Articadent

Articadent (articaine HCl and epinephrine) is an amide local anesthetic containing a vasoconstrictor indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures. Common side effects of Articadent include:

• headache and
• pain

The dose of Articadent depends on the procedure being performed. For infiltration the dose of Articadent is 0.5-2.5 mL; for nerve block the dose of Articadent is 0.5-3.4 mL; and for oral surgery the dose of Articadent is 1.0-5.1 mL. Articadent may interact with monoamine oxidase inhibitors (MAOIs), beta-blockers, tricyclic antidepressants, phenothiazines, or butyrophenones. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Articadent; it may harm a fetus. Consult your doctor before breastfeeding.

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

 

Articadent Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling or puffiness of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

• weak or shallow breathing;
• a slow heart rate;
• a light-headed feeling, like you might pass out;
• blurred vision, ringing in your ears; or
• anxiety, confusion, restless feeling, or tremors.

Call your doctor or dentist at once if you have any swelling, pain, or heavy bleeding after your procedure.

Common side effects may include:

• tongue pain or swelling, red or swollen gums;
• mild swelling in your face;
• headache; or
• numbness and tingling.

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.

Read the entire detailed patient monograph for Articadent (Articaine HCl and Epinephrine Injection)

 

Articadent 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 Articadent containing epinephrine 1:100,000. Table 3 displays the adverse reactions reported in clinical trials where 182 individuals were exposed to Articadent containing epinephrine 1:100,000 and 179 individuals were exposed to Articadent 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 Articadent containing Epinephrine 1:100,000

Body System/Reaction	Articadent 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 Articadent containing Epinephrine 1:200,000 and Articadent containing Epinephrine 1:100,000

Reaction	Articadent with epinephrine 1:200,000 (N=179) Incidence	Articadent 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 Articadent

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 Articadent. 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 Articadent (Articaine HCl and Epinephrine Injection)