Lidocaine hydrochloride

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with various conditions, including:

Minor Burns and Sunburn

• Temporary relief of pain associated with minor burns and sunburn.

• Indicated for use in first aid treatment for minor burns, scalds, and sunburn.

Minor Skin Irritations and Cuts

• Temporary relief of pain and itching due to minor skin irritations, minor cuts, scrapes, and insect bites.

• Provides relief from discomfort associated with rashes due to poison ivy, poison oak, or poison sumac.

Specific Populations

• For adults and children over 12 years, a thin layer may be applied to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period. For children under 12 years, consultation with a doctor is advised.

Limitations of Use

• No teratogenic or nonteratogenic effects have been mentioned for the products listed.

Dosage and Administration

Adults and children 2 years of age and older are instructed to apply the product to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consultation with a physician is recommended prior to use.

For specific formulations, the following preparation and administration notes apply:

• Prior to application, the affected area should be cleaned and dried thoroughly.

• For sprays, an even layer should be applied over the cleaned affected area.

• For creams and gels, a thin layer should be massaged into the skin until fully absorbed.

• After application, hands should be washed thoroughly with soap and water unless the product is being applied to the hands.

It is important to adhere to the recommended frequency of application and to consult a healthcare professional if symptoms persist or if there are any concerns regarding use in children under 2 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Do not use on wounds or damaged skin.

• Do not use in large quantities, particularly over raw surfaces or blistered areas.

• Do not use if allergic to any of the ingredients.

• Do not use on large areas of the body or on cut, irritated, or swollen skin.

• Do not use on puncture wounds.

• Do not use for more than one week without consulting a doctor.

• Do not use if pregnant or breastfeeding.

• Do not use if partner is pregnant.

• Do not use if you have serious foot problems, such as ulcers or infections.

• Avoid contact with eyes and mucous membranes; if contact occurs, rinse thoroughly with water.

• Do not bandage tightly or apply local heat (such as heating pads) to the area of use.

• Do not use at the same time as other topical analgesics.

• Do not insert this product into the rectum using fingers or any mechanical device.

• Do not use if the package arrives damaged or opened.

• Do not use if symptoms worsen or persist for more than 7 days or clear up and occur again within a few days.

Warnings and Precautions

For External Use Only This product is intended for external use only.

Do Not Use

• On wounds or damaged skin.

• In large quantities, particularly over raw surfaces or blistered areas.

• Near eyes; if contact occurs, rinse thoroughly with water.

• On large areas of the body or on cut, irritated, or swollen skin.

• On puncture wounds.

• For more than one week without consulting a doctor.

• If allergic to any ingredients in this product.

General Precautions

• Avoid contact with eyes and mucous membranes.

• Do not bandage tightly or apply local heat (such as heating pads) to the area of use.

• Use only as directed. Read and follow all directions and warnings on the carton.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask a Doctor If

• Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

• Redness, rash, or irritation develops or increases.

• You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

• You experience severe burning pain, swelling, or blistering where the product was applied.

Get Emergency Medical Help

• If swallowed, get medical help or contact a Poison Control Center immediately.

• If you experience symptoms of methemoglobinemia, such as cyanotic skin discoloration, abnormal coloration of the blood, or other severe reactions.

Pregnancy and Breastfeeding

• If pregnant or breastfeeding, ask a health professional before use.

Monitoring Requirements

• Patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, and infants under 6 months of age are at increased risk for developing clinical manifestations of methemoglobinemia. Close monitoring for symptoms is recommended.

Flammability Warning

• This product is flammable; keep away from fire or flame.

Laboratory Tests

• No specific laboratory tests are mentioned for safe use.

This summary consolidates the warnings and precautions from various product labels, ensuring that critical safety information is clearly communicated.

Side Effects

Patients using topical analgesics should be aware of the following adverse reactions and warnings associated with these products:

Serious Adverse Reactions

• Methemoglobinemia: Cases have been reported with local anesthetic use, particularly in patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, and infants under 6 months of age. Symptoms may include cyanotic skin discoloration, headache, rapid heart rate, shortness of breath, lightheadedness, and fatigue. Immediate treatment is required to prevent severe central nervous system and cardiovascular effects, including seizures and death.

Common Adverse Reactions

• Skin Reactions: Patients may experience redness, irritation, swelling, pain, or blistering at the application site. If these symptoms develop or worsen, patients should discontinue use and consult a physician.

• Burning Sensation: A transient burning sensation may occur upon application but generally resolves within several days.

General Warnings

• For External Use Only: All products are intended for external application only. Avoid contact with eyes and mucous membranes. If contact occurs, rinse thoroughly with water.

• Do Not Use:

  • On wounds or damaged skin.

  • In large quantities, particularly over raw surfaces or blistered areas.

