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Lidocaine and Prilocaine

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Overview

What is Medolor Pak?

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 Medolor Pak look like?



What are the available doses of Medolor Pak?

Sorry No records found.

What should I talk to my health care provider before I take Medolor Pak?

Sorry No records found

How should I use Medolor Pak?

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: for local analgesia. for superficial minor surgery and as pretreatment for infiltration anesthesia.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 WARNINGS).

Adult Patients - Intact Skin

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 Table 2, ** footnote, in Individualization of Dose.

Adult Female Patients - Genital Mucous Membranes

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 Skin

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 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).


What interacts with Medolor Pak?

Lidocaine 2.5% and prilocaine 2.5% cream 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 Medolor Pak?

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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 (see Individualization of Dose).

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:

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 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 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 2.5% and prilocaine 2.5% cream, provided the test results can be obtained quickly.


What are the precautions of Medolor Pak?

General:

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 intradermal injections of live vaccines has not been determined.

Information for Patients:

Lidocaine 2.5% and prilocaine 2.5% cream should not be applied near the eyes or on open wounds.

Drug Interactions:

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 WARNINGS).

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 -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.

Mutagenesis

Salmonella

n vitro

in vivo

Ortho

Escherichia coli

ortho

Salmonella typhimurium

ortho

Salmonella typhimurium

Impairment of Fertility

Use in Pregnancy: Teratogenic Effects: Pregnancy Category B.

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:

Nursing Mothers:

Pediatric Use:

Lidocaine 2.5% and prilocaine 2.5% cream should be used with care in patients with conditions or therapy associated with methemoglobinemia (see Methemoglobinemia subsection of WARNINGS).

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 DOSAGE AND ADMINISTRATION and Methemoglobinemia).

In neonates (minimum gestation age: 37 weeks) and children weighing less than 20 kg, the area and duration of application should be limited (see TABLE 2 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:

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 PRECAUTIONS.)

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 CLINICAL PHARMACOLOGY.)


What are the side effects of Medolor Pak?

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 Medolor Pak?

Lidocaine 2.5% and prilocaine 2.5% cream 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 (see Individualization of Dose).

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:

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 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 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 2.5% and prilocaine 2.5% cream, provided the test results can be obtained quickly.


What might happen if I take too much Medolor Pak?

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 mcg/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 Medolor Pak?

