Lidocaine And Prilocaine
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Questions & Answers
Side Effects & Adverse Reactions
Application of lidocaine and prilocaine cream to larger areas or for longer times than those recommended could result in sufficient absorption of lidocaine and prilocaine resulting in serious adverse effects (see Individualization of Dose).
Patients treated with class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, dofetilide) should be under close surveillance and ECG monitoring considered, because cardiac effects may be additive.
Studies in laboratory animals (guinea pigs) have shown that lidocaine and prilocaine cream has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to lidocaine and prilocaine cream in the external auditory canal only, showed no abnormality. Lidocaine and prilocaine cream should not be used in any clinical situation when its penetration or migration beyond the tympanic membrane into the middle ear is possible.
Methemoglobinemia: Lidocaine and prilocaine cream should not be used in those rare patients with congenital or idiopathic methemoglobinemia and in infants under the age of twelve months who are receiving treatment with methemoglobin-inducing agents.
Very young patients or patients with glucose-6-phosphate dehydrogenase deficiencies are more susceptible to methemoglobinemia.
Patients taking drugs associated with drug-induced methemoglobinemia such as sulfonamides, acetaminophen, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine, are also at greater risk for developing methemoglobinemia.
There have been reports of significant methemoglobinemia (20 to 30%) in infants and children following excessive applications of lidocaine and prilocaine cream. These cases involved the use of large doses, larger than recommended areas of application, or infants under the age of 3 months who did not have fully mature enzyme systems. In addition, a few of these cases involved the concomitant administration of methemoglobin-inducing agents. Most patients recovered spontaneously after removal of the cream. Treatment with IV methylene blue may be effective if required.
Physicians are cautioned to make sure that parents or other caregivers understand the need for careful application of lidocaine and prilocaine cream, to ensure that the doses and areas of application recommended in TABLE 2 are not exceeded (especially in children under the age of 3 months) and to limit the period of application to the minimum required to achieve the desired anesthesia.
Neonates and infants up to 3 months of age should be monitored for Met-Hb levels before, during, and after the application of lidocaine and prilocaine cream, provided the test results can be obtained quickly.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Lidocaine and prilocaine cream USP, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:
• normal intact skin for local analgesia.
• genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.
Lidocaine and prilocaine cream is not recommended in any clinical situation in which penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).
History
There is currently no drug history available for this drug.
Other Information
Lidocaine and prilocaine cream USP, 2.5%/2.5% is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes.
Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure:
C14H22N2O M.W. 234.3
Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure:
C13H20N2O M.W. 220.3
Each gram of lidocaine and prilocaine cream contains lidocaine 25 mg, prilocaine 25 mg, purified water, PEG-60/hydrogenated castor oil, carbopol 5984 and sodium hydroxide to adjust pH to approximately 9. Lidocaine and prilocaine cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream is 1.00.
The therapeutic class is topical anesthetic agent.
Sources
Lidocaine And Prilocaine Manufacturers
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Preferred Pharmaceuticals, Inc.
![Lidocaine And Prilocaine Cream [Preferred Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Lidocaine And Prilocaine | Preferred Pharmaceuticals, Inc.
Adult Patients-Intact Skin: A thick layer of lidocaine and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION).
Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine and prilocaine cream (1/2 the 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.
Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.
Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream.
Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in TABLE 2, ** footnote, in Individualization of Dose.
Adult Female Patients-Genital Mucous Membranes: For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of lidocaine and prilocaine cream for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine and prilocaine cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream.
Pediatric Patients-Intact Skin: The following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream based on a child's age and weight:
Age and Body Weight Requirements
Maximum Total Dose of Lidocaine and Prilocaine Cream
Maximum Application Area
Maximum Application Time
0 up to 3 months or < 5 kg
1 g
10 cm2
1 hour
3 up to 12 months and > 5 kg
2 g
20 cm2
4 hours
1 to 6 years and > 10 kg
10 g
100 cm2
4 hours
7 to 12 years and > 20 kg
20 g
200 cm2
4 hours
Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream should be restricted to that which corresponds to the patient's weight (see INSTRUCTIONS FOR APPLICATION).
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream (see PRECAUTIONS).
When applying lidocaine and prilocaine cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream, or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Lidocaine and prilocaine cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of twelve months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).
