Chalocaine Viscous Solution is a clear colorless to slightly yellow viscous liquid with odor of cherries.
Each mL contains Lidocaine Hydrochloride 20 mg.
Excipients/Inactive Ingredients: Carboxymethylcellulose sodium, Methylparaben, Propylparaben, Saccharin sodium, Cherry flavor, Propylene glycol, Sodium hydroxide, Purified water.
Pharmacology: Pharmacodynamics: Chalocaine Viscous Solution contains Lidocaine, the amide type local anaesthetics. Lidocaine blocks conduction of the impulse through nerve fiber by decreasing the cell membrane permeability to sodium ions, thereby effecting local anesthetic action. Surface or topical anaesthetics blocks the sensory nerve endings in the skin or mucous membrane.
Lidocaine has a rapid onset with an intermediate duration of action. Onset and the duration of the local anesthetic effect of lidocaine depend on the dose and the site of administration.
Pharmacokinetics: Absorption: Following topical administration Lidocaine is absorbed from mucous membrane and through damaged skin. The plasma concentration of Lidocaine depends upon the dose, the route of administration and the site of administration.
Serum Lidocaine concentrations were usually so low as to be unmeasurable in patients who gargled and expectorated 15 mL (300 mg) of a 2% viscous solution before endoscopy.
Distribution: Lidocaine is bound to plasma proteins (mainly to alpha1-acid glycoprotein) the extent of binding is about 60-80%. The plasma binding of Lidocaine is dependent on drug concentration.
Lidocaine crosses the placenta and blood-brain barrier also is distributed breast milk.
Metabolism: Lidocaine is rapidly metabolized in the liver by de-ethylation. The active metabolites formed from Lidocaine are monoethylglycinexylidide (MEGX) and glycinexylidide (GX) which can accumulate and may cause CNS toxicity.
Excretion: Lidocaine has a terminal half-life of 1.5-2 hours. Half-life elimination may also be decreased in patients congestive heart failure or liver disease. May be prolonged lasting longer than 24 hours.
Metabolites and unchanged drug are excreted by the kidneys, metabolites are excreted in the urine with less than 10% of unchanged.
Chalocaine Viscous Solution used as topical anaesthetics of: Relief of irritated or inflamed mucous membrane of the mouth and the pharynx; Reducing gagging during the taking of X-ray pictures and dental impressions.
Recommended Dose: Adult: See Table 1.
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Pediatric: See Table 2.
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Mode of Administration: Do not dilute. Shake well before using.
The serious effects of Lidocaine toxicity are on the CNS and CVS such as severe hypotension, asystole, bradycardia, apnoea, seizures, coma, cardiac arrest, respiratory arrest and death.
Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsant drugs.
If circulatory arrest should occur, immediate cardiopulmonary resuscitation should be instituted.
Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance.
Hypersensitivity to another local anaesthetics of the amide type or to any component of the formulation.
Hypersensitivity to methyl and/or propyl parahydroxybenzoate (methyl-/propyl paraben), or to their metabolite para-aminobenzoic acid (PABA).
Life-threatening and fatal events in infants and young children; Post-marketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine 2% Viscous Solution when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Chalocaine Viscous Solution should generally not be used. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed.
To decrease the risk of serious adverse events with use of Chalocaine Viscous Solution, instruct caregivers to strictly adhere to the prescribed dose and frequency of administration and store the prescription bottle safely out of reach of children.
Not approved for relief of teething pain and discomfort in infants and children; serious adverse (toxic) effects have been reported.
Lidocaine should not be given to patients with hypovolemia, heart block or other conduction disturbances, and should be used with caution in patients with congestive heart failure, bradycardia, or respiratory depression. Lidocaine is metabolized in the liver and must be given with caution to patients with hepatic impairment. Metabolites of Lidocaine may accumulate in patients with renal impairment, may have increased risk of Lidocaine toxicity.
When use in the mouth or throat, local anaesthetics may impair swallowing and increase the risk of aspiration. Patients who have received local anaesthetics for procedures such as laryngoscopy or tracheoscopy should be cautioned not to eat or drink for at least 3 to 4 hours after the anaesthetics.
Pregnancy: Lidocaine crosses the placental barrier and may be taken up by foetal tissues. There are no adequate or well-controlled studies in pregnant women. Lidocaine should be used during pregnancy only when clearly needed.
Lactation: Lidocaine is distributed into milk, the drug should be used with caution in nursing women.
Systemic adverse reactions may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or reduced tolerance on the part of the patient. The systemic effects mainly involves the central nervous system and the cardiovascular system.
Central Nervous System: CNS reactions are excitatory and/or depressant and may be characterised by restlessness, excitement, nervousness, paraesthesias, dizziness, tinnitus, blurred vision, nausea and vomiting. Numbness of the tongue, lightheadedness followed by sedation. Excitation when it occurs maybe transient or followed by depression with drowsiness, respiratory failure and coma.
Cardiovascular System: Cardiovascular reactions are usually depressant and may be characterized by hypotension, bradycardia, arrhythmias and possibly cardiac arrest.
Allergic reactions: Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to other ingredients in the formulation. Allergic reactions as a result of sensitivity to lignocaine are rare. Allergic reactions are characterized by cutaneous lesions, urticarial, edema or anaphylactoid reaction.
Antiarrhythmic drugs: Lidocaine should be used with caution in patients receiving antiarrhythmic drug such as mexiletine, since the Lidocaine toxicity are arising from the use of Lidocaine oral preparation.
Antiepileptics: The long-term use of phenytoin or barbiturates may increase dosage requirements for Lidocaine due to induction of drug-metabolising microsomal enzymes, appear to enhance the metabolism of Lidocaine. Phenytoin and Lidocaine have additive cardiac depressant effects.
Enzyme inducing drugs: Lidocaine should be used with caution in patients receiving Cimetidine and Beta blockers, these drugs have been shown to cause potentially toxic plasma concentrations when Lidocaine is given in repeated high doses over a long period of time.
Beta blockers: Significant increases in plasma Lidocaine concentrations have occurred with beta blockers such as propranolol, nadolol, and metoprolol due to reduction in the clearance of Lidocaine. The reduction in clearance produced by propranolol seems to be mainly by direct inhibition of hepatic microsomal enzymes.
H2 antagonists: The clearance of Lidocaine may be reduced by H2 antagonists, cimetidine appears to reduce the hepatic metabolism of Lidocaine, it may also reduce by decreasing hepatic blood flow.
N01BB02 - lidocaine ; Belongs to the class of amides. Used as local anesthetics.
Chalocaine Viscous Solution oromucosal soln 20 mg/mL
((100 mL)) 1's
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