|genericName=Articaine hydrochloride and epinephrine
|genericName=Articaine hydrochloride and epinephrine
|aOrAn=a
|aOrAn=a
|drugClass=amide local anesthetic
|drugClass=amide local anesthetic
|indicationType=procedure
|indicationType=procedure
|indication=local, infiltrative, or conductive anesthesia in both simple and complex dental procedures
|indication=local, infiltrative, or conductive anesthesia in both simple and complex dental procedures
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<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* Articadent is contraindicated in patients who are hypersensitive to products containing sulfites. Products containing sulfites may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episode in certain susceptible people. Sulfite sensitivity is seen more frequently in asthmatic that in non-asthmatic people
* Accidental intravascular injection of Articadent may be associated with convulsions, followed by central nervous system or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Dental practitioners who employ local anesthetic agents including Articadent 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 avoid intravascular injection, aspiration should be performed before Articadent is injected. 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 guarantee that intravascular injection has been avoided.
====Precautions====
Small doses of local anesthetics injected in dental blocks may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. Confusion, convulsions, respiratory depression or respiratory arrest, and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should be observed constantly. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded [see DOSAGE AND ADMINISTRATION (2.1)].
* Description
5.2 Systemic Toxicity
This includes toxicity arising from accidental intravascular injection of Articadent discussed in Section 5.1, as well as that related to higher systemic concentrations of local anesthetics or epinephrine [see WARNINGS AND PRECAUTIONS (5.3)]. Systemic absorption of local anesthetics including Articadent can produce effects on the central nervous and cardiovascular systems.
At blood concentrations achieved with therapeutic doses of Articadent, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal. However, toxic blood concentrations of Articadent can depress cardiac conduction and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, possibly resulting in fatalities. In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure. Articadent should also be used with caution in patients with heart block as well as those with impaired cardiovascular function since they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs.
Restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression, or drowsiness may be early warning signs of central nervous system toxicity.
Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness should be performed after each local anesthetic injection of Articadent. Repeated doses of Articadent may cause significant increases in blood levels because of possible accumulation of the drug or its metabolites. The lowest dosage that results in effective anesthesia should be used to decrease the risk of high plasma levels and serious adverse effects. Tolerance to elevated blood levels varies with the status of the patient. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use. Precautions for epinephrine administration, discussed in Section 5.3 should be observed.
Debilitated patients, elderly patients, acutely ill patients, and pediatric patients should be given reduced doses commensurate with their age and physical condition [see DOSAGE AND ADMINISTRATION (2.1, 2.3)]. No studies have been performed in patients with liver dysfunction, and caution should be used in patients with severe hepatic disease.
5.3 Vasoconstrictor Toxicity
Articadent contains epinephrine, a vasoconstrictor that can cause local or systemic toxicity and should be used cautiously. Local toxicity may include ischemic injury or necrosis, which may be related to vascular spasm. Articadent should be used with caution in patients during or following the administration of potent general anesthetic agents, since cardiac arrhythmias may occur under such conditions. Patients with peripheral vascular disease and those with hypertensive vascular disease may exhibit exaggerated vasoconstrictor response.
The American Heart Association has made the following recommendation regarding the use of local anesthetics with vasoconstrictors in patients with ischemic heart disease: "Vasoconstrictor agents should be used in local anesthesia solutions during dental practice only when it is clear that the procedure will be shortened or the analgesia rendered more profound. When a vasoconstrictor is indicated, extreme care should be taken to avoid intravascular injection. The minimum possible amount of vasoconstrictor should be used." (Kaplan, 1986).
It is essential to aspirate before any injection to avoid administration of the drug into the blood stream.
5.4 Methemoglobinemia
Articadent, like other local anesthetics, can cause methemoglobinemia, particularly in conjunction with methemoglobin-inducing agents. Articadent should not be used in patients with congenital or idiopathic methemoglobinemia, or in patients who are receiving treatment with methemoglobin-inducing agents since they are more susceptible to drug-induced methemoglobinemia.
Signs and symptoms of methemoglobinemia may be delayed some hours after exposure. Initial signs and symptoms of methemoglobinemia include slate grey cyanosis seen in buccal mucus membranes, lips and nail beds. In severe cases, symptoms may include central cyanosis, headache, lethargy, dizziness, fatigue, syncope, dyspnea, CNS depression, seizures, dysrhythmia and shock. Methemoglobinemia should be considered if central cyanosis unresponsive to oxygen therapy occurs, especially if methemoglobin-inducing agents have been used. Calculated oxygen saturation and pulse oximetry are inaccurate in the setting of methemoglobinemia. The diagnosis can be confirmed by an elevated methemoglobin level of at least 10% is present. The development of methemoglobinemia is dose-related.
Management of methemoglobinemia: If methemoglobinemia does not respond to administration of oxygen, clinically significant symptoms of methemoglobinemia should be treated with administration of a slow intravenous injection (over 5 minutes) of methylene blue at a dosage of 1-2 mg/kg body weight.
5.5 Anaphylaxis and Allergic-Type Reactions
Articadent contains 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. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
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Overview
Articaine is a amide local anesthetic that is FDA approved for the procedure of local, infiltrative, or conductive anesthesia in both simple and complex dental procedures. Common adverse reactions include headache and pain.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Articadent, an amide local anesthetic containing a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures.
General Dosing Information
Table 1 (below) summarizes the recommended volumes and concentrations of Articadent for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults, administered by submucosal infiltration or nerve block.
The recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient. In all cases, the smallest dose that will produce the desired result should be given.
The onset of anesthesia, and the duration of anesthesia are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Caution should be exercised when employing large volumes because the incidence of side effects may be dose-related.
For most routine dental procedures, Articadent containing epinephrine 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, Articadent containing epinephrine 1:100,000 may be used.
