Venipuncture CPI

Lidocaine and prilocaine cream, 2.5%/2.5% application in adults prior to IV cannulation or venipuncture was studied in 200 patients in four clinical studies in Europe. Application for at least 1 hour provided significantly more dermal analgesia than placebo cream or ethyl chloride. Lidocaine and prilocaine cream, 2.5%/2.5% was comparable to subcutaneous lidocaine, but was less efficacious than intradermal lidocaine. Most patients found lidocaine and prilocaine cream, 2.5%/2.5% treatment preferable to lidocaine infiltration or ethyl chloride spray.

Lidocaine and prilocaine cream, 2.5%/2.5% was compared with 0.5% lidocaine infiltration prior to skin graft harvesting in one open label study in 80 adult patients in England. Application of lidocaine and prilocaine cream, 2.5%/2.5% for 2 to 5 hours provided dermal analgesia comparable to lidocaine infiltration.

Lidocaine and prilocaine cream, 2.5%/2.5% application in children was studied in seven non-US studies (320 patients) and one US study (100 patients). In controlled studies, application of lidocaine and prilocaine cream, 2.5%/2.5% for at least 1 hour with or without presurgical medication prior to needle insertion provided significantly more pain reduction than placebo. In children under the age of seven years, lidocaine and prilocaine cream, 2.5%/2.5% was less effective than in older children or adults.

Lidocaine and prilocaine cream, 2.5%/2.5% was compared with placebo in the laser treatment of facial port-wine stains in 72 pediatric patients (ages 5-16). Lidocaine and prilocaine cream, 2.5%/2.5% was effective in providing pain relief during laser treatment.

Lidocaine and prilocaine cream, 2.5%/2.5% alone was compared to lidocaine and prilocaine cream, 2.5%/2.5% followed by lidocaine infiltration and lidocaine infiltration alone prior to cryotherapy for the removal of male genital warts. The data from 121 patients demonstrated that lidocaine and prilocaine cream, 2.5%/2.5% was not effective as a sole anesthetic agent in managing the pain from the surgical procedure. The administration of lidocaine and prilocaine cream, 2.5%/2.5% prior to lidocaine infiltration provided significant relief of discomfort associated with local anesthetic infiltration and thus was effective in the overall reduction of pain from the procedure only when used in conjunction with local anesthetic infiltration of lidocaine.

Lidocaine and prilocaine cream, 2.5%/2.5% was studied in 105 full term neonates (gestational age: 37 weeks) for blood drawing and circumcision procedures. When considering the use of lidocaine and prilocaine cream, 2.5%/2.5% in neonates, the primary concerns are the systemic absorption of the active ingredients and the subsequent formation of methemoglobin. In clinical studies performed in neonates, the plasma levels of lidocaine, prilocaine, and methemoglobin were not reported in a range expected to cause clinical symptoms.

Local dermal effects associated with lidocaine and prilocaine cream, 2.5%/2.5% application in these studies on intact skin included paleness, redness and edema and were transient in nature (see ADVERSE REACTIONS).

The application of lidocaine and prilocaine cream, 2.5%/2.5% on genital mucous membranes for minor, superficial surgical procedures (eg, removal of condylomata acuminata) was studied in 80 patients in a placebo-controlled clinical trial (60 patients received lidocaine and prilocaine cream, 2.5%/2.5% and 20 patients received placebo). Lidocaine and prilocaine cream, 2.5%/2.5% (5 to 10 g) applied between 1 and 75 minutes before surgery, with a median time of 15 minutes, provided effective local anesthesia for minor superficial surgical procedures. The greatest extent of analgesia, as measured by VAS scores, was attained after 5 to 15 minutes. The application of lidocaine and prilocaine cream, 2.5%/2.5% to genital mucous membranes as pretreatment for local anesthetic infiltration was studied in a double-blind, placebo-controlled study in 44 female patients (21 patients received lidocaine and prilocaine cream, 2.5%/2.5% and 23 patients received placebo) scheduled for infiltration prior to a surgical procedure of the external vulva or genital mucosa. Lidocaine and prilocaine cream, 2.5%/2.5% applied to the genital mucous membranes for 5 to 10 minutes resulted in adequate topical anesthesia for local anesthetic injection.

Individualization of Dose: The dose of lidocaine and prilocaine cream, 2.5%/2.5% which provides effective analgesia depends on the duration of the application over the treated area.

