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Benzocaine, butamben, and tetracaine: Drug information

Benzocaine, butamben, and tetracaine: Drug information
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Brand Names: US
  • Cetacaine
Pharmacologic Category
  • Local Anesthetic
Dosing: Adult
Anesthesia, topical

Anesthesia, topical:

Gel: Apply 200 mg (~1/4 to 1/2 inch); application of >400 mg (>1 inch) is contraindicated

Liquid: Apply 200 mg (~0.2 mL); application of >400 mg (~0.4 mL) is contraindicated

Spray: Apply for ≤1 second; use of sprays >2 seconds is contraindicated. Note: Spray provides ~200 mg/second

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Dose reduction is suggested; refer to adult dosing.

Dosing: Pediatric

(For additional information see "Benzocaine, butamben, and tetracaine: Pediatric drug information")

Anesthesia, topical

Anesthesia, topical:

Children ≥2 years and Adolescents: Appropriate pediatric dose has not been established; the manufacturer recommends reducing the dosage in very young patients, but does not provide a specific age or reduction.

Gel: Topical: Apply up to 200 mg (~1/4 to 1/2 inch); maximum dose: 400 mg/dose (~1 inch).

Liquid: Topical: Apply up to 200 mg (~0.2 mL); maximum dose: 400 mg/dose (~0.4 mL).

Spray: Topical: Apply for ≤1 second (spray provides ~200 mg/second); maximum dose: 2 seconds (~400 mg).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined. Also see Benzocaine and Tetracaine monographs.

Dermatologic: Contact dermatitis (eg, erythema, local oozing, localized vesiculation, pruritus), eschar, xeroderma

Hypersensitivity: Anaphylaxis (rare), hypersensitivity reaction (rare)

Contraindications

Hypersensitivity to benzocaine, butamben, tetracaine, or any component of the formulation; ophthalmic use; cholinesterase deficiencies; application to large areas of denuded or inflamed tissue; administration in excess of product labeling; administration via injection; application under dentures or cotton rolls; children <2 years of age

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reaction: Hypersensitivity reactions, including anaphylaxis, may occur (rare). Localized reactions, including erythema, pruritus, vesiculation, and eschar, may occur; most commonly following prolonged or repeated use. Discontinue if rash, urticaria, edema, or other allergic response develop at application site. Prolonged use should only be done under continual medical supervision.

• Methemoglobinemia: Has been reported with local anesthetics; clinically significant methemoglobinemia requires immediate treatment along with discontinuation of the anesthetic and other oxidizing agents. Onset may be immediate or delayed (hours) after anesthetic exposure. Patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, exposure to oxidizing agents or their metabolites, or infants <6 months of age are more susceptible and should be closely monitored for signs and symptoms of methemoglobinemia (eg, cyanosis, headache, rapid pulse, shortness of breath, lightheadedness, fatigue).

Special populations:

• Acutely ill patients: Use with caution in acutely ill patients; dose adjustment is suggested.

• Debilitated patients: Use with caution in debilitated patients; dose adjustment is suggested.

• Older adult: Use with caution in older adults; dose adjustment is suggested.

• Pediatric: Use with caution in very young patients (contraindicated in children <2 years of age); dose adjustment is suggested.

Other warnings/precautions:

• Administration: For topical use only. Use under dentures or cotton rolls is contraindicated; retention of active ingredients may cause escharotic effect.

• Topical application: When topical anesthetics are used prior to cosmetic or medical procedures, the lowest amount of anesthetic necessary for pain relief should be applied. High systemic levels and toxic effects (eg, methemoglobinemia, irregular heart beats, respiratory depression, seizures, death) have been reported in patients who (without supervision of a trained professional) have applied topical anesthetics in large amounts (or to large areas of the skin), left these products on for prolonged periods of time, or have used wraps/dressings to cover the skin following application.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Aerosol, External:

Cetacaine: Benzocaine 14%, butamben 2%, and tetracaine hydrochloride 2% (5 g, 20 g) [contains benzalkonium chloride, saccharin sodium]

Gel, External:

Cetacaine: Benzocaine 14%, butamben 2%, and tetracaine hydrochloride 2% (32 g) [contains polyethylene glycol (macrogol), saccharin]

Liquid, External:

Cetacaine: Benzocaine 14%, butamben 2%, and tetracaine hydrochloride 2% (14 g, 30 g [DSC]) [contains benzalkonium chloride, saccharin]

Generic Equivalent Available: US

No

Pricing: US

Aerosol (Cetacaine External)

2-2-14% (per gram): $15.48

Gel (Cetacaine External)

2-2-14% (per gram): $2.17

Liquid (Cetacaine External)

2-2-14% (per gram): $9.03

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Avoid application to large areas of broken skin. When possible, apply to clean, dry area; however, tissue need not be dried prior to application.

