity
The most common adverse effects with the combination cream are localized reactions such as: erythema (47%), skin discoloration (16%), and edema (14%). Systemic adverse events were less common, occurring at a rate of <1% and included vomiting, headache, dizziness, and fever. Similar to other amide and ester anesthetics, CNS excitation and/or depression may occur. It is not well known at which plasma concentration systemic toxicity occurs with tetracaine; however, the threshold is thought to be much lower than that of lidocaine which is 1000 ng/mL.
Active Ingredient/Synonyms
2-(dimethylamino)ethyl 4-(butylamino)benzoate | 2-(Dimethylamino)ethyl p-(butylamino)benzoate | Amethocaine | Amethocaine HCl | Diäthylaminoäthanol ester der p-butylaminobenzösäure | Dicaine | Medihaler-Tetracaine | Metraspray | p-(butylamino)benzoic acid β-(dimethylamino)ethyl ester | p-Butylaminobenzoyl-2-dimethylaminoethanol | Tetracaína | Tétracaïne | Tetracaine HCl | Tetracaine |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.