Lidocaine and prilocaine 25 mg/g; 25 mg/g Cream — NDC 72578-165-96 (Billing 72578-0165-96)
This is a package of Lidocaine and prilocaine 25 mg/g; 25 mg/g Cream from Viona Pharmaceuticals Inc, marketed since Jan 2025 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 72578-165-96 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 72578 labeler · 165 product · 96 package
- Package marketed since
- Jan 1, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 7257816596 3
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 035495
- GCN: 05987
- GPI-14 (Medi-Span): 90859902903710
- HICL (First Databank): 016196
- AHFS class code: 72:00.00.00
- RxCUI (RxNorm): 197877
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Antiarrhythmic class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.3852 | $9.63 / 25 g |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 72578-0165-06 72578-165-06 Main listing | 1 TUBE in 1 CARTON / 30 g in 1 TUBE | $0.2317 / g | $6.95 | 2025-01-01 | — | Active |
| 72578-0165-96 You're viewing this | 5 TUBE in 1 CARTON / 5 g in 1 TUBE | — | — | 2025-01-01 | — | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Lidocaine and prilocaine 25 mg/g; 25 mg/g Cream?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lidocaine and Prilocaine 25 mg/g; 25 mg/g 00121-1002-30 | PAI | 1 tube | $0.221 | — | Discontinued | — |
| Lidocaine and Prilocaine 25 mg/g; 25 mg/g 00168-0357-30 | E. | 1 tube | $0.232 | AB | Availability likely | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 00574-2042-30 | Padagis | 1 tube | $0.232 | AB | Availability likely | — |
| Lidocaine And Prilocaine Lidocaine And Prilocaine 25 mg/g; 25 mg/g 21922-0076-05 | Encube | 1 tube | $0.232 | AB | Availability likely | — |
| Lidocaine and Prilocaine 25 mg/g; 25 mg/g 62332-0582-04 | Alembic | 1 tube | $1.335 | AB | Availability likely | — |
| Lidocaine and Prilocaine 25 mg/g; 25 mg/g 46708-0582-04 | Alembic | 1 tube | — | AB | FDA listed | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 50090-6589-00 | A-S | 1 tube | — | AB | FDA listed | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 63629-9604-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Lidocaine and Prilocaine 25 mg/g; 25 mg/g 68071-1625-03 | NuCare | 30 g | — | — | FDA listed | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 68071-3856-03 | NuCare | 1 tube | — | AB | FDA listed | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 68788-4090-03 | Preferred | 1 tube | — | AB | FDA listed | — |
| Lidocaine and Prilocaine 25 mg/g; 25 mg/g 68788-8150-03 | Preferred | 1 tube | — | AB | FDA listed | — |
| Lidocaine and prilocaine 25 mg/g; 25 mg/g 70771-1872-02 | Zydus | 1 tube | — | AB | FDA listed | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 71335-2716-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 71335-2970-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Lidocaine And Prilocaine 25 mg/g; 25 mg/g 72162-1125-03 | Bryant | 1 tube | — | AB | FDA listed | — |
| Lidocaine and prilocaine 25 mg/g; 25 mg/gthis 72578-0165-96 | Viona | 5 tubes | — | AB | FDA listed | — |
| Cadira Compliant Blood Stat 25 mg/g; 25 mg/g 76420-0313-01 | Asclemed | 1 tube | — | — | FDA listed | — |
| Lidocaine and prilocaine 25 mg/g; 25 mg/g 50090-8089-00 | A-S | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII HHT01ZNK31
Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
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UNII 7YC686GQ8F
A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Viona Pharmaceuticals Inc labeler code 72578
- Ketoconazole 20 mg/mL Shampoo NDC 72578-156-12
- Candesartan cilexetil 4 mg Tablet NDC 72578-157-06
- Candesartan cilexetil 8 mg Tablet NDC 72578-158-06
- Candesartan cilexetil 16 mg Tablet NDC 72578-159-06
- Candesartan cilexetil 32 mg Tablet NDC 72578-160-06
- Fludrocortisone acetate .1 mg Tablet NDC 72578-164-01
- Dexamethasone 1 mg Tablet NDC 72578-166-01
- Dexamethasone 2 mg Tablet NDC 72578-167-01
- Dexamethasone .5 mg Tablet NDC 72578-168-01
- Dexamethasone .75 mg Tablet NDC 72578-169-01
- Dexamethasone 1.5 mg Tablet NDC 72578-170-01
- Dexamethasone 4 mg Tablet NDC 72578-171-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Lidocaine and prilocaine cream USP, (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 are 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 ).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Adult Patients-Intact Skin A thick layer of lidocaine and prilocaine cream is applied to intact skin and covered with an occlusive dressing (see INSTRUCTIONS FOR APPLICATION ). Minor Dermal Procedures For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of lidocaine and prilocaine cream (1/2 the 5 g tube) over 20 cm 2 to 25 cm 2 of skin surface for at least 1 hour. In controlled clinical trials using lidocaine and prilocaine cream, 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 per 10 cm 2 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 (1 g/10 cm 2 ) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of lidocaine and prilocaine cream.
Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 hour 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 grams to 10 grams) of lidocaine and prilocaine cream for 5 minutes 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 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 The following are the maximum recommended doses, application areas and application times for lidocaine and prilocaine cream based on a child's age and weight: Age and Body Weight Requirements Maximum Total Dose of Lidocaine and Prilocaine Cream Maximum Application Area Maximum Application Time 0 up to 3 months or < 5 kg 1 g 10 cm 2 1 hour 3 up to 12 months and > 5 kg 2 g 20 cm 2 4 hours 1 year to 6 years and > 10 kg 10 g 100 cm 2 4 hours 7 years to 12 years and > 20 kg 20 g 200 cm 2 4 hours 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 weight (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 12 months who are receiving treatment with methemoglobin-inducing agents (see Methemoglobinemia subsection of WARNINGS). When lidocaine and prilocaine cream (lidocaine 2.5% and prilocaine 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… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Lidocaine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.
⚠️ Warnings ▾
WARNINGS 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 only in the external auditory canal, 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 Cases of methemoglobinemia have been reported in association with local anesthetic use.
Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood.
Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias and death. Discontinue lidocaine and prilocaine cream and any other oxidizing agents. Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration.
A more severe clinical presentation may require treatment with methylene blue, exchange transfusion or hyperbaric oxygen.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Localized Reactions During or immediately after treatment with lidocaine and prilocaine cream on intact skin, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation. Rare cases of discrete purpuric or petechial reactions at the application site have been reported. Rare cases of hyperpigmentation following the use of lidocaine and prilocaine cream have been reported.
The relationship to lidocaine and prilocaine cream or the underlying procedure has not been established. In clinical studies on intact skin involving over 1,300 lidocaine and prilocaine cream -treated subjects, one or more such local reactions were noted in 56% of patients, and were generally mild and transient, resolving spontaneously within 1 hour or 2 hours. There were no serious reactions that were ascribed to lidocaine and prilocaine cream.
Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision. Both neonates received 1 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 Allergic and anaphylactoid reactions associated with lidocaine or prilocaine can occur.
They are characterized by urticaria, angioedema, bronchospasm and shock. If they occur they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.
Systemic (Dose Related) Reactions Systemic adverse reactions following appropriate use of lidocaine and prilocaine cream are unlikely due to the small dose absorbed (see Pharmacokinetics subsection of CLINICAL PHARMACOLOGY ). Systemic adverse effects of lidocaine and/or prilocaine are similar in nature to those observed with other amide local anesthetic agents including CNS excitation and/or depression (light-headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest).
Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest. To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
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. Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine 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.
🧒 Pediatric Use ▾
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 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 and prilocaine cream for heel lancing in neonates.
🧓 Geriatric Use ▾
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 ).
🆘 Overdosage ▾
OVERDOSAGE Peak blood levels following a 60 g application to 400 cm 2 of intact skin for 3 hours are 0.05 mcg/mL to 0.16 mcg/mL for lidocaine and 0.02 mcg/mL 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 hydrochloride) or Citanest (prilocaine hydrochloride) for further information for the management of overdose.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action Lidocaine and prilocaine cream, 2.5%/2.5%, applied to intact skin under occlusive dressing, provides dermal analgesia by the release of lidocaine and prilocaine from the cream into the epidermal and dermal layers of the skin and by the accumulation of lidocaine and prilocaine in the vicinity of dermal pain receptors and nerve endings. Lidocaine and prilocaine are amide-type local anesthetic agents. Both lidocaine and prilocaine stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.
The onset, depth and duration of dermal analgesia on intact skin provided by lidocaine and prilocaine cream depend 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 hours to 3 hours and persists for 1 hour to 2 hours after removal. Absorption from the genital mucosa is more rapid and onset time is shorter (5 minutes to 10 minutes) than after application to intact skin. After a 5 minutes 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 minutes to 20 minutes (individual variations in the range of 5 minutes to 45 minutes).
Dermal application of lidocaine and prilocaine cream may cause a transient, local blanching followed by a transient, local redness or erythema. Pharmacokinetics Lidocaine and prilocaine cream are a eutectic mixture of lidocaine 2.5% and prilocaine 2.5% formulated as an oil in water emulsion. In this eutectic mixture, both anesthetics are liquid at room temperature (see DESCRIPTION ) and the penetration and subsequent systemic absorption of both prilocaine and lidocaine are enhanced over that which would be seen if each component in crystalline form was applied separately as a 2.5% topical cream.
