Z-Lidocain Plus2%+0.00125%

Z-Lidocain Plus is indicated for the production of local or regional anesthesia by infiltration and peripheral nerve block techniques. Established, guideline-supported and approved uses include:

• Dental anesthesia: Infiltration anesthesia and all standard dental nerve block techniques prior to restorative, extraction, and minor oral surgical procedures. This is the most common and best-established use.
• Minor surgical and dermatologic procedures: Local infiltration anesthesia for excisions, wound repair/suturing, and other minor surgical procedures where a longer duration of anesthesia and reduced local bleeding are desirable.
• Diagnostic and therapeutic procedures: Local or regional anesthesia for selected diagnostic and minor therapeutic procedures, as directed by a physician or dentist.
• Peripheral nerve blocks: Used by trained clinicians for regional nerve block anesthesia outside the head and neck when a vasoconstrictor is not contraindicated by the injection site.

Z-Lidocain Plus is not intended for spinal anesthesia, intravenous regional anesthesia (Bier block), or for anesthesia of areas supplied by end-arterial circulation (see Contraindications). It should only be administered by, or under the supervision of, a qualified physician or dentist experienced in the technique and in the management of anesthetic emergencies.

Lidocaine + Epinephrine injection is available in various fixed-dose combinations. Typical strengths include:

• Lidocaine Hydrochloride 1% or 2% (10 mg/mL or 20 mg/mL) with Epinephrine 1:100,000 or 1:200,000 (as Epinephrine Bitartrate or Epinephrine Hydrochloride)

Each mL of a common presentation contains Lidocaine Hydrochloride 20 mg and Epinephrine 5 micrograms (1:200,000), supplied as a sterile injectable solution in single-use ampoules, vials, or dental cartridges. The exact strength and pack size should be confirmed on the product label, as multiple concentrations of Lidocaine + Epinephrine are marketed.

Z-Lidocain Plus is a fixed-dose injectable combination of an amide-type local anesthetic (lidocaine) and a vasoconstrictor sympathomimetic amine (epinephrine/adrenaline). Lidocaine provides the local anesthetic effect by blocking nerve conduction, while epinephrine constricts blood vessels at the injection site, which slows systemic absorption of lidocaine, prolongs the duration of anesthesia, and reduces local bleeding — making the combination particularly useful for dental and minor surgical procedures.

Z-Lidocain Plus is administered only by injection (infiltration or nerve block) by trained healthcare professionals; it is not for oral, intravenous, or topical use.

Local anesthetic (amide-type), combined with a vasoconstrictor (sympathomimetic amine) — Z-Lidocain Plus belongs to the pharmacological class of injectable local anesthetics with adrenergic vasoconstrictor.

Lidocaine + Epinephrine combines two agents with complementary actions:

• Lidocaine is an amide-type local anesthetic. It stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses, chiefly by blocking voltage-gated sodium channels. This produces reversible loss of sensation (and, at higher concentrations, motor function) in the area supplied by the anesthetized nerve(s).
• Epinephrine is a direct-acting sympathomimetic that acts predominantly on alpha-adrenergic receptors in the vasculature at the injection site, producing local vasoconstriction. This reduces the rate of systemic vascular absorption of lidocaine, which prolongs the duration of anesthesia (typically to approximately 1.5–2 hours, compared with a shorter duration for lidocaine alone) and reduces local bleeding, improving the surgical/dental field.

Onset of anesthesia with Lidocaine + Epinephrine is typically rapid (within a few minutes of infiltration), reflecting lidocaine's intermediate onset profile among amide local anesthetics.

Z-Lidocain Plus is intended for injection only (local infiltration or peripheral nerve block) by, or under the direct supervision of, a physician or dentist experienced in regional anesthesia techniques and trained to manage anesthetic emergencies. It must not be given intravenously.

