Strong Safety Profile
Oraqix is not contraindicated for use on inflamed tissue, a common condition for patients undergoing periodontal scaling and root planing procedures.
The active pharmaceutical ingredients in Oraqix, lidocaine and prilocaine, have an established safety profile. Unlike Oraqix, topical anesthetics may contain butamben, benzocaine and/or tetracaine, which are esters, which tend to induce a higher rate of allergic reactions.1
Oraqix offers minimal risk for an allergic reaction, and Oraqix may be reapplied to a maximum of five treatment cartridges if longer duration of the anesthetic effect is required. Overdose reactions are similar to overdoses from injectable amides (such as lidocaine), which are rare.1
Other safety features of Oraqix include:
- Low systemic toxicity; only 20-40% of the dispensed drug is available systemically1
- Easy dosage tracking, especially when compared to multi-dose packaging that is common with some topical products1
- Cartridges include a "safety collar", which prevents accidental placement into a standard syringe1
Individual Packaging Reduces Risk
of Cross-Contamination
Vigilance with regard to aseptic procedures within the dental practice is a critical part of patient care.
The convenience of Oraqix packaging may help busy dentists and dental hygienists cut down on procedure time. Individual packaging may help to protect you and your patients and allows your office to maintain high aseptic standards.
Packaging Features
- Individually blister-packaged cartridges of Oraqix are distributed in a carton of 20
- Each individual blister package contains a sterile, blunt-tipped applicator, reducing cross contamination risk
- Each blunt tip applicator is designed for single use
- Dispensers may be autoclaved following procedures for thorough sterilization
Following SRP treatment with Oraqix in 391 patients, the most frequent adverse events were local reactions in the oral cavity. These events, which occurred in approximately 15% of patients, included pain, soreness, irritation, numbness, vesicles, ulcerations, edema and/or redness in the treated area. Of the 391 patients treated with Oraqix, five developed ulcerative lesions and two developed vesicles of mild to moderate severity near the site of SRP. In addition, ulcerative lesions in or near the treated area were also reported for three out of 168 patients who received placebo. Other symptoms reported in more than one patient were headache, taste perversion, nausea, fatigue, flu, respiratory infection, musculoskeletal pain and accident/injury.
The toxicities of lidocaine and prilocaine are thought to be additive.
Systemic CNS toxicity may occur over a range of plasma concentrations of local anesthetics. CNS toxicity may typically be found around 5000 ng/mL of lidocaine, however, a small number of patients reportedly may show signs of toxicity at approximately 1000 ng/mL. Pharmacological thresholds for prilocaine are poorly defined.
The peak plasma rate of Oraqix® is in the 20-40 minute range. The lidocaine Cmax was in the 99-266 ng/mL range and the prilocaine Cmax was in the range 46-118 ng/mL.
* from Oraqix Package Insert
1 Basset, K.B.;DiMarco, A.C.;Naughton, D.K., (2010) Local Anesthesia for Dental Professionals. Upper Saddle River, NJ: Pearson Education, Inc.