Absorption The amount of lidocaine and prilocaine systemically absorbed from lidocaine and prilocaine cream is directly related to both the duration of application and to the area over which it is applied. In two pharmacokinetic studies, 60 g of lidocaine and prilocaine cream (1.5 g lidocaine and 1.5 g prilocaine) was applied to 400 cm 2 of intact skin on the lateral thigh and then covered by an occlusive dressing. The subjects were then randomized such that one-half of the subjects had the occlusive dressing and residual cream removed after 3 hours, while the remainder left the dressing in place for 24 hours.
The results from these studies are summarized below. TABLE 1 Absorption of Lidocaine and Prilocaine from Lidocaine and Prilocaine Cream: Normal Volunteers (N=16) *Maximum recommended duration of exposure is 4 hours. Lidocaine and Prilocaine Cream (g) Area (cm 2 ) Time on (hrs) Drug Content (mg) Absorbed (mg) C max (mcg/mL) T max (hr) 60 400 3 lidocaine 1,500 54 0.12 4 prilocaine 1,500 92 0.07 4 60 400 24 * lidocaine 1,500 243 0.28 10 prilocaine 1,500 503 0.14 10 When 60 g of lidocaine and prilocaine cream was applied over 400 cm 2 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 and prilocaine 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 and prilocaine cream application in this study were c… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
Mechanism of Action Lidocaine and prilocaine cream, 2.5%/2.5%, applied to intact skin under occlusive dressing, provides dermal analgesia by the release of lidocaine and prilocaine from the cream into the epidermal and dermal layers of the skin and by the accumulation of lidocaine and prilocaine in the vicinity of dermal pain receptors and nerve endings. Lidocaine and prilocaine are amide-type local anesthetic agents. Both lidocaine and prilocaine stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.
The onset, depth and duration of dermal analgesia on intact skin provided by lidocaine and prilocaine cream depend 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 hours to 3 hours and persists for 1 hour to 2 hours after removal. Absorption from the genital mucosa is more rapid and onset time is shorter (5 minutes to 10 minutes) than after application to intact skin. After a 5 minutes 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 minutes to 20 minutes (individual variations in the range of 5 minutes to 45 minutes).
Dermal application of lidocaine and prilocaine cream may cause a transient, local blanching followed by a transient, local redness or erythema.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Lidocaine and prilocaine cream, USP 2.5%/2.5% is white to off-white homogeneous cream free from lumps and foreign matter, without any phase separation, available as the following: NDC No. Strength Size NDC 72578-165-96 5 gram/tube packed in 5 NDC 72578-165-06 30 gram/tube packed individually, in a child-resistant tube NOT FOR OPHTHALMIC USE . KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE .
Store at 20° C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]. Rx only Keep this and all drugs out of the reach of children.
📋 Description ▾
DESCRIPTION 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, USP 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, USP 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 and prilocaine cream, USP contains lidocaine 25 mg, prilocaine 25 mg, carbomer homopolymer Type B, polyoxyl 40 hydrogenated castor oil, purified water to 1 gram and sodium hydroxide to adjust to a pH approximating 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. Image Image
💬 Information for Patients ▾
Information for Patients Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue. 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.
⚠️ Precautions ▾
PRECAUTIONS General Repeated doses of lidocaine and prilocaine cream may increase blood levels of lidocaine and prilocaine. Lidocaine and prilocaine cream should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine and prilocaine including acutely ill, debilitated or elderly patients. Lidocaine 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 intradermal injections of live vaccines has not been determined. Information for Patients Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly.
Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue. 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. 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. Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine 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. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: Long-term studies in animals designed to evaluate the… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
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.
🧬 Pharmacokinetics ▾
Pharmacokinetics Lidocaine and prilocaine cream are a eutectic mixture of lidocaine 2.5% and prilocaine 2.5% formulated as an oil in water emulsion. In this eutectic mixture, both anesthetics are liquid at room temperature (see DESCRIPTION ) and the penetration and subsequent systemic absorption of both prilocaine and lidocaine are enhanced over that which would be seen if each component in crystalline form was applied separately as a 2.5% topical cream. Absorption The amount of lidocaine and prilocaine systemically absorbed from lidocaine and prilocaine cream is directly related to both the duration of application and to the area over which it is applied.