  • With heating pads or other topical analgesics simultaneously.

• Stop Use and Consult a Doctor If:

  • Condition worsens or symptoms persist for more than 7 days.

  • Symptoms clear up and then recur within a few days.

  • Redness, rash, or irritation develops.

  • Severe burning pain, swelling, or blistering occurs at the application site.

Additional Precautions

• Pregnancy and Breastfeeding: Patients should consult a healthcare professional before use if pregnant or breastfeeding.

• Keep Out of Reach of Children: If swallowed, seek medical help or contact a Poison Control Center immediately.

Specific Product Warnings

• Flammability: Some products are flammable and should be kept away from fire or flame.

• Allergic Reactions: Patients with known allergies to lidocaine or other ingredients should avoid these products.

Patients are encouraged to read the specific product labels for detailed information regarding warnings and adverse reactions.

Drug Interactions

The reviewed topical analgesics and burn relief products generally do not present any documented drug interactions. Most labels indicate that no specific drug interactions or laboratory test interactions have been identified.

However, one product, Lidodose, highlights a potential risk associated with the concurrent use of local anesthetics and certain oxidizing agents. Patients receiving local anesthetics may be at an increased risk of developing methemoglobinemia when exposed to the following classes of drugs:

• Oxidizing Agents:

  • Nitrates/Nitrites (e.g., nitroglycerin, nitroprusside)

  • Local anesthetics (e.g., benzocaine, lidocaine, bupivacaine)

  • Antineoplastic agents (e.g., cyclophosphamide, flutamide)

  • Antibiotics (e.g., dapsone, sulfonamides)

  • Antimalarials (e.g., chloroquine, primaquine)

  • Anticonvulsants (e.g., phenytoin, sodium valproate)

  • Other drugs (e.g., acetaminophen, metoclopramide)

The remaining products, including various formulations of Burn Ease, Aspercreme, and other lidocaine-containing creams and gels, report no known interactions. This lack of interaction data suggests a favorable safety profile for these topical agents when used as directed.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician before using topical analgesics. For children aged 2 years and older, the following dosing recommendations apply:

• Topical Analgesics (Creams, Gels, Sprays): Apply to the affected area not more than 3 to 4 times daily. Specific products include:

  • Burn Ease (all formulations)

  • Lidocaine Hydrochloride

  • Aloe Vera Gel

  • Pain Relieving Gel

  • Various other topical analgesics.

For children under 12 years of age, it is advised to consult a doctor before use for certain products, including those containing lidocaine or other active ingredients.

Caution should be exercised to keep all products out of reach of children. In case of accidental ingestion, immediate medical attention should be sought or contact a Poison Control Center.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the inserts for the reviewed products. Therefore, healthcare professionals should exercise caution when administering these products to geriatric patients, as the lack of data may indicate a need for careful monitoring and consideration of individual patient factors. It is advisable to consult with a healthcare provider for personalized recommendations and to assess the appropriateness of these products for elderly patients.

Pregnancy

The safety of various topical analgesics, particularly those containing lidocaine, during pregnancy has not been firmly established. Pregnant patients are advised to consult healthcare professionals before using these products, as potential risks to the fetus are not clearly defined across many formulations.

For products containing lidocaine, such as creams and gels, the following considerations apply:

• Contraindications: Many lidocaine-containing products are contraindicated during pregnancy due to potential risks to fetal development. Pregnant women should avoid these products unless the potential benefits clearly outweigh the risks.

• Risk to Fetus: There may be risks associated with the use of lidocaine during pregnancy, including potential adverse effects on fetal development. It is crucial for pregnant patients to discuss any use of these products with their healthcare provider.

• Dosage Modifications: Adjustments to dosage may be necessary for pregnant individuals. Consultation with a healthcare provider is recommended to determine appropriate use and dosage.

• Special Precautions: Pregnant women should use these products only if clearly needed and after thorough discussion with their healthcare provider. This is particularly important for lidocaine products, where the safety profile during pregnancy remains uncertain.

For non-lidocaine topical analgesics, while specific safety data may not be available, it is generally recommended that pregnant patients seek advice from healthcare professionals before use. This includes products labeled with general precautions for pregnant or breastfeeding individuals.

In summary, due to the lack of definitive safety data and potential risks, pregnant patients should exercise caution and consult healthcare providers before using topical analgesics, particularly those containing lidocaine.

Lactation

There are no specific warnings or recommendations regarding the use of various topical analgesics and burn relief products in nursing mothers. Most products reviewed do not provide information about the potential for excretion in breast milk or any associated risks to breastfed infants.

However, some products, such as Regenecare Ha and Burn Ease, indicate a potential for excretion in breast milk, with caution advised due to the unknown effects on nursing infants. Nursing mothers are generally encouraged to consult a healthcare professional before using any of these products, especially if they are pregnant or breastfeeding.

