Indications : התוויות

2    THERAPEUTIC INDICATIONS
Local anesthetic, not to be used for procedures requiring sterile products.
3       CONTRAINDICATIONS
•     Esracain® Gel is contraindicated in patients who are hypersensitive to the active substance or to any of the excipients of the gel or components of the container. For a complete listing, see 6 Dosage Forms, Strengths, Composition and Packaging.
•     Patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components in the formulation (see 6 Dosage Forms, Strengths, Composition and Packaging).
•     Not to be used for procedures requiring sterile products
•     Patients with congenital or idiopathic methemoglobinemia and patients with glucose-6- phosphate dehydrogenase deficiency, which are more susceptible to drug-induced methemoglobinemia.
•     Infants who require treatment with methemoglobin-inducing agents, e.g., sulfonamides and are 12 months of age or younger (see 9 DRUGS INTERACTIONS).

4       DOSAGE AND ADMINISTRATION
4.1     Recommended Dose and Dosage Adjustment

The standard dosage is usually:
Dosage for adults (over the age of 18):
Use the smallest amount necessary to control your symptoms.
• Usually the effective dose is no more than 5 to 10 ml per application.
• No more than 6 doses should be used per day (24 hours).


Dosage in Children:
The gel is usually not intended for children under the age of 2 years and in any case children under the age of 3 will be treated under medical supervision only.
When using the gel on a child under the age of 2 years, do not use for more than one day (24 hours).


Dosage in children weighing less than 50 kg (and over the age of 2 years):
• The dosage depends on the child's weight. Use the smallest amount necessary to control the symptoms.
• For each dose, do not use more than 1 ml for every 5 kg of body weight. Do not exceed a maximum dose of 10 ml in each application. E.g.: for a child weighing 25 kg a maximum of 5 ml of gel can be used in each dose.
• No more than 4 doses should be used per day (24 hours). The gel can be applied once every six hours.

Dosage in Children weighing over 50 kg:
•  Use the smallest amount necessary to control the symptoms.
•  Usually the effective dose is no more than 5 to 10 ml per application.
•  No more than 4 doses should be used per day (24 hours). The gel can be applied once every six hours.