lidocaine topical (Rx, OTC)

Brand and Other Names:Xylocaine Jelly, Xylocaine Topical Solution, more...AneCream, AneCream5, Derma Numb, Epic, Hawaiian Tropic Gel, Lidocoll, LidoRx, LidoStat, LMX4, Premjact, Promescent, Regenecare HA, Solarcaine Aloe Extra Burn Relief, Topicaine, Xolido
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical jelly

  • 2% (Xylocaine Jelly)

topical gel

  • 0.5% (Solarcaine Aloe Extra Burn Relief)
  • 0.8% (Hawaiian Tropic Gel)
  • 3% (LidoRx)
  • 4% (Topicaine)

topical cream

  • 2% (Xolido)
  • 4% (AneCream, LidoStat, LMX4, Xolido)
  • 5% (AneCream5)

topical ointment

  • 5%

topical lotion

  • 3%

topical spray

  • 2% (Regenecare HA)
  • 4% (Derma Numb, Lidocoll)
  • 10mg/spray (Epic, Premjact, Promescent)

topical solution, mouth/throat

  • 2%
  • 4% (Xylocaine Solution)

Anesthetic Lubricant for Intubation

Indicated as an anesthetic lubricant for oral or nasal endotracheal intubation

Jelly (2%): Apply moderate amount to external surface of endotracheal tube shortly before use

Ointment: Apply to tube prior to intubation

Not to exceed 600 mg/12 hr

Urethral Surface Anesthesia

When using Xylocaine 2% Jelly 30 mL tubes for urologic procedures, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube

Females

  • Instill 2-5 mL jelly (60-100 mg) into urethra
  • Some jelly may also be deposited on a cotton swab and introduced into urethra
  • Allow several minutes following instillation prior to performing urological procedure

Males

  • Slowly instill 15 mL (300 mg lidocaine) into urethra or until patient experiences tension
  • Apply a penile clamp for several minutes at the corona
  • An additional dose of not more than 15 mL (300 mg) can be instilled for adequate anesthesia
  • Prior to sounding or cystoscopy, a penile clamp should be applied for 5-10 minutes to obtain adequate anesthesia
  • A total dose of 30 mL (600 mg) is usually required to fill and dilate the male urethra
  • Prior to catheterization, smaller volumes of 5-10 mL (100-200 mg) are usually adequate for lubrication

Premature Ejaculation

Temporarily reduces sensitivity of the penis, which helps to delay ejaculation

Epic, Premject, Promescent: Apply 3 or more sprays (10 mg/spray), not to exceed 10 sprays, to the head and shaft of the penis before intercourse

Wash product off after intercourse

Correct quantity and time of application will be determined by individual requirements; use the minimum effective quantity

Do not exceed 24 sprays/24 hr

Skin Irritation

Indicated for temporary relief of pain and itching caused by minor skin irritations (eg, sunburn, minor burns, minor cuts, scrapes, insect bites, minor skin irritations)

Apply topically to affected area TID/QID

Dosage Forms & Strengths

topical jelly

  • 2% (Xylocaine Jelly)

topical gel

  • 0.5% (Solarcaine Aloe Extra Burn Relief)
  • 0.8% (Hawaiian Tropic Gel)
  • 3% (LidoRx)
  • 4% (Topicaine)

topical cream

  • 2% (Xolido) 4%
  • (AneCream, LidoStat, LMX4, Xolido)
  • 5% (AneCream5)

topical ointment

  • 5%

topical lotion

  • 3%

topical spray

  • 2% (Regenecare HA)
  • 4% (Derma Numb, Lidocoll)

topical solution, mouth/throat

  • 2%
  • 4% (Xylocaine Solution)

Anesthetic Lubricant for Intubation

Indicated as an anesthetic lubricant for oral or nasal endotracheal intubation

Jelly (2%): Apply moderate amount to external surface of endotracheal tube shortly before use