When lidocaine and prilocaine cream is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine and prilocaine cream is determined by the area over which it is applied and the duration of application under occlusion (see TABLE 2, ** footnote, in Individualization of Dose).
Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
INSTRUCTIONS FOR APPLICATION
To measure 1 gram of lidocaine and prilocaine cream, the cream should be gently squeezed out of the tube as a narrow strip that is 1.5 inches (3.8 cm) long and 0.2 inches (5 mm) wide. The strip of lidocaine and prilocaine cream should be contained within the lines of the diagram shown below.
≈ 1 g strip
1.5 x 0.2 inches
Use the number of strips that equals your dose, like the examples in the table below.
Dosing Information
1 gram =
1 strip
2 grams =
2 strips
2.5 grams =
2.5 strips
For adult and pediatric patients, apply ONLY as prescribed by your physician.
If your child is below the age of 3 months or small for their age, please inform your doctor before applying lidocaine and prilocaine cream, which can be harmful, if applied over too much skin at one time in young children.
When applying lidocaine and prilocaine cream to the intact skin of young children, it is important that they be carefully observed by an adult in order to prevent the accidental ingestion of or eye contact with lidocaine and prilocaine cream.
Lidocaine and prilocaine cream must be applied to intact skin at least 1 hour before the start of a routine procedure and for 2 hours before the start of a painful procedure. A protective covering of the cream is not necessary for absorption but may be helpful to keep the cream in place. If using a protective covering, your doctor will remove it, wipe off the lidocaine and prilocaine cream, and clean the entire area with an antiseptic solution before the procedure.
The duration of effective skin anesthesia will be at least 1 hour after removal of the protective covering.
PRECAUTIONS:
1. Do not apply near eyes or on open wounds.
2. Keep out of reach of children.
3. If your child becomes very dizzy, excessively sleepy, or develops duskiness of the face or lips after applying lidocaine and prilocaine cream, remove the cream and contact your physician at once.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Rebel Distributors Corp
Lidocaine And Prilocaine | Rebel Distributors Corp
Adult Patients-Intact SkinA thick layer of lidocaine and prilocaine cream, 2.5%/2.5% is applied to intact skin and covered with an occlusive dressing.
Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine and prilocaine cream, 2.5%/2.5% over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, 2.5%/2.5%, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.
Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream, 2.5%/2.5% per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.
Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream, 2.5%/2.5% (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream, 2.5%/2.5%.
Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.
Adult Female Patients-Genital Mucous MembranesFor minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5-10 grams) of lidocaine and prilocaine cream, 2.5%/2.5% for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine and prilocaine cream, 2.5%/2.5% application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream, 2.5%/2.5%.
Pediatric Patients-Intact SkinThe following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream, 2.5%/2.5% based on a child's age and weight:
Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream, 2.5%/2.5% should be restricted to that which corresponds to the patient's weight.
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream, 2.5%/2.5% (see PRECAUTIONS).
When applying lidocaine and prilocaine cream, 2.5%/2.5% to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream, 2.5%/2.5% or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Age and Body Weight Requirements Maximum total Dose of
Lidocaine and
Prilocaine Cream, 2.5%/2.5% Maximum
Application Area Maximum
Application Time 0 up to 3 months or < 5 kg 1g 10 cm2 1 hour 3 up to 12 months and >5 kg 2g 20 cm2 4 hours 1 to 6 years and >10 kg 10g 100 cm2 4 hours 7 to 12 years and >20 kg 20g 200 cm2 4 hoursLidocaine and prilocaine cream, 2.5%/2.5% should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of twelve months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).
When lidocaine and prilocaine cream, 2.5%/2.5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine and prilocaine cream, 2.5%/2.5% is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).
Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream, 2.5%/2.5% is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
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Physicians Total Care, Inc.
Lidocaine And Prilocaine | Physicians Total Care, Inc.
Adult Patients-Intact SkinA thick layer of lidocaine and prilocaine cream, 2.5%/2.5% is applied to intact skin and covered with an occlusive dressing.
Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine and prilocaine cream, 2.5%/2.5% over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, 2.5%/2.5%, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.
Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream, 2.5%/2.5% per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.
Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream, 2.5%/2.5% (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream, 2.5%/2.5%.
Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.
