Zorcaine

Name: Zorcaine

Zorcaine Overview

Zorcaine is a brand name medication included in the following groups of medications: Adrenergic and dopaminergic agents, Inhaled alpha and beta adrenoreceptor agonists, Local hemostatics, Other agents for local oral treatment, Sympathomimetics in glaucoma therapy, Sympathomimetics, plain, Amides. For more information about Zorcaine see its generics Articaine, Epinephrine

How is this medicine (Zorcaine) best taken?

Use Zorcaine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Your doctor will give this medicine.
  • It is given as a shot into the gums.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

How do I store and/or throw out Zorcaine?

  • If you need to store Zorcaine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Indications and Usage for Zorcaine

ZurcaineTM, an amide local anesthetic containing a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures.

Adverse Reactions

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 ZorcaineTM containing epinephrine 1:100,000. Table 3 displays the adverse reactions reported in clinical trials where 182 individuals were exposed to ZorcaineTM containing epinephrine 1:100,000 and 179 individuals were exposed to articaine hydrochloride 4% containing epinephrine 1:200,000. containing epinephrine 1:200,000.

Adverse reactions observed in at least 1% of patients.


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 Zorcaine containing Epinephrine 1:100,000
Body System/Reaction Zorcaine 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 hydrochloride 4% containing Epinephrine 1:200,000 and Zorcaine containing Epinephrine 1:100,000
Reaction articaine hydrochloride 4% with epinephrine 1:200,000
(N=179)
Incidence
Zorcaine 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 Zorcaine
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 ZorcaineTM. 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.

Overdosage

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution [see Warnings and Precautions (5.1, 5.2)].

The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered.

The first step in the management of convulsions, as well as hypo-ventilation, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation as needed. The adequacy of the circulation should be assessed. Should convulsions persist despite adequate respiratory support, treatment with appropriate anticonvulsant therapy is indicated. The practitioner should be familiar with the use of anticonvulsant drugs, prior to the use of local anesthetics. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor.

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias, and/or cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted.

For additional information about overdose treatment, call a poison control center (1-800-222-1222).

Clinical Studies

Three randomized, double-blind, active-controlled studies were designed to evaluate effectiveness of Zorcaine™ containing epinephrine 1:100,000 as a dental anesthetic. Patients ranging in age from 4 years to over 65 years old underwent simple dental procedures such as single uncomplicated extractions, routine operative procedures, single apical resections, and single crown procedures, or complex dental procedures such as multiple extractions, multiple crowns and/or bridge procedures, multiple apical resections, alveolectomies, muco-gingival operations, and other surgical procedures on the bone. Zorcaine™ containing epinephrine 1:100,000 was administered as submucosal infiltration and/or nerve block. Efficacy was measured immediately following the procedure by having the patient and investigator rate the patient’s procedural pain using a 10 cm visual analog scale (VAS), in which a score of zero represented no pain and a score of 10 represented the worst pain imaginable. Mean patient and investigator VAS pain scores were 0.3-0.4 cm for simple procedures and 0.5-0.6 cm for complex procedures.
Four randomized, double-blind, active-controlled studies were performed comparing Zorcaine™ containing epinephrine 1:100,000 versus articaine hydrochloride 4% containing epinephrine 1:200,000. The first two studies used electric pulp testers (EPT) to evaluate the success rate (maximum EPT value within 10 minutes), onset, and duration of Zorcaine™ containing epinephrine 1:100,000 versus articaine hydrochloride 4% containing epinephrine 1:200,000 and articaine solution without epinephrine in healthy adults between 18 and 65 years old. Results indicated that the anesthetic characteristics of the 1:100,000 and 1:200,000 formulations are not significantly different.
A third study compared the difference in visualization of the surgical field after administration of Zorcaine™ containing epinephrine 1:100,000 versus articaine hydrochloride 4% containing epinephrine 1:200,000 during bilateral maxillary periodontal surgeries in patients ranging from 21 to 65 years old. Zorcaine™ containing epinephrine 1:100,000 provided better visualization of the surgical field and less blood loss during the procedures. In a fourth study, designed to assess and compare cardiovascular safety, when the maximum dose of each formulation was administered, no clinically relevant differences in blood pressure or heart rate between formulations were observed.

References

Kaplan, EL, editor. Cardiovascular disease in dental practice. Dallas; American Heart Association; 1986.

Principal Display Panel - Carton

NDC 31382-830-50

Cook-Waite

ZorcaineTM (articaine HCl and epinephrine ) Injection

Articaine hydrochloride 4% and epinephrine 1:100,000

FOR INFILTRATION AND NERVE BLOCK ANESTHESIA

Rx only

50 Cartridges • 1.7 mL each

Warning: Contains sodium metabisulfite. See warnings section of insert for detailes.

See warnings section of insert for details

Marketed by Carestream Dental a division of Carestream Health, Inc.

Cook-Waite and Zorcaine are trademarks of Creamstream Health, Inc.

For more information, call 1-800-933-8031 (U.s / Canada)

Manufactured for CARESTREAM HEALTH INC by Novocol Pharmaceutical of Canada Inc.

Cambridge, Ontario, Canada N1R 6X3

Zorcaine 
articaine hydrochloride and epinephrine bitartrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:31382-830
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Articaine hydrochloride (Articaine) Articaine hydrochloride 40 mg  in 1 mL
Epinephrine Bitartrate (Epinephrine) Epinephrine Bitartrate 0.018 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium chloride 1.6 mg  in 1 mL
Sodium metabisulfite 0.5 mg  in 1 mL
Water  
Sodium hydroxide  
Packaging
# Item Code Package Description
1 NDC:31382-830-50 50 CARTRIDGE (CARTRIDGE) in 1 CARTON
1 1.7 mL in 1 CARTRIDGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020971 09/01/2011
Labeler - Carestream Health, Inc. (793169512)
Registrant - Novocol Pharmaceutical of Canada, Inc. (201719960)
Establishment
Name Address ID/FEI Operations
Novocol Pharmaceutical of Canada, Inc. 201719960 MANUFACTURE
Revised: 08/2011   Carestream Health, Inc.
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