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

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

AVVISO

In ottemperanza a quanto previsto dalla normativa vigente, dichiaro sotto la mia responsabilità di essere un professionista del settore odontoiatrico (Odontoiatra, Odontotecnico, Igienista dentale, Assistente alla poltrona) e di essere pertanto autorizzato a prendere visione del contenuto di questo sito internet che riporta anche notizie relative a beni pericolosi per la salute e la sicurezza dei pazienti.