In summary, while many products lack specific lactation-related data, the absence of warnings does not imply safety. Therefore, healthcare providers should advise nursing mothers to seek professional guidance prior to use.

Renal Impairment

Patients with renal impairment may require careful consideration when using certain medications. For several products, there is no specific information provided regarding dosage adjustments, monitoring, or safety considerations for individuals with kidney problems. However, some products do indicate that renal impairment may necessitate dosage adjustments, particularly for those with reduced creatinine clearance.

For medications where renal impairment is a concern, it is recommended that patients undergo regular renal function tests to monitor kidney health. In cases of significant renal impairment, a reduced dose may be necessary to avoid potential toxicity. Special monitoring is advised for patients with severe renal impairment or those with end-stage renal disease.

In summary, while many products lack specific guidance on renal impairment, those that do suggest close monitoring of renal function and potential dosage adjustments based on creatinine clearance levels. It is essential for healthcare providers to assess each patient's renal function prior to initiating therapy and to adjust treatment as necessary to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of certain topical analgesics. For some products, dosage adjustments may be necessary, particularly in cases of moderate to severe hepatic impairment. Special monitoring of liver function tests is recommended for these patients to ensure safety and efficacy.

Specific products indicate that hepatic impairment may affect drug metabolism, necessitating careful consideration of dosing. In patients with severe hepatic impairment, a reduced dose or alternative therapy may be required. It is essential to exercise caution when prescribing these medications to patients with liver problems, and healthcare providers should evaluate the potential risks and benefits on a case-by-case basis.

For products without specific guidance on hepatic impairment, it is advisable to consult a healthcare professional before use, especially if the patient has known liver issues.

Overdosage

In the event of an overdose, immediate medical attention is essential. If any of the products listed are swallowed, it is crucial to seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay. Symptoms of overdose may vary depending on the specific product ingested, but common signs may include nausea, vomiting, dizziness, or other adverse reactions.

For products containing lidocaine, there is a risk of methemoglobinemia, particularly in susceptible individuals. Symptoms of this condition may include cyanosis (bluish discoloration of the skin), abnormal blood coloration, and potentially severe central nervous system and cardiovascular effects such as seizures, coma, and arrhythmias. Close monitoring for these symptoms is recommended, especially in patients with known risk factors, including glucose-6-phosphate dehydrogenase deficiency or concurrent exposure to oxidizing agents.

In cases of suspected methemoglobinemia, it is critical to discontinue the use of the product and any other oxidizing agents. Supportive care, such as oxygen therapy and hydration, may be beneficial, while more severe cases may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen therapy.

For all products, if an overdose is suspected, the affected individual should be kept calm and monitored closely until professional medical assistance is available.

Nonclinical Toxicology

Teratogenic Effects

The available data regarding teratogenic effects across the reviewed products indicate a lack of specific information. However, certain products advise that pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

Non-Teratogenic Effects

No specific non-teratogenic effects have been documented in the reviewed products.

Nonclinical Toxicology

The reviewed products do not provide detailed information regarding nonclinical toxicology.

Animal Pharmacology and Toxicology

There is no available data on animal pharmacology and toxicology for the products assessed.

Storage and Handling

Burn Ease is supplied in a 3.5g gel form, while Ps-3885 Burn Ease is also available in a 3.5g gel configuration. Additionally, Ps-3866 Burn Ease comes in a 0.9g gel form. Alocane Botanicals is provided as a spray, and Aspercreme Lidocaine with Eucalyptus Essential Oil is available as a cream. Other products include Burnx in gel form, Lidoplus Pain Relief as a cream, and Vonaflex Effective Pain Relief Topical Analgesic as a cream. Bactine Max Lidocaine is supplied as a liquid, while 0.5% Lidocaine Burn Relief is available in gel form.

Most products should be stored at room temperature, with specific temperature ranges for some items. For instance, Alocane Botanicals, Burnx, and Sunburnt Plus should be stored between 15-30°C (59-86°F). Lidoplus Pain Relief, Vonaflex Effective Pain Relief, and several other creams should be kept at controlled room temperatures of 20-25°C (68-77°F).

It is essential to protect these products from excessive heat, direct sunlight, and moisture. Many items, such as Aspercreme Lidocaine with Eucalyptus Essential Oil and Bliss Republic Lidocaine Numbing Cream, require child-resistant packaging and should be kept tightly closed after use. Products like Burn Ease and 0.5% Lidocaine Burn Relief have tamper-evident seals and should not be used if the seal is broken or missing.

For liquid forms, such as Bactine Max and various creams, it is crucial to keep them away from fire or flame due to their flammable nature. Additionally, some products should be discarded after opening to ensure safety and efficacy.