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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 21.04.2022
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Lidocaine Topical (Toplap)™ (lindocaine hydrochloride monohydrate) is indicated for use on intact skin to provide topical local analgesia prior to venipuncture or peripheral intravenous cannulation, in children 3–18 years of age.
Lidocaine Topical (Toplap)™ (lindocaine hydrochloride monohydrate) is indicated for use on intact skin to provide topical local analgesia prior to venipuncture in adults.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Injection
Dental infiltration and dental nerve block
Adult: 40-80 mg (1-2 ml) as a 4% solution without felypressin or 30-150 mg (1-5 ml) as a 3% solution with felypressin 0.03 IU/ml. Max: 400 mg if used alone and 300 mg if used with felypressin.
Child: <10 yr: 40 mg (1 ml) as a 4% soln without felypressin or 30-60 mg (1-2 ml) as a 3% soln with felypressin 0.03 units/ml.
Topical/Cutaneous
Local anaesthesia
Adult: Eutectic mixture of Prilocaine Topical (Toplap) base 2.5% and lignocaine base 2.5% applied as a cream under occlusive dressing (except for removal of genital warts).
Lidocaine Topical (Toplap) is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.
Lidocaine Topical (Toplap) is used to relieve post-shingles pain. Apply Lidocaine Topical (Toplap) only to intact skin with no blisters.
Lidocaine Topical (Toplap) in other formulations is used to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches, hemorrhoids, and burns. Lidocaine Topical (Toplap) can also be used to treat sores inside the mouth, during dental procedures to numb the gums, and to numb the skin for a medical procedure (such as getting stiches).
Prilocaine Topical (Toplap) injection is used to numb the mouth before a dental procedure.
Prilocaine Topical (Toplap) is to be given by or under the direct supervision of your dentist.
Important Dosage and Administration Instructions
Because of the difference in bioavailability of Lidocaine Topical (Toplap) compared to Lidocaine Topical (Toplap) (lidocaine patch 5%), a different dosage strength is required to be administered to the patient. One Lidocaine Topical (Toplap) (Lidocaine Topical (Toplap) system) 1.8% provides equivalent lidocaine exposure to one Lidocaine Topical (Toplap) (lidocaine patch 5%).
When Lidocaine Topical (Toplap) is used concomitantly with other products containing local anesthetic agents, the total amount of drug absorbed from all formulations must be considered.
Lidocaine Topical (Toplap) may not stick if it gets wet. Advise patients to avoid contact with water, such as bathing, swimming, or showering.
Instruct patients to wash hands immediately after handling Lidocaine Topical (Toplap) and to avoid contact with eyes.
Instruct patients to store Lidocaine Topical (Toplap) inside the sealed envelope and to apply immediately after removal from the envelope. Advise them to store Lidocaine Topical (Toplap) out of the reach of children, pets, and others. Instruct patients to, after use, fold used Lidocaine Topical (Toplap) so that the adhesive side sticks to itself and safely discard used Lidocaine Topical (Toplap) or pieces of cut Lidocaine Topical (Toplap) where children and pets cannot get to them.
Advise patients not to apply external heat sources, such as heating pads or electric blankets, directly to Lidocaine Topical (Toplap) because plasma lidocaine levels are increased. Lidocaine Topical (Toplap) can be applied, however, to the administration site after moderate heat exposure, such as 15 minutes of heating pad exposure on a medium setting.
Lidocaine Topical (Toplap) may be used during moderate exercise, such as biking for 30 minutes.
Lidocaine Topical (Toplap) topical systems that have lifted at the edges may be reattached by pressing firmly on the edges. If a Lidocaine Topical (Toplap) topical system comes off completely and will not stick to patient’s skin, it should be thrown away and a new Lidocaine Topical (Toplap) topical system should be applied for a total duration of 12 hours of used and new topical system together.
Post-herpetic Neuralgia
Apply Lidocaine Topical (Toplap) to intact skin to cover the most painful area. Apply the prescribed number of topical systems (maximum of 3), only once for up to 12 hours within a 24-hour period (12 hours on and 12 hours off). Lidocaine Topical (Toplap) may be cut into smaller sizes with scissors prior to removal of the release liner. Clothing may be worn over the area of application. Smaller areas of treatment are recommended in a debilitated patient, or a patient with impaired elimination.
If irritation or a burning sensation occurs during application, advise patients to remove Lidocaine Topical (Toplap) and do not reapply until the irritation subsides.
Injection
Dental infiltration and dental nerve block
Adult: 40-80 mg (1-2 ml) as a 4% solution without felypressin or 30-150 mg (1-5 ml) as a 3% solution with felypressin 0.03 IU/ml. Max: 400 mg if used alone and 300 mg if used with felypressin.
