Cetacaine

What is Cetacaine?

• Cetacaine is a topical anesthetic that contains the active ingredients benzocaine (14%), butamben (2%), and tetracaine hydrochloride (2%).

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Benzocaine

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Butamben

Tetracaine Structural Formulae V.1

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What are the uses of this medicine?

• 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 used 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.

How does this medicine work?

• The onset of Cetacaine Topical Anesthetic Gel produced anesthesia is rapid (approximately 30 seconds) and the duration of anesthesia is typically 30-60 minutes, when used as directed.
• This effect is due to the rapid onset, but short duration of action of Benzocaine coupled with the slow onset, but extended duration of Tetracaine HCl and bridged by the intermediate action of Butamben.
• It is believed that all of these agents act by reversibly blocking nerve conduction.
• Speed and duration of action is determined by the ability of the agent to be absorbed by the mucous membrane and nerve sheath and then to diffuse out, and ultimately be metabolized (primarily by plasma cholinesterases) to inert metabolites which are excreted in the urine.

Who Should Not Use this medicine ?

This medicine cannot be used in:

• Do not use Cetacaine to treat infants or children younger than 2 years.
• 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.
• Cetacaine should not be used under dentures or cotton rolls, as retention of the active gel 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.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• Nitrates/Nitrites: nitroglycerin, nitroprusside, nitric oxide, nitrous oxide
• Local anesthetics: benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine
• Antineoplastic agents:cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea
• Antibiotics: dapsone, sulfonamides, nitrofurantoin, para-aminosalicylic acid
• Antimalarials:chloroquine, primaquine
• Anticonvulsants: phenytoin, sodium valproate, phenobarbital
• Other drugs: acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), quinine

Is this medicine FDA approved?

• Although Cetacaine has been widely used in the medical and dental fields, it has yet to be officially approved by the FDA.
• Cetacaine is produced by the company Cetylite Industries, Inc. and they provide Cetacaine in three forms: liquid, gel, and spray.

How should this medicine be used?

Recommended dosage: Cetacaine Spray:

• Cetacaine Spray should be applied for approximately one second or less for normal anesthesia.
• Spray in excess of two seconds is contraindicated.
• Each one-second spray contains an average of 200 mg of product, not including propellant.

Cetacaine Liquid:

• Apply 200 mg liquid (approximately 0.2 mL) directly to tissue.
• Liquid in excess of 400 mg (approximately 0.4 mL) is contraindicated.
• Dosages should be reduced in the debilitated elderly, acutely ill, and very young patients (i.e., children 2 years and older).

Cetacaine Topical Anesthetic Gel:

• Dispense 200 mg of gel (a bead approximately 1/4 to 1/2 inches long) by gently depressing the pump.
• Dispensing a bead of gel in excess of 400 mg is contraindicated.
• Spread thinly and evenly over the desired area using a cotton swab.
• Dosages should be reduced in the debilitated elderly, acutely ill, and very young patients.

Administration:

• Cetacaine should be applied directly to the site where pain control is required.
• Anesthesia is produced within one minute with an approximate duration of thirty minutes.
• Each 200 mg dose of Cetacaine (Spray or Liquid) contains 28 mg of benzocaine, 4 mg of butamben and 4 mg of tetracaine HCl.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As liquid, gel, and spray.

This medicine is available in fallowing brand namesː

• Cetacaine

What side effects can this medication cause?

The most common side effects of this medicine include:

• hypersensitivity in the form of anaphylaxis
• dermatitis
• erythema
• pruritus
• rashes
• edema
• urticarial and other allergic symptoms as well as methemoglobinemia

Additional side effects may include:

• tremors, twitching, dizziness, confusion, hypotension, vomiting, euphoria, and blurred or double vision

What special precautions should I follow?

• Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.
• 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.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Safe use of Cetacaine has not been established with respect to possible adverse effects upon fetal development.
• Therefore, Cetacaine should not be used during early pregnancy, unless in the judgement of a physician, the potential benefits outweigh the unknown hazards.

Can this medicine be used in children?

• Do not use Cetacaine to treat infants or children younger than 2 years.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• Benzocaine
• Butamben
• Tetracaine Hydrochloride

Inactive Ingredients:

• Dipropylene glycol
• Saccharin
• Benzalkonium chloride
• Mecetronium Bromide

Who manufactures and distributes this medicine?

• Cetylite Industries, Inc.
• Pennsauken, NJ
• Made in USA

What should I know about storage and disposal of this medication?

• Store at controlled room temperature 20-25°C (68-77°F).

• Dailymed label info on Cetacaine
• FDA Cetacaine

Cetacaine Resources
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