Articadent
(Articaine Hydrochloride And Epinephrine Bitartrate)Articadent Prescribing Information
WARNINGS AND PRECAUTIONS, Methemoglobinemia (
Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration, and/or abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue ARTICADENT and any other oxidizing agents. Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.
ARTICADENT is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.
- For dental procedures by intraoral submucosal infiltration or nerve block. ()
2.1 Important Dosage InformationTable 1 summarizes the recommended dosages of ARTICADENT administered by intraoral submucosal infiltration or nerve block for various types of anesthetic dental procedures in healthy adults and pediatric patients.
Table 1: Recommended Dosages for Both Strengths Procedure ARTICADENT Injection Volume (mL) Total dose of articaine HCl (mg) Infiltration 0.5 mL to 2.5 mL 20 mg to 100 mg Nerve block 0.5 mL to 3.4 mL 20 mg to 136 mg Oral surgery 1 mL to 5.1 mL 40 mg to 204 mg The recommended dosages of ARTICADENT in healthy adults serve only as a guide to the amount of anesthetic required for most routine dental procedures. The dosages to be used in adults depend on several factors such as type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient. In all cases, administer the lowest dosage that will produce the desired result.
The dosages of ARTICADENT to be used in pediatric patients aged 4 to 16 years old are determined by the age and weight of the patient and the type of dental procedure. 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.
The onset of anesthesia and the duration of anesthesia are proportional to the dosage of the local anesthetic used. Exercise caution when employing large volumes because the incidence of adverse reactions may be dose-related.
- For infiltration: 0.5-2.5 mL (20-100 mg articaine HCl)- For nerve block: 0.5-3.4 mL (20-136 mg articaine HCl)- For oral surgery: 1.0-5.1 mL (40-204 mg articaine HCl)
- 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. ()
2.1 Important Dosage InformationTable 1 summarizes the recommended dosages of ARTICADENT administered by intraoral submucosal infiltration or nerve block for various types of anesthetic dental procedures in healthy adults and pediatric patients.
Table 1: Recommended Dosages for Both Strengths Procedure ARTICADENT Injection Volume (mL) Total dose of articaine HCl (mg) Infiltration 0.5 mL to 2.5 mL 20 mg to 100 mg Nerve block 0.5 mL to 3.4 mL 20 mg to 136 mg Oral surgery 1 mL to 5.1 mL 40 mg to 204 mg The recommended dosages of ARTICADENT in healthy adults serve only as a guide to the amount of anesthetic required for most routine dental procedures. The dosages to be used in adults depend on several factors such as type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient. In all cases, administer the lowest dosage that will produce the desired result.
The dosages of ARTICADENT to be used in pediatric patients aged 4 to 16 years old are determined by the age and weight of the patient and the type of dental procedure. 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.
The onset of anesthesia and the duration of anesthesia are proportional to the dosage of the local anesthetic used. Exercise caution when employing large volumes because the incidence of adverse reactions may be dose-related.
- Maximum recommended dosages ():
2.2 Maximum Recommended Dosages- Healthy Adults: The maximum recommended dosage of ARTICADENT is 7 mg/kg of articaine and 0.0017 mg/kg of epinephrine (equivalent to 0.175 mL/kg for either product presentation, articaine HCl and 1:100,000 or 1:200,000 epinephrine).
- Pediatric Patients Ages 4 to 16 Years: The maximum recommended dosage of ARTICADENT is 7 mg/kg of articaine and 0.0017 mg/kg of epinephrine (equivalent to 0.175 mL/kg for either product presentation, articaine HCl and 1:100,000 or 1:200,000 epinephrine)[see Use in Specific Populations (8.4)].
- Healthy adults: 7 mg/kg of articaine HCl and 0.0017 mg/kg of epinephrine (equivalent to 0.175 mL/kg for either product presentation, articaine HCl and epinephrine 1:100,000 or 1:200,000)- Pediatric patients: 4-16 years: 7 mg/kg of articaine HCl and 0.0017 mg/kg of epinephrine (equivalent to 0.175 mL/kg for either product presentation, articaine HCl and epinephrine 1:100,000 or 1:200,000)
Injection (clear, colorless solution), provided in:
- Glass cartridges (single-dose) containing (less than a full cartridge or more than one cartridge may be used for an individual patient):
- Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:200,000 (as epinephrine bitartrate 0.009 mg/mL)- Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:100,000 (as epinephrine bitartrate 0.018 mg/mL)
There are no adequate and well-controlled studies in pregnant women with ARTICADENT. Articaine hydrochloride and epinephrine (1:100,000) has been shown to increase fetal deaths and skeletal variations in rabbits when given in doses approximately 4 times the maximum recommended human dose (MRHD). ARTICADENT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In embryo-fetal toxicity studies in rabbits, 80 mg/kg, subcutaneously (approximately 4 times the MRHD based on body surface area) caused fetal death and increased fetal skeletal variations, but these effects may be attributable to severe maternal toxicity, including seizures, observed at this dose. In contrast, no embryo-fetal toxicities were observed when articaine and epinephrine (1:100,000) was administered subcutaneously throughout organogenesis at doses up to 40 mg/kg in rabbits and 80 mg/kg in rats (approximately 2 times the MRHD based on body surface area).
In pre- and postnatal developmental studies subcutaneous administration of articaine hydrochloride to pregnant rats throughout gestation and lactation, at a dose of 80 mg/kg (approximately 2 times the MRHD based on body surface area) increased the number of stillbirths and adversely affected passive avoidance, a measure of learning, in pups. This dose also produced severe maternal toxicity in some animals. A dose of 40 mg/kg (approximately equal to the MRHD on a mg/m2basis) did not produce these effects. A similar study using articaine and epinephrine (1:100,000) rather than articaine hydrochloride alone produced maternal toxicity, but no effects on offspring.
It is not known whether ARTICADENT is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ARTICADENT is administered to a nursing woman. When using ARTICADENT, nursing mothers may choose to pump and discard breast milk for approximately 4 hours (based on plasma half-life) following an injection of ARTICADENT (to minimize infant ingestion) and then resume breastfeeding.
Safety and effectiveness of ARTICADENT in pediatric patients below the age of 4 years have not been established. Safety of doses greater than 7 mg/kg (0.175 mL/kg) in pediatric patients has not been established.
The safety and effectiveness of ARTICADENT for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures have been established in pediatric patients ages 4 to 16 years old. Safety and effectiveness was established in clinical trials with 61 pediatric patients between the ages of 4 and 16 years administered articaine hydrochloride 4% and epinephrine 1:100,000 injections. Fifty-one of these patients received doses from 0.76 mg/kg to 5.65 mg/kg (0.9 to 5.1 mL) for simple dental procedures and 10 patients received doses between 0.37 mg/kg and 7.48 mg/kg (0.7 to 3.9 mL) for complex dental procedures. Approximately 13% of these pediatric patients required additional injections of anesthetic for complete anesthesia. Dosages in pediatric patients should be reduced, commensurate with age, body weight, and physical condition
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 episodes in certain susceptible people. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people
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.