Medical Editor: John P. Cunha, DO, FACOEP
- facial swelling,
- gum inflammation (gingivitis),
- numbness and tingling,
- heart palpitations,
- ear infection, or
Dosage of Ultacan and Ultacan Forte depends on the procedure being performed. Ultacan and Ultacan Forte may interact with monoamine oxidase inhibitors (MAOIs), nonselective beta-adrenergic antagonists, tricyclic antidepressants, phenothiazines, and butyrophenones. Tell your dentist or doctor all medications and supplements you use. Tell your dentist doctor if you are pregnant or plan to become pregnant before using Ultacan or Ultacan Forte; it may harm a fetus. It is unknown if Ultacan and Ultacan Forte pass into breast milk. When using Ultacan or Ultacan Forte, nursing mothers may choose to pump and discard breast milk for approximately 4 hours (based on plasma half life) following an injection (to minimize infant ingestion) and then resume breastfeeding. Consult your dentist or doctor before breastfeeding.
Our Ultacan and Ultacan Forte (Articaine HCl and Epinephrine Injection); Intra-oral Submucosal Injection 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.
Reactions to articaine are characteristic of those associated with other amide-type 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 in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The reported adverse reactions are derived from clinical trials in the United States and the United Kingdom. Table 2 displays the adverse reactions reported in clinical trials where 882 individuals were exposed to articaine HCl 4% with epinephrine 1:100,000. Table 3 displays the adverse reactions reported in clinical trials where 182 individuals were exposed to articaine HCl 4% with epinephrine 1:100,000 and 179 individuals were exposed to articaine HCl 4% with 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 HCl 4% with Epinephrine 1:100,000
|Body System/Reaction||Articaine HCl 4% with epinephrine 1:100,000 (N=882) Incidence|
|Body as a whole|
|Face Edema||13 (1%)|
Table 3: Adverse Reactions in Controlled Trials with an Incidence of 1% or Greater in Patients
Administered Articaine HCl 4% with Epinephrine 1:200,000 and Articaine HCl 4%
with Epinephrine 1:100,000
|Reaction||Articaine HCl 4% with epinephrine 1:200,000 (N=179) Incidence||Articaine HCl 4% with epinephrine 1:100,000 (N=182) Incidence|
|Any adverse reaction||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 (0.5%)||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 in Patients Administered Articaine HCl 4% with epinephrine
|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|
The following adverse reactions have been identified during postapproval use of articaine HCl 4% 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.
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 Ultacan (Articaine HCl and Epinephrine for Injection)
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