Adult Female Patients-Genital Mucous MembranesFor minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5-10 grams) of lidocaine and prilocaine cream, 2.5%/2.5% for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine and prilocaine cream, 2.5%/2.5% application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream, 2.5%/2.5%.
Pediatric Patients-Intact SkinThe following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream, 2.5%/2.5% based on a child's age and weight:
Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream, 2.5%/2.5% should be restricted to that which corresponds to the patient's weight.
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream, 2.5%/2.5% (see PRECAUTIONS).
When applying lidocaine and prilocaine cream, 2.5%/2.5% to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream, 2.5%/2.5% or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Age and Body Weight Requirements Maximum total Dose of
Lidocaine and
Prilocaine Cream, 2.5%/2.5% Maximum
Application Area Maximum
Application Time 0 up to 3 months or < 5 kg 1g 10 cm2 1 hour 3 up to 12 months and >5 kg 2g 20 cm2 4 hours 1 to 6 years and >10 kg 10g 100 cm2 4 hours 7 to 12 years and >20 kg 20g 200 cm2 4 hoursLidocaine and prilocaine cream, 2.5%/2.5% should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of twelve months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).
When lidocaine and prilocaine cream, 2.5%/2.5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine and prilocaine cream, 2.5%/2.5% is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).
Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream, 2.5%/2.5% is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
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Rebel Distributors Corp
Lidocaine And Prilocaine | Rebel Distributors Corp
Adult Patients − Intact Skin A thick layer of lidocaine 2.5% and prilocaine 2.5% cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION: ). Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine 2.5% and prilocaine 2.5% cream (1/2 the 5 g tube) over 20 to 25 cm 2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine 2.5% and prilocaine 2.5% cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site. Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine 2.5% and prilocaine 2.5% cream per 10 cm 2 of skin and allow to remain in contact with the skin for at least 2 hours. Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine 2.5% and prilocaine 2.5% cream (1 g/10 cm 2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine 2.5% and prilocaine 2.5% cream.Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.
Adult Female Patients − Genital Mucous MembranesFor minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5-10 grams) of lidocaine 2.5% and prilocaine 2.5% cream for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine 2.5% and prilocaine 2.5% cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine 2.5% and prilocaine 2.5% cream.
Pediatric Patients − Intact SkinThe following are the maximum recommended doses, application areas and application times for lidocaine 2.5% and prilocaine 2.5% cream based on a child’s age and weight:
Age and Body Weight Requirements
Maximum Total Dose of lidocaine 2.5% and prilocaine 2.5% cream
Maximum Application Area
Maximum Application Time
0 up to 3 months or < 5 kg
1 g
10 cm2
1 hour
3 up to 12 months and > 5 kg
2 g
20 cm2
4 hours
1 to 6 years and > 10 kg
10 g
100 cm2
4 hours
7 to 12 years and > 20 kg
20 g
200 cm2
4 hours
Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine 2.5% and prilocaine 2.5% cream should be restricted to that which corresponds to the patient’s weight. (see INSTRUCTIONS FOR APPLICATION).
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine 2.5% and prilocaine 2.5% cream (see PRECAUTIONS).
When applying lidocaine 2.5% and prilocaine 2.5% cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine 2.5% and prilocaine 2.5% cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Lidocaine 2.5% and prilocaine 2.5% cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).
When lidocaine 2.5% and prilocaine 2.5% cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine 2.5% and prilocaine 2.5% cream is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).
Although the incidence of systemic adverse reactions with lidocaine 2.5% and prilocaine 2.5% cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
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Preferred Pharmaceuticals, Inc.
Lidocaine And Prilocaine | Preferred Pharmaceuticals, Inc.
Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor: It is recommended that ketoconazole cream, 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment.
If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.
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Global Pharmaceuticals, Division Of Impax Laboratories Inc.
Lidocaine And Prilocaine | Global Pharmaceuticals, Division Of Impax Laboratories Inc.
Adult Patients-Intact Skin: A thick layer of lidocaine and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION).
Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine and prilocaine cream (1/2 the 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.
Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.
Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream.
Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in TABLE 2, ** footnote, in Individualization of Dose.
Adult Female Patients-Genital Mucous Membranes: For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of lidocaine and prilocaine cream for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine and prilocaine cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream.