Child: <10 yr: 40 mg (1 ml) as a 4% soln without felypressin or 30-60 mg (1-2 ml) as a 3% soln with felypressin 0.03 units/ml.
Topical/Cutaneous
Local anaesthesia
Adult: Eutectic mixture of Prilocaine Topical (Toplap) base 2.5% and lignocaine base 2.5% applied as a cream under occlusive dressing (except for removal of genital warts).
See also:
What is the most important information I should know about Lidocaine Topical (Toplap)?
An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). However, overdose has also occurred in women treated with a numbing medicine before having a mammography. Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).
Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.
Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of Lidocaine Topical (Toplap), or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.
Keep both used and unused lidocaine skin patches out of the reach of children or pets. The amount of lidocaine in the skin patches could be harmful to a child or pet who accidentally sucks on or swallows the patch. Seek emergency medical attention if this happens.
Known hypersensitivity to anaesthetics of the amide type or to any of the excipients.
Hypersensitivity to methyl and/or propyl parahydroxybenzoate (methyl-/propyl paraben), or to their metabolite para-aminobenzoic acid (PABA).
Formulations of Prilocaine Topical (Toplap) containing parabens should be avoided in patients allergic to ester local anaesthetics or its metabolite PABA.
this medicine should be avoided in patients with anaemia or congenital or acquired methaemoglobinaemia.
Use Lidocaine Topical (Toplap) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Lidocaine Topical (Toplap) is only to be used on intact, clean, dry skin. Do not apply Lidocaine Topical (Toplap) to broken, damaged, or inflamed skin.
- Wash your hands before and immediately after using Lidocaine Topical (Toplap).
- Remove the liner on the patch. Apply the patch so that it covers the painful area. If the painful area is larger than the patch, apply the patch over the most painful area. Patches may also be cut into smaller sizes before removing the liner if desired. Be sure to discard the unused pieces of cut patches out of the reach of children and away from pets.
- If irritation or burning occurs when you apply the patch, remove it. Do not reapply any patches until the irritation stops.
- Patches may be worn for up to 12 hours within a 24-hour period as directed by your doctor. Clothing may be worn over the area where the patch is applied.
- After removing a patch, fold it in half with the sticky sides together. Discard the patch out of reach of children and away from pets. Do not apply another patch to the same area of skin for 12 hours.
- If you miss a dose of Lidocaine Topical (Toplap), use the dose when you remember. Continue to use it as directed by your doctor. Do not use Lidocaine Topical (Toplap) for more than 12 hours in a 24-hour period. Do not use 2 doses sooner than 12 hours apart.
Ask your health care provider any questions you may have about how to use Lidocaine Topical (Toplap).
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.
How to use Lidocaine Topical (Toplap) (acetaminophen)
Take this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.
There are many brands and forms of acetaminophen available. Read the dosing instructions carefully for each product because the amount of acetaminophen may be different between products. Do not take more acetaminophen than recommended.
If you are giving acetaminophen to a child, be sure you use a product that is meant for children. Use your child's weight to find the right dose on the product package. If you don't know your child's weight, you can use their age.
For suspensions, shake the medication well before each dose. Some liquids do not need to be shaken before use. Follow all directions on the product package. Measure the liquid medication with the provided dose-measuring spoon/dropper/syringe to make sure you have the correct dose. Do not use a household spoon.
For rapidly-dissolving tablets, chew or allow to dissolve on the tongue, then swallow with or without water. For chewable tablets, chew thoroughly before swallowing.
Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.
For effervescent tablets, dissolve the dose in the recommended amount of water, then drink.
Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.
Do not take this medication for fever for more than 3 days unless directed by your doctor. For adults, do not take this product for pain for more than 10 days (5 days in children) unless directed by your doctor. If the child has a sore throat (especially with high fever, headache, or nausea/vomiting), consult the doctor promptly.
Tell your doctor if your condition persists or worsens or if you develop new symptoms. If you think you may have a serious medical problem, get medical help right away.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Prilocaine Topical (Toplap) is always used in combination with lidocaine as a local anesthetic during superficial minor surgery and medical procedures.
See also:
What other drugs will affect Lidocaine Topical (Toplap)?
Clinically Significant Drug Interactions
The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors, tricyclic antidepressants or phenothiazines may produce severe prolonged hypotension or hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential.
Concurrent administration of vasopressor drugs and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.
As the 2% Lidocaine Topical (Toplap) DENTAL solutions both contain a vasoconstrictor (epinephrine), concurrent use of either with a Beta-adrenergic blocking agent (propranolol, timolol, etc.) may result in dosedependent hypertension and bradycardia with possible heart block.
Drug/Laboratory Test Interactions
The intramuscular injection of lidocaine may result in an increase in creatine phosphokinase levels. Thus, the use of this enzyme determination, without isoenzyme separation, as a diagnostic test for the presence of acute myocardial infarction may be compromised by the intramuscular injection of lidocaine.