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) This kit contains:3 - Lidocaine/Prilocaine, Cream, 2.5%/2.5% - 30 Grams1 - TegadermTM Transparent Film Dressing - 20 EachFor Topical Use Only NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:03 2/13MG #16518NDC 69665-828-01                MEDOLOR PAK™                    3 x 30 gramsLidocaine 2.5% / Prilocaine 2.5% Cream, 30 gram tubesNDC 50383-667-30Marketed by MedArbor LLC, Bala Cynwyd, PATegaderm™ is a trademark of 3M Corporation.MEDOLOR PAK™ is a trademark of MedArbor LLC.NOTE TO PHARMACIST:See package insert for full prescribing information.This kit contains:3 - Lidocaine/Prilocaine, Cream, 2.5%/2.5% - 30 Grams1 - TegadermTM Transparent Film Dressing - 20 EachFor Topical Use Only NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:03 2/13MG #16518NDC 69665-828-01                MEDOLOR PAK™                    3 x 30 gramsLidocaine 2.5% / Prilocaine 2.5% Cream, 30 gram tubesNDC 50383-667-30Marketed by MedArbor LLC, Bala Cynwyd, PATegaderm™ is a trademark of 3M Corporation.MEDOLOR PAK™ is a trademark of MedArbor LLC.NOTE TO PHARMACIST:See package insert for full prescribing information.This kit contains:3 - Lidocaine/Prilocaine, Cream, 2.5%/2.5% - 30 Grams1 - TegadermTM Transparent Film Dressing - 20 EachFor Topical Use Only NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:03 2/13MG #16518NDC 69665-828-01                MEDOLOR PAK™                    3 x 30 gramsLidocaine 2.5% / Prilocaine 2.5% Cream, 30 gram tubesNDC 50383-667-30Marketed by MedArbor LLC, Bala Cynwyd, PATegaderm™ is a trademark of 3M Corporation.MEDOLOR PAK™ is a trademark of MedArbor LLC.NOTE TO PHARMACIST:See package insert for full prescribing information.This kit contains:3 - Lidocaine/Prilocaine, Cream, 2.5%/2.5% - 30 Grams1 - TegadermTM Transparent Film Dressing - 20 EachFor Topical Use Only NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:03 2/13MG #16518NDC 69665-828-01                MEDOLOR PAK™                    3 x 30 gramsLidocaine 2.5% / Prilocaine 2.5% Cream, 30 gram tubesNDC 50383-667-30Marketed by MedArbor LLC, Bala Cynwyd, PATegaderm™ is a trademark of 3M Corporation.MEDOLOR PAK™ is a trademark of MedArbor LLC.NOTE TO PHARMACIST:See package insert for full prescribing information.This kit contains:3 - Lidocaine/Prilocaine, Cream, 2.5%/2.5% - 30 Grams1 - TegadermTM Transparent Film Dressing - 20 EachFor Topical Use Only NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:03 2/13MG #16518NDC 69665-828-01                MEDOLOR PAK™                    3 x 30 gramsLidocaine 2.5% / Prilocaine 2.5% Cream, 30 gram tubesNDC 50383-667-30Marketed by MedArbor LLC, Bala Cynwyd, PATegaderm™ is a trademark of 3M Corporation.MEDOLOR PAK™ is a trademark of MedArbor LLC.NOTE TO PHARMACIST:See package insert for full prescribing information.This kit contains:3 - Lidocaine/Prilocaine, Cream, 2.5%/2.5% - 30 Grams1 - TegadermTM Transparent Film Dressing - 20 EachFor Topical Use Only NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:03 2/13MG #16518NDC 69665-828-01                MEDOLOR PAK™                    3 x 30 gramsLidocaine 2.5% / Prilocaine 2.5% Cream, 30 gram tubesNDC 50383-667-30Marketed by MedArbor LLC, Bala Cynwyd, PATegaderm™ is a trademark of 3M Corporation.MEDOLOR PAK™ is a trademark of MedArbor LLC.NOTE TO PHARMACIST:See package insert for full prescribing information.This kit contains:3 - Lidocaine/Prilocaine, Cream, 2.5%/2.5% - 30 Grams1 - TegadermTM Transparent Film Dressing - 20 EachFor Topical Use Only NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:03 2/13MG #16518NDC 69665-828-01                MEDOLOR PAK™                    3 x 30 gramsLidocaine 2.5% / Prilocaine 2.5% Cream, 30 gram tubesNDC 50383-667-30Marketed by MedArbor LLC, Bala Cynwyd, PATegaderm™ is a trademark of 3M Corporation.MEDOLOR PAK™ is a trademark of MedArbor LLC.NOTE TO PHARMACIST:See package insert for full prescribing information.This kit contains:3 - Lidocaine/Prilocaine, Cream, 2.5%/2.5% - 30 Grams1 - TegadermTM Transparent Film Dressing - 20 EachFor Topical Use Only NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:03 2/13MG #16518NDC 69665-828-01                MEDOLOR PAK™                    3 x 30 gramsLidocaine 2.5% / Prilocaine 2.5% Cream, 30 gram tubesNDC 50383-667-30Marketed by MedArbor LLC, Bala Cynwyd, PATegaderm™ is a trademark of 3M Corporation.MEDOLOR PAK™ is a trademark of MedArbor LLC.NOTE TO PHARMACIST:See package insert for full prescribing information.This kit contains:3 - Lidocaine/Prilocaine, Cream, 2.5%/2.5% - 30 Grams1 - TegadermTM Transparent Film Dressing - 20 EachFor Topical Use Only NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:03 2/13MG #16518NDC 69665-828-01                MEDOLOR PAK™                    3 x 30 gramsLidocaine 2.5% / Prilocaine 2.5% Cream, 30 gram tubesNDC 50383-667-30Marketed by MedArbor LLC, Bala Cynwyd, PATegaderm™ is a trademark of 3M Corporation.MEDOLOR PAK™ is a trademark of MedArbor LLC.NOTE TO PHARMACIST:See package insert for full prescribing information.This kit contains:3 - Lidocaine/Prilocaine, Cream, 2.5%/2.5% - 30 Grams1 - TegadermTM Transparent Film Dressing - 20 EachFor Topical Use Only NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:03 2/13MG #16518NDC 69665-828-01                MEDOLOR PAK™                    3 x 30 gramsLidocaine 2.5% / Prilocaine 2.5% Cream, 30 gram tubesNDC 50383-667-30Marketed by MedArbor LLC, Bala Cynwyd, PATegaderm™ is a trademark of 3M Corporation.MEDOLOR PAK™ is a trademark of MedArbor LLC.NOTE TO PHARMACIST:See package insert for full prescribing information.This kit contains:3 - Lidocaine/Prilocaine, Cream, 2.5%/2.5% - 30 Grams1 - TegadermTM Transparent Film Dressing - 20 EachFor Topical Use Only NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:03 2/13MG #16518NDC 69665-828-01                MEDOLOR PAK™                    3 x 30 gramsLidocaine 2.5% / Prilocaine 2.5% Cream, 30 gram tubesNDC 50383-667-30Marketed by MedArbor LLC, Bala Cynwyd, PATegaderm™ is a trademark of 3M Corporation.MEDOLOR PAK™ is a trademark of MedArbor LLC.NOTE TO PHARMACIST:See package insert for full prescribing information.This kit contains:3 - Lidocaine/Prilocaine, Cream, 2.5%/2.5% - 30 Grams1 - TegadermTM Transparent Film Dressing - 20 EachFor Topical Use Only NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:03 2/13MG #16518NDC 69665-828-01                MEDOLOR PAK™                    3 x 30 gramsLidocaine 2.5% / Prilocaine 2.5% Cream, 30 gram tubesNDC 50383-667-30Marketed by MedArbor LLC, Bala Cynwyd, PATegaderm™ is a trademark of 3M Corporation.MEDOLOR PAK™ is a trademark of MedArbor LLC.NOTE TO PHARMACIST:See package insert for full prescribing information.This kit contains:3 - Lidocaine/Prilocaine, Cream, 2.5%/2.5% - 30 Grams1 - TegadermTM Transparent Film Dressing - 20 EachFor Topical Use Only NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Manufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 667:03 2/13MG #16518NDC 69665-828-01                MEDOLOR PAK™                    3 x 30 gramsLidocaine 2.5% / Prilocaine 2.5% Cream, 30 gram tubesNDC 50383-667-30Marketed by MedArbor LLC, Bala Cynwyd, PATegaderm™ is a trademark of 3M Corporation.MEDOLOR PAK™ is a trademark of MedArbor LLC.NOTE TO PHARMACIST:See package insert for full prescribing information.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Mechanism of Action:

