Data from FDA - Curated by EPG Health - Last updated 09 October 2017

Indication(s)

Indications Cetacaine is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. Cetacaine Spray is indicated for use to control pain or gagging. Cetacaine in all forms is indicated to control pain and for use for surgical or endoscopic or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. It may also be used for vaginal or rectal procedures when feasible.

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Advisory information

contraindications
Cetacaine is not suitable and should never be used for injection. Do not use on the eyes. To avoid excessive systemic absorption, Cetacaine should not be applied to large areas of denuded or inflamed tissue. Cetacaine should not be administered to patients who are hypersensitive to any of its ingredients or to patients known to have cholinesterase deficiencies. Tolerance may vary with the status of the patient. Cetacaine should not be used under dentures or cotton rolls, as retention of the active ingredients under a denture or cotton roll could possibly cause an escharotic effect. Routine precaution for the use of any topical anesthetic should be observed when using Cetacaine. Jetco® Cannula for Cetacaine Spray The supplied 4" stainless steel Jetco® cannula (J-4) for Cetacaine Spray is specially designed for accessibility and application of Cetacaine, at the required site of pain control. Replacement J-4 cannulas are available as a 10-pack (Item # 0205).
Adverse reactions
Adverse Reactions Hypersensitivity Reactions : Unpredictable adverse reactions (i.e. hypersensitivity, including anaphylaxis) are extremely rare. Localized allergic reactions may occur after prolonged or repeated use of any aminobenzoate anesthetic. The most common adverse reaction caused by local anesthetics is contact dermatitis characterized by erythema and pruritus that may progress to vesiculation and oozing. This occurs most commonly in patients following prolonged self-medication, which is contraindicated. If rash, urticaria, edema, or other manifestations of allergy develop during use, the drug should be discontinued. To minimize the possibility of a serious allergic reaction, Cetacaine preparations should not be applied for prolonged periods except under continual supervision. Dehydration of the epithelium or an escharotic effect may also result from prolonged contact. Precaution: On rare occasions, methemoglobinemia has been reported in connection with the use of benzocaine-containing products. Care should be used not to exceed the maximum recommended dosage (see Dosage and Administration). If a patient becomes cyanotic, treat appropriately to counteract (such as with methylene blue, if medically indicated).

Usage information

Dosing and administration
Dosage and Administration Cetacaine Spray should be applied for approximately one second or less for normal anesthesia. Only a limited quantity of Cetacaine is required for anesthesia. Spray in excess of two seconds is contraindicated. Average expulsion rate of residue from spray, at normal temperatures, is 200 mg per second. To apply, insert the Jetco cannula (J-4) firmly onto the protruding plastic stem on the bottle and press the cannula forward to actuate the spray valve. The cannula may be removed and reinserted as many times as required for cleaning, or sterilization, and is autoclavable. Cetacaine Liquid Apply 200 mg (approximately 6 – 7 drops or 0.2 cc) with a cotton applicator or directly to tissue. Do not hold the cotton applicator in position for extended periods of time, since local reactions to benzoate topical anesthetics are related to the length of time of application. Liquid in excess of 400 mg (approx. 12 – 14 drops or 0.4 cc) is contraindicated. *See Cetacaine Liquid Kit instructions for additional directions for application by Luer-lock syringe and applicator tip. Cetacaine Gel Apply 200 mg of gel (a bead approximately 0.5 inch (13 mm) in length and 3/16 inch (5 mm) in diameter) and spread thinly and evenly over the application area. Gel in excess of 400 mg (a bead approximately 1 inch (26 mm) in length and 3/16 inch (5 mm) in diameter) is contraindicated. An appropriate pediatric dosage has not been established for Cetacaine Spray, Liquid or Gel. Dosages should be reduced in the debilitated elderly, acutely ill, and very young patients. Tissue need not be dried prior to application of Cetacaine. Cetacaine should be applied directly to the site where pain control is required. Anesthesia is produced within 30 seconds with an approximate duration of 30 – 60 minutes. Each 200 mg dose of Cetacaine (Spray residue, Liquid or Gel) contains 28 mg of benzocaine, 4 mg of butamben and 4 mg of tetracaine HCl.

More information

Category Value
Agency product number U3RSY48JW5
Orphan designation No
Product NDC 10223-0201
Date Last Revised 22-09-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 1722107
Marketing authorisation holder Cetylite Industries, Inc.