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lidocaine and prilocaine

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Overview

What is Venipuncture CPI?

Lidocaine and prilocaine cream, 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 30 gram tubes and 5 gram tubes for hospital use. Lidocaine is chemically designated as acetamide, 2-(diethylamino)--(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, -(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 and prilocaine cream, 2.5%/2.5% contains lidocaine 25 mg, prilocaine 25 mg, polyoxyethylene fatty acid esters (as emulsifiers), carbomer 934P (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water. Lidocaine and prilocaine cream, 2.5%/2.5% contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream, 2.5%/2.5% is approximately 1.



What does Venipuncture CPI look like?



What are the available doses of Venipuncture CPI?

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What should I talk to my health care provider before I take Venipuncture CPI?

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How should I use Venipuncture CPI?

Lidocaine and prilocaine cream, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:

Lidocaine and prilocaine cream, 2.5%/2.5% 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 and prilocaine cream, 2.5%/2.5% is applied to intact skin and covered with an occlusive dressing.


What interacts with Venipuncture CPI?

Lidocaine and prilocaine cream, 2.5%/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 Venipuncture CPI?

Lidocaine Ointment USP, 5% should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.

Application of lidocaine and prilocaine cream, 2.5%/2.5% 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 ).

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 and prilocaine cream, 2.5%/2.5% has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to lidocaine and prilocaine cream, 2.5%/2.5% in the external auditory canal only, showed no abnormality. Lidocaine and prilocaine cream, 2.5%/2.5% should not be used in any clinical situation when its penetration or migration beyond the tympanic membrane into the middle ear is possible.

Methemoglobinemia

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


What are the precautions of Venipuncture CPI?







Information for Patients:





Carcinogenesis, Mutagenesis, Impairment of Fertility

















Use in Pregnancy: Teratogenic Effects: Pregnancy Category B.

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 and prilocaine cream, 2.5%/2.5% 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.



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Geriatric Use

Of the total number of patients in clinical studies of lidocaine and prilocaine cream, 2.5%/2.5%, 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, 2.5%/2.5% 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, 2.5%/2.5%. 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 Venipuncture CPI?







Allergic Reactions:



Systemic (Dose Related) Reactions:

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CLINICAL PHARMACOLOGY


What should I look out for while using Venipuncture CPI?

Lidocaine and prilocaine cream, 2.5%/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 and prilocaine cream, 2.5%/2.5% 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 ).

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 and prilocaine cream, 2.5%/2.5% has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to lidocaine and prilocaine cream, 2.5%/2.5% in the external auditory canal only, showed no abnormality. Lidocaine and prilocaine cream, 2.5%/2.5% should not be used in any clinical situation when its penetration or migration beyond the tympanic membrane into the middle ear is possible.


What might happen if I take too much Venipuncture CPI?

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 Venipuncture CPI?

Store protected from light in the aluminum pouch at controlled room temperature (20° to 25°C [68° to 77°F]); excursions permitted to 15°to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Store at controlled room temperature (20° to 25°C [68° to 77°F]); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Store protected from light in the aluminum pouch at controlled room temperature (20° to 25°C [68° to 77°F]); excursions permitted to 15°to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Store at controlled room temperature (20° to 25°C [68° to 77°F]); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Lidocaine and Prilocaine Cream, 2.5%/2.5% is available as follows:NDC 0168-0357-05      5 gram tubeNOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.WARNING: Keep out of reach of children.Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature).Lidocaine and Prilocaine Cream, 2.5%/2.5% is available as follows:NDC 0168-0357-05      5 gram tubeNOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.WARNING: Keep out of reach of children.Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature).Lidocaine and Prilocaine Cream, 2.5%/2.5% is available as follows:NDC 0168-0357-05      5 gram tubeNOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.WARNING: Keep out of reach of children.Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature).Lidocaine and Prilocaine Cream, 2.5%/2.5% is available as follows:NDC 0168-0357-05      5 gram tubeNOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.WARNING: Keep out of reach of children.Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature).Lidocaine and Prilocaine Cream, 2.5%/2.5% is available as follows:NDC 0168-0357-05      5 gram tubeNOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.WARNING: Keep out of reach of children.Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature).Lidocaine and Prilocaine Cream, 2.5%/2.5% is available as follows:NDC 0168-0357-05      5 gram tubeNOT FOR OPHTHALMIC USE.KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.WARNING: Keep out of reach of children.Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature).


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Mechanism of Action:

The onset, depth and duration of dermal analgesia on intact skin provided by lidocaine and prilocaine cream, 2.5%/2.5% 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, 2.5%/2.5% 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, 2.5%/2.5% 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, 2.5%/2.5% 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, 2.5%/2.5% may cause a transient, local blanching followed by a transient, local redness or erythema.

Non-Clinical Toxicology
Lidocaine and prilocaine cream, 2.5%/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 and prilocaine cream, 2.5%/2.5% 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 ).

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 and prilocaine cream, 2.5%/2.5% has an ototoxic effect when instilled into the middle ear. In these same studies, animals exposed to lidocaine and prilocaine cream, 2.5%/2.5% in the external auditory canal only, showed no abnormality. Lidocaine and prilocaine cream, 2.5%/2.5% should not be used in any clinical situation when its penetration or migration beyond the tympanic membrane into the middle ear is possible.

Drug Interactions:













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 and prilocaine cream, 2.5%/2.5% be used concomitantly with other products containing lidocaine and/or prilocaine, cumulative doses from all formulations must be considered.

General:

Lidocaine and prilocaine cream, 2.5%/2.5% should not be applied to open wounds. Care should be taken not to allow lidocaine and prilocaine cream, 2.5%/2.5% 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, 2.5%/2.5% 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 para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine, however, lidocaine and prilocaine cream, 2.5%/2.5% 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, 2.5%/2.5% on injections of vaccines has not been determined.

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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).