pharmacopeia

Butamben

US-FDASourced from openFDA
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Mechanism of action

Sourced from openFDA

Action The onset of Cetacaine-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 HCI and bridged by the intermediate action of Butamben.

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

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 drop-wise to accessible mucous membrane (such as buccal and lingual sulcus) by slowly depressing the syringe plunger.

Warnings & precautions

Sourced from openFDA

Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Cetacaine and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

Use in specific populations

Sourced from openFDA

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.

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
32 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Methaemoglobinaemia825%
  2. 2Dyspnoea516%
  3. 3Hypoxia516%
  4. 4Drug Hypersensitivity413%
  5. 5Oxygen Saturation Decreased413%
  6. 6Chronic Kidney Disease39.4%
  7. 7Acute Kidney Injury26.3%
  8. 8Cyanosis26.3%
  9. 9Fatigue26.3%
  10. 10Renal Injury26.3%
  11. 11Throat Irritation26.3%
  12. 12Agitation13.1%
  13. 13Anxiety13.1%
  14. 14Bacteraemia13.1%
  15. 15Blood Methaemoglobin Present13.1%

Clinical trials

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The 6 most recently updated of 6 ClinicalTrials.gov registrations naming Butamben as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Butamben work?
Action The onset of Cetacaine-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 HCI and bridged by the intermediate action of Butamben.
What is Butamben used for?
According to FDA labeling, Butamben carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What are the brand names for Butamben?
Butamben is marketed under brand names including Cetacaine.
What are the contraindications for Butamben?
Butamben labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for butamben is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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