Pediatric Patients-Intact Skin: The following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream based on a child's age and weight:
Age and Body Weight Requirements Maximum Total Dose of Lidocaine and Prilocaine Cream Maximum Application Area Maximum Application Time 0 up to 3 months or < 5 kg 1 g 10 cm2 1 hour 3 up to 12 months and > 5 kg 2 g 20 cm2 4 hours 1 to 6 years and > 10 kg 10 g 100 cm2 4 hours 7 to 12 years and > 20 kg 20 g 200 cm2 4 hoursPlease note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream should be restricted to that which corresponds to the patient's weight (see INSTRUCTIONS FOR APPLICATION).
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream (see PRECAUTIONS).
When applying lidocaine and prilocaine cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream, or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Lidocaine and prilocaine cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of twelve months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).
When lidocaine and prilocaine cream is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine and prilocaine cream is determined by the area over which it is applied and the duration of application under occlusion (see TABLE 2, ** footnote, in Individualization of Dose).
Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
INSTRUCTIONS FOR APPLICATION
To measure 1 gram of lidocaine and prilocaine cream, the cream should be gently squeezed out of the tube as a narrow strip that is 1.5 inches (3.8 cm) long and 0.2 inches (5 mm) wide. The strip of lidocaine and prilocaine cream should be contained within the lines of the diagram shown below.
≈ 1 g strip1.5 x 0.2 inches
Use the number of strips that equals your dose, like the examples in the table below.
Dosing Information 1 gram = 1 strip 2 grams = 2 strips 2.5 grams = 2.5 stripsFor adult and pediatric patients, apply ONLY as prescribed by your physician.
If your child is below the age of 3 months or small for their age, please inform your doctor before applying lidocaine and prilocaine cream, which can be harmful, if applied over too much skin at one time in young children.
When applying lidocaine and prilocaine cream to the intact skin of young children, it is important that they be carefully observed by an adult in order to prevent the accidental ingestion of or eye contact with lidocaine and prilocaine cream.
Lidocaine and prilocaine cream must be applied to intact skin at least 1 hour before the start of a routine procedure and for 2 hours before the start of a painful procedure. A protective covering of the cream is not necessary for absorption but may be helpful to keep the cream in place. If using a protective covering, your doctor will remove it, wipe off the lidocaine and prilocaine cream, and clean the entire area with an antiseptic solution before the procedure.
The duration of effective skin anesthesia will be at least 1 hour after removal of the protective covering.
PRECAUTIONS:
1. Do not apply near eyes or on open wounds.
2. Keep out of reach of children.
3. If your child becomes very dizzy, excessively sleepy, or develops duskiness of the face or lips after applying lidocaine and prilocaine cream, remove the cream and contact your physician at once.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
-
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
Lidocaine And Prilocaine | E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
Adult Patients-Intact SkinA thick layer of lidocaine and prilocaine cream, 2.5%/2.5% is applied to intact skin and covered with an occlusive dressing.
Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams (1/2 the 5 g tube) of lidocaine and prilocaine cream, 2.5%/2.5% over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, 2.5%/2.5%, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.
Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream, 2.5%/2.5% per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.
Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream, 2.5%/2.5% (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream, 2.5%/2.5%.
Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.
Adult Female Patients-Genital Mucous MembranesFor minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5-10 grams) of lidocaine and prilocaine cream, 2.5%/2.5% for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine and prilocaine cream, 2.5%/2.5% application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream, 2.5%/2.5%.
Pediatric Patients-Intact SkinThe following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream, 2.5%/2.5% based on a child's age and weight:
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream, 2.5%/2.5% (see PRECAUTIONS).Age and Body Weight Requirements
Maximum total Dose of
Lidocaine and
Prilocaine Cream, 2.5%/2.5%Maximum
Application AreaMaximum
Application Time0 up to 3 months or < 5 kg
1g
10 cm2
1 hour
3 up to 12 months and >5 kg
2g
20 cm2
4 hours
1 to 6 years and >10 kg
10g
100 cm2
4 hours
7 to 12 years and >20 kg
20g
200 cm2
4 hours
Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream, 2.5%/2.5% should be restricted to that which corresponds to the patient's weight.
When applying lidocaine and prilocaine cream, 2.5%/2.5% to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream, 2.5%/2.5% or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Lidocaine and prilocaine cream, 2.5%/2.5% should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).