Ointment: Apply to tube prior to intubation

Children aged <10 years: Not to exceed 4.5 mg/kg per 12 hr

Older children/adolescents: Not to exceed 600 mg/12 hr

Skin Irritation

Indicated for temporary relief of pain and itching caused by minor skin irritations (eg, sunburn, minor burns, minor cuts, scrapes, insect bites, minor skin irritations)

<2 years: Safety and efficacy not established

≥2 years: Apply topically to affected area TID/QID

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Adverse Effects

Frequency Not Defined

Cardiovascular (with excessive systemic absorption): CV depressant effect characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest

Allergic: Cutaneous lesions, urticaria, edema, or anaphylactoid reactions

Central nervous system

  • CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression, and arrest
  • Excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest
  • Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption
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Warnings

Black Box Warnings

Significant systemic absorption may occur with topical use

Twenty-two case reports have shown evidence of serious adverse reaction when viscous lidocaine 2% is used in young children to treat mouth pain

Resulting reactions include seizures, severe brain injury, and cardiovascular depression characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest

Contraindications

Hypersensitivity to drug or amide type anesthetic

Cautions

Some formulations may contain sulfites

Contact with eye may cause severe eye irritation; if eye contact occurs, immediately wash out the eye with water or saline and protect eye until sensation returns

Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine due to inability to metabolize lidocaine normally

When used concomitantly with other products containing local anesthetic agents, the amount of lidocaine absorbed from all formulations must be considered

Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of lidocaine from increased absorption; apply only to intact skin

Jelly for endotracheal use

  • When used for endotracheal tube lubrication care should be taken to avoid introducing the jelly into the lumen of the tube
  • Do not use the jelly to lubricate the endotracheal stylettes
  • If allowed into the inner lumen, the jelly may dry on the inner surface leaving a residue which tends to clump with flexion, narrowing the lumen
  • There have been rare reports in which this residue has caused the lumen to occlude

Excessive systemic absorption

  • Sepsis, severely traumatized mucosa, or open wounds in the area of application (potential for rapid systemic absorption)
  • Doses applied to large surface areas that remain on the skin for >2 hr
  • Repeated doses with short dosing intervals

2% Viscous solution

  • Parents and caregivers should be cautioned about the following:
  • Use special care for patients <3 years of age to accurately measure prescribed dose and not to administer product more often than prescribed
  • Use a measuring device to carefully measure correct volume
  • Use product for prescribed indication only
  • Keep product container should be tightly closed and product stored well out of reach of all children immediately after each use
  • If patient shows signs of systemic toxicity (e.g., lethargy, shallow breathing, seizure activity) seek emergency medical attention immediately with no additional product administered
  • Discard unused product in manner that prevents possible exposure to children and pets
  • When topical anesthetics used in mouth or throat, production of topical anesthesia may impair swallowing and thus enhance danger of aspiration; food should not be ingested for 60 min following use of local anesthetic preparations in mouth or throat area especially in children because of their frequency of eating; numbness of tongue or buccal mucosa may increase danger of biting trauma (food and/or chewing gum should not be used while mouth or throat area is anesthetized)
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Pregnancy & Lactation

Pregnancy

There are no available data regarding use in pregnant women

Reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg SC and have revealed no evidence of harm to the fetus due to lidocaine

There are, however, no adequate and well-controlled studies in pregnant women

Because animal reproduction studies are not always predictive of human response, should be used during pregnancy only if clearly needed

Lactation

There are no available data regarding use in breastfeeding women; caution if administered

Lidocaine is excreted in human milk, and the milk: plasma ratio of lidocaine is 0.4

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

Elicits local anesthesia; stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action

Absorption

Onset of action: 3-5 minutes (eg, gel, cream, ointment)

Metabolism

It is not known if lidocaine is metabolized in the skin

Lidocaine is metabolized rapidly by the liver to a number of metabolites, including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent than that of lidocaine

Elimination

Half-life: 81-149 minutes (IV)

Total body clearance: 0.33-0.9 L/min

Excretion: Kidneys (<10% unchanged)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

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.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.