Articaine Hydrochloride And Epinephrine Bitartrate (Articadent)

Trade Name : Articadent

Dentsply Pharmaceutical

INJECTION, SOLUTION

Strength 40.01 mg/mLmg/mL

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Articaine Hydrochloride And Epinephrine Bitartrate (Articadent) which is also known as Articadent and Manufactured by Dentsply Pharmaceutical. It is available in strength of 40; .01 mg/mL; mg/mL per ml. Read more

Articaine Hydrochloride And Epinephrine Bitartrate (Articadent) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

WARNINGS AND PRECAUTIONS, Methemoglobinemia ()

ARTICADENT is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.
ARTICADENT is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.

No data

For dental procedures by intraoral submucosal infiltration or nerve block. ()n
For most routine dental procedures, ARTICADENT containing epinephrine 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, ARTICADENT containing epinephrine 1:100,000 may be used. ()
Maximum recommended dosages ():n

Injection (clear, colorless solution), provided in:
Injection provided in:

Glass cartridges (single-dose) containing:n

ARTICADENT is contraindicated in patients who are hypersensitive to products containing sulfites. Products containing sulfites may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people n
Known hypersensitivity to sulfite. ()

Accidental Intravascular Injection
Systemic Toxicity
Vasoconstrictor Toxicity
Methemoglobinemia

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.
The most common adverse reactions (incidence >2%) are headache and pain. () To report SUSPECTED ADVERSE REACTIONS, contact DENTSPLY Pharmaceutical at 1-800-989-8826 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The administration of local anesthetic solutions containing epinephrine to patients receiving monoamine oxidase inhibitors, nonselective beta-adrenergic antagonists, or tricyclic antidepressants may produce severe, prolonged hypertension. Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine. Concurrent use of these agents should be avoided; however, in situations when concurrent therapy is necessary, careful patient monitoring is essential n
Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics:
Monoamine Oxidase Inhibitors, Nonselective Beta-Adrenergic Antagonists, or Tricyclic Antidepressants
Phenothiazines and Butyrophenones

Pregnancy
Nursing Mothers
Pediatric Use

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 n
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).

ARTICADENT (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 1:100,000 strength.
Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula:
Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH 7.35) of 17 and a pKa of 7.8.
Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula:
ARTICADENT contains the following inactive ingredients: sodium chloride (1.6 mg/mL), and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide.

No data

Studies to evaluate the carcinogenic potential of articaine HCl in animals have not been conducted. Five standard mutagenicity tests, including three tests (the nonmammalian Ames test, the mammalian Chinese hamster ovary chromosomal aberration test, and a mammalian gene mutation test with articaine HCl) and two mouse micronucleus tests (one with articaine and epinephrine 1:100,000 and one with articaine HCl alone) showed no mutagenic effects.
No effects on male or female fertility were observed in rats for articaine and epinephrine 1:100,000 administered subcutaneously in doses up to 80 mg/kg/day (approximately 2 times the MRHD based on body surface area).

Three randomized, double-blind, active-controlled studies were designed to evaluate effectiveness of ARTICADENT 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, mucogingival operations, and other surgical procedures on the bone. ARTICADENT containing epinephrine 1:100,000 was administered by intraoral submucosal infiltration and/or nerve block for these dental procedures.
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 ARTICADENT containing epinephrine 1:100,000 versus ARTICADENT 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 ARTICADENT containing epinephrine 1:100,000 versus ARTICADENT 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 ARTICADENT containing epinephrine 1:100,000 versus ARTICADENT containing epinephrine 1:200,000 during bilateral maxillary periodontal surgeries in patients ranging from 21 to 65 years old. ARTICADENT 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.

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

ARTICADENT (articaine hydrochloride and epinephrine) injection is a clear, colorless solution available in 1.7 mL single-dose glass cartridges, packaged in boxes of 50 cartridges in the following two strengths (less than a full cartridge or more than one cartridge may be used for an individual patient):
Storage and Handling
Store at controlled room temperature 25u00b0C (77u00b0F) with brief excursions permitted between 15u00b0 and 30u00b0C (59u00b0F-86u00b0F) Protect from light. Do Not Freeze.

No data

Manufactured for Dentsply PharmaceuticalYork, PA 17404By Novocol Pharmaceutical of Canada, Inc.Cambridge, Ontario, Canada N1R 6X3Rev 07/2019 (2639-7)

DentsplySirona
NDC 66312-601-16Reorder #: 51116
Articadent DENTAL(articaine HCl and epinephrine) Injection
Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:100,000
Intraoral Submucosal InjectionContains sodium metabisulfite50 Single-Dose Cartridges, 1.7 mL each
Sterile aqueous Solution for InjectionRx only

DentsplySirona
NDC 66312-602-16Reorder #: 52216
Articadent DENTAL(articaine HCl and epinephrine) Injection
Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:200,000
Intraoral Submucosal InjectionContains sodium metabisulfite50 Single-Dose Cartridges, 1.7 mL each
Sterile aqueous solution for InjectionRx only

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Articaine Hydrochloride And Epinephrine Bitartrate (Articadent)

Trade Name : Articadent

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Articaine Hydrochloride And Epinephrine Bitartrate (Articadent)

Trade Name : Articadent

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Disclaimer

Browse from other international pharmaceuticals

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Canadian DIN

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