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

Each ml contains:

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

This preparation is a sterile dental cartridge containing Articaine Hydrochloride and Epinephrine Bitartrate in an aqueous solution. Articaine is an amide-type local anesthetic that blocks nerve conduction to produce loss of sensation. Epinephrine is a vasoconstrictor that reduces bleeding during procedures, delays systemic absorption of articaine, and prolongs its anesthetic effect. After administration of Articaine 4% with Epinephrine 1:100,000, the onset of anesthesia typically occurs within approximately 3.5 minutes (range: 1–6 minutes). The average duration of anesthesia is about 68 minutes (range: 20–175 minutes). Peak plasma concentration is reached about 25 minutes after a single injection. Around 60–80% of articaine binds to plasma proteins such as albumin and gamma globulins. The elimination half-life of articaine is approximately 1.8 hours, and it is primarily excreted in urine, with about 53–57% of the administered dose eliminated.

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.

Administration of local anesthetics containing epinephrine in patients taking monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants may result in severe and prolonged hypertension. Phenothiazines and butyrophenones may reduce or counteract the pressor effect of epinephrine. Therefore, concurrent use should generally be avoided. If co-administration is necessary, careful monitoring of the patient is essential.

This combination is contraindicated in patients with known hypersensitivity to amide-type local anesthetics or to sodium metabisulphite.

Reported adverse effects include abdominal pain, accidental injury, weakness, back pain, injection site pain, malaise, neck pain, bleeding, migraine, tachycardia, constipation, diarrhea, indigestion, glossitis, tongue swelling, dental disorders, vomiting, dizziness, dry mouth, increased salivation, nervousness, neuropathy, pharyngitis, rhinitis, itching, skin reactions, and menstrual pain.

There are no adequate and well-controlled studies in pregnant women. This medication should be used during pregnancy only if the potential benefit justifies the possible risk to the fetus. It is not known whether articaine is excreted in human breast milk; therefore, caution should be exercised when administered to nursing mothers.

Accidental intravascular injection may lead to convulsions, followed by depression of the central nervous system or cardiorespiratory system, coma, and may ultimately progress to respiratory arrest. Dental practitioners and clinicians using local anaesthetic agents should be adequately trained in the diagnosis and management of emergencies that may arise during their use. Resuscitation equipment, oxygen, and emergency medications must be readily available for immediate use.

The minimum effective dose required to achieve adequate anaesthesia should be used to avoid high plasma levels and serious adverse reactions. Repeated administration of Articaine HCl with Epinephrine may lead to a significant rise in blood concentrations due to possible accumulation of the drug or its metabolites. Patient tolerance to elevated blood levels varies depending on their clinical condition. Reduced doses should be considered for debilitated patients, elderly individuals, acutely ill patients, and paediatric patients, in accordance with their age and physical status. This product should also be used cautiously in patients with heart block.

Local anaesthetic solutions containing vasoconstrictors, such as those found in dental cartridges, should be used with caution. Patients with peripheral vascular disease or hypertensive vascular disease may exhibit an exaggerated vasoconstrictor response, which may result in ischemic injury or tissue necrosis. Caution is also advised when this product is used during or after administration of potent general anaesthetic agents, as cardiac arrhythmias may occur under such conditions.

Systemic absorption of local anaesthetics can affect both the central nervous system and the cardiovascular system. At therapeutic blood concentrations, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are generally minimal.

Local and surface anesthetic

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