All pharmacokinetic and clinical studies employed a thick layer of lidocaine and prilocaine cream, 2.5%/2.5% (1 to 2 g/10 cm2). The duration of application prior to venipuncture was 1 hour. The duration of application prior to taking split thickness skin grafts was 2 hours. A thinner application has not been studied and may result in less complete analgesia or a shorter duration of adequate analgesia.

The systemic absorption of lidocaine and prilocaine is a side effect of the desired local effect. The amount of drug absorbed depends on surface area and duration of application. The systemic blood levels depend on the amount absorbed and patient size (weight) and rate of systemic drug elimination. Long duration of application, large treatment area, small patients, or impaired elimination may result in high blood levels. The systemic blood levels are typically a small fraction (1/20 to 1/36) of the blood levels which produce toxicity. Table 2 below gives maximum recommended doses, application areas and application times for infants and children.

TABLE 2 LIDOCAINE AND PRILOCAINE CREAM, 2.5%/2.5% MAXIMUM RECOMMENDED DOSE, APPLICATION AREA, AND APPLICATION TIME BY AGE AND WEIGHT*

For Infants and Children Based on Application to 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, 2.5%/2.5% should be restricted to that which corresponds to the patient's weight.

* These are broad guidelines for avoiding systemic toxicity in applying lidocaine and prilocaine cream, 2.5%/2.5% to patients with normal intact skin and with normal renal and hepatic function.
** For more individualized calculation of how much lidocaine and prilocaine may be absorbed, physicians can use the following estimates of lidocaine and prilocaine absorption for children and adults:
   The estimated mean (±SD) absorption of lidocaine is 0.045 (±0.016) mg/cm2/hr.
   The estimated mean (±SD) absorption of prilocaine is 0.077 (±0.036) mg/cm2/hr.

An IV antiarrhythmic dose of lidocaine is 1 mg/kg (70 mg/70 kg) and gives a blood level of about 1 mcg/mL. Toxicity would be expected at blood levels above 5 mcg/mL. Smaller areas of treatment are recommended in a debilitated patient, a small child or a patient with impaired elimination. Decreasing the duration of application is likely to decrease the analgesic effect.

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:

• normal intact skin for local analgesia. 
• genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.

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 WARNINGS).

Peak blood levels following a 60 g application to 400 cm2 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.

Adult Patients-Intact Skin

A thick layer of lidocaine and prilocaine cream, 2.5%/2.5% is applied to intact skin and covered with an occlusive dressing.

Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams (1/2 the 5 g tube) of lidocaine and prilocaine cream, 2.5%/2.5% over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, 2.5%/2.5%, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.

Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of lidocaine and prilocaine cream, 2.5%/2.5% per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.

Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of lidocaine and prilocaine cream, 2.5%/2.5% (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream, 2.5%/2.5%.

Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2, ** footnote, in Individualization of Dose.

Adult Female Patients-Genital Mucous Membranes

For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5-10 grams) of lidocaine and prilocaine cream, 2.5%/2.5% for 5 to 10 minutes.

Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the lidocaine and prilocaine cream, 2.5%/2.5% application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of lidocaine and prilocaine cream, 2.5%/2.5%.

Pediatric Patients-Intact Skin

The following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream, 2.5%/2.5% based on a child's age and weight:
Practitionersshould carefully instruct caregivers to avoid application of excessive amounts of lidocaine and prilocaine cream, 2.5%/2.5% (see PRECAUTIONS).

Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of lidocaine and prilocaine cream, 2.5%/2.5% should be restricted to that which corresponds to the patient's weight.

When applying lidocaine and prilocaine cream, 2.5%/2.5% to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of lidocaine and prilocaine cream, 2.5%/2.5% or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.

Lidocaine and prilocaine cream, 2.5%/2.5% should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS).

When lidocaine and prilocaine cream, 2.5%/2.5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose). The amount absorbed in the case of lidocaine and prilocaine cream, 2.5%/2.5% is determined by the area over which it is applied and the duration of application under occlusion (see Table 2, ** footnote, in Individualization of Dose).

Although the incidence of systemic adverse reactions with lidocaine and prilocaine cream, 2.5%/2.5% is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure (see Individualization of Dose).

Packaged in the USA by:
PureTek Corporation
San Fernando, CA 91340

For questions or information
call toll-free: 877-921-7873

Rev. 37769    02/16

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How to use Venipuncture CPI Kit

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Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

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Storage

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Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.