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lidocaine and prilocaine
Overview
What is LiProZonePak?
Lidocaine 2.5% and Prilocaine 2.5%, a topical anesthetic agent, 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 15 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:
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:
Each gram of lidocaine 2.5% and prilocaine 2.5% cream contains lidocaine 25 mg, prilocaine 25 mg, carboxypolymethylene (as a thickening agent), polyoxyethylene fatty acid esters (as emulsifiers), purified water to 1 gram, and sodium hydroxide to adjust pH (pH range 9.0-9.4). Lidocaine 2.5% and prilocaine 2.5% cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine 2.5% and prilocaine 2.5% cream is 1.00.
What does LiProZonePak look like?
What are the available doses of LiProZonePak?
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What should I talk to my health care provider before I take LiProZonePak?
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How should I use LiProZonePak?
Lidocaine 2.5% and prilocaine 2.5% cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:
normal intact skin
genital mucous membranes
Lidocaine 2.5% and prilocaine 2.5% cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see ).
A thick layer of lidocaine 2.5% and prilocaine 2.5% cream is applied to intact skin and covered with an occlusive dressing (see ).
Minor Dermal Procedures
Major Dermal Procedures
Adult Male Genital Skin
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 , ** footnote, in Individualization of Dose.
What interacts with LiProZonePak?
lidocaine 2.5% and prilocaine 2.5% cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.
What are the warnings of LiProZonePak?
A cardiovertor/defibrillator should not be discharged through a paddle electrode that overlies a Nitroglycerin Transdermal Delivery System patch. The arcing that may be seen in this situation is harmless in itself, but it may be associated with local current concentration that can cause damage to the paddles and burns to the patient.
Application of lidocaine 2.5% and prilocaine 2.5% 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 ().
Patients treated with class III anti-arrhythmic drugs (eg, 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 2.5% and prilocaine 2.5% cream has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to lidocaine 2.5% and prilocaine 2.5% cream only in the external auditory canal, showed no abnormality. lidocaine 2.5% and prilocaine 2.5% 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 2.5% and prilocaine 2.5% 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, paraaminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine, are also at greater risk for developing methemoglobinemia.
There have been reports of significant methemoglobinemia (20-30%) in infants and children following excessive applications of lidocaine 2.5% and prilocaine 2.5% 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 2.5% and prilocaine 2.5% cream, to ensure that the doses and areas of application recommended in 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 2.5% and prilocaine 2.5% cream, provided the test results can be obtained quickly.
What are the precautions of LiProZonePak?
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General:
Repeated doses of lidocaine 2.5% and prilocaine 2.5% cream may increase blood levels of lidocaine and prilocaine. lidocaine 2.5% and prilocaine 2.5% cream should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine and prilocaine including acutely ill, debilitated, or elderly patients.
Lidocaine 2.5% and prilocaine 2.5% cream should not be applied to open wounds.
Care should be taken not to allow lidocaine 2.5% and prilocaine 2.5% cream to come in contact with the eye because animal studies have demonstrated severe eye irritation. Also the loss of protective reflexes can permit corneal irritation and potential abrasion. Absorption of lidocaine 2.5% and prilocaine 2.5% cream in conjunctival tissues has not been determined. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine; however, lidocaine 2.5% and prilocaine 2.5% cream should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.
Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations of lidocaine and prilocaine.
Lidocaine and prilocaine have been shown to inhibit viral and bacterial growth. The effect of lidocaine 2.5% and prilocaine 2.5% cream on injections of vaccines has not been determined.
Information for Patients:
When lidocaine 2.5% and prilocaine 2.5% cream is used, the patient should be aware that the production of dermal analgesia may be accompanied by the block of all sensations in the treated skin. For this reason, the patient should avoid inadvertent trauma to the treated area by scratching, rubbing, or exposure to extreme hot or cold temperatures until complete sensation has returned.
Lidocaine 2.5% and prilocaine 2.5% cream should not be applied near the eyes or on open wounds.
Drug Interactions:
Lidocaine 2.5% and prilocaine 2.5% cream should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.
Prilocaine may contribute to the formation of methemoglobin in patients treated with other drugs known to cause this condition
Specific interaction studies with lidocaine/prilocaine and class III anti-arrhythmic drugs (eg, amiodarone, bretylium, sotalol, dofetilide) have not been performed, but caution is advised (see ).
