benzocaine/butamben/tetracaine topical (Rx)Brand and Other Names:Cetacaine

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

benzocaine/butamben/tetracaine topical

topical gel

  • 14%/2%/2%

topical liquid

  • 14%/2%/2%

ointment

  • 14%/2%/2%

topical aerosol

  • 14%/2%/2%
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Topical Anesthetic

Minor dermal procedure

  • Normal intact skin for local analgesia: Apply 2.5 g of cream over 20-25 cm of skin surface or 1 anesthetic disc (1 g over 10 cm) for at least 1 hour

Major dermal procedure

  • Apply 2 g of the cream per 10 cm of skin surface and allow to remain in contact with skin for at least 2 hours

Genital mucous membrane

  • Superficial minor surgery and as pretreatment for infiltration anesthesia
  • Male genital skin: apply thick layer of cream (1 g/10 cm) to skin surface for 15 minutes
  • Perform local anesthetic infiltration immediately after removal of the cream
  • Female genital mucous membranes: apply a thick layer (5 to 10 g) of cream for 5 to 10 minutes

Other Information

For topical use only; not for ophthalmic or otic use

Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream

Dosage Forms & Strengths

benzocaine/butamben/tetracaine topical

topical gel

  • 14%/2%/2%

topical liquid

  • 14%/2%/2%

ointment

  • 14%/2%/2%

topical aerosol

  • 14%/2%/2%
more...

Topical Anesthetic

Intact skin only

0-3 months or < 5 kg: Apply 1 g per 10 cm for a maximum of 1 hour

3-12 months and > 5 kg : Apply 2 g per 20 cm for a maximum of 4 hours

1-6 years and > 10 kg : Apply 10 g per 100 cm for a maximum of 4 hours

7-12 years and > 20 kg : Apply 20 g per 200 cm for a maximum of 4 hours

Other Information

If > 3 months and does not meet the minimum weight requirement, the maximum total dose should be restricted to that which corresponds to the patient's weight

<7 years: less overall benefit than older children or adults

Do not use in neonates with a gestational age of 37 weeks or less

Do not use in infants under 12 months of age who are receiving treatment with methemoglobin-inducing agents (eg, acetaminophen, nitrates, phenytoin, sulfonamides)

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Adverse Effects

>10%

Paleness (37%)

Erythema (30%)

Burning sensation (17%)

Edema (10%)

1-10%

Alterations in temperature sensations (7%)

Itching (2%)

Frequency Not Defined

CNS excitement or depression

Lightheadedness

Nervousness

Apprehension

Euphoria

Confusion

Dizziness

Drowsiness

Sensations of hot, cold, or numbness

Twitching

Tremors

Convulsions

Bradycardia

Hypotension

Cardiovascular collapse leading to arrest

Vomiting

Discrete purpuric or petechial reactions at the site of application

Hyperpigmentation (cream)

Redness

Blistering of foreskin in neonates about to undergo circumcision

Tinnitus

Blurred or double vision

Allergic and anaphylactoid reactions (characterized by urticaria, angioedema, bronchospasm, and shock)

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Warnings

Contraindications

Hypersensitivity to local anesthetics of the amide type or any component of the product

Cautions

Application to larger areas or for longer than recommended could result in sufficient absorption causing serious adverse reactions

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Pregnancy & Lactation

Pregnancy Category: B

Lactation: Unknown whether distributed in breast milk, caution advised

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Stabilizes neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action

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Images

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Formulary

FormularyPatient Discounts

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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