Benzocaine, Butamben, And Tetracaine Hydrochloride
FDA Drug Information • Also known as: Cetacaine Anesthetic, Cetacaine Topical Anesthetic
- Brand Names
- Cetacaine Anesthetic, Cetacaine Topical Anesthetic
- Drug Class
- Standardized Chemical Allergen [EPC]
- Route
- TOPICAL
- Dosage Form
- GEL
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
Active ingredients Benzocaine 14.0% Butamben 2.0% Tetracaine Hydrochloride 2.0% Contains Benzalkonium Chloride 0.5% Cetyl Dimethyl Ethyl Ammonium Bromide 0.005% In a bland, water-soluble base.
What Is Benzocaine, Butamben, And Tetracaine Hydrochloride Used For?
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.
Dosage 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. Each one-second spray contains an average of 200 mg of product, not including propellant. To apply, insert the cannula 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 liquid (approximately 0.2 mL) directly to tissue. Liquid in excess of 400 mg (approximately 0.4 mL) is contraindicated. To apply, remove and discard the shipping cap from the bottle. Replace it with the supplied Luer-lock cap. Caution: Do not over-tighten. Remove small cap from luer-lock port, retaining it for replacement after use. Port allows for a single dip of a cotton or brush applicator for application directly to accessible mucous membrane. For application into periodontal pockets, Cetylite Luer-lock syringes and Microcapillary Delivery Tips are recommended. Cetylite Syringes are clearly marked in (4) 0.1 mL increments. To fill, attach syringe to port by gently twisting clockwise until secure. Invert and draw desired amount of liquid into the syringe. Remove filled syringe and attach Microcapillary Delivery Tip to the syringe. Tip may be bent to improve access. Apply dropwise to accessible mucous membrane (such as buccal and lingual sulcus) by slowly depressing the syringe plunger. Discard all applicators after use. An appropriate pediatric dosage has not been established for Cetacaine Spray or Cetacaine Liquid. Dosages should be reduced in the debilitated elderly, acutely ill, and very young patients (i.e., children 2 years and older). Do not use Cetacaine Spray or Cetacaine Liquid to treat infants or children younger than 2 years. 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 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.
Drug Interactions
DRUG INTERACTIONS Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: Class Examples 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
Contraindications
Contraindications Do not use Cetacaine Spray or Cetacaine Liquid 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. 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.
Pregnancy and Breastfeeding
Use 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. Routine precaution for the use of any topical anesthetic should be observed when Cetacaine is used.
How Supplied
How Supplied Cetacaine Spray, 20 g bottle, including propellant WARNING Cetacaine Spray contains CFC-114 and CFC-11, substances which harm public health and environment by destroying ozone in the upper atmosphere. The propellant leak rate of Cetacaine Spray does not meet the USP requirements. (Item # 0220, NDC 10223-0201-3) which includes one cannula. Cetacaine Spray Single Patient Use, 5 g bottle, including propellant (Item # 0222, NDC 10223-0201-4) which includes one cannula. Cetacaine Liquid Chairside Kit (Item # 0218 NDC 10223-0202-6) which includes one 14 g bottle of Cetacaine Liquid with Luer-lock dispenser cap, 20 syringes and 20 delivery tips. Cetacaine Liquid Clinical Kit (Item # 0212, NDC 10223-0202-5) which includes one 30 g bottle of Cetacaine Liquid with Luer-lock dispenser cap, 100 syringes and 100 delivery tips. Cetacaine Liquid, 14 g bottle (Item # 0203, NDC 10223-0202-2) with Luer-lock dispenser cap. Cetacaine Liquid, 30 g bottle (Item # 0211, NDC 10223-0202-4) with Luer-lock dispenser cap.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.