TETRACAINE THEA 1 % eye drops solution in single-dose container 100 unit-dose/0,4 ml

VIDAL
Medicines
Update of the 19/03/2024

TETRACAINE THEA^®

Forms and presentations

Eye drops in solution at 1 % :  Single-dose containers of 0,4 ml, box of 100.

Composition

	single-dose p
Tetracaine hydrochloride	4 mg

Excipients: sodium chloride, sodium hydroxide solution 1N, water ppi.

Indications

All procedures requiring local anaesthesia of the cornea and conjunctiva, such as:

• Tonometry.
  
• Examinations using contact lens.
  
• Removal of superficial foreign bodies from the cornea and conjunctiva.
  

Dosage and administration

Dosage

1 drop of tetracaine solution one to two minutes before the examination or procedure.

A single instillation is sufficient to ensure corneoconjunctival anaesthesia for about ten minutes. To obtain deeper or longer-lasting anaesthesia, repeat the procedure 2 to 4 times at one-minute intervals.

Method of administration:

Instil the drop of eye drops into the lower conjunctival sac of the affected eye(s) while looking upwards and gently pulling the lower eyelid downwards.

The eye drops are sterile until the first opening of the single-dose container. To avoid any risk of contamination, do not touch any surface with the tip of the bottle. It must also not come into contact with the eye as this may cause eye injury and/or contamination.

In order to minimise systemic absorption of the medicine, patients should compress the lacrimal sac at the inner canthus during and after instillation of the drops (see Warnings and Precautions for Use).

Contraindications

This medicine is contraindicated in the following cases:

• Hypersensitivity to ester-type local anaesthetics.
  
• Known hypersensitivity to tetracaine or to any of the excipients.
  
• In premature newborns due to immaturity of the enzymatic metabolism system.
  

Warnings and precautions

Do not inject, do not swallow.

Tetracaine must not be prescribed for home use by patients. During anaesthesia, as the blink reflex is temporarily abolished by tetracaine, the eyes must be protected from any irritating chemical, foreign body or friction to prevent the anaesthetised cornea and conjunctiva from being damaged.

A deficiency in pseudocholinesterase is associated with an increased half-life of tetracaine, and consequently with local and systemic toxicity of the medicine. Frequent use interferes with the healing process and may cause corneal melting.

Incorrect use of local anaesthetics may lead to excessive absorption of the medicine into the bloodstream and may cause life-threatening systemic adverse events such as cardiac rhythm irregularities, epileptic seizures, breathing difficulties, coma, or even death of the patient. In order to minimise systemic absorption of the medicine, patients should be asked to press on the lacrimal sac at the inner corner of the eye during and after instillation of the drops (see Posology and Method of administration).

In ophthalmology, whether used alone or in combination, local anaesthetics all carry a risk of damage to the corneal epithelium, even at low concentrations.

Interactions

The data available to date do not suggest the existence of clinically significant interactions.

Fertility, pregnancy and breastfeeding

Women of childbearing potential:

There are no specific recommendations for women of childbearing potential.

Pregnancy:

Data available on the use of tetracaine in pregnant women are limited. Tetracaine should be used during pregnancy only if the expected benefits outweigh the risks to the foetus.

Breastfeeding:

As the passage of tetracaine into breast milk is not known, caution is required when it is administered to a breastfeeding woman.

Fertility:

There are no available data on the effect of tetracaine treatment on human fertility.

Driving and using machines

Visual disturbances, particularly in the case of corneal lesions, may impair the ability to drive vehicles or use machines. Patients must not drive vehicles or use machines until these disturbances have resolved. The physician will assess when the patient may resume driving vehicles or using machines.

Adverse effects

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.

Overdose

Repeated and prolonged use exposes the patient to a risk of serious eye damage, particularly to the cornea.

Pharmacodynamics

Pharmacotherapeutic class: Ophthalmological medicines, local anaesthetics (ATC code: S01HA03).

Tetracaine is a long-acting amino-ester. Like other local anaesthetics, tetracaine blocks nerve conduction by reducing the large transient increase in membrane permeability of nerve fibres to sodium ions (Na+) which, under normal conditions, results from a slight depolarisation of the membrane. The major and generally accepted mechanism of action of these medicines involves their interaction with one or more specific binding site(s) on sodium channels. Nerve conduction is blocked first in autonomic fibres, then in sensory fibres, and finally in motor fibres.

Pharmacokinetics

Preclinical safety

In conventional studies performed in animals, no teratogenic or developmental toxicity effect of tetracaine has been demonstrated. No mutagenic, carcinogenic or teratogenic effect is expected after ophthalmic administration of tetracaine. Repeated ophthalmic administration of tetracaine at 0,5% in rabbits showed no deleterious effect.

Storage conditions

No special precautions for storage.

Do not keep after opening.

HANDLING/DISPOSAL INSTRUCTIONS

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Prescription, supply and reimbursement

LIST I

For professional use only.
Marketing authorisation (AMM)	3400932161379 (1977, SmPC rev 11.01.2019).

Collection.

THÉA PHARMA
37, rue Georges-Besse
63100 Clermont-Ferrand

http://www.theapharma.fr