Articaine Hydrochloride + Epinephrine Bitartrate

This combination is indicated for local, infiltrative or conductive anesthesia in both simple and complex dental and periodontal procedures.

Each ml contains-

• Articaine Hydrochloride BP 40 mg
• Epinephrine Bitartrate USP equivalent to Epinephrine 10 mcg (1 in 100,000)

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.

The recommended dose for normal healthy adults, administered by submucosal infiltration and/or nerve block are given below-

Infiltration: 0.5 mL to 2.5 mL or 20 mg to 100 mg of articaine
Nerve block: 0.5 mL to 3.4 mL or 20 mg to 136 mg of articaine
Oral surgery: 1.0 mL to 5.1 mL or 40 mg to 204 mg of articaine

The above suggested volumes serve only as a guide. Other volumes may be used provided the total maximum recommended dose is not exceeded.

For normal healthy adult, the maximum recommended dose of Articaine hydrochloride administered by submucosal infiltration and/or nerve block should not exceed 7 mg/kg. For the children more than 4 years dose of Articaine hydrochloride should not exceed 7 mg/kg (0.175 mL/kg) body weight. The dose should be determined by the age and weight of the child and the magnitude of the operation.

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.

This is contraindicated with known history of hypersensitivity to local anesthetics of the amide type, or in patients with known hypersensitivity to sodium metabisulphite.

The following adverse events of the product have been reported in some patients:- Abdominal pain, accidental injury, asthenia, back pain, injection site pain, malaise, neck pain, haemorrhage, migraine, tachycardia, constipation, diarrhoea, dyspepsia, glossitis, tongue edemas, tooth disorder, vomiting, dizziness, dry mouth, increased salivation, nervousness, neuropathy, pharyngitis, rhinitis, pruritus, skin disorder, dysmenorrhoea.

There are no adequate and well controlled studies in pregnant women. This product should be used during
pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Articaine is excreted in human milk, caution should be exercised when this product is administered to a nursing mother.

Accidental intravascular injection may be associated with convulsions, followed by central nervous system or
cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Dental practitioners and/or
clinicians who employ local anaesthetic agents should be well versed in diagnosis and management of emergencies that may arise from their use. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use.

The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated dose of Articaine HCl and Epinephrine may cause significant increase in blood levels with each repeated dose because of possible accumulation of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient. Debilitated patients, elderly patients, acutely ill patients and pediatric patients should be given reduced doses commensurate their age & physical condition. This product should also be used with caution in patients with heart block.

Local anesthetic solutions, such as this dental cartridge contains a vasoconstrictor should be used cautiously. Patients with peripheral vascular disease and those with hypertensive vascular disease may exhibit exaggerated
vasoconstrictor response. Ischemic injury or necrosis may result. This product should be used with caution in patients during or following the administration of potent general anaesthetic agents, since cardiac arrhythmias may occur under such conditions.

Systemic absorption of local anesthetics can produce effects on the central nervous and cardiovascular systems. At blood concentrations achieved with therapeutic doses, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal.

Local & Surface anesthesia

Store below 25°C in a dry place, away from light. Keep out of the reach of children.