Oraqix (Lidocaine / Prilocaine Periodontal) - Indications and Dosage

INDICATIONS AND USAGE

Oraqix is an amide local anesthetic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing.

DOSAGE AND ADMINISTRATION

General Dosing Information

DO NOT INJECT [see Warnings and Precautions]

Apply Oraqix on the gingival margin around the selected teeth using the blunt-tipped applicator included in the package. Wait 30 seconds, and then fill the periodontal pockets with Oraqix using the blunt-tipped applicator until the gel becomes visible at the gingival margin. Wait another 30 seconds before starting treatment. A longer waiting time does not enhance the anesthesia. Anesthetic effect, as assessed by probing of pocket depths, has a duration of approximately 20 minutes (individual overall range 14 – 31 minutes). If the anesthesia starts to wear off, Oraqix may be re-applied if needed.

Typically, 1 cartridge (1.7g) or less of Oraqix will be sufficient for one quadrant of the dentition.

When administered, Oraqix should be a liquid. If it has formed a gel, it should be placed in a refrigerator (do not freeze) until it becomes a liquid again. When in the liquid state, the air bubble visible in the cartridge will move if the cartridge is tilted.

Maximum Recommended Dosage

The maximum recommended dose of Oraqix at one treatment session is 5 cartridges, i.e., 8.5g gel.

DOSAGE FORMS AND STRENGTHS

Periodontal gel containing: lidocaine 25 mg/mL and prilocaine 25 mg/mL.

Each cartridge contains 1.7 mL (42.5 mg of lidocaine and 42.5 mg of prilocaine).

HOW SUPPLIED/STORAGE AND HANDLING

Oraqix (lidocaine and prilocaine periodontal gel), 2.5%/2.5%, is supplied in dental cartridges that provide 1.7g gel.

Individually blister-packaged cartridges of Oraqix are distributed in a carton of 20 (NDC 66312-110-20). Each individual blister package also contains a sterile blunt-tipped applicator. Each blunt-tipped applicator is for single use only.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]

At temperatures below +5°C Oraqix may become opaque. This opacity will disappear when the cartridge is warmed to room temperature.

DO NOT FREEZE. Some components of Oraqix may precipitate if cartridges are frozen. Cartridges should not be used if they contain a precipitate.

Do not use dental cartridge warmers with Oraqix. The heat will cause the product to gel.

See FDA-approved patient labeling (Patient Information)