Version May 2024
Topical anesthesia:
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
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Dose reduction is suggested; refer to adult dosing.
Dose has not been established; dose reduction is suggested
There are no dosage adjustments provided in manufacturer’s labeling.
There are no dosage adjustments provided in manufacturer’s labeling.
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)
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
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Aerosol, Spray, Topical:
Cetacaine: Benzocaine 14%, butamben 2%, and tetracaine hydrochloride 2% (5g, 20 g) [contains benzalkonium chloride]
Gel, Topical:
Cetacaine: Benzocaine 14%, butamben 2%, and tetracaine hydrochloride 2% (32 g)
Liquid, External:
Cetacaine: Benzocaine 14%, butamben 2%, and tetracaine hydrochloride 2% (14 g, 30 g) [contains benzalkonium chloride]
No
Aerosol (Cetacaine External)
2-2-14% (per gram): $14.64
Gel (Cetacaine External)
2-2-14% (per gram): $2.17
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.
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).
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.
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).
Gel: Spread thinly and evenly over application area using a cotton swab.
Liquid: Apply with cotton applicator or directly onto tissue; do not hold applicator in position for prolonged periods of time.
Topical anesthesia: 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)
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]).
None known.
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy
Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy
Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Safety has not been established; use is not recommended during early pregnancy unless the potential benefits outweigh the risks.
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.
Reversible blockage of initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions
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)
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