lidocaine 5 % Topical Ointment
WARNINGS
EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS, PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT.
THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS.
Lidocaine Ointment 5% should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.
OVERDOSAGE
Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics.
(see ADVERSE REACTIONS , WARNINGS , and PRECAUTIONS ).
Management of local anesthetic emergencies: The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic administration.
At the first sign of change, oxygen should be administered.
The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask.
Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously.
Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously.
The clinician should be familiar, prior to use of local anesthetics, with these anticonvulsant drugs.
Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (e.g., ephedrine).
If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest.
If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted.
Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.
The oral LD50 of lidocaine HCl in non-fasted female rats is 459 (346-773) mg/kg (as the salt) and 214 (159-324) mg/kg (as the salt) in fasted female rats.
DESCRIPTION
Lidocaine Ointment 5% contains a local anesthetic agent and is administered topically.
See INDICATIONS AND USAGE for specific uses.
Lidocaine Ointment 5% contains lidocaine, which is chemically designated as acetamide, 2- (diethylamino) – N -(2,6-dimethylphenyl)-, and has the following structural formula: C 14 H 22 N 2 O M.W.
234.34 Composition of Lidocaine Ointment 5%: acetamide, 2-(diethylamino)- N -(2,6-dimethylphenyl)-, (lidocaine) 5% in a water miscible ointment vehicle containing polyethylene glycols and peppermint oil.
structural formula
HOW SUPPLIED
Product: 50436-0933 NDC: 50436-0933-1 35.44 g in a TUBE NDC: 50436-0933-2 50 g in a JAR
INDICATIONS AND USAGE
Lidocaine Ointment 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx.
It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.
PEDIATRIC USE
Pediatric Use Dosage in children should be reduced, commensurate with age, body weight and physical condition.
Caution must be taken to avoid overdosage when applying Lidocaine Ointment 5% to large areas of injured or abraded skin, since the systemic absorption of lidocaine may be increased under such conditions.
See DOSAGE and ADMINISTRATION .
PREGNANCY
Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine.
There are, however, no adequate and well-controlled studies in pregnant women.
Animal reproduction studies are not always predictive of human response.
General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.
NUSRING MOTHERS
Nursing Mothers It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when lidocaine is administered to a nursing woman.
INFORMATION FOR PATIENTS
Information for Patients When topical anesthetics are used in the mouth, the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration.
For this reason, food should not be ingested for 60 minutes following the use of local anesthetic preparations in the mouth or throat area.
This is particularly important in children because of their frequency of eating.
Numbness of the tongue or buccal mucosa may enhance the danger of unintentional biting trauma.
Food and chewing gum should not be taken while the mouth or throat area is anesthetized.
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 from the tube.
In a 70 kg adult this dose equals 3.6 mg/kg (1.6 mg/lb) lidocaine 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 throughout the fitting period.