Local anesthetic for periodontal administration Not for Injection

®

(lidocaine and prilocaine periodontal gel) 2.5% / 2.5%

Brief Summary of Prescribing Information

 

INDICATIONS AND USAGE Information for Patients: Patients are cautioned to avoid injury to the treated area, or
Oraqix® (lidocaine and prilocaine periodontal gel) 2.5%/2.5% is indicated for adults exposure to extreme hot or cold temperatures, until complete sensation has returned.
who require localized anesthesia in periodontal pockets during scaling and/or root
planing. Drug Interactions: Oraqix^® should be used with caution in combination with dental
injection anesthesia, other local anesthetics, or agents structurally related to local

CONTRAINDICATIONS anesthetics, e.g., Class 1 antiarrhythmics such as tocainide and mexiletine, as the Oraqix® is contraindicated in patients with hypersensitivity to amide type local toxic effects of these drugs are likely to be additive and potentially synergistic. anesthetics or to any other product component.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILI TY:

WARNINGS Carcinogenesis - Chronic oral toxicity studies of o-toluidine, a metabolite of prilocaine,
Prilocaine can cause elevated methemoglobin levels particularly in conjunction with have shown that this compound is a carcinogen in both mice and rats. The tumors
methemoglobin-inducing agents. Methemoglobinemia has been reported in a few associated with o-toluidine included hepatocarcinomas/adenomas in female mice,
cases in association with lidocaine treatment. Patients with glucose-6-phosphate multiple occurrences of hemangiosarcomas/hemangiomas in both sexes of mice,
dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are more sarcomas of multiple organs, transitional-cell carcinomas/papillomas of urinary bladder
susceptible to drug-induced methemoglobinemia. Oraqix^® should not be used in those in both sexes of rats, subcutaneous fibromas/fibrosarcomas and mesotheliomas in
patients with congenital or idiopathic methemoglobinemia and in infants under the age male rats, and mammary gland fibroadenomas/ adenomas in female rats. These
of twelve months who are receiving treatment with methemoglobin-inducing agents. findings were observed at the lowest tested dose of 150 mg/kg/day or greater over
Signs and symptoms of methemoglobinemia may be delayed some hours after two years (estimated daily exposures in mice and rats were approximately 6 and 12
exposure. Initial signs and symptoms of methemoglobinemia are characterized by a times, respectively, the estimated exposure to o-toluidine at the maximum
slate grey cyanosis seen in, e.g., buccal mucous membranes, lips and nail beds. In recommended human dose of 8.5g of Oraqix^® gel on a mg/m2 basis).
severe cases symptoms may include central cyanosis, headache, lethargy, dizziness,
fatigue, syncope, dyspnea, CNS depression, seizures, dysrhythmia and shock. o-Toluidine, a metabolite of prilocaine, was positive in Escherichia coli DNA repair and
Methemoglobinemia should be considered if central cyanosis unresponsive to oxygen phage-induction assays. Urine concentrates from rats treated orally with 300 mg/kg
therapy occurs, especially if metHb-inducing agents have been used. Calculated o-toluidine were mutagenic to Salmonella typhimurium in the presence of metabolic
oxygen saturation and pulse oximetry are inaccurate in the setting of activation.
methemoglobinemia. The diagnosis can be confirmed by an elevated methemoglobin
level measured with co-oximetry. Normally, metHb levels are <1%, and cyanosis may USE IN PREGNANCY:
not be evident until a level of at least 10% is present. The development of Teratogenic Effects: Pregnancy Category B
methemoglobinemia is generally dose related. The individual maximum level of metHb Treatment of rabbits with 15 mg/kg (180 mg/m2) produced evidence of maternal
in blood ranged from 0.8% to 1.7% following administration of the maximum dose of toxicity and evidence of delayed fetal development, including a non-significant
8. 5 g Oraqix®. decrease in fetal weight (7%) and an increase in minor skeletal anomalies (skull and
sternebral defects, reduced ossification of the phalanges). The effects of lidocaine and

Management of Methemoglobinemia: Clinically significant symptoms of prilocaine on post-natal development was examined in rats treated for 8 months with methemoglobinemia should be treated with a standard clinical regimen such as a slow 10 or 30 mg/kg, s.c. lidocaine or prilocaine (60 mg/m2 and 180 mg/m2 on a body intravenous injection of methylene blue at a dosage of 1-2 mg/kg given over a five surface area basis, respectively up to 1.4-fold the maximum recommended exposure minute period. for a single procedure). This time period encompassed 3 mating periods. Both doses of either drug significantly reduced the average number of pups per litter surviving until

Patients taking drugs associated with drug-induced methemoglobinemia such as weaning of offspring from the first 2 mating periods. There are, however, no adequate sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, and well-controlled studies in pregnant women. Because animal reproduction studies dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, are not always predictive of human response, Oraqix^® should be used during pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, pregnancy only if the benefits outweigh the risks. primaquine, and quinine are also at greater risk for developing methemoglobinemia.

Nursing Mothers: Lidocaine and, possibly, prilocaine are excreted in breast milk.
Treatment with Oraqix^® should be avoided in patients with any of the above conditions Caution should be exercised when Oraqix^® is administered to nursing women.
or with a previous history of problems in connection with prilocaine treatment.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
PRECAUTIONS Very young children are more susceptible to methemoglobinemia. There have been
General: reports of clinically significant methemoglobinemia in infants and children following
DO NOT INJECT excessive applications of lidocaine 2.5% and prilocaine 2.5% topical cream (See
Oraqix^® should not be used with standard dental syringes. Only use this product with WARNINGS).
the Oraqix™ Dispenser, available from DEN TSPLY Pharmaceutical.

Geriatric Use: In general, dose selection for an elderly patient should be cautious,

Allergic and anaphylactic reactions associated with lidocaine or prilocaine can occur. usually starting at the low end of the dosing range, reflecting the greater frequency of These reactions may be characterized by urticaria, angioedema, bronchospasm, and decreased hepatic, renal, or cardiac function, and of concomitant disease or other shock. drug therapy.

Eye contact with Oraqix^® should be avoided. Animal studies have demonstrated severe ADVERSE REACTIONS eye irritation. Corneal irritation and potential abrasion may occur. If eye contact occurs, In clinical studies, the most common adverse reactions are application site reaction immediately rinse the eye with water or saline and protect it until normal sensation (including pain, soreness, irritation, numbness, ulcerations, vesicles, edema, abscess returns. In addition, the patient should be evaluated by an ophthalmologist. and/or redness), headache and taste perversion.

 

Oraqix^® should be used with caution in patients with a history of drug sensitivities, Rx only.
especially if the etiologic agent is uncertain. For more detailed information, consult your DENTSPLY Pharmaceutical representative
and read the full Prescribing Information.

Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations of Manufactured by Recip AB for DENTSPLY Pharmaceutical, York, PA 17404 lidocaine and prilocaine.