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4% Citanest Plain Dental Prilocaine Hydrochloride Injection, USP for Local Anesthesia in Dentistry Rx Only DESCRIPTION and Death

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4% Citanest Plain Dental Prilocaine Hydrochloride Injection, USP for Local Anesthesia in Dentistry Rx Only DESCRIPTION and Death 4% Citanest Plain Dental Prilocaine Hydrochloride Injection, USP For Local Anesthesia in Dentistry Rx only DESCRIPTION and death. Discontinue Prilocaine Hydrochloride Injection, USP, 4% and any other 4% Citanest Plain Dental (prilocaine HCI Injection, USP), is a sterile, non pyrogenic oxidizing agents. Depending on the severity of the signs and symptoms, patients isotonic solution that contains a local anesthetic agent and is administered may respond to supportive care, i.e., oxygen therapy, hydration. A more severe parenterally by injection. See INDICATIONS AND USAGE for specific uses. The clinical presentation may require treatment with methylene blue exchange quantitative composition is shown in Table 1. transfusion, or hyperbaric oxygen. PRECAUTIONS 4% Citanest Plain Dental contains prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and General: The safety and effectiveness of prilocaine depend on proper dosage, has the following structural formula: correct technique, adequate precautions, and readiness for emergencies. Standard textbooks should be consulted for specific techniques and precautions CH3 for various regional anesthetic procedures. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use. (See WARNINGS and ADVERSE REACTIONS.) The lowest dosage that results in NHCOCHNHCH CH CH • HCl 2 23 effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated doses of prilocaine may cause significant increases in CH3 blood levels with each repeated dose because of slow accumulation of the drug C H N O • HCI molecular wt = 256.77 or its metabolites. Tolerance to elevated blood levels varies with the status of the 13 20 2 patient. Debilitated, elderly patients, acutely ill patients, and children should be Parenteral drug productsC13H 20shouldNO2 • HCl be inspectedmolecular wtvisually = 256.77 for particulate matter and given reduced doses commensurate with their age and physical status. Prilocaine discoloration prior to administration. should also be used with caution in patients with severe shock or heart block. The specific quantitative composition is shown in Table 1. Cardiovascular and respiratory (adequacy of ventilation) vital signs and the TABLE 1. COMPOSITION patient’s state of consciousness should be monitored after each local anesthetic injection. Restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, Product Identification Formula (mg/mL) depression or drowsiness should alert the practitioner to the possibility of central nervous system toxicity. Signs and symptoms of depressed cardiovascular function may commonly result from a vasovagal reaction, particularly if the Prilocaine HCI pH patient is in an upright position. (See ADVERSE REACTIONS, Cardiovascular System). 4% Citanest Plain Dental 40.0 6.0 to 7.0 Since amide-type local anesthetics are metabolized by the liver, prilocaine Note: Sodium hydroxide or hydrochloric acid may be used to adjust the pH of 4% should be used with caution in patients with hepatic disease. Citanest Plain Dental Injection. Patients with severe hepatic disease, because of their inability to metabolize CLINICAL PHARMACOLOGY local anesthetics normally, are at greater risk of developing toxic plasma Mechanism of Action: Prilocaine stabilizes the neuronal membrane by inhibiting concentrations. Prilocaine should also be used with caution in patients with the ionic fluxes required for the initiation and conduction of impulses, thereby impaired cardiovascular function since they may be less able to compensate effecting local anesthetic action. for functional changes associated with the prolongation of A-V conduction produced by these drugs. Onset and Duration of Action: When used for infiltration injection in dental patients, the time of onset of anesthesia averages less than 2 minutes with an Many drugs used during the conduct of anesthesia are considered potential average duration of soft tissue anesthesia of approximately 2 hours. triggering agents for familial malignant hyperthermia. Since it is not known whether amide-type local anesthetics may trigger this reaction and since the Based on electrical stimulation studies, 4% Citanest Plain Dental Injection provides need for supplemental general anesthesia cannot be predicted in advance, a duration of pulpal anesthesia of approximately 10 minutes in maxillary infiltration it is suggested that a standard protocol for the management of malignant injections. In clinical studies, this has been found to provide complete anesthesia hyperthermia