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Cadira Compliant Blood Stat

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Overview

What is Cadira Compliant Blood Stat?

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:

CHNO 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:

CHNO 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.



What does Cadira Compliant Blood Stat look like?



What are the available doses of Cadira Compliant Blood Stat?

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What should I talk to my health care provider before I take Cadira Compliant Blood Stat?

Sorry No records found

How should I use Cadira Compliant Blood Stat?

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:

• for local analgesia.

• 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).

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 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:

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 (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.

1.5 x 0.2 inches

Use the number of strips that equals your dose, like the examples in the table below.

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.


What interacts with Cadira Compliant Blood Stat?

Lidocaine and prilocaine 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 Cadira Compliant Blood Stat?

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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:

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.


What are the precautions of Cadira Compliant Blood Stat?

General:

Lidocaine and prilocaine cream should not be applied to open wounds.

Care should be taken not to allow lidocaine and prilocaine 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 and prilocaine 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 and prilocaine 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 and prilocaine cream on injections of vaccines has not been determined.

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Information for Patients

When lidocaine and prilocaine 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 and prilocaine cream should not be applied near the eyes or on open wounds.

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Drug Interactions

Lidocaine and prilocaine 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 (e.g., amiodarone, bretylium, sotalol, dofetilide) have not been performed, but caution is advised (see WARNINGS).

Should lidocaine and prilocaine cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.

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Carcinogenesis, Mutagenesis, Impairment of Fertility

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Metabolites of prilocaine have been shown to be carcinogenic in laboratory animals. In the animal studies reported below, doses or blood levels are compared to the Single Dermal Administration (SDA) of 60 g of lidocaine and prilocaine cream to 400 cm for 3 hours to a small person (50 kg). The typical application of lidocaine and prilocaine 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/min 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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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.

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Labor and Delivery

Neither lidocaine nor prilocaine are contraindicated in labor and delivery. Should lidocaine and prilocaine cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.

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Nursing Mothers

Lidocaine, and probably prilocaine, are excreted in human milk. Therefore, caution should be exercised when lidocaine and prilocaine cream is administered to a nursing mother since the milk: plasma ratio of lidocaine is 0.4 and is not determined for prilocaine.

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Pediatric Use

Controlled studies of lidocaine and prilocaine 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 and prilocaine cream should be used with care in patients with conditions or therapy associated with methemoglobinemia (see Methemoglobinemia subsection of WARNINGS).

When using lidocaine and prilocaine 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: 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). 

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Geriatric Use

Of the total number of patients in clinical studies of lidocaine and prilocaine 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 and prilocaine 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 and prilocaine 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 Cadira Compliant Blood Stat?

Localized Reactions:

Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision. Both neonates received 1.0 g of lidocaine and prilocaine cream.

In patients treated with lidocaine and prilocaine 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 and prilocaine 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 Cadira Compliant Blood Stat?

Lidocaine and prilocaine 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 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:

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.


What might happen if I take too much Cadira Compliant Blood Stat?

Peak blood levels following a 60 g application to 400 cm of intact skin for 3 hours are 0.05 to 0.16 mcg/mL for lidocaine and 0.02 to 0.10 mcg/mL for prilocaine. Toxic levels of lidocaine (>5 mcg/mL) and/or prilocaine (>6 mcg/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 Cadira Compliant Blood Stat?

