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.

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 Septodont at 1-800-872-8305 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 epinephrine 1:100,000.

Table 3 displays the adverse reactions reported in clinical trials where 182 individuals were exposed to Articaine HCl and Epinephrine containing epinephrine 1:100,000 and 179 individuals were exposed to Articaine HCl and Epinephrine containing epinephrine 1:200,000.

Adverse reactions observed in at least 1% of patients: Table 2: Adverse Reactions in Controlled Trials with an Incidence of 1% or Greater in Patients Administered Articaine HCl and Epinephrine containing Epinephrine 1:100,000 Body System/Reaction Articaine HCl and Epinephrine containing epinephrine 1:100,000 (N=882) Incidence Body as a whole Face Edema 13 (1%) Headache 31 (4%) Infection 10 (1%) Pain 114 (13%) Digestive system Gingivitis 13 (1%) Nervous system Paresthesia 11 (1%) Table 3: Adverse Reactions in Controlled Trials with an Incidence of 1% or Greater in Patients Administered Articaine HCl and Epinephrine containing Epinephrine 1:200,000 and Articaine HCl and Epinephrine containing Epinephrine 1:100,000 Reaction Articaine HCl and epinephrine 1:200,000 (N=179) Incidence Articaine HCl and epinephrine 1:100,000 (N=182) Incidence Any adverse reaction 33 (18%) 35 (19%) Pain 11 (6.1%) 14 (7.6%) Headache 9 (5%) 6 (3.2%) Positive blood aspiration into syringe 3 (1.6%) 6 (3.2%) Swelling 3 (1.6%) 5 (2.7%) Trismus 1 (0.5%) 3 (1.6%) Nausea and emesis 3 (1.6%) 0 (0%) Sleepiness 2 (1.1%) 1 (0.5%) Numbness and tingling 1 (0.5%) 2 (1%) Palpitation 0 (0%) 2 (1.%) Ear symptoms (earache, otitis media) 1 (0.5%) 2 (1%) Cough, persistent cough 0 (0%) 2 (1%) Adverse reactions observed in less than 1% of patients: Table 4: Adverse Reactions in Controlled Trials with an Incidence of Less than 1% but Considered Clinically Relevant in Patients Administered Articaine HCl and Epinephrine Body System Reactions Body as a Whole Asthenia; back pain; injection site pain; burning sensation above injection site; malaise; neck pain Cardiovascular System Hemorrhage; migraine; syncope; tachycardia; elevated blood pressure Digestive System Dyspepsia; glossitis; gum hemorrhage; mouth ulceration; nausea; stomatitis; tongue edemas; tooth disorder; vomiting Hemic and Lymphatic System Ecchymosis; lymphadenopathy Metabolic and Nutritional System Edema; thirst Musculoskeletal System Arthralgia; myalgia; osteomyelitis Nervous System Dizziness; dry mouth; facial paralysis; hyperesthesia; increased salivation; nervousness; neuropathy; paresthesia; somnolence; exacerbation of Kearns-Sayre Syndrome Respiratory System Pharyngitis; rhinitis; sinus pain; sinus congestion Skin and Appendages Pruritus; skin disorder Special Senses Ear pain; taste perversion 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of Articaine HCl and Epinephrine.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.

Persistent paresthesias of the lips, tongue, and oral tissues have been reported with use of articaine hydrochloride, with slow, incomplete, or no recovery.

These postmarketing events have been reported chiefly following nerve blocks in the mandible and have involved the trigeminal nerve and its branches.

Hypoesthesia has been reported with use of articaine, especially in pediatric age groups, which is usually reversible.

Prolonged numbness can result in soft tissue injuries such as that of the lips and tongue in these age groups.

Ischemic injury and necrosis have been described following use of articaine with epinephrine and have been postulated to be due to vascular spasm of terminal arterial branches.

Paralysis of ocular muscles has been reported, especially after posterior, superior alveolar injections of articaine during dental anesthesia.

Symptoms include diplopia, mydriasis, ptosis, and difficulty in abduction of the affected eye.

These symptoms have been described as developing immediately after injection of the anesthetic solution and persisting one minute to several hours, with generally complete recovery.