FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
DENTAL PRACTITIONERS WHO EMPLOY LOCAL ANESTHETIC AGENTS SHOULD BE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF EMERGENCIES THAT MAY ARISE FROM THEIR USE. RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS SHOULD BE AVAILABLE FOR IMMEDIATE USE.
To minimize the likelihood of intravascular injection, aspiration should be performed before the local anesthetic solution is injected. If blood is aspirated, the needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not assure that intravascular injection will be avoided.
Citanest Dental with epinephrine injections contain sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Prilocaine has been associated with the development of methemoglobinemia. Very young patients, patients with congenital or idiopathic methemoglobinemia, or patients with glucose-6-phosphate deficiencies are more susceptible to methemoglobinemia.
Patients taking drugs associated with drug induced methemoglobinemia such as sulfonamides, acetaminophen, acetanilid, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine are also at greater risk for developing methemoglobinemia.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
4% Citanest Plain Dental (prilocaine HCl) and 4% Citanest Forte Dental Injections are indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.
History
There is currently no drug history available for this drug.
Other Information
Citanest Dental (prilocaine HCl) Injection is a sterile, non pyrogenic isotonic solution that contains a local anesthetic agent with or without epinephrine (as bitartrate) and is administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The quantitative composition of each available injection is shown in Table 1.
Citanest Dental injections contain prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula:
C13H20N2o ∙ HCl molecular wt = 256.77
Epinephrine is (-) -3, 4-Dihydroxy-a-[(methylamino) methyl] benzyl alcohol and has the following structural formula:
C9H13NO3 molecular wt = 183.21
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
The specific quantitative composition of each available injection is shown in Table 1.
Product Identification | Formula (mg/mL) | ||||
---|---|---|---|---|---|
Prilocaine HCL | Epinephrine (as the bitartrate) |
Citric Acid | Sodium Metabisulfate | ph | |
Citanest Plain Dental Injection | 40.0 | None | None | None | 6.0-7.0 |
Citanest Forte Dental Injection with Epinephrine | 40.0 | 0.005 | 0.2 | 0.5 | 3.3-5.5 |
Note: Sodium hydroxide and/or hydrochloric acid may be used to adjust the pH of Citanest Dental Injections. Filled under nitrogen.
Sources
Citanest Forte Manufacturers
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Dentsply Pharmaceutical Inc.
Citanest Forte | Dentsply Pharmaceutical Inc.
The dosage of Citanest Plain Dental Injection and Citanest Forte Dental Injection varies and depends on the physical status of the patient, the area of the oral cavity to be anesthetized, the vascularity of the oral tissues, and the technique of anesthesia. The least volume of injection that results in effective local anesthesia should be administered. For specific techniques and procedures of local anesthesia in the oral cavity, refer to standard textbooks.
Inferior Alveolar BlockThere are no practical clinical differences between Citanest Dental with and without epinephrine when used for inferior alveolar blocks.
Maxillary InfiltrationCitanest Plain Dental is recommended for use in maxillary infiltration anesthesia for procedures in which the painful aspects can be completed within 15 minutes after the injection. Citanest Plain Dental is therefore especially suited to short procedures in the maxillary anterior teeth. For long procedures, or those involving maxillary posterior teeth where soft tissue numbness is not troublesome to the patient, Citanest Forte Dental is recommended.
For most routine procedures, initial dosages of 1 to 2 mL of Citanest Plain Dental Injection or Citanest Forte Dental Injection will usually provide adequate infiltration or major nerve block anesthesia.
The maximum recommended dose that should ever be administered within a two hour period in normal healthy adults should be calculated based upon the patient's weight as follows:
Weight Maximum recommended dose <150 lbs
(<70 kg) 4 mg/lb
(8 mg/kg) ≥150 lbs
(≥70 kg) 600 mg (15 mL) or
8 cartridgesIn children under 10 years of age it is rarely necessary to administer more than one-half cartridge (40 mg) of Citanest Plain Dental Injection or Citanest Forte 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 intra-vascular 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 of Citanest Plain Dental or Citanest Forte Dental Injection should be discarded.
Maximum Recommended DosagesIn 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.
ChildrenIt 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 (eg, Clark's rule). For example, in a child of five years weighing 50 lbs., the dose of prilocaine hydrochloride should not exceed 150–200 mg (6.6–8.8 mg/kg or 3–4 mg/lb of body weight) when calculated according to Clark's rule.
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