Should lidocaine 2.5% and prilocaine 2.5% cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Metabolites of prilocaine have been shown to be carcinogenic in laboratory animals. In the animal studies reported below, doses or blood levels are compared with the Single Dermal Administration (SDA) of 60 g of lidocaine 2.5% and prilocaine 2.5% cream to 400 cm for 3 hours to a small person (50 kg). The typical application of lidocaine 2.5% and prilocaine 2.5% cream for one or two treatments for venipuncture sites (2.5 or 5 g) would be 1/24 or 1/12 of that dose in an adult or about the same mg/kg dose in an infant.
Chronic oral toxicity studies of ortho-toluidine, a metabolite of prilocaine, in mice (450 to 7,200 mg/m; 60 to 960 times SDA) and rats (900 to 4,800 mg/m; 60 to 320 times SDA) have shown that -toluidine is a carcinogen in both species. The tumors included hepatocarcinomas/adenomas in female mice, multiple occurrences of hemangiosarcomas/hemangiomas in both sexes of mice, sarcomas of multiple organs, transitional-cell carcinomas/papillomas of urinary bladder in both sexes of rats, subcutaneous fibromas/fibrosarcomas and mesotheliomas in male rats, and mammary gland fibroadenomas/adenomas in female rats. The lowest dose tested (450 mg/m in mice, 900 mg/m in rats, 60 times SDA) was carcinogenic in both species. Thus the no-effect dose must be less than 60 times SDA. The animal studies were conducted at 150 to 2,400 mg/kg in mice and at 150 to 800 mg/kg in rats. The dosages have been converted to mg/m for the SDA calculations above.
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Impairment of Fertility
PREGNANCY
Reproduction studies with lidocaine have been performed in rats and have revealed no evidence of harm to the fetus (30 mg/kg subcutaneously; 22 times SDA). Reproduction studies with prilocaine have been performed in rats and have revealed no evidence of impaired fertility or harm to the fetus (300 mg/kg intramuscularly; 188 times SDA). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, lidocaine 2.5% and prilocaine 2.5% cream should be used during pregnancy only if clearly needed.
Reproduction studies have been performed in rats receiving subcutaneous administration of an aqueous mixture containing lidocaine HCl and prilocaine HCl at 1:1 (w/w). At 40 mg/kg each, a dose equivalent to 29 times SDA lidocaine and 25 times SDA prilocaine, no teratogenic, embryotoxic or fetotoxic effects were observed.
Labor and Delivery:
Neither lidocaine nor prilocaine are contraindicated in labor and delivery. Should lidocaine 2.5% and prilocaine 2.5% cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.
Nursing Mothers:
Lidocaine, and probably prilocaine, are excreted in human milk. Therefore, caution should be exercised when lidocaine 2.5% and prilocaine 2.5% cream is administered to a nursing mother since the milk: plasma ratio of lidocaine is 0.4 and is not determined for prilocaine.
Pediatric Use:
Controlled studies of lidocaine 2.5% and prilocaine 2.5% cream in children under the age of seven years have shown less overall benefit than in older children or adults. These results illustrate the importance of emotional and psychological support of younger children undergoing medical or surgical procedures.
Lidocaine 2.5% and prilocaine 2.5% cream should be used with care in patients with conditions or therapy associated with methemoglobinemia (see ).
When using lidocaine 2.5% and prilocaine 2.5% cream in young children, especially infants under the age of 3 months, care must be taken to insure that the caregiver understands the need to limit the dose and area of application, and to prevent accidental ingestion (see and ).
In neonates (minimum gestation age: 37 weeks) and children weighing less than 20 kg, the area and duration of application should be limited (see in Individualization of Dose).
Studies have not demonstrated the efficacy of lidocaine 2.5% and prilocaine 2.5% cream for heel lancing in neonates.
Geriatric Use:
Of the total number of patients in clinical studies of lidocaine 2.5% and prilocaine 2.5% cream, 180 were age 65 to 74 and 138 were 75 and over. No overall differences in safety or efficacy were observed between these patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Plasma levels of lidocaine and prilocaine in geriatric and non-geriatric patients following application of a thick layer of lidocaine 2.5% and prilocaine 2.5% cream are very low and well below potentially toxic levels. However, there are no sufficient data to evaluate quantitative differences in systemic plasma levels of lidocaine and prilocaine between geriatric and non-geriatric patients following application of lidocaine 2.5% and prilocaine 2.5% cream.
