Dosing & Uses
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%
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
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%
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
Dosing Considerations
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)
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)
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
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.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
Administration
Topical Administration
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
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Formulary
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