International reference: 6 US FDA recalls for this ingredient
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. (tetracaine)
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. (tetracaine)
Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY. (tetracaine)
CGMP Deviations (tetracaine)
CGMP Deviations (tetracaine)
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product. (tetracaine)
US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Zambia.
ACAINE-T
TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP 0.5% W/V
What it does
Tetracaine is a local anesthetic used to numb specific areas of the body.
Commonly used for: local pain relief, numbing during minor surgical procedures
Read more in plain English ↓Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.
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Sourcing - Kenya onlyRegistration & product details
Source: Zambia Medicines Regulatory Authority · fetched 2026-06-28 06:24:36 · updated 2026-09-17 03:36:52
About this medicine
Tetracaine is a local anesthetic used to numb specific areas of the body.
What it treats
- local pain relief
- numbing during minor surgical procedures
How it works
It works by blocking nerve signals in the area where it is applied, preventing pain sensation.
Who it's for
It is suitable for adults and children needing localized numbing for procedures.
Cautions
- • Be cautious if you are taking other medications that can cause drowsiness or sedation.
AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.
Clinical monograph: Tetracaine
BNF-referencedTetracaine, also known as Amethocaine, is an ester-type local anesthetic commonly used for inducing local anesthesia in various medical procedures, particularly in ophthalmic applications. It acts by blocking nerve signal transmission to temporarily numb the area where it is applied. Tetracaine is often utilized during surgical procedures involving the eye, such as cataract surgery, and is also indicated for post-operative pain management.
Indications
- Local anaesthesia
- Post-operative pain and inflammation
- Intraocular anaesthesia during cataract surgery
Dosage
Children: Refer to the BNF for Children for appropriate dosing information.
Adults: Apply as required, specific dosing may vary based on clinical circumstance.
Mechanism of action
Tetracaine produces local anesthesia by blocking sodium ion channels involved in the initiation and conduction of neuronal impulses. This inhibition prevents the propagation of action potentials along nerves, leading to a loss of sensation in the targeted area.
Pharmacodynamics
As a local anesthetic, tetracaine exhibits a rapid onset of action and provides prolonged anesthesia compared to some other local anesthetics. It is highly lipid-soluble, which enhances its ability to penetrate nerve membranes and effectively block nerve conduction.
Pharmacokinetics
Tetracaine is primarily metabolized in the liver via hydrolysis by esterases. The onset of action is usually within minutes, with a duration of anesthesia that can last from 1 to 3 hours, depending on the concentration and method of administration. It is important to note that systemic absorption can occur, and caution is advised in patients with conditions that may be exacerbated by systemic exposure.
Contra-indications
- Known hypersensitivity to tetracaine or other ester-type local anesthetics
- History of acute, narrow-angle glaucoma
- Conditions where systemic exposure to tetracaine could be harmful
Adverse effects
- Dermatitis
- Eye disorders
- Headache
- Hyperaemia
- Hypertension
- Keratitis
Interactions
- Anaesthetics, local
- Antiarhythmics
- Sympathomimetics
- Vasoconstrictors
Precautions
- Use with caution in patients with a history of seizures, cardiac conditions, or respiratory issues
- Risk of floppy iris syndrome
- Patients should be counseled about effects on driving and skilled tasks
Pregnancy
Manufacturer advises avoiding use during pregnancy as systemic uptake cannot be excluded; insufficient data available for tetracaine in pregnancy.
Breast-feeding
Manufacturer advises avoiding use during breastfeeding; tetracaine is present in milk in small amounts.
Storage
Store in a cool, dry place, away from light. Protect from freezing.
Formulations
- Tetracaine 40 mg per 1 gram gel for local anaesthesia
- Tetracaine solution for injection in ampoules
AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.
Molecular reference: Tetracaine
PubChem CID 5411Molecular formula: C15H24N2O2
Mechanism of action
Tetracaine is an ester-type anesthetic and produces local anesthesia by blocking the sodium ion channels involved in the initiation and conduction of neuronal impulses.
Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.
This drug in other countries
The same active ingredient registered across other registries we cover - including different brands.