Consideration should be given for those elderly patients who have enhanced sensitivity to systemic absorption. (See .)
After intravenous dosing, the elimination half-life of lidocaine is significantly longer in elderly patients (2.5 hours) than in younger patients (1.5 hours). (See .)
What are the side effects of LiProZonePak?
To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Localized Reactions:
Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision. Both neonates received 1.0 g of lidocaine 2.5% and prilocaine 2.5% cream.
In patients treated with lidocaine 2.5% and prilocaine 2.5% cream on intact skin, local effects observed in the trials included: paleness (pallor or blanching) 37%, redness (erythema) 30%, alterations in temperature sensations 7%, edema 6%, itching 2% and rash, less than 1%.
In clinical studies on genital mucous membranes involving 378 lidocaine 2.5% and prilocaine 2.5% cream-treated patients, one or more application site reactions, usually mild and transient, were noted in 41% of patients. The most common application site reactions were redness (21%), burning sensation (17%) and edema (10%).
Allergic Reactions:
Systemic (Dose Related) Reactions:
What should I look out for while using LiProZonePak?
lidocaine 2.5% and prilocaine 2.5% cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.
Application of lidocaine 2.5% and prilocaine 2.5% 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 ().
Patients treated with class III anti-arrhythmic drugs (eg, 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 2.5% and prilocaine 2.5% cream has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to lidocaine 2.5% and prilocaine 2.5% cream only in the external auditory canal, showed no abnormality. lidocaine 2.5% and prilocaine 2.5% 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 2.5% and prilocaine 2.5% 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, paraaminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine, are also at greater risk for developing methemoglobinemia.
There have been reports of significant methemoglobinemia (20-30%) in infants and children following excessive applications of lidocaine 2.5% and prilocaine 2.5% 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 2.5% and prilocaine 2.5% cream, to ensure that the doses and areas of application recommended in 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 2.5% and prilocaine 2.5% cream, provided the test results can be obtained quickly.
What might happen if I take too much LiProZonePak?
Peak blood levels following a 60 g application to 400 cm of intact skin for 3 hours are 0.05 to 0.16 /mL for lidocaine and 0.02 to 0.10/mL for prilocaine. Toxic levels of lidocaine (> 5 /mL) and/or prilocaine (> 6/mL) cause decreases in cardiac output, total peripheral resistance and mean arterial pressure. These changes may be attributable to direct depressant effects of these local anesthetic agents on the cardiovascular system. In the absence of massive topical overdose or oral ingestion, evaluation should include evaluation of other etiologies for the clinical effects or overdosage from other sources of lidocaine, prilocaine or other local anesthetics. Consult the package inserts for parenteral Xylocaine (lidocaine HCl) or Citanest (prilocaine HCl) for further information for the management of overdose.
How should I store and handle LiProZonePak?
Store APTIOM tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Lidocaine 2.5% and Prilocaine 2.5% Cream is available as the following:NDC 50383-667-15 15 gram tube, box of 1NDC 50383-667-30 30 gram tube, box of 1NOT FOR OPHTALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Store at controlled room temperature 15° to 30°C (59° to 86°F) [see USP].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:02 7/09MG #16518Lidocaine 2.5% and Prilocaine 2.5% Cream is available as the following:NDC 50383-667-15 15 gram tube, box of 1NDC 50383-667-30 30 gram tube, box of 1NOT FOR OPHTALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Store at controlled room temperature 15° to 30°C (59° to 86°F) [see USP].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:02 7/09MG #16518Lidocaine 2.5% and Prilocaine 2.5% Cream is available as the following:NDC 50383-667-15 15 gram tube, box of 1NDC 50383-667-30 30 gram tube, box of 1NOT FOR OPHTALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Store at controlled room temperature 15° to 30°C (59° to 86°F) [see USP].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:02 7/09MG #16518Lidocaine 2.5% and Prilocaine 2.5% Cream is available as the following:NDC 50383-667-15 15 gram tube, box of 1NDC 50383-667-30 30 gram tube, box of 1NOT FOR OPHTALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Store at controlled room temperature 15° to 30°C (59° to 86°F) [see USP].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:02 7/09MG #16518Lidocaine 2.5% and Prilocaine 2.5% Cream is available as the following:NDC 50383-667-15 15 gram tube, box of 1NDC 50383-667-30 30 gram tube, box of 1NOT FOR OPHTALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Store at controlled room temperature 15° to 30°C (59° to 86°F) [see USP].Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:02 7/09MG #16518
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Lidocaine 2.5% and prilocaine 2.5% cream, applied to intact skin under occlusive dressing, provides dermal analgesia by the release of lidocaine and prilocaine from the cream into the epidermal and dermal layers of the skin and by the accumulation of lidocaine and prilocaine in the vicinity of dermal pain receptors and nerve endings. Lidocaine and prilocaine are amide-type local anesthetic agents. Both lidocaine and prilocaine stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.
