Adult Dosing

Topical anesthesia

Gel form

• Dispense 200 mg of gel (a bead approximately 1/4 to 1/2 inches long) by gently depressing the pump and spread thinly and evenly over the desired area using a cotton swab
• Max: 400 mg (a bead approx. 1 inch in length)

• Do not apply to large areas of denuded or inflamed tissue

Liquid form

• Apply 200 mg (approximately 6–7 drops or 0.2 cc) with a cotton applicator or directly to tissue
• Max: 400 mg (approx. 12–14 drops or 0.4 cc)

• Do not hold the cotton applicator in position for extended periods of time
• Do not apply to large areas of denuded or inflamed tissue

Spray form

• Apply 200 mg for about 1 sec or less for normal anesthesia
• Max: For about 2 sec

• Do not apply to large areas of denuded or inflamed tissue

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Topical anesthetic indicated for production of anesthesia of all accessible mucous membrane except the eyes
• For pain control and for use for surgical or endoscopic or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus
• Topical anesthetic for vaginal or rectal procedures when feasible
• Indicated to control pain and gagging (spray)

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to PABA
• Do not use for injection
• Do not use in eyes
• Do not apply to large areas of denuded or inflamed tissue
• Patients with cholinesterase deficiency
• Do not use under dentures or cotton rolls

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Rarely, methemoglobinemia has been reported with the use of benzocaine-containing products. If the patient becomes cyanotic, consider treating appropriately to counteract, such as with methylene blue, if medically indicated
• Do not exceed the maximum recommended dosage
• Localized allergic reactions may occur with prolonged or repeated use of aminobenzoate anesthetics
• Prolonged self-medication is contraindicated as it may cause contact dermatitis characterized by erythema and pruritus which may progress to vesiculation and oozing. Discontinue therapy if rash, urticaria, edema, or other manifestations of allergy develop during use. To reduce the risk of a serious allergic reaction, do not apply this product for prolonged periods except under continual supervision. Prolonged contact may result in epithelial dehydration or an escharotic effect
• The drug may not be suitable for everyone, including patients hypersensitive to any of its ingredients or those with known case of cholinesterase deficiency
• Dose reduction is recommended in debilitated elderly, acutely ill, and very young patients
• Safety of benzocaine/butamben/tetracaine products has not been established with respect to possible adverse effects upon fetal development. Hence, this drug should not be used during early pregnancy, unless according to the physician's judgment, the potential benefits outweigh the unknown hazards. Routine precaution should be observed during the product use

Cautions: Use cautiously in

• Hemoglobin-M disease
• NADH methemoglobin reductase deficiency
• Elderly patients
• Debilitated patients

Pregnancy Category:NR

Breastfeeding: Safety unknown. Topical benzocaine has not been evaluated during breastfeeding, but is unlikely to adversely affect the breastfed infant if it is applied away from the breast. Avoid application to the breast or nipple area as the infant may ingest the drug during nursing and it has been associated with severe methemoglobinemia. Topical application of tetracaine to the mother is unlikely to adversely affect the breastfed infant if it is applied away from the breast. However, an alternate drug might be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 7th February 2012).

• DERM: Contact dermatitis, erythema, vesicles, dry skin, dehydration of the epithelium (prolonged use)
• HEMA: Methemoglobinemia
• HYPERSENSITIVITY: Anaphylaxis/anaphylactoid reactions, hypersensitivity reactions

Benzocaine

• Local anesthetic; decreases neuronal membrane permeability to sodium ions by reversibly stabilizing the neuronal membrane, thereby blocking the initiation and conduction of nerve impulses
• Minimal systemic absorption
• Metabolized by plasma cholinesterases; CYP450: None
• Excretion: Unknown
• Half-life: Unknown

Butamben

• Local anesthetic; decreases neuronal membrane permeability to sodium ions by reversibly stabilizing the neuronal membrane, thereby blocking the initiation and conduction of nerve impulses
• Metabolized by plasma cholinesterases; CYP450: None
• Excretion: Urine
• Half-life: Unknown

Tetracaine

• Local anesthetic; inhibits depolarization of neuronal membrane and thereby blocks initiation and conduction of nerve impulses
• Metabolized by plasma cholinesterases; CYP450: None
• Excretion: Urine
• Half-life: Unknown

US Trade Name(s)

• Cetacaine

US Availability

Cetacaine (benzocaine/butamben/tetracaine)

• GEL: 14%/2%/2%
• LIQ: 14%/2%/2%
• SPRAY: 14%/2%/2%

Canadian Trade Name(s)

• Cetacaine

Canadian Availability

Cetacaine (benzocaine/butamben/tetracaine)

• LIQ: 14%/2%/2%
• SPRAY: 14%/2%/2%

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Anesthesia

Topical/Mucosal Anesthetic Combinations