It is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, 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.
Local & Surface anesthesia
This is a sterile dental cartridge that contains Articaine hydrochloride and Epinephrine Bitartrate in an aqueous solution. Articaine is a local anesthetic of the amide type. Epinephrine, an adrenergic vasoconstrictor, is added to Articaine, reduces bleeding during surgery, slows down the passage of Articaine into the general circulation & thus ensures the prolonged maintenance of an active tissue concentration. The onset of anaesthesia after administration of Articaine hydrochloride 4% with Epinephrine 1:100,000 is about 3.5 minutes with a range of 1 to 6 minutes and the mean duration of anaesthesia is about 68 minutes with a range of 20 to 175 minutes. Peak plasma concentration is reached after 25 minutes of a single dose injection. Approximately 60-80% of Articaine hydrochloride is bound to human serum albumin & γ globulins. Elimination half-life of Articaine is about 1.8 hours. Articaine is excreted primarily through urine with 53-57% of the administered dose.
For dental procedures by intraoral submucosal infiltration or nerve block. - For infiltration: 0.5-2.5 mL (20-100 mg articaine HCl) - For nerve block: 0.5-3.4 mL (20-136 mg articaine HCl) - For oral surgery: 1.0-5.1 mL (40-204 mg articaine HCl) ? For most routine dental procedures, It containing epinephrine 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, It containing epinephrine 1:100,000 may be used. (2.1) ? Maximum recommended dosages (2.2): - Healthy adults: 7 mg/kg of articaine HCl and 0.0017mg/kg of epinephrine (equivalent to 0.175 mL/kg for either product presentation, articaine HCl and epinephrine 1:100,000 or 1:200,000) - Pediatric patients 4-16 years: 7 mg/kg of articaine HCl and 0.0017mg/kg of epinephrine (equivalent to 0.175 mL/kg for either product presentation, articaine HCl and epinephrine 1:100,000 or 1:200,000) --
The administration of local anesthetic solutions containing Epinephrine to patients receiving monoamine oxidase inhibitors 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 generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential.
Known hypersensitivity to sulfite. Accidental Intravascular Injection: May be associated with convulsions followed by coma and respiratory arrest. Resuscitative equipment, oxygen and other resuscitative drugs should be available. Systemic Toxicity: Systemic absorption of It can produce effects on the central nervous and cardiovascular systems. Vasoconstrictor Toxicity: Local anesthetic solutions like It that contain a vasoconstrictor should be used cautiously, especially in patients with impaired cardiovascular function or vascular disease. Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use.
Pregnancy: Based on animal studies, may cause fetal harm. Nursing Mothers: Exercise caution when administering to a nursing woman,It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lidocaine HCl is administered to a nurs- ing woman
Store below 25°C in a dry place, away from light. Keep out of the reach of children.
Each ml contains-
Articaine Hydrochloride BP 40 mg
Epinephrine Bitartrate USP equivalent to Epinephrine 10 mcg (1 in 100,000)
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