The onset, depth and duration of dermal analgesia on intact skin provided by lidocaine 2.5% and prilocaine 2.5% cream depend primarily on the duration of application. To provide sufficient analgesia for clinical procedures such as intravenous catheter placement and venipuncture, lidocaine 2.5% and prilocaine 2.5% cream should be applied under an occlusive dressing for at least 1 hour. To provide dermal analgesia for clinical procedures such as split skin graft harvesting, lidocaine 2.5% and prilocaine 2.5% cream should be applied under occlusive dressing for at least 2 hours. Satisfactory dermal analgesia is achieved 1 hour after application, reaches maximum at 2 to 3 hours, and persists for 1 to 2 hours after removal. Absorption from the genital mucosa is more rapid and onset time is shorter (5 to 10 minutes) than after application to intact skin. After a 5 to 10 minute application of lidocaine 2.5% and prilocaine 2.5% cream to female genital mucosa, the average duration of effective analgesia to an argon laser stimulus (which produced a sharp, pricking pain) was 15 to 20 minutes (individual variations in the range of 5 to 45 minutes).
Dermal application of lidocaine 2.5% and prilocaine 2.5% cream may cause a transient, local blanching followed by a transient, local redness or erythema.
Non-Clinical Toxicology
lidocaine 2.5% and prilocaine 2.5% cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.Application of lidocaine 2.5% and prilocaine 2.5% 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 ().
Patients treated with class III anti-arrhythmic drugs (eg, 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 2.5% and prilocaine 2.5% cream has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to lidocaine 2.5% and prilocaine 2.5% cream only in the external auditory canal, showed no abnormality. lidocaine 2.5% and prilocaine 2.5% 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 2.5% and prilocaine 2.5% 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, paraaminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine, are also at greater risk for developing methemoglobinemia.
There have been reports of significant methemoglobinemia (20-30%) in infants and children following excessive applications of lidocaine 2.5% and prilocaine 2.5% 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 2.5% and prilocaine 2.5% cream, to ensure that the doses and areas of application recommended in 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 2.5% and prilocaine 2.5% cream, provided the test results can be obtained quickly.
Lidocaine 2.5% and prilocaine 2.5% cream should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.
Prilocaine may contribute to the formation of methemoglobin in patients treated with other drugs known to cause this condition
Specific interaction studies with lidocaine/prilocaine and class III anti-arrhythmic drugs (eg, amiodarone, bretylium, sotalol, dofetilide) have not been performed, but caution is advised (see ).
Should lidocaine 2.5% and prilocaine 2.5% cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.
To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Localized Reactions:
Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision. Both neonates received 1.0 g of lidocaine 2.5% and prilocaine 2.5% cream.
In patients treated with lidocaine 2.5% and prilocaine 2.5% cream on intact skin, local effects observed in the trials included: paleness (pallor or blanching) 37%, redness (erythema) 30%, alterations in temperature sensations 7%, edema 6%, itching 2% and rash, less than 1%.
In clinical studies on genital mucous membranes involving 378 lidocaine 2.5% and prilocaine 2.5% cream-treated patients, one or more application site reactions, usually mild and transient, were noted in 41% of patients. The most common application site reactions were redness (21%), burning sensation (17%) and edema (10%).
Allergic Reactions:
Systemic (Dose Related) Reactions:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
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