Bupivacaine (Liposomal): Local Anesthetics may enhance the adverse/toxic effect of Bupivacaine (Liposomal). Management: Liposomal bupivacaine should not be administered with local anesthetics. Liposomal bupivacaine may be administered 20 minutes or more after the administration of lidocaine, but the optimal duration of dose separation for other local anesthetics is unknown Avoid combination
Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Monitor therapy
Hyaluronidase: May enhance the adverse/toxic effect of Local Anesthetics. Monitor therapy
Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Monitor therapy
Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Prilocaine Topical (Toplap). Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when Prilocaine Topical (Toplap) is used in combination with other agents associated with development of methemoglobinemia. Avoid Prilocaine Topical (Toplap) in infants receiving such agents. Monitor therapy
Neuromuscular-Blocking Agents: Local Anesthetics may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Monitor therapy
Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Monitor therapy
Technetium Tc 99m Tilmanocept: Local Anesthetics may diminish the diagnostic effect of Technetium Tc 99m Tilmanocept. Management: Avoid mixing and simultaneously co-injecting technetium Tc 99m tilmanocept with local anesthetics. This interaction does not appear to apply to other uses of these agents in combination. Monitor therapy
See also:
What are the possible side effects of Lidocaine Topical (Toplap)?
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of Lidocaine Topical (Toplap)™ has been evaluated in 10 clinical trials, five in adults and five in pediatric patients.
The five adult clinical trials consisted of a randomized, double-blind, parallel-arm, sham-placebo controlled Phase 3 trial that enrolled 693 patients, two randomized, double-blind, crossover design, sham-placebo controlled Phase 1 trials that enrolled 455 patients, and two open-label studies that enrolled 44 patients. A total of 742 adults received an active treatment with an active treatment that delivered a 0.5 mg dose of lidocaine, while 775 received placebo.
The five pediatric clinical trials consisted of five randomized, double-blind, parallel-arm, sham-placebo controlled trials in which 1761 patients, ages 3 to 18, received either Lidocaine Topical (Toplap)™ or a sham placebo device. A total of 906 pediatric patients received active treatment, while 855 received placebo.
Application Site Reaction
The application site was specifically assessed for four categories of skin site reaction (erythema, edema, pruritus, and petechiae).
In adults, erythema occurred in 67.3% of Lidocaine Topical (Toplap)™-treated patients, and in 25.0% of placebo-treated patients. Petechiae occurred in 46.4% of Lidocaine Topical (Toplap)™-treated patients, and in 7.0% of placebo-treated patients. Edema occurred in 4.3% of Lidocaine Topical (Toplap)™-treated patients, and in 0.8% of placebo-treated patients. Pruritus occurred in 9.4% of Lidocaine Topical (Toplap)™-treated patients and in 6.2% of placebo-treated patients.
In pediatric patients, erythema occurred in 53% of Lidocaine Topical (Toplap)-treated patients, and in 27% of placebo-treated patients. Petechiae occurred in 44% of Lidocaine Topical (Toplap)-treated patients, and in 5% of placebo-treated patients. Edema occurred in 8% of Lidocaine Topical (Toplap)-treated patients, and in 3% of placebo-treated patients. Pruritus occurred in 1% of patients in both treatment groups.
Adverse Reactions
Amongst the 742 adult patients receiving active treatment and 775 adult patients receiving sham placebo treatment in the 5 adult studies, the percentage of adult patients with any adverse reactions was 3.9% in the active-treated patients and 4.9% in the sham placebo treated patients.
Most adverse reactions were application-site related (i.e., hypoaesthesia (0% active, 0.5% sham placebo), burning (0.54% active, 0.4% sham placebo), and venipuncture site hemorrhage (0.4% active, 1.7% sham placebo)).
The most common systemic adverse reaction was dizziness, which occurred in 0.9% of active-treated adult patients and in 0.7% of sham placebo treated adult patients. No other systemic adverse events occurred in more than two patients in either treatment group.
Amongst the 906 pediatric patients receiving active treatment and 855 pediatric patients receiving sham placebo treatment, the percentage of pediatric patients with any adverse reactions was approximately 9% in each treatment group.
Most adverse reactions were application-site related (i.e., bruising, burning, pain, contusion, hemorrhage), occurring in 4% of pediatric patients in each treatment group.
The most common systemic adverse reactions were nausea (2%) and vomiting (1%).
See also:
What are the possible side effects of Prilocaine Topical (Toplap)?
Application site itching, Application site swelling, Burning sensation, Changes in skin color, Skin rash, Skin redness
A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of procaine but its duration of action is shorter than that of bupivacaine or prilocaine.
A local anesthetic that is similar pharmacologically to lidocaine. Currently, it is used most often for infiltration anesthesia in dentistry. (From AMA Drug Evaluations Annual, 1992, p165)