Premium Lidocaine Extra: Uses, Side Effects and Dosage

DOSAGE AND ADMINISTRATION

When Lidocaine Ointment 5% is used concomitantly with other products containing lidocaine, the total

dose contributed by all formulations must be kept in mind.

Adult

A single application should not exceed 5 g of Lidocaine Ointment 5%, containing 250 mg of lidocaine base

(equivalent chemically to approximately 300 mg of lidocaine hydrochloride). This is roughly equivalent to

squeezing a six (6) inch length of ointment form the tube. In a 70 kg adult this dose equals 3.6 mg/kg (1.6

mg/lb) loidocaine base. No more than one-half tube or one-third of a jar, approximately 17-20 g of ointment

or 850-1000 mg lidocaine base should be administered in any one day.

Although the incidence of adverse effects with Lidocaine Ointment 5% is quite low, caution should be

exercised, particularly when employing large amounts, since the incidence of adverse effects is directly

proportional to the total dose of local anesthetic agent administered.

Dosage for children

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age

and weight. For children less than ten years who have a normal lean body mass and a normal lean body

development, the maximum dose may be determined by the application of one of the standard pediatric

drug formulas (e.g. Clark's rule). For example a child of five years weighing 50 lbs., the dose of lidocaine

should not exceed 75-100 mg when calculated according to Clark's rule. In any case, the maximum amount of

lidocaine administered should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

Administration

For medical use, apply topically for adequate control of symptoms. The use of a sterile gauze pad is

suggested for application to broken skin tissue. Apply to the tube prior to intubation.

In dentistry, apply to previously dried oral mucosa. Subsequent removal of excess saliva with cotton rolls

or saliva ejector minimizes dilution of the ointment, permits maximum penetration, and minimizes the

possibility of swallowing the topical ointment.

For use in connection with the insertion of new dentures, apply to all denture surfaces contacting mucosa.

IMPORTANT: Patients should consult a dentist at intervals not exceeding 48 hours throughou the

fitting period

HOW SUPPLIED

Lidocaine Ointment, 5% is available in 50 g (1.76 oz) laminate tube

Store at controlled room temperature 20-25 C (68-77 F). Do not permit to freeze.

Distributed By:

Alivio Medical Products, LLC

PRINCIPAL DISPLAY PANEL 50g (1.76

oz) Tube Carton

Alivio Medical Products, LLC

Hollywood, Fla. 33020

NDC 69512-030-03

Lidocaine Ointment, 5%

Rx Only

Laminate Tube

FOR TOPICAL USE ONLY

NET WT 50 g (1.76 oz)