AneCream

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

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)

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

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.

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 (

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