• Use aseptic technique; inspect the solution visually — do not use if discolored or if it contains particulate matter.
• Aspirate before and periodically during injection to check for inadvertent entry into a blood vessel.
• Inject slowly, using the smallest volume and lowest effective concentration.
• Have resuscitation equipment, oxygen, and emergency drugs readily available whenever Z-Lidocain Plus is administered.
• Do not inject into inflamed or infected tissue, or into areas with compromised blood supply (see Contraindications).

Clinically significant interactions with Z-Lidocain Plus include:

• Non-selective beta-blockers (e.g., propranolol): Can lead to unopposed alpha-adrenergic stimulation from the epinephrine component, causing severe and potentially serious hypertension and reflex bradycardia.
• Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants: May potentiate the pressor (blood pressure-raising) response to epinephrine, increasing the risk of severe, prolonged hypertension.
• Ergot-type oxytocic drugs: Concurrent use with epinephrine-containing anesthetics may cause severe, persistent hypertension and risk of stroke.
• Other local anesthetics or agents structurally related to amide-type local anesthetics: The toxic effects of lidocaine may be additive if given concurrently with other local anesthetics.
• Class I antiarrhythmic drugs (e.g., tocainide, mexiletine): Additive cardiac depressant/toxic effects with lidocaine; use with caution.
• Halogenated inhalational anesthetics (e.g., halothane): May sensitize the myocardium to the arrhythmogenic effects of epinephrine.
• CYP3A4/CYP1A2 inhibitors (e.g., certain antifungals, macrolides): May reduce lidocaine metabolism and increase systemic lidocaine levels/toxicity risk.

Adverse effects of Z-Lidocain Plus are usually related to excessive plasma concentration (from overdose, rapid absorption, or accidental intravascular injection) or to the epinephrine component's systemic effects. Serious reactions are uncommon when the drug is administered correctly.

Central nervous system

Lightheadedness, nervousness, apprehension, confusion, dizziness, drowsiness, blurred or double vision, tinnitus, sensations of heat/cold/numbness, tremors, and, with significant overdose, seizures and respiratory depression/arrest.

Cardiovascular

Palpitations, tachycardia, and transient hypertension may occur from the epinephrine component, particularly with inadvertent intravascular injection; conversely, high systemic lidocaine levels can cause bradycardia, hypotension, and cardiovascular collapse.

Allergic/hypersensitivity

Rare allergic reactions can present as urticaria, angioedema, or, rarely, anaphylaxis; these are more often related to preservatives (e.g., sulfites, methylparaben) than to the anesthetic itself.

Other

Injection-site pain, bruising, or transient numbness; rarely, methemoglobinemia (more common with high doses or in susceptible individuals) and prolonged nerve block-related paresthesia.

Pregnancy: Z-Lidocain Plus should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Available human data on lidocaine have not shown an increased risk of major birth defects, but animal studies with high, repeated doses of the combination have shown adverse fetal effects. Z-Lidocain Plus should be used with particular caution in obstetric paracervical block anesthesia, and only under the direction of a physician familiar with its use in this setting. Always consult a physician before use in pregnancy.

Lactation: Lidocaine passes into breast milk in small amounts, with limited oral absorption in the infant; epinephrine is rapidly metabolized and unlikely to reach the infant in clinically significant amounts through milk. However, breastfeeding mothers should use Z-Lidocain Plus only when clearly needed and consult a physician, weighing the benefit of the procedure against any theoretical risk to the nursing infant.

Z-Lidocain Plus should be administered only by clinicians familiar with the diagnosis and management of dose-related toxicity and other acute emergencies that may arise from its use, and resuscitative equipment, oxygen, and emergency drugs should always be immediately available.

