Lidocaine Topical

Lidocaine topical is a prescription or over-the-counter medication used for the treatment of premature ejaculation and skin irritation, and as urethral surface anesthesia and anesthetic lubrication for intubation.

• Lidocaine topical is available under the following different brand names: Xylocaine Jelly, Xylocaine Topical Solution, AneCream, AneCream5, Derma Numb, Epic, Hawaiian Tropic Gel, Lidocoll, LidoRx, LidoStat, LMX4, Premjact, Promescent, Regenecare HA, Solarcaine Aloe Extra Burn Relief, Topicaine, Xolido

Common side effects of Lidocaine topical include:

• mild irritation at the injection site, and
• numbness in places where the medicine is accidentally applied 

Serious side effects of Lidocaine topical include:

• severe burning,
• stinging,
• irritation at the injection site,
• swelling or redness,
• sudden dizziness or drowsiness after application,
• confusion,
• blurred vision,
• ringing in the ears, and
• unusual sensations of temperature

 Rare side effects of Lidocaine topical include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

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

Adult dosage

• Jelly (2%): Apply a moderate amount to the external surface of endotracheal tube shortly before use
• Ointment: Apply to the tube before intubation
• Not to exceed 600 mg/12 hours

Pediatric dosage

• Children aged below 10 years: Not to exceed 4.5 mg/kg per 12 hours
• Older children/adolescents: Not to exceed 600 mg/12 hr

Urethral Surface Anesthesia

Adult dosage

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

Females

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

Adult dosage

• 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
• Do not exceed 24 sprays/24 hours

Skin Irritation

Adult dosage

• Apply topically to the affected area three times or four times every dayPediatric dosage
• Children aged below 2 years: Safety and efficacy not established
• Children aged above 2 years: Apply topically to the affected area three or four times a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages.”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Lidocaine topical has no noted severe interactions with any other drugs.
• Lidocaine topical has no noted serious interactions with any other drugs.
• Lidocaine topical has no noted moderate interactions with any other drugs.
• Lidocaine topical has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to drug or amide-type anesthetic

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Lidocaine topical?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lidocaine topical?”

Cautions

• Some formulations may contain sulfites
• Contact with the eye may cause severe eye irritation; if eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns
• Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine due to the 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 at the application site (potential for rapid systemic absorption)
  • Doses applied to large surface areas that remain on the skin for more than 2 hours
  • Repeated doses with short dosing intervals
• 2% Viscous solution
  • Parents and caregivers should be cautioned about the following:
  • Use special care for patients above 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 the 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 products in a manner that prevents possible exposure to children and pets
  • When topical anesthetics are used in the mouth or throat, production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration; food should not be ingested for 60 min following use of local anesthetic preparations in the mouth or throat area especially in children because of their frequency of eating; numbness of the tongue or buccal mucosa may increase the danger of biting trauma (food and/or chewing gum should not be used while mouth or throat area is anesthetized)

Pregnancy and Lactation

• 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 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