Lidocaine and prilocaine cream USP, 2.5%/2.5% is available as the following:NDC 0115-1468-60: 5 gram tube (NDC 0115-1468-53), box of 5NDC 0115-1468-45: 30 gram tube, box of 1Xylocaine and Citanest are registered trademarks of ABRAXIS BIOSCIENCE and DENTSPLY PHARM, respectively, and are not the trademarks of TOLMAR Inc.NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].44942 Rev. 1 09/15Manufactured by:TOLMAR Inc.Fort Collins, CO 80526Distributed by:Impax GenericsHayward, CA 94544Lidocaine and prilocaine cream USP, 2.5%/2.5% is available as the following:NDC 0115-1468-60: 5 gram tube (NDC 0115-1468-53), box of 5NDC 0115-1468-45: 30 gram tube, box of 1Xylocaine and Citanest are registered trademarks of ABRAXIS BIOSCIENCE and DENTSPLY PHARM, respectively, and are not the trademarks of TOLMAR Inc.NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].44942 Rev. 1 09/15Manufactured by:TOLMAR Inc.Fort Collins, CO 80526Distributed by:Impax GenericsHayward, CA 94544Lidocaine and prilocaine cream USP, 2.5%/2.5% is available as the following:NDC 0115-1468-60: 5 gram tube (NDC 0115-1468-53), box of 5NDC 0115-1468-45: 30 gram tube, box of 1Xylocaine and Citanest are registered trademarks of ABRAXIS BIOSCIENCE and DENTSPLY PHARM, respectively, and are not the trademarks of TOLMAR Inc.NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].44942 Rev. 1 09/15Manufactured by:TOLMAR Inc.Fort Collins, CO 80526Distributed by:Impax GenericsHayward, CA 94544Lidocaine and prilocaine cream USP, 2.5%/2.5% is available as the following:NDC 0115-1468-60: 5 gram tube (NDC 0115-1468-53), box of 5NDC 0115-1468-45: 30 gram tube, box of 1Xylocaine and Citanest are registered trademarks of ABRAXIS BIOSCIENCE and DENTSPLY PHARM, respectively, and are not the trademarks of TOLMAR Inc.NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].44942 Rev. 1 09/15Manufactured by:TOLMAR Inc.Fort Collins, CO 80526Distributed by:Impax GenericsHayward, CA 94544Lidocaine and prilocaine cream USP, 2.5%/2.5% is available as the following:NDC 0115-1468-60: 5 gram tube (NDC 0115-1468-53), box of 5NDC 0115-1468-45: 30 gram tube, box of 1Xylocaine and Citanest are registered trademarks of ABRAXIS BIOSCIENCE and DENTSPLY PHARM, respectively, and are not the trademarks of TOLMAR Inc.NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].44942 Rev. 1 09/15Manufactured by:TOLMAR Inc.Fort Collins, CO 80526Distributed by:Impax GenericsHayward, CA 94544Lidocaine and prilocaine cream USP, 2.5%/2.5% is available as the following:NDC 0115-1468-60: 5 gram tube (NDC 0115-1468-53), box of 5NDC 0115-1468-45: 30 gram tube, box of 1Xylocaine and Citanest are registered trademarks of ABRAXIS BIOSCIENCE and DENTSPLY PHARM, respectively, and are not the trademarks of TOLMAR Inc.NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].44942 Rev. 1 09/15Manufactured by:TOLMAR Inc.Fort Collins, CO 80526Distributed by:Impax GenericsHayward, CA 94544Lidocaine and prilocaine cream USP, 2.5%/2.5% is available as the following:NDC 0115-1468-60: 5 gram tube (NDC 0115-1468-53), box of 5NDC 0115-1468-45: 30 gram tube, box of 1Xylocaine and Citanest are registered trademarks of ABRAXIS BIOSCIENCE and DENTSPLY PHARM, respectively, and are not the trademarks of TOLMAR Inc.NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].44942 Rev. 1 09/15Manufactured by:TOLMAR Inc.Fort Collins, CO 80526Distributed by:Impax GenericsHayward, CA 94544Lidocaine and prilocaine cream USP, 2.5%/2.5% is available as the following:NDC 0115-1468-60: 5 gram tube (NDC 0115-1468-53), box of 5NDC 0115-1468-45: 30 gram tube, box of 1Xylocaine and Citanest are registered trademarks of ABRAXIS BIOSCIENCE and DENTSPLY PHARM, respectively, and are not the trademarks of TOLMAR Inc.NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].44942 Rev. 1 09/15Manufactured by:TOLMAR Inc.Fort Collins, CO 80526Distributed by:Impax GenericsHayward, CA 94544Lidocaine and prilocaine cream USP, 2.5%/2.5% is available as the following:NDC 0115-1468-60: 5 gram tube (NDC 0115-1468-53), box of 5NDC 0115-1468-45: 30 gram tube, box of 1Xylocaine and Citanest are registered trademarks of ABRAXIS BIOSCIENCE and DENTSPLY PHARM, respectively, and are not the trademarks of TOLMAR Inc.NOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].44942 Rev. 1 09/15Manufactured by:TOLMAR Inc.Fort Collins, CO 80526Distributed by:Impax GenericsHayward, CA 94544


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Mechanism of Action:

The onset, depth and duration of dermal analgesia on intact skin provided by lidocaine and prilocaine cream depends primarily on the duration of application. To provide sufficient analgesia for clinical procedures such as intravenous catheter placement and venipuncture, lidocaine and prilocaine 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 and prilocaine 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 and prilocaine 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 and prilocaine cream may cause a transient, local blanching followed by a transient, local redness or erythema.

Non-Clinical Toxicology
Lidocaine and prilocaine 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 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:

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.

Lidocaine and prilocaine 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 (e.g., amiodarone, bretylium, sotalol, dofetilide) have not been performed, but caution is advised (see WARNINGS).

Should lidocaine and prilocaine cream be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.

General:

Lidocaine and prilocaine cream should not be applied to open wounds.

Care should be taken not to allow lidocaine and prilocaine 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 and prilocaine 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 and prilocaine 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 and prilocaine cream on injections of vaccines has not been determined.

Localized Reactions:

Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision. Both neonates received 1.0 g of lidocaine and prilocaine cream.

In patients treated with lidocaine and prilocaine 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 and prilocaine 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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Professional

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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Tips

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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).