Articaine Hydrochloride and Epinephrine 40 mg/mL
ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE · INJECTION, SOLUTION · Burkhart Dental Supply Co., Inc
Articaine hydrochloride and epinephrine is a local anesthetic injection used to numb tissues in the mouth during dental procedures. The epinephrine in the formulation helps constrict blood vessels to reduce bleeding and prolong the numbing effect.
Key Facts
- Brand Name
- Articaine Hydrochloride and Epinephrine
- Generic Name
- ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE
- NDC Code (Product)
43498-993- Manufacturer
- Burkhart Dental Supply Co., Inc
- Strength
- 40 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Marketing Status
- Application #
- NDA022466
- Marketing Start
- 11/04/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Articaine HCl and Epinephrine 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. Articaine HCl and Epinephrine is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, 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 ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • For dental procedures by intraoral submucosal infltration or nerve block ( 2.1 ): - For infltration: 0.5 mL-2.5 mL (20 mg-100 mg articaine HCl) ( 2.1 ) - For nerve block: 0.5 mL-3.4 mL (20 mg-136 mg articaine HCl) ( 2.1 ) - For oral surgery: 1 ml-5.1 mL (40 mg-204 mg articaine HCl) ( 2.1 ) • For most routine dental procedures, Articaine HCl and Epinephrine containing epinephrine 1:200,000 is preferred. However, when more pronounced homeostasis or improved visualization of the surgical field are required, Articaine HCl and Epinephrine containing epinephrine 1:100,000 may be used. ( 2.1 ) • Maximum recommended dosages ( 2.2 ): - Healthy adults: 7 mg/kg of articaine HCl and 0.0017mg/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 0.0017mg/kg of epinephrine (equivalent to 0.175 mL/kg for either product presentation, articaine HCl and epinephrine 1:100,000 or 1:200,000) 2.1 Important Dosage Information Table 1 summarizes the recommended dosages of Articaine HCl and Epinephrine administered by intraoral submucosal …
Contraindications
4 CONTRAINDICATIONS Articaine HCl and Epinephrine 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 [ see Warnings and Precautions ( 5.5 )]. Known hypersensitivity to sulfite. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS The administration of local anesthetic solutions containing epinephrine to patients receiving monoamine oxidase inhibitors, nonselective beta-adrenergic antagonists or tricyclic antidepressants may produce severe, prolonged hypertension. Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential [see Warnings and Precautions ( 5.1 )]. Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Table 5. Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, ropivacaine, procaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroq…
Adverse Reactions
6 ADVERSE REACTIONS Reactions to articaine are characteristic of those associated with other amide-type local anesthetics. Adverse reactions to this group of drugs may also result from excessive plasma levels (which may be due to overdosage, unintentional intravascular injection, or slow metabolic degradation), injection technique, volume of injection, or hypersensitivity or they may be idiosyncratic. The most common adverse reactions (incidence >2%) are headache and pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pierrel S.p.A. at 610-989-4213 or FDA at 1-800-FDA-1088 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The reported adverse reactions are derived from clinical trials in the United States and the United Kingdom. Table 2 displays the adverse reactions reported in clinical trials where 882 individuals were exposed to Articaine HCl and Epinephrine containing epinephrin…
Frequently Asked Questions
What is Articaine Hydrochloride and Epinephrine used for?
Articaine hydrochloride and epinephrine is a local anesthetic injection used to numb tissues in the mouth during dental procedures. The epinephrine in the formulation helps constrict blood vessels to reduce bleeding and prolong the numbing effect.
Is Articaine Hydrochloride and Epinephrine a controlled substance?
Articaine Hydrochloride and Epinephrine is not classified as a controlled substance by the DEA.
What is the generic name for Articaine Hydrochloride and Epinephrine?
The generic name for Articaine Hydrochloride and Epinephrine is ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE. There are no other listed brand versions of ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE.
What is the NDC code for Articaine Hydrochloride and Epinephrine 40 mg/mL?
The NDC (National Drug Code) for Articaine Hydrochloride and Epinephrine 40 mg/mL is 43498-993, listed by Burkhart Dental Supply Co., Inc.
Other Articaine Hydrochloride and Epinephrine Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)