Orabloc
- Generic Name: articaine hcl and epinephrine injection
- Brand Name: Orabloc
Orabloc (Articaine HCl and Epinephrine Injection) side effects drug center
- Related Drugs
- headache,
- pain,
- facial swelling,
- infection,
- gum inflammation (gingivitis), and
- numbness and tingling
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:
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.
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)