USA

Orabloc

Orabloc

Articaine hydrochloride 4% and epinephrine 1:200,000. Articaine hydrochloride 4% and epinephrine 1:100,000.

Dental Anesthetics based on Articaine

Suitable for infiltrative or conductive local anesthesia in simple and complex dental procedures…

Highlights of Prescribing Information

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)
 
For most routine dental procedures, ORABLOC containing epinephrine 1:200,000 is preferred. However, when more pronounced homeostasis or improved visualization of the surgical field are required, ORABLOC 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)
 
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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)

 

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Distributors

BURKHART DENTAL

BURKHART DENTAL

https://www.burkhartdental.com/

Benco

Benco

https://www.benco.com/

DARBY

DARBY

https://www.darbydental.com/

DC Dental

DC Dental

https://www.dcdental.com/

Henry Schein US

Henry Schein US

https://www.henryschein.com/us-en/dental/Default.aspx?did=dental

Midway Dental

Midway Dental

https://midwaydental.com/

Patterson Dental

Patterson Dental

https://www.pattersoncompanies.com/home/default.aspx

Safco

Safco

https://www.safcodental.com/

Orabloc is also sold by many other US and Canadian distributors, please check with your preferred distributor

Distributors

Patterson Dental Holdings, Inc.

Patterson Dental Holdings, Inc.

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SAFCO

SAFCO

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex.

Orabloc is also sold by many other US and Canadian distributors, please check with your preferred distributor.

NOTICE

In compliance with the provisions of current legislation, I declare under my responsibility to be a professional in the dental sector (Dentist, Dental technician, Dental hygienist, Chair Assistant) and therefore be entitled to read the content of this website which also contains information on goods dangerous to the health and safety of patients.