• Cardiovascular disease: Use with caution in patients with significant heart disease, arrhythmias, hypertension, or hyperthyroidism, as the epinephrine component may cause tachycardia and elevated blood pressure, particularly with accidental intravascular injection.
• Concurrent non-selective beta-blockers: May result in unopposed alpha-adrenergic effects from epinephrine and severe hypertension (see Interactions).
• Accidental intravascular injection: Can produce systemic toxicity, including central nervous system excitation/depression and cardiac arrhythmia. Aspiration before and during injection, and use of the smallest effective dose given in incremental fractions, reduces this risk.
• Hepatic impairment: Patients with severe liver disease are at greater risk of developing toxic plasma concentrations of lidocaine, since it is metabolized in the liver; dose reduction and careful monitoring are advised.
• Injection site: Do not inject into infected or inflamed tissue, or into anatomic sites with end-arterial circulation (see Contraindications).
• Sulfite sensitivity: Some formulations contain sodium metabisulfite, which can cause allergic-type reactions, including anaphylaxis, in susceptible individuals (particularly those with asthma).
• Repeated doses: May cause significant increases in blood lidocaine levels with each repeated dose due to slow accumulation; monitor cumulative dose carefully during prolonged or repeated procedures.

Overdose or accidental intravascular injection of Z-Lidocain Plus can cause systemic toxicity affecting the central nervous system and cardiovascular system, including agitation, confusion, tremors, seizures, respiratory depression or arrest, bradycardia, hypotension, and cardiac arrhythmia or collapse. Excessive epinephrine effect may additionally cause severe headache, marked hypertension, and palpitations.

Suspected overdose or signs of systemic toxicity following administration of Z-Lidocain Plus constitute a medical emergency. Seek immediate medical attention or contact emergency services; management requires prompt supportive care (airway management, oxygen, seizure control, and cardiovascular support) in a facility equipped for resuscitation. Do not attempt to manage a suspected overdose at home.

Store at room temperature (below 30°C), protected from light. Do not freeze. Keep out of reach of children. Discard any unused portion after opening; do not use if the solution is discolored or contains particulate matter.

Pediatric patients: Z-Lidocain Plus may be used in children for appropriate dental and minor surgical procedures, with doses reduced and calculated according to age, body weight, and physical condition. See Pediatric Uses for further detail.

Elderly and debilitated patients: Require reduced doses due to age-related decline in hepatic function and cardiovascular reserve; the lowest effective dose should be used and patients monitored closely.

Hepatic impairment: Patients with severe liver disease are at increased risk of developing toxic plasma lidocaine concentrations because lidocaine is hepatically metabolized; use with caution and reduced dosing (see Precautions and Warnings).

Renal impairment: No specific dose adjustment is established for renal impairment alone, but caution is advised, as active metabolites may accumulate in severe renal failure.

Cardiovascular disease: Use cautiously; see Precautions and Warnings.

Z-Lidocain Plus is intended for single-procedure, short-term use only — it is not a chronic or maintenance therapy. A single administration typically provides local anesthesia for approximately 1.5–2 hours, depending on the site, dose, and individual response. Repeat dosing during a prolonged procedure should be limited to the minimum necessary and must remain within the maximum recommended cumulative dose; it should only be directed by the treating physician or dentist.

Local anesthetics, amide-type; Vasoconstrictors (sympathomimetic amines/adrenergic agonists)

Lidocaine + Epinephrine works through two complementary mechanisms: lidocaine blocks voltage-gated sodium channels in neuronal membranes, preventing the generation and propagation of nerve impulses and producing reversible local anesthesia; epinephrine acts on alpha-adrenergic receptors to constrict blood vessels at the injection site, which limits systemic absorption of lidocaine, prolongs its local anesthetic effect, and reduces bleeding in the anesthetized field.

Z-Lidocain Plus can be used in pediatric patients for dental and minor surgical local/regional anesthesia, but doses must be carefully individualized and reduced according to the child's age, body weight, and physical condition — the maximum adult dose limits do not apply directly to children. Safety and efficacy in neonates and very young infants have not been well established, and Z-Lidocain Plus should be used with particular caution and only under close medical/dental supervision in this age group. As with adults, injection into digits, the nose, ears, or other end-arterial sites is contraindicated in children.