In two pharmacokinetic studies, 60 g of lidocaine and prilocaine cream (1.5 g lidocaine and 1.5 g prilocaine) was applied to 400 cm 2 of intact skin on the lateral thigh and then covered by an occlusive dressing. The subjects were then randomized such that one-half of the subjects had the occlusive dressing and residual cream removed after 3 hours, while the remainder left the dressing in place for 24 hours. The results from these studies are summarized below.
TABLE 1 Absorption of Lidocaine and Prilocaine from Lidocaine and Prilocaine Cream: Normal Volunteers (N=16) *Maximum recommended duration of exposure is 4 hours. Lidocaine and Prilocaine Cream (g) Area (cm 2 ) Time on (hrs) Drug Content (mg) Absorbed (mg) C max (mcg/mL) T max (hr) 60 400 3 lidocaine 1,500 54 0.12 4 prilocaine 1,500 92 0.07 4 60 400 24 * lidocaine 1,500 243 0.28 10 prilocaine 1,500 503 0.14 10 When 60 g of lidocaine and prilocaine cream was applied over 400 cm 2 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 and prilocaine 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 and prilocaine cream application in this study were consistently low (2.5 ng/mL to 16 ng/mL for lidocaine and 2.5 ng/mL to 7 ng/mL for prilocaine).
The application of lidocaine and prilocaine cream to broken or inflamed skin, or to 2,000 cm 2 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 and prilocaine cream applied to genital mucous membranes was studied in two open-label clinical trials. Twenty-nine patients received 10 g of lidocaine and prilocaine cream applied for 10 minutes to 60 minutes in the vaginal fornices.
Plasma concentrations of lidocaine and prilocaine following lidocaine and prilocaine cream application in these studies ranged from 148 ng/mL to 641 ng/mL for lidocaine and 40 ng/mL to 346 ng/mL for prilocaine and time to reach maximum concentration (t max ) ranged from 21 minutes to 125 minutes for lidocaine and from 21 minutes to 95 minutes for prilocaine. These levels are well below the concentrations anticipated to give rise to systemic toxicity (approximately 5,000 ng/mL for lidocaine and prilocaine). Distribution When each drug is administered intravenously, the steady-state volume of distribution is
1.1 L/kg to
2.1L/kg (mean 1.5, ±0.3 SD, n=13) for lidocaine and is
0.7 L/kg to
4.4L/kg (mean 2.6, ±1.3 SD, n=13) for prilocaine. The larger distribution volume for prilocaine produces the lower plasma concentrations of prilocaine observed when equal amounts of prilocaine and lidocaine are administered. At concentrations produced by application of lidocaine and prilocaine cream, lidocaine is approximately 70% bound to plasma proteins, primarily alpha-1-acid glycoprotein.
At much higher plasma concentrations (1 mcg/mL to 4 mcg/mL of free base) the plasma protein binding of lidocaine is concentration dependent. Prilocaine is 55% bound to plasma proteins. Both lidocaine and prilo… [Excerpted — this section continues on DailyMed.]
🔬 Clinical Studies ▾
CLINICAL STUDIES Lidocaine and prilocaine cream application in adults prior to intravenous cannulation or venipuncture were 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 were comparable to subcutaneous lidocaine, but was less efficacious than intradermal lidocaine.
Most patients found lidocaine and prilocaine cream treatment preferable to lidocaine infiltration or ethyl chloride spray. Lidocaine and prilocaine cream were 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 for 2 hours to 5 hours provided dermal analgesia comparable to lidocaine infiltration.
Lidocaine and prilocaine cream application in children were studied in seven non-US studies (320 patients) and one US study (100 patients). In controlled studies, application of lidocaine and prilocaine cream 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 was less effective than in older children or adults.
Lidocaine and prilocaine cream were compared with placebo in the laser treatment of facial port-wine stains in 72 pediatric patients (ages 5 to 16). Lidocaine and prilocaine cream were effective in providing pain relief during laser treatment. Lidocaine and prilocaine cream alone were compared with lidocaine and prilocaine cream 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 was not effective as a sole anesthetic agent in managing the pain from the surgical procedure. The administration of lidocaine and prilocaine cream 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 were 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 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 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 on genital mucous membranes for minor, superficial surgical procedures (e.g., removal of condylomata acuminata) was studied in 80 patients in a placebo-controlled clinical trial (60 patients received lidocaine and prilocaine cream and 20 patients received placebo). Lidocaine and prilocaine cream (5 g to 10 g) applied between 1 minute 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 minutes to 15 minutes' application. The application of lidocaine and prilocaine cream 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 and 23 patients received placebo) scheduled for infiltration prior to a surgical procedure of the… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 72578-165-05 Lidocaine and Prilocaine Cream USP, 2.5%/2.5% 5 grams Rx 5 gm tube
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