Lidocaine / Prilocaine

What it is and how it works

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.

Indications

INDICATIONS AND USAGE 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 ).

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION 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 (see INSTRUCTIONS FOR APPLICATION ). 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 cm 2 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.

Contraindications

CONTRAINDICATIONS 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.

Warnings and precautions

WARNINGS 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 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.

Storage and supply

HOW SUPPLIED Lidocaine and prilocaine cream, 2.5%/2.5% is supplied as follows: NDC 68788-8150-3 30 gram tube NOT FOR OPHTHALMIC USE. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. KEEP OUT OF THE REACH OF CHILDREN. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . E. FOUGERA & CO.

Source: Lidocaine And Prilocaine (Lidocaine And Prilocaine) — US FDA prescribing information, 2026-05-21, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.