2.2 Maximum Recommended Dosages
Adults: For normal healthy adults, the maximum dose of articaine HCl administered by submucosal infiltration and/or nerve block should not exceed 7 mg/kg (0.175 mL/kg).
Pediatric Patients Ages 4 to 16 Years: The quantity of articaine HCl in children ages 4 to 16 years of age to be injected should be determined by the age and weight of the child and the magnitude of the operation. The maximum dose of articaine HCl should not exceed 7 mg/kg (0.175 mL/kg) [see USE IN SPECIFIC POPULATIONS (8.4)].
Safety and effectiveness of Articadent in pediatric patients below the age of 4 years have not been established.
2.3 Dosing in Special Populations
Dose reduction may be required in debilitated patients, acutely ill patients, elderly patients, and pediatric patients commensurate with their age and physical condition. No studies have been performed in patients with renal or liver dysfunction. Caution should be used in patients with severe liver disease
There is limited information regarding Off-Label Guideline-Supported Use of Articaine in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Articaine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Articaine in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Articaine in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Articaine in pediatric patients.
Contraindications
Articadent is contraindicated in patients who are hypersensitive to products containing sulfites. Products containing sulfites may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episode in certain susceptible people. Sulfite sensitivity is seen more frequently in asthmatic that in non-asthmatic people
Warnings
Accidental Intravascular Injection
Accidental intravascular injection of Articadent may be associated with convulsions, followed by central nervous system or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Dental practitioners who employ local anesthetic agents including Articadent 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 avoid intravascular injection, aspiration should be performed before Articadent is injected. 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 guarantee that intravascular injection has been avoided.
Small doses of local anesthetics injected in dental blocks may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. Confusion, convulsions, respiratory depression or respiratory arrest, and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should be observed constantly. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded [see DOSAGE AND ADMINISTRATION (2.1)].
5.2 Systemic Toxicity
This includes toxicity arising from accidental intravascular injection of Articadent discussed in Section 5.1, as well as that related to higher systemic concentrations of local anesthetics or epinephrine [see WARNINGS AND PRECAUTIONS (5.3)]. Systemic absorption of local anesthetics including Articadent can produce effects on the central nervous and cardiovascular systems.
At blood concentrations achieved with therapeutic doses of Articadent, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal. However, toxic blood concentrations of Articadent can depress cardiac conduction and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, possibly resulting in fatalities. In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure. Articadent should also be used with caution in patients with heart block as well as those with impaired cardiovascular function since they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs.
Restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression, or drowsiness may be early warning signs of central nervous system toxicity.
Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness should be performed after each local anesthetic injection of Articadent. Repeated doses of Articadent may cause significant increases in blood levels because of possible accumulation of the drug or its metabolites. The lowest dosage that results in effective anesthesia should be used to decrease the risk of high plasma levels and serious adverse effects. Tolerance to elevated blood levels varies with the status of the patient. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use. Precautions for epinephrine administration, discussed in Section 5.3 should be observed.
Debilitated patients, elderly patients, acutely ill patients, and pediatric patients should be given reduced doses commensurate with their age and physical condition [see DOSAGE AND ADMINISTRATION (2.1, 2.3)]. No studies have been performed in patients with liver dysfunction, and caution should be used in patients with severe hepatic disease.
5.3 Vasoconstrictor Toxicity
Articadent contains epinephrine, a vasoconstrictor that can cause local or systemic toxicity and should be used cautiously. Local toxicity may include ischemic injury or necrosis, which may be related to vascular spasm. Articadent should be used with caution in patients during or following the administration of potent general anesthetic agents, since cardiac arrhythmias may occur under such conditions. Patients with peripheral vascular disease and those with hypertensive vascular disease may exhibit exaggerated vasoconstrictor response.
The American Heart Association has made the following recommendation regarding the use of local anesthetics with vasoconstrictors in patients with ischemic heart disease: "Vasoconstrictor agents should be used in local anesthesia solutions during dental practice only when it is clear that the procedure will be shortened or the analgesia rendered more profound. When a vasoconstrictor is indicated, extreme care should be taken to avoid intravascular injection. The minimum possible amount of vasoconstrictor should be used." (Kaplan, 1986).
It is essential to aspirate before any injection to avoid administration of the drug into the blood stream.
5.4 Methemoglobinemia
Articadent, like other local anesthetics, can cause methemoglobinemia, particularly in conjunction with methemoglobin-inducing agents. Articadent should not be used in patients with congenital or idiopathic methemoglobinemia, or in patients who are receiving treatment with methemoglobin-inducing agents since they are more susceptible to drug-induced methemoglobinemia.
Signs and symptoms of methemoglobinemia may be delayed some hours after exposure. Initial signs and symptoms of methemoglobinemia include slate grey cyanosis seen in buccal mucus membranes, lips and nail beds. In severe cases, symptoms may include central cyanosis, headache, lethargy, dizziness, fatigue, syncope, dyspnea, CNS depression, seizures, dysrhythmia and shock. Methemoglobinemia should be considered if central cyanosis unresponsive to oxygen therapy occurs, especially if methemoglobin-inducing agents have been used. Calculated oxygen saturation and pulse oximetry are inaccurate in the setting of methemoglobinemia. The diagnosis can be confirmed by an elevated methemoglobin level of at least 10% is present. The development of methemoglobinemia is dose-related.
Management of methemoglobinemia: If methemoglobinemia does not respond to administration of oxygen, clinically significant symptoms of methemoglobinemia should be treated with administration of a slow intravenous injection (over 5 minutes) of methylene blue at a dosage of 1-2 mg/kg body weight.
5.5 Anaphylaxis and Allergic-Type Reactions
Articadent contains 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. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Articaine in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Articaine in the drug label.
