Ultacan

Last updated on RxList: 7/19/2017
Ultacan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/19/2017

Ultacan and Ultacan Forte (articaine HCl and epinephrine injection); Intra-oral Submucosal Injection are amide local anesthetics containing a vasoconstrictor indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures. Common side effects of Ultacan and Ultacan Forte include:

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.

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Ultacan Professional Information

SIDE EFFECTS

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%)
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 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 System Reactions
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 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.

Ischemic injury and necrosis have been described following use of articaine with epinephrine and have 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 Ultacan (Articaine HCl and Epinephrine for Injection)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow

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

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