When lidocaine and prilocaine cream, 2.5%/2.5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine and prilocaine cream, 2.5%/2.5% is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).
Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream, 2.5%/2.5% is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
-
Hi-tech Pharmacal Co., Inc.
Lidocaine And Prilocaine | Hi-tech Pharmacal Co., Inc.
Adult Patients − Intact Skin A thick layer of lidocaine 2.5% and prilocaine 2.5% cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION: ). Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine 2.5% and prilocaine 2.5% cream (1/2 the 5 g tube) over 20 to 25 cm 2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine 2.5% and prilocaine 2.5% cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site. Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine 2.5% and prilocaine 2.5% cream per 10 cm 2 of skin and allow to remain in contact with the skin for at least 2 hours. Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine 2.5% and prilocaine 2.5% cream (1 g/10 cm 2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine 2.5% and prilocaine 2.5% cream.Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.
Adult Female Patients − Genital Mucous MembranesFor minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5-10 grams) of lidocaine 2.5% and prilocaine 2.5% cream for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine 2.5% and prilocaine 2.5% cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine 2.5% and prilocaine 2.5% cream.
Pediatric Patients − Intact SkinThe following are the maximum recommended doses, application areas and application times for lidocaine 2.5% and prilocaine 2.5% cream based on a child’s age and weight:
Age and Body Weight Requirements
Maximum Total Dose of lidocaine 2.5% and prilocaine 2.5% cream
Maximum Application Area
Maximum Application Time
0 up to 3 months or < 5 kg
1 g
10 cm2
1 hour
3 up to 12 months and > 5 kg
2 g
20 cm2
4 hours
1 to 6 years and > 10 kg
10 g
100 cm2
4 hours
7 to 12 years and > 20 kg
20 g
200 cm2
4 hours
Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine 2.5% and prilocaine 2.5% cream should be restricted to that which corresponds to the patient’s weight. (see INSTRUCTIONS FOR APPLICATION).
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine 2.5% and prilocaine 2.5% cream (see PRECAUTIONS).
When applying lidocaine 2.5% and prilocaine 2.5% cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine 2.5% and prilocaine 2.5% cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Lidocaine 2.5% and prilocaine 2.5% cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).
When lidocaine 2.5% and prilocaine 2.5% cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine 2.5% and prilocaine 2.5% cream is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).
Although the incidence of systemic adverse reactions with lidocaine 2.5% and prilocaine 2.5% cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
-
Akorn, Inc.
Lidocaine And Prilocaine | Akorn, Inc.
Adult Patients-Intact SkinA thick layer of lidocaine and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION).
Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine and prilocaine cream (1/2 the 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.
Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.
Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream.
Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.
Adult Female Patients-Genital Mucous MembranesFor minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of lidocaine and prilocaine cream for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine and prilocaine cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream.
Pediatric Patients-Intact SkinThe following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream based on a child's age and weight:
Age and Body Weight
Requirements Maximum Total
Dose of Lidocaine and
Prilocaine Cream Maximum
Application Area Maximum
Application Time 0 up to 3 months or < 5 kg 1 g 10 cm2 1 hour
3 up to 12 months and > 5 kg 2 g 20 cm2 4 hours 1 to 6 years and > 10 kg 10 g 100 cm2 4 hours 7 to 12 years and 20 kg 20 g 200 cm2 4 hoursPlease note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream should be restricted to that which corresponds to the patient's weight (see INSTRUCTIONS FOR APPLICATION).
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream (see PRECAUTIONS).
When applying lidocaine and prilocaine cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Lidocaine and prilocaine cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).
When lidocaine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine and prilocaine cream is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).
Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
-
Aidarex Pharmaceuticals Llc
Lidocaine And Prilocaine | Aidarex Pharmaceuticals Llc
Adult Patients − Intact Skin A thick layer of lidocaine 2.5% and prilocaine 2.5% cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION: ). Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine 2.5% and prilocaine 2.5% cream (1/2 the 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine 2.5% and prilocaine 2.5% cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site. Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine 2.5% and prilocaine 2.5% cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours. Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine 2.5% and prilocaine 2.5% cream (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine 2.5% and prilocaine 2.5% cream.Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.
