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Orabloc

Last reviewed on RxList: 11/26/2018
Orabloc Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 11/26/2018

Orabloc (articaine HCl and epinephrine) is a combination an amide local anesthetic and 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. Common side effects of Orabloc include:

  • headache,
  • pain,
  • facial swelling,
  • infection,
  • gum inflammation (gingivitis), and
  • numbness and tingling

The dose of Orabloc for dental procedures for infiltration is 0.5 mL-2.5 mL (20 mg-100 mg articaine HCl), for nerve block is 0.5 mL-3.4 mL (20 mg-136 mg articaine HCl), and for oral surgery is 1 ml-5.1 mL (40 mg-204 mg articaine HCl). Orabloc may interact with monoamine oxidase inhibitors (MAOIs), beta-blockers, tricyclic antidepressants, phenothiazines, abutyrophenones, nitrates/nitrites, other local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, acetaminophen, metoclopramide, quinine, and sulfasalazine. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Orabloc; it may harm a fetus. It is unknown if Orabloc passes into breast milk. When using Orabloc nursing mothers may choose to pump and discard breast milk for approximately 4 hours (based on plasma half-life) following an injection of Orabloc (to minimize infant ingestion) and then resume breastfeeding. Consult your doctor before breastfeeding.

Our Orabloc (articaine HCl and epinephrine) Injection, for Intraoral Submucosal Infiltration Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Orabloc Professional Information

SIDE EFFECTS

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.

Clinical 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

Postmarketing 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 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 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.

Read the entire FDA prescribing information for Orabloc (Articaine HCl and Epinephrine Injection)

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© Orabloc Patient Information is supplied by Cerner Multum, Inc. and Orabloc Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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