Orabloc® is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age and older (1).

For dental procedures by intraoral submucosal infiltration or nerve block (2.1):

• For infiltration: 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)

Injection provided in glass cartridges (single-dose) containing:

• Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:200,000 (as epinephrine bitartrate 0.009 mg/mL) (3)
• Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:100,000 (as epinephrine bitartrate 0.018 mg/mL) (3)

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Known hypersensitivity to sulfite (4)

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Accidental Intravascular Injection: May be associated with convulsions followed by coma and respiratory arrest. Resuscitative equipment, oxygen and other resuscitative drugs should be available. (5.1) 

Systemic Toxicity: Systemic absorption of ORABLOC can produce effects on the central nervous and cardiovascular systems. (5.2) 

Vasoconstrictor Toxicity: Local anesthetic solutions like ORABLOC that contain a vasoconstrictor should be used cautiously, especially in patients with impaired cardiovascular function or vascular disease. (5.3) 

Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. (5.4)

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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 www.fda.gov/medwatch. 

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Monoamine Oxidase Inhibitors, Nonselective Beta-adrenergic Antagonists, or Tricyclic Antidepressants: May produce severe, prolonged hypertension (7) 

Phenothiazines and butyrophenones: May reduce or reverse the pressor effect of epinephrine (7)

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Pregnancy: Based on animal studies, may cause fetal harm (8.1)

Nursing Mothers: Exercise caution when administering to a nursing woman (8.3)

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 4 years have not been

established (8.4)