Gel: Spread thinly and evenly directly over application area where pain control is desired using a cotton swab.

Liquid: Apply with cotton or brush applicator or directly onto tissue; do not hold applicator in position for prolonged periods of time. Discard all applicators after use. Refer to manufacturer’s labeling for additional detailed information.

Spray: Apply directly to the site where pain or gag control is desired for procedure (ear, nose, mouth, pharynx, larynx, trachea, bronchi, esophagus, vagina, or rectum).

Administration: Pediatric

Topical: Avoid application to large areas of broken skin, especially in children. When possible, apply to clean, dry area; however, tissue need not be dried prior to application.

Gel: Spread thinly and evenly over application area using a cotton swab.

Liquid: Apply with cotton or brush applicator or directly onto tissue; do not hold applicator in position for prolonged periods of time. Discard all applicators after use. Refer to manufacturer’s labeling for details.

Spray: Apply directly to the site where pain or gag control is desired for procedure.

Use: Labeled Indications

Anesthesia, topical: Topical anesthetic to control pain in surgical or endoscopic procedures, or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus (may also be used for vaginal or rectal procedure, when feasible); anesthetic for accessible mucous membranes except for the eyes; to control pain or gagging (spray only)

Medication Safety Issues
Pediatric patients: High-risk medication:

KIDs List: Benzocaine, when used in pediatric patients <2 years of age for teething or pharyngitis, is identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be avoided due to risk of methemoglobinemia (strong recommendation; high quality of evidence) (PPA [Meyers 2020]).

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Articaine: May increase adverse/toxic effects of Local Anesthetics. Risk C: Monitor

Dapsone (Topical): May increase adverse/toxic effects of Methemoglobinemia Associated Agents. Risk C: Monitor

Nitric Oxide: May increase adverse/toxic effects of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor

Prilocaine: Methemoglobinemia Associated Agents may increase adverse/toxic effects of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor for signs of methemoglobinemia when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid use of these agents with prilocaine/lidocaine cream in infants less than 12 months of age. Risk C: Monitor

Primaquine: Methemoglobinemia Associated Agents may increase adverse/toxic effects of Primaquine. Specifically, the risk for methemoglobinemia may be increased. Management: Avoid concomitant use of primaquine and other drugs that are associated with methemoglobinemia when possible. If combined, monitor methemoglobin levels closely. Risk D: Consider Therapy Modification

ROPivacaine: May increase adverse/toxic effects of Local Anesthetics. Risk C: Monitor

Sodium Nitrite: Methemoglobinemia Associated Agents may increase adverse/toxic effects of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor

Pregnancy Considerations

Safety has not been established; use is not recommended during early pregnancy unless the potential benefits outweigh the risks.

Monitoring Parameters

Monitor patients for signs and symptoms of methemoglobinemia such as pallor, cyanosis, nausea, muscle weakness, dizziness, confusion, agitation, dyspnea and tachycardia. The classical clinical finding of methemoglobinemia is chocolate brown-colored arterial blood. However, suspected cases should be confirmed by co-oximetry, which yields a direct and accurate measure of methemoglobin levels. Standard pulse oximetry readings or arterial blood gas values are not reliable. Clinically significant methemoglobinemia requires immediate treatment.

Mechanism of Action

Reversible blockage of initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions

Pharmacokinetics (Adult Data Unless Noted)

Also see individual monographs for Benzocaine and Tetracaine.

Onset of action: ~30 seconds

Duration: 30 to 60 minutes

Metabolism: Plasma via hydrolysis by cholinesterase to inactive metabolites

Excretion: Urine (as inactive metabolites)

  1. Cetacaine (benzocaine/butamben/tetracaine) gel [prescribing information]. Pennsauken, NJ: Cetylite Industries Inc; October 2018.
  2. Cetacaine (benzocaine/butamben/tetracaine) spray and liquid [prescribing information]. Pennsauken, NJ: Cetylite Industries Inc; October 2018.
  3. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
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