Adult Female Patients − Genital Mucous MembranesFor minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5-10 grams) of lidocaine 2.5% and prilocaine 2.5% cream for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine 2.5% and prilocaine 2.5% cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine 2.5% and prilocaine 2.5% cream.
Pediatric Patients − Intact SkinThe following are the maximum recommended doses, application areas and application times for lidocaine 2.5% and prilocaine 2.5% cream based on a child’s age and weight:
Age and Body Weight Requirements
Maximum Total Dose of lidocaine 2.5% and prilocaine 2.5% cream
Maximum Application Area
Maximum Application Time
0 up to 3 months or < 5 kg
1 g
10 cm2
1 hour
3 up to 12 months and > 5 kg
2 g
20 cm2
4 hours
1 to 6 years and > 10 kg
10 g
100 cm2
4 hours
7 to 12 years and > 20 kg
20 g
200 cm2
4 hours
Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine 2.5% and prilocaine 2.5% cream should be restricted to that which corresponds to the patient’s weight. (see INSTRUCTIONS FOR APPLICATION).
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine 2.5% and prilocaine 2.5% cream (see PRECAUTIONS).
When applying lidocaine 2.5% and prilocaine 2.5% cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine 2.5% and prilocaine 2.5% cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Lidocaine 2.5% and prilocaine 2.5% cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).
When lidocaine 2.5% and prilocaine 2.5% cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine 2.5% and prilocaine 2.5% cream is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).
Although the incidence of systemic adverse reactions with lidocaine 2.5% and prilocaine 2.5% cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
-
Direct Rx
Lidocaine And Prilocaine | Direct Rx
Adult Patients-Intact Skin
A thick layer of lidocaine and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION).
Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine and prilocaine cream (1/2 the 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.
Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.
Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream.
Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.
Adult Female Patients-Genital Mucous Membranes
For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of lidocaine and prilocaine cream for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine and prilocaine cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream.
Pediatric Patients-Intact Skin
The following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream based on a child's age and weight:
Age and Body Weight
Requirements Maximum Total
Dose of Lidocaine and
Prilocaine Cream Maximum
Application Area Maximum
Application Time 0 up to 3 months or < 5 kg 1 g 10 cm2 1 hour 3 up to 12 months and > 5 kg 2 g 20 cm2 4 hours 1 to 6 years and > 10 kg 10 g 100 cm2 4 hours 7 to 12 years and 20 kg 20 g 200 cm2 4 hoursPlease note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream should be restricted to that which corresponds to the patient's weight (see INSTRUCTIONS FOR APPLICATION).
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream (see PRECAUTIONS).
When applying lidocaine and prilocaine cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Lidocaine and prilocaine cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).
When lidocaine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine and prilocaine cream is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).
Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
-
Actavis Pharma, Inc.
Lidocaine And Prilocaine | Actavis Pharma, Inc.
Adult Patients-Intact SkinA thick layer of lidocaine and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION).
Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine and prilocaine cream (1/2 the 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.
Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.
Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream (1 g/10 cm2 ) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream.
Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.
Adult Female Patients-Genital Mucous MembranesFor minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5 to 10 grams) of lidocaine and prilocaine cream for 5 to 10 minutes.
Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine and prilocaine cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream.
Pediatric Patients-Intact SkinThe following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream based on a child's age and weight:
Age and Body Weight
Requirements Maximum Total
Dose of Lidocaine and
Prilocaine Cream Maximum
Application Area Maximum
Application Time 0 up to 3 months or < 5 kg 1 g 10 cm2 1 hour
3 up to 12 months and > 5 kg 2 g 20 cm2 4 hours 1 to 6 years and > 10 kg 10 g 100 cm2 4 hours 7 to 12 years and > 20 kg 20 g 200 cm2 4 hoursPlease note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream should be restricted to that which corresponds to the patient's weight (see INSTRUCTIONS FOR APPLICATION).
Practitioners should carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream (see PRECAUTIONS).
When applying lidocaine and prilocaine cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.
Lidocaine and prilocaine cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).
When lidocaine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine and prilocaine cream is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).
Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).
![Lidocaine And Prilocaine Cream [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b61c6a09-7764-4a92-93a9-a1356aeeaa9c&name=b61c6a09-7764-4a92-93a9-a1356aeeaa9c-09.jpg)
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