pharmacopeia
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/api/v1/drug/tetracaine

Mechanism of action

Sourced from openFDA

Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.

Indications

Sourced from openFDA
  • Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine Hydrochloride Ophthalmic Solution 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.

Contraindications

Sourced from openFDA
  • None.contraindicated

Dosage & administration

Sourced from openFDA

One drop topically in the eye(s) as needed. Discard unused portion. ( 2.1 ) 2.1 Topical Administration One drop topically in the eye as needed. Discard unused portion. 2.2 Sterile Field Administration Open package using standard aseptic technique. The DROP‑TAINER ® dispenser may then be allowed to fall upon a sterile surface. The entire outer surface of the DROP‑TAINER ® dispenser and its contents are sterile.

Warnings & precautions

Sourced from openFDA

Do not use intracamerally since use may damage corneal endothelial cells ( 5.1 ) Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. ( 5.2 ) Patients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. ( 5.3 ) For Administration by Healthcare Provider: Tetracaine Hydrochloride Ophthalmic Solution 0.5% is not intended for patient self-administration. ( 5.4 ) 5.1 Corneal injury with Intracameral Use Not for injection or intraocular use. Do not use intracamerally because use of TetracaineHydrochloride Ophthalmic Solution 0.5% may lead to damage of the corneal endothelial cells. 5.2 Corneal Toxicity Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. 5.3 Corneal Injury due to Insensitivity Patients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. 5.4 For Administration by Healthcare Provider Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for administration under the direct supervision of a healthcare provider. Tetracaine Hydrochloride Ophthalmic Solution 0.5% is not intended for patient self-administration [ see Warnings and Precautions ( 5.2 )].

Adverse reactions

Sourced from openFDA

The following serious ocular adverse reactions are described elsewhere in the labeling: Corneal injury with Intracameral Use [See Warnings and Precautions (5.1) ] Corneal Toxicity [See Warnings and Precautions (5.2) ] Corneal Injury due to Insensitivity [ See Warnings and Precautions (5.3) ] The following adverse reactions have been identified following use of Tetracaine Hydrochloride Ophthalmic Solution 0.5%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ocular Adverse Reactions Transient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort. Ocular adverse events: stinging, burning, conjunctival redness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc., at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution 0.5% in pregnant women. Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature. 8.2 Lactation Risk Summary There are no data to assess whether Tetracaine Hydrochloride Ophthalmic Solution 0.5% is excreted in human milk or to assess its effects on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tetracaine Hydrochloride Ophthalmic Solution 0.5% and any potential adverse effects on the breastfed child from Tetracaine Hydrochloride Ophthalmic Solution 0.5% or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution 0.5% on fertility are available. 8.4 Pediatric Use Safety in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population.

Pharmacokinetics

Sourced from openFDA
Metabolism
The systemic exposure to tetracaine following topical ocular administration of Tetracaine Hydrochloride Ophthalmic Solution 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.

Overdosage

Sourced from openFDA

Prolonged use of a topical ocular anesthetic including TetracaineHydrochloride Ophthalmic Solution 0.5% may produce permanent corneal opacification and ulceration with accompanying visual loss. Symptoms related to systemic toxicity consist mainly of effects on the neurologic and cardiovascular systems.

Approval history

Sourced from openFDA
  • Jun 29, 2006NDANDA021717Crescita Therap
  • Feb 29, 2016NDANDA208135Alcon Labs
  • Mar 12, 2019NDANDA210821Bausch Lomb Ireland
  • Dec 20, 2024ANDAANDA217227Somerset Theraps Llc

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
615 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Toxic Anterior Segment Syndrome599.6%
  2. 2Off Label Use518.3%
  3. 3Endophthalmitis396.3%
  4. 4Inflammation386.2%
  5. 5Erythema335.4%
  6. 6Eye Pain315.0%
  7. 7Vision Blurred315.0%
  8. 8Drug Hypersensitivity284.6%
  9. 9Eye Irritation284.6%
  10. 10Nausea274.4%
  11. 11Drug Ineffective264.2%
  12. 12Headache264.2%
  13. 13Fatigue233.7%
  14. 14Pain233.7%
  15. 15Visual Impairment233.7%

Literature

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Recent PubMed references pinned to Tetracaine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 149 ClinicalTrials.gov registrations naming Tetracaine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Tetracaine work?
Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.
What is Tetracaine used for?
According to FDA labeling, Tetracaine carries indications including: Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. Tetracaine Hydrochloride Ophthalmic Solution 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Tetracaine?
Tetracaine is classified as Anesthetics for topical use, Esters of aminobenzoic acid, Local anesthetics, Ester Local Anesthetic, Sodium Channel Interactions, Decreased Sensory-Somatic Nervous System Organized Electrical Activity, Local Anesthesia.
What are the brand names for Tetracaine?
Tetracaine is marketed under brand names including Altacaine, Cetacaine, Kovanaze, Neo-Predef, Numfast, Pliaglis, Pontocaine, Synera.
What are the contraindications for Tetracaine?
Tetracaine labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.
Note. Data for tetracaine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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