Pharmacokinetics:

Absorption:

TABLE 1

*Maximum recommended duration of exposure is 4 hours.

When 60 g of lidocaine 2.5% and prilocaine 2.5% cream was applied over 400 cm for 24 hours, peak blood levels of lidocaine are approximately 1/20 the systemic toxic level. Likewise, the maximum prilocaine level is about 1/36 the toxic level. In a pharmacokinetic study, lidocaine 2.5% and prilocaine 2.5% cream was applied to penile skin in 20 adult male patients in doses ranging from 0.5 g to 3.3 g for 15 minutes. Plasma concentrations of lidocaine and prilocaine following lidocaine 2.5% and prilocaine 2.5% cream application in this study were consistently low (2.5-16 ng/mL for lidocaine and 2.5-7 ng/mL for prilocaine). The application of lidocaine 2.5% and prilocaine 2.5% cream to broken or inflamed skin, or to 2,000 cm or more of skin where more of both anesthetics are absorbed, could result in higher plasma levels that could, in susceptible individuals, produce a systemic pharmacologic response.

The absorption of lidocaine 2.5% and prilocaine 2.5% cream applied to genital mucous membranes was studied in two open-label clinical trials. Twenty-nine patients received 10 g of lidocaine 2.5% and prilocaine 2.5% cream applied for 10 to 60 minutes in the vaginal fornices. Plasma concentrations of lidocaine and prilocaine following lidocaine 2.5% and prilocaine 2.5% cream application in these studies ranged from 148 to 641 ng/mL for lidocaine and 40 to 346 ng/mL for prilocaine and time to reach maximum concentration (t) ranged from 21 to 125 minutes for lidocaine and from 21 to 95 minutes for prilocaine. These levels are well below the concentrations anticipated to give rise to systemic toxicity (approximately 5000 ng/mL for lidocaine and prilocaine).

Distribution:

mcg

Metabolism:

ortho

ortho

ortho

Elimination

Pediatrics:

Special Populations:

Non-Clinical Toxicology
Lidocaine 2.5% and prilocaine 2.5% cream 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 (see Individualization of Dose).

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:

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 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 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 2.5% and prilocaine 2.5% cream, provided the test results can be obtained quickly.

Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with atenolol tablets plus a catecholamine depletor should therefore be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or postural hypotension.

Calcium channel blockers may also have an additive effect when given with atenolol tablets (see ).

Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta blockers.

Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta blockers.

Beta blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the beta blocker should be withdrawn several days before the gradual withdrawal of clonidine. If replacing clonidine by beta-blocker therapy, the introduction of beta blockers should be delayed for several days after clonidine administration has stopped.

Concomitant use of prostaglandin synthase inhibiting drugs, e.g., indomethacin, may decrease the hypotensive effects of beta blockers.

Information on concurrent usage of atenolol and aspirin is limited. Data from several studies, i.e., TIMI-II, ISIS-2, currently do not suggest any clinical interaction between aspirin and beta blockers in the acute myocardial infarction setting.

While taking beta blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction.

Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

General:

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 intradermal injections of live vaccines has not been determined.

Information for Patients:

Lidocaine 2.5% and prilocaine 2.5% cream should not be applied near the eyes or on open wounds.

Drug Interactions:

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 WARNINGS).

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 -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.

Mutagenesis

Salmonella

n vitro

in vivo

Ortho

Escherichia coli

ortho

Salmonella typhimurium

ortho

Salmonella typhimurium

Impairment of Fertility

Use in Pregnancy: Teratogenic Effects: Pregnancy Category B.

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:

Nursing Mothers:

Pediatric Use:

Lidocaine 2.5% and prilocaine 2.5% cream should be used with care in patients with conditions or therapy associated with methemoglobinemia (see Methemoglobinemia subsection of WARNINGS).

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 DOSAGE AND ADMINISTRATION and Methemoglobinemia).

In neonates (minimum gestation age: 37 weeks) and children weighing less than 20 kg, the area and duration of application should be limited (see TABLE 2 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:

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 PRECAUTIONS.)

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 CLINICAL PHARMACOLOGY.)

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:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).