Skisia 2.5%+2.5%

INDICATIONS

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.

PHARMACOLOGY

Lidocaine and prilocaine are local anaesthetic agents of the amide type. Both work by stabilising the neuronal membranes and inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby giving rise to the anaesthetic action.

DOSAGE & ADMINISTRATION

A thick layer of Lidocaine & Prilocaine cream is applied to intact skin and covered with an occlusive dressing.Minor Dermal Procedures: For intravenous cannulation and venipuncture, apply 2.5 grams of Lidocaine & Prilocaine cream over 20-25 cm2 of skin surface for at least 1 hour.Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area, apply 2 grams of Lidocaine & Prilocaine cream 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 & Prilocaine cream to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of Lidocaine & Prilocaine cream. Adult Female 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 & Prilocaine cream 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 & 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 & Prilocaine cream.Pediatric Patients: The following are the maximum recommended doses, application areas and application times for Lidocaine & Prilocaine cream based on a child’s age and weight:

0 to 3 months or <5 kg: Maximum Total Dose 1 gm, Maximum Application Time: 1 hour
3 to 12 months and >5 kg: Maximum Total Dose 2 gm, Maximum Application Time 4 hour
1 to 6 years and >10 kg: Maximum Total Dose 10 gm, Maximum Application Time 4 hour
7 to 12 years and >20 kg: Maximum Total Dose 20 gm, Maximum Application Time 4 hour

INTERACTION

Cream should be used with caution in patients receiving antiarrhythmic drugs, such as tocainide, since the toxic effects are additive.

SIDE EFFECTS

Nervousness, dizziness, blurred vision, tremors, drowsiness, convulsions, unconsciousness, respiratory arrest, hypotension, myocardial depression, bradycardia, cardiac arrest and anaphylactoid reactions (cutaneous lesion, urticaria, oedema).

PREGNANCY & LACTATION

There is no, or inadequate, evidence of safety of the drug in human pregnancy but it has been in wide use for many years without apparent ill consequence. If drug therapy is needed in pregnancy, this drug can be used if there is no safer alternative. Cream enters the mothers milk, but in such small quantities that there is generally no risk of affecting the child at therapeutic dose levels.

PRECAUTIONS & WARNINGS

Absorption from wound surfaces and mucous membranes is relatively high, especially in the bronchial tree. This cream should be used with caution in patients with traumatised mucosa and/or sepsis in the region of the proposed application. If the dose or site of administration is likely to result in high blood levels, cream should be used cautiously in patients with epilepsy, impaired cardiac condition, bradycardia, impaired hepatic function and in severe shock. The use of oropharyngeal topical anesthetic agents may interfere with swallowing and thus enhance the danger of aspiration. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may increase the danger of biting trauma.

THERAPEUTIC CLASS

Local & Surface anesthesia, Topical Local Anesthetics

STORAGE CONDITIONS

Store in a cool and dry place, protected from light