anyone [150:<70 kg) (8 mg/kg) 150 lbs 600 mg (15 mL) or ( 70 kg) 8 cartridges In children under 10 years of age it is rarely necessary to administer more than one-half cartridge (40 mg) of 4% Citanest Plain Dental Injection per procedure to achieve local anesthesia for a procedure involving a single tooth. In maxillary infiltration, this amount will often suffice to the treatment of two or even three teeth. In the mandibular block, however, satisfactory anesthesia achieved with this amount of drug will allow treatment of the teeth in an entire quadrant. ASPIRATION PRIOR TO INJECTION IS RECOMMENDED, since it reduces the possibility of intravascular injection, thereby keeping the incidence of side effects and anesthetic failure to a minimum. NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and/or contain particulate matter should not be used. Any unused portion of a cartridge should be discarded. Maximum Recommended Dosages In patients weighing> <150 lbs (70 kg), no more than 4 mg/lb (8 mg/kg) should be administered. In patients weighing> <150 lbs, no more than 600 mg (8 cartridges) of prilocaine HCl should be administered as a single injection. 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 of less than ten years who have a normal lean body mass and normal 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, in a child of five years weighing 50 lbs., the dose of prilocaine hydrochloride should not exceed 150 to 200 mg (6.6 to 8.8 mg/kg or 3 to 4 mg/lb of body weight) when calculated according to Clark's rule. How is Citanest Plain Dental Injection Supplied 4% Citanest Plain Dental Injection (NDC 66312-630-14) is dispensed in 1.8 mL cartridges, packed 50 per box. Sterilization, Storage and Technical Procedures Cartridges should not be autoclaved, becausee the closures employed in cartridges cannot withstand autoclaving temperatures and pressures. If chemical disinfection of anesthetic cartridges is desired, either 91% isopropyl alcohol or 70% ethyl alcohol is recommended. Many commercially available brands of rubbing alcohol, as well as solutions of ethyl alcohol not of U.S.P. grade, contain denaturants that are injurious to rubber and, therefore, are not to be used. It is recommended that chemical disinfection be accomplished by wiping the cartridge cap thoroughly with a pledget of cotton that has been moistened with the recommended alcohol just prior to use. IMMERSION IS NOT RECOMMENDED. Certain metallic ions (mercury, zinc, copper, etc.) have been related to swelling and edema after local anesthesia in dentistry. Therefore, chemical disinfectants containing or releasing those ions are not recommended. Antirust tablets usually contain metal ions. Accordingly, aluminum sealed cartridges should not be kept in such solutions. Quaternary ammonium salts, such as benzalkonium chloride, are electrolytically incompatible with aluminum. Cartridges are sealed with aluminum caps and therefore should not be immersed in any solution containing these salts. To avoid leakage of solutions during injection, be sure to penetrate the center of the rubber diaphragm when loading the syringe. An off-center penetration produces an oval shaped puncture that allows leakage around the needle. Other causes of leakage and breakage included badly worn syringes, aspirating syringes with bent harpoons, the use of syringes not designed to take 1.8 mL cartridges, and inadvertent freezing. Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature]. Rev.06/2017 (2730-1) Citanest Is a trademark of the AstraZeneca Group Manufactured for Dentsply Pharmaceutical, York, PA 17404 by Novocol Pharmaceutical of Canada, Inc Principal Display Panel - 1.8 mL Cartridge Carton NDC 66312-630-14 Reorder# 46616 Dentsply Sirona 4% Citanest Plain DENTAL (prilocaine HCl Injection, USP) 40 mg/mL For dental block and infiltration injections only. 50 Cartridges, 1.8 mL each Rx Only CITANEST PLAIN prilocaine hydrochloride injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66312-630 Route of Administration SUBMUCOSAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRILOCAINE HYDROCHLORIDE (PRILOCAINE) PRILOCAINE HYDROCHLORIDE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE WATER 1 mL in 1 mL HYDROCHLORIC ACID Packaging # Item Code Package Description 1 NDC:66312-630-14 50 CARTRIDGE in 1 CARTON 1 1.8 mL in 1 CARTRIDGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079235 11/18/1965 Labeler - Dentsply Pharmaceutical Inc. (102221942) Establishment Name Address ID/FEI Operations Novocol 201719960 manufacture(66312-630) Revised: 11/2017 Dentsply Pharmaceutical Inc. Next Interactions Print this page Add to My Med List More about Citanest HCl Plain (prilocaine) Side Effects Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons 0 Reviews Add your own review/rating Drug class: local injectable anesthetics Professional resources Prilocaine Hydrochloride (AHFS Monograph) Prilocaine Hydrochloride Injection (FDA)> ] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Availability Discontinued B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Local injectable anesthetics Related Drugs local injectable anesthetics lidocaine , Marcaine , bupivacaine , prilocaine , tetracaine , Novocain Citanest HCl Plain Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! diagnosed
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