FDA

Orabloc

Approved 26 Feb 2010InjectionInjectable

The FDA lists this product in 2 strengths and forms.

Indications

ORABLOC is 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. 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 ).

Contraindications

ORABLOC 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 )

Warnings and precautions

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 )

5.1Accidental Intravascular Injection

Accidental intravascular injection of ORABLOC may be associated with convulsions, followed by central nervous system or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Dental practitioners who employ local anesthetic agents including ORABLOC should be well versed in diagnosis and management of emergencies that may arise from their use. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use.

To avoid intravascular injection, aspiration should be performed before ORABLOC is injected. The needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not guarantee that intravascular injection has been avoided. Small doses of local anesthetics injected in dental blocks may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses.

At a glance

Brand name: Orabloc
Active substance: articaine hydrochloride
Route: Injection
Dosage form: Injectable
Applicant: Pierrel
Status: Prescription
FDA approval: 26 Feb 2010
Application: NDA022466-002

Indications

Contraindications

Warnings and precautions

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

5.1Accidental Intravascular Injection

Adverse reactions

Reactions to articaine are characteristic of those associated with other amide 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 www.fda.gov/medwatch.

6.1Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice. The reported adverse events are derived from clinical trials in the United States and the United Kingdom with a similar product containing articaine and epinephrine. Table 2 displays the adverse events reported in clinical trials where 882 individuals were exposed to articaine containing epinephrine 1:100,000.

Table 3 displays the adverse events reported in clinical trials where 182 individuals were exposed to articaine containing epinephrine 1:100,000 and 179 individuals were exposed to articaine 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 containing epinephrine 1:100,000 Body System/Reaction articaine 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 containing epinephrine 1:200,000 and articaine containing epinephrine 1:100,000 Reaction articaine with epinephrine 1:200,000 (N=179) Incidence articaine with epinephrine 1:100,000 (N=182) Incidence Any adverse event 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 (0.3%) 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 Body System Events 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

6.2Postmarketing Experience

The following adverse reactions have been identified during post-approval use of articaine hydrochloride with 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 causal 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 has been described following use of articaine with epinephrine and has 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.

Orabloc

Indications

Contraindications

Warnings and precautions

5.1Accidental Intravascular Injection

At a glance

Two medicines in one question?

Orabloc

Indications

Contraindications

Warnings and precautions

5.1Accidental Intravascular Injection

At a glance

Two medicines in one question?

5.2Systemic Toxicity

5.3Vasoconstrictor Toxicity

5.4Methemoglobinemia Cases

5.5Anaphylaxis and Allergic-Type Reactions

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Teratogenic Effects-Pregnancy Category C.

Adverse reactions

6.1Clinical Studies Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information