should be available. Early unexplained signs of tachycardia, for procedures lasting an average of 20 minutes. tachypnea, labile blood pressure, and metabolic acidosis may precede When used for inferior alveolar nerve block, the time of onset of 4% Citanest Plain temperature elevation. Successful outcome is dependent on early diagnosis, Dental Injection averages less than three minutes with an average duration of soft prompt discontinuance of the suspect triggering agent(s) and institution of tissue anesthesia of approximately 2 1/2 hours. treatment, including oxygen therapy, indicated supportive measures and Hemodynamics: Excessive blood levels may cause changes in cardiac output, dantrolene (consult dantrolene sodium intravenous package insert before using). total peripheral resistance, and mean arterial pressure. These changes may be Prilocaine should be used with caution in persons with known drug sensitivities. attributable to a direct depressant effect of the local anesthetic agent on various Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, components of the cardiovascular system. benzocaine, etc.) have not shown cross sensitivity to prilocaine. Pharmacokinetics and Metabolism: Information derived from diverse formulations, Use in the Head and Neck Area: Small doses of local anesthetics injected into the concentrations and usages reveals that prilocaine is completely absorbed head and neck area, including retrobulbar, dental and stellate ganglion blocks, following parenteral administration, its rate of absorption depending, for example, may produce adverse reactions similar to systemic toxicity seen with unintentional upon such factors as the site of administration and the presence or absence of a intravascular injections of larger doses. Confusion, convulsions, respiratory vasoconstrictor agent. Prilocaine is metabolized in both the liver and the kidney depression and/or respiratory arrest, and cardiovascular stimulation or depression and excreted via the kidney. It is not metabolized by plasma esterases. Hydrolysis have been reported. These reactions may be due to intra-arterial injection of the of prilocaine by amidases yields ortho-toluidine and N-proylalanine. Both of these local anesthetic with retrograde flow to the cerebral circulation. Patients receiving compounds may undergo ring hydroxylation. these blocks should have their circulation and respiration monitored and be O-toluidine has been found to produce methemoglobin, both in vitro and in vivo constantly observed. Resuscitative equipment and personnel for treating adverse (see ADVERSE REACTIONS). reactions should be immediately available. Dosage recommendations should not Because prilocaine is metabolized in both the liver and kidneys, hepatic and renal be exceeded. (See DOSAGE AND ADMINISTRATION.) dysfunction may alter prilocaine kinetics. Information for Patients/Patient Counseling Information: The patient should be As with other local anesthetic agents, the plasma binding of prilocaine may be informed of the possibility of temporary loss of sensation and muscle function dependent on drug concentration. At 0.5 to 1.0 mg/mL it is 55% protein bound. following infiltration or nerve block injections. Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be Prilocaine crosses the blood-brain and placental barriers, presumably by passive treated promptly. Advise patients or caregivers to seek immediate medical diffusion. attention if they or someone in their care experience the following signs or Factors such as acidosis and the use of CNS stimulants and depressants affect the symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart CNS levels of prilocaine required to produce overt systemic effects. In the rhesus rate; shortness of breath; lightheadedness; or fatigue. monkey, arterial blood levels of 20 mg/mL have been shown to be the threshold The patient should be advised to exert caution to avoid inadvertent trauma for convulsive activity. to the lips, tongue, cheek mucosae, or soft palate when these structures are INDICATIONS AND USAGE anesthetized. The ingestion of food should therefore be postponed until normal 4% Citanest Plain Dental Injection is indicated for the production of local anesthesia function returns. in dentistry by nerve block or infiltration techniques. Only accepted procedures for The patient should be advised to consult the dentist if anesthesia persists, or if these techniques as described in standard textbooks are recommended. a rash develops. CONTRAINDICATIONS Clinically Significant Drug Interactions: Prilocaine is contraindicated in patients with a known history of hypersensitivity to Concurrent administration of vasopressor drugs and ergot-type oxytocic drugs local anesthetics of the amide type and in those rare patients with congenital or
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