Lidocaine Plus

Lidocaine Plus

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Product Description

Lidocaine Plus

DESCRIPTION

LIDOCAINE-PLUS® is a sterile, aqueous solution that contains a local anesthetic agent-Lidocaine Hydrochloride with epinephrine. Lidocaine is a local anesthetic of the amide type. It stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Lidocaine has a rapid onset of action and intermediate duration of action. The speed of onset and duration of action are increased by the addition of vasoconstrictor-epinephrine and absorption into circulation from the site of injection is reduced. The duration of action is approximately one and a half to two hours with epinephrine.

COMPOSITION

LIDOCAINE-PLUS® Injection: Each ml contains Lidocaine Hydrochloride BP 20 mg & Epinephrine Bitartrate BP 36 mcg eq. to Epinephrine  BP 20 mcg.

INDICATIONS

It is a local anesthetic for use in infiltration anesthesia and nerve blocks.

DOSAGE AND ADMINISTRATION

In estimating the safe dosage of this drug, it is important to take account of the rate at which it is absorbed and excreted as well as its potency. The patient’s age, weight, physique and clinical condition, the degree of vascularity of the area to which the drug is to be applied, and the duration of administration are other factors which must be taken into account. The dosage is adjusted according to the response of the patient and site of administration. The lowest concentration and smallest dose producing the required effect should be given.

For healthy adults, the individual maximum recommended dose should not exceed 7 mg/kg of body weight and in general it is recommended that the maximum total dose not exceed 500 mg. Children and elderly or debilitated patients require smaller doses, commensurate with age and physical condition.

The following doses have been recommended for individual local anesthetic procedure.

The dosage of Lidocaine Plus depends on the physical status of the patient, the area of the oral cavity to be anesthetized, the vascularity of the oral tissues, and the technique of anesthesia used. The least volume of solution that results in effective local anesthesia should be administered; time should be allowed between injections to observe the patient for manifestations of an adverse reaction. For specific techniques and procedures of a local anesthesia in the oral cavity, refer to standard textbooks. For most routine dental procedures, Lidocaine Plus is preferred. However, when greater depth and a more pronounced hemostasis are required, Lidocaine Plus should be used.

Dosage requirements should be determined on an individual basis. In oral infiltration and / or mandibular block, initial dosages of 1.0 – 5.0 ml Lidocaine Plus are usually effective.

In children under 10 years of age, it is rarely necessary to administer more than one-half cartridge (0.9-1.0 ml or 18-20 mg of lidocaine) per procedure to achieve local anesthesia for a procedure involving a single tooth. In maxillary infiltration, this amount will often suffice to the treatment of two or even three teeth. In the mandibular block, however, satisfactory anesthesia achieved with this amount of drug, will allow treatment of the teeth of an entire quadrant. Aspiration is recommended since it reduces the possibility of intravascular injection, thereby keeping the incidence of side effects and anesthetic failures to a minimum. Moreover, injection should always be made slowly.

Maximum recommended dosages for Lidocaine Plus:

Adult

For normal healthy adults, the amount of Lidocaine Hydrochloride administered should be kept below 500 mg, and in any case, should not exceed 7 mg/kg (3.2 mg/lb) of body weight.

Pediatric

Pediatric patients : It is difficult to recommend a maximum dose of any drug for pediatric patients since this varies as a function of age and weight. For pediatric patients of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark’s rule). For example, in pediatric patients of five years weighing 50 Ibs, the dose of Lidocaine Hydrochloride should not exceed 75-100 mg when calculated according to Clark’s rule. In any case, the maximum dose of Lidocaine Hydrochloride should not exceed 7 mg/kg (3.2 mg/lb) of body weight.

CONTRAINDICATION

Known hypersensitivity to anesthetics of the amide type. It should not be injected into tissues supplied by end arteries, for example, fingers and toes, ears, the nose, and the penis. The intense vasoconstriction produced by adrenaline may result in gangrene. For the same reason, it should be avoided if  solutions  injected  intracutaneously.  Since adrenaline is also absorbed into the circulation, its use should  be  avoided  in  those  for  whom  adrenergic stimulation is undesirable.

DRUG INTERACTIONS

It exhibits interaction with monoamine oxidase inhibitors, tricyclic antidepressants, phenothiazines, butyrophenones, vasopressor  drugs (for  the  treatment  of  hypotension related to obstetric blocks) and ergot-type oxytocic drugs.

SIDE EFFECTS/ADVERSE REACTIONS

In common with other local anesthetics, adverse reactions are rare and are usually the result of excessively high blood concentrations due to inadvertent intravascular injection,   excessive   dosage, rapid   absorption   or occasionally to hypersensitivity, idiosyncracy or diminished tolerance on the part of the patient. In such circumstances systemic effects occur involving the CNS and/or the cardiovascular system. CNS reactions are excitatory and/or depressant, and may be characterized by nervousness, dizziness,  blurred  vision  and  tremors,  followed  by drowsiness, convulsions, unconsciousness and possibly respiratory arrest.  The excitatory reactions may be very brief or may not occur at all, in which case the first manifestations of toxicity may be drowsiness, merging into unconsciousness and respiratory arrest. Cardiovascular reactions   are   hypotension,   myocardial   depression, bradycardia and possibly cardiac arrest. Allergic reactions are  extremely  rare. They may  be  characterized  by cutaneous lesions, urticaria, oedema or anaphylactoid reactions.

PRECAUTIONS

LIDOCAINE-PLUS® for infiltration and nerve block should be employed only by clinicians who are well versed in diagnosis and management of dose-related toxicity.  The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies.  Standard text books should be  consulted for specific techniques and precautions for various regional anesthetic procedures. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use. It should be used cautiously in patients with epilepsy, impaired cardiac conduction, impaired respiratory function and in patients with impaired hepatic function, if the dose or site of administration is likely to result in high blood levels. The lowest dosage  that  results  in  effective  anesthesia should be used to avoid high plasma levels and serious adverse effects. The effect of local anesthetics may be reduced if an injection is made into an inflamed or infected area. It should be used with caution in patients with hypertension, cardiac  disease,  cerebrovascular insufficiency, thyrotoxicosis, in patients taking tricyclic antidepressants, MAOI’s or receiving potent general anesthetic agents.  Careful and constant monitoring of cardiovascular  and  respiratory  vital  signs  and  the patient’s state of consciousness should be accomplished after each local anesthetic injection.

USE IN PREGNANCY AND LACTATION

Although there is no evidence from animal studies of harm to the foetus, as with all drugs, it should not be given during early pregnancy unless the benefits are considered to outweigh the risks.

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 it is administered to a nursing woman.

 STORAGE

Store below 25oC. Protect from light. Retain in original carton until time of use.

Keep out of reach of children.

PHARMACEUTICAL PRECAUTIONS

Do not autoclave.

The Injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

PACKAGING

LIDOCAINE-PLUS® Injection : Each box contains one 50 ml vial for multiple use.

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