Tetracaine Throat Spray 0.5%

Administered as a topical oropharyngeal spray. Direct the nozzle toward the posterior pharynx and spray the directed number of actuations. Instruct the patient to avoid swallowing immediately after application and not to eat or drink until sensation fully returns (typically 30–60 minutes). The spray should not be swallowed. Avoid spraying into the eyes or near open wounds.

Apply as directed by the prescriber. Typical use involves 1–3 sprays (or actuations) to the oropharyngeal mucosa immediately before a procedure or as needed for symptomatic relief. Onset of anesthesia is rapid (1–5 minutes); duration of effect is approximately 30–60 minutes.

• Do not exceed the prescribed number of applications.
• The maximum safe mucosal dose for tetracaine is generally cited as 20 mg in adults; the 0.5% formulation delivers 5 mg per mL, limiting systemic exposure at therapeutic spray volumes.
• All dosing decisions are made by the prescribing clinician.

• Tetracaine: An ester-type local anesthetic that penetrates mucosal membranes and binds to voltage-gated sodium channels (Na+) on the intracellular side, stabilizing the channel in its inactivated state. This prevents sodium influx, inhibits neuronal membrane depolarization, and blocks conduction of sensory impulses—producing reversible, localized anesthesia without loss of consciousness. The ester linkage is hydrolyzed by plasma and tissue esterases, limiting systemic accumulation.

Topical tetracaine spray provides surface anesthesia of the oropharynx, larynx, and trachea prior to or during oropharyngeal procedures (e.g., endoscopy, laryngoscopy, nasopharyngeal intubation) or for symptomatic throat conditions under prescriber direction. It does not provide systemic analgesia. Careful application is required to avoid over-anesthesia of the gag reflex and aspiration risk.

Clinical considerations:

• Suppression of the gag reflex: instruct patients not to eat or drink until sensation fully returns to prevent aspiration.
• Monitor for systemic absorption in patients with mucosal disruption or with multiple spray applications.
• Avoid use in patients with known cholinesterase deficiency (impaired ester hydrolysis).
• Use with caution in patients with cardiovascular disease; systemic local anesthetic absorption at high doses may cause cardiovascular toxicity.

Contraindications:

• Known hypersensitivity to tetracaine, other ester local anesthetics, or para-aminobenzoic acid (PABA)
• Cholinesterase deficiency (reduced ester hydrolysis capacity)
• Application to infected or severely traumatized mucosa (increased absorption risk)

Warnings & Precautions:

• Aspiration risk: the spray suppresses gag reflex; do not allow eating or drinking until sensation returns
• Systemic toxicity: CNS excitation (tremors, convulsions) and cardiovascular depression (bradycardia, hypotension) can occur with excessive absorption; use minimum effective dose
• Methemoglobinemia: rare with ester anesthetics at therapeutic doses but possible; avoid in patients susceptible to oxidative stress
• Cross-reactivity between ester local anesthetics (tetracaine, benzocaine, procaine)

Drug Interactions:

• Sulfonamide antibiotics: PABA metabolite of tetracaine may antagonize sulfonamide activity
• Cholinesterase inhibitors: may prolong tetracaine effect
• Other local anesthetics: additive toxicity risk if combined

Common Side Effects: Temporary burning or tingling on application, transient numbness, altered taste, and gag reflex suppression. Systemic effects (dizziness, tinnitus, palpitations) indicate excessive absorption.

Store at room temperature (15–25°C) in a tightly sealed container, protected from light and heat. Do not freeze. Keep away from children. Use within the beyond-use date specified by Genesis Compounding. Discard unused solution after the BUD.

What is tetracaine throat spray used for?

It provides temporary surface anesthesia (numbing) of the throat and oropharynx. Common uses include reducing discomfort before procedures such as throat scopes (laryngoscopy or endoscopy) or intubation, and for prescriber-directed symptomatic management.

How quickly does this spray work?

Onset is typically within 1–5 minutes of application. The numbing effect generally lasts 30–60 minutes depending on the area treated and number of sprays used.

Why can't I eat or drink after the spray?

The spray numbs your gag reflex and throat muscles. Eating or drinking before sensation fully returns risks silent aspiration of food or liquid into the airway. Wait until you can feel normal sensation before swallowing anything.

Is this FDA-approved?

This is a 503A compounded preparation prepared by Genesis Compounding for a specific patient. Tetracaine is an established pharmacologic agent; this specific spray formulation and concentration are compounded and not independently FDA-approved.

Who should not use tetracaine spray?

Patients with known allergies to ester local anesthetics (benzocaine, procaine, tetracaine) or PABA, or those with cholinesterase deficiency, should not use this product. Discuss your medication allergies with your prescriber before use.