Instasia

Topical Anesthetic, Minor dermal procedure, Major dermal procedure

Topical Administration For topical use only; not for ophthalmic or otic use 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

Topical Anesthetic Minor dermal procedure Normal intact skin for local analgesia: Apply 2.5 g of cream over 20-25 cm of skin surface or 1 anesthetic disc (1 g over 10 cm) for at least 1 hour Major dermal procedure Apply 2 g of the cream per 10 cm of skin surface and allow to remain in contact with skin for at least 2 hours Genital mucous membrane Superficial minor surgery and as pretreatment for infiltration anesthesia Male genital skin: apply thick layer of cream (1 g/10 cm) to skin surface for 15 minutes Perform local anesthetic infiltration immediately after removal of the cream Female genital mucous membranes: apply a thick layer (5 to 10 g) of cream for 5 to 10 minutes

Topical Anesthetic Intact skin only 0-3 months or <5 kg: Apply 1 g per 10 cm for a maximum of 1 hour 3-12 months and >5 kg : Apply 2 g per 20 cm for a maximum of 4 hours 1-6 years and >10 kg : Apply 10 g per 100 cm for a maximum of 4 hours 7-12 years and >20 kg : Apply 20 g per 200 cm for a maximum of 4 hours

Hypersensitivity to local anesthetics of the amide type or any component of the product

Stabilizes neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action

Application to larger areas or for longer than recommended could result in sufficient absorption causing serious adverse reactions

>10% Paleness (37%) Erythema (30%) Burning sensation (17%) Edema (10%) 1-10% Alterations in temperature sensations (7%) Itching (2%) Frequency Not Defined CNS excitement or depression Lightheadedness Nervousness Apprehension Euphoria Confusion Dizziness Drowsiness Sensations of hot, cold, or numbness Twitching Tremors Convulsions Bradycardia Hypotension Cardiovascular collapse leading to arrest Vomiting Discrete purpuric or petechial reactions at the site of application Hyperpigmentation (cream) Redness Blistering of foreskin in neonates about to undergo circumcision Tinnitus Blurred or double vision Allergic and anaphylactoid reactions (characterized by urticaria, angioedema, bronchospasm, and shock)

Pregnancy Category: B Lactation: Unknown whether distributed in breast milk, caution advised