This combination is indicated for use in dental infiltration anesthesia and various dental nerve block techniques.

Each mL contains:

• Lidocaine Hydrochloride USP (equivalent to anhydrous 20 mg)
• Epinephrine 12.5 mcg (as Epinephrine Bitartrate USP)

This is a sterile, non-pyrogenic aqueous solution containing lidocaine hydrochloride along with epinephrine. Lidocaine is an amide-type local anesthetic that stabilizes neuronal membranes by blocking ionic movement necessary for the initiation and conduction of nerve impulses, thereby producing local anesthesia. It has a rapid onset and an intermediate duration of action. The addition of epinephrine, a vasoconstrictor, enhances the onset and prolongs the duration of action by reducing blood flow at the injection site and slowing systemic absorption. The anesthetic effect typically lasts about 1.5 to 2 hours when used with epinephrine.

Infiltration: The usual dose is 1 mL.

Nerve block: The usual dose is 1.5 to 2.0 mL.

The maximum recommended dose for Lidocaine Hydrochloride when given with Epinephrine is 500 mg. Children and elderly or debilitated patients require smaller doses.

This combination may interact with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, phenothiazines, butyrophenones, vasopressor agents used for hypotension, and ergot-type drugs, potentially altering cardiovascular responses.

This product is contraindicated in patients with known hypersensitivity to amide-type local anesthetics. The use of vasoconstrictors is contraindicated for anesthesia in areas supplied by end arteries such as fingers, toes, the tip of the nose, ears, and penis due to the risk of tissue ischemia. It should not be administered intravenously.

Similar to other local anaesthetics, adverse reactions to this combination are very rare in dental practice. When they occur, they are usually due to significantly elevated blood levels caused by accidental intravascular injection, excessive dosage, rapid absorption, or, in some cases, hypersensitivity, idiosyncratic reactions, or reduced patient tolerance. In such situations, systemic effects may involve the central nervous system and/or the cardiovascular system. Central nervous system (CNS) effects may be either stimulatory or depressant. Early symptoms may include nervousness, dizziness, blurred vision, and tremors, which can progress to drowsiness, seizures, loss of consciousness, and possibly respiratory arrest. In some instances, the initial excitatory phase may be brief or absent, with drowsiness appearing as the first sign, progressing directly to unconsciousness and respiratory arrest.

Cardiovascular effects are generally depressant and may present as hypotension, myocardial depression, bradycardia, and in severe cases, cardiac arrest. Allergic reactions are extremely rare but may present as skin lesions, urticaria, oedema, or anaphylactic reactions. Skin testing for sensitivity is of limited reliability.

Although animal studies have not shown fetal harm, this drug should be used during early pregnancy only if the potential benefits outweigh the risks. It is not known whether this drug is excreted in human milk; therefore, caution is advised when used in breastfeeding women.

Use cautiously in patients with epilepsy, cardiac conduction disorders, respiratory impairment, or hepatic dysfunction, especially when high blood levels may occur. Resuscitation facilities should always be available during administration.

The effectiveness of local anesthetics may be reduced when injected into inflamed or infected tissues.Solutions containing epinephrine should be used cautiously in patients with hypertension, cardiac disease, cerebrovascular disorders, or thyrotoxicosis.

The inclusion of epinephrine helps prolong anesthesia and reduce systemic absorption, which is particularly beneficial in highly vascular areas.

Local and surface anesthetic

Store below 30°C in a dry place, protected from light. Keep out of reach of children.