Lidocaine Viscous

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Overview

What is Lidocaine Viscous?

Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP) contains a local anesthetic agent and is administered topically. Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP) contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-,monohydrochloride, and has the following structural formula:

The molecular formula of lidocaine is CHNO. The molecular weight is 234.34.

Composition of Solution

Each mL contains 20 mg (2%) of lidocaine hydrochloride USP and the following inactive ingredients: carboxymethylcellulose sodium, flavoring, methylparaben, propylparaben, purified water and saccharin sodium.

What does Lidocaine Viscous look like?

What are the available doses of Lidocaine Viscous?

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What should I talk to my health care provider before I take Lidocaine Viscous?

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How should I use Lidocaine Viscous?

Lidocaine is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.

The maximum recommended single dose of lidocaine for healthy adults should be such that the dose of lidocaine does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is 15 mL undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period. The dosage should be adjusted commensurate with the patient’s age, weight and physical condition (see ).

What interacts with Lidocaine Viscous?

Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of the solution.

What are the warnings of Lidocaine Viscous?

Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See .)

EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS. PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS.

Lidocaine should be used with extreme caution if the mucosa in the area of application has been traumatized, since under such conditions there is the potential for rapid systemic absorption.

Life-threatening and fatal events in infants and young children

Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Viscous 2% when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Viscous 2% 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.

What are the precautions of Lidocaine Viscous?

Information for Patients

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Parents and caregivers should be cautioned about the following:

All patients should be aware that when topical anesthetics are used in the mouth or throat, the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, food should not be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating.

Numbness of the tongue or buccal mucosa may increase the danger of biting trauma. For this reason food and/or chewing gum should not be used while the mouth or throat area is anesthetized.

General

The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies (see and ). The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated doses of lidocaine may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug and/or its metabolites. Tolerance varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age, weight and physical condition. Lidocaine should also be used with caution in patients with severe shock or heart block.

Lidocaine should be used with caution in persons with known drug sensitivities. Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Pregnancy

Nursing Mothers

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 lidocaine is administered to nursing women.

Pediatric Use

Dosage in children should be reduced, commensurate with age, body weight and physical conditions. See .

What are the side effects of Lidocaine Viscous?

Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported:

Central Nervous System

CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.

Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.

What should I look out for while using Lidocaine Viscous?

Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of the solution.

EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS. PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS.

Lidocaine should be used with extreme caution if the mucosa in the area of application has been traumatized, since under such conditions there is the potential for rapid systemic absorption.

Life-threatening and fatal events in infants and young children

Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Viscous 2% when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Viscous 2% 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.

What might happen if I take too much Lidocaine Viscous?

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (See , , and )

How should I store and handle Lidocaine Viscous?

Store at Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)The 2% oral topical solution is supplied as a clear, colorless, viscous solutionNDC 0054-0548-44: Squeeze Bottle of 20 mLNDC 0054-3500-49: Squeeze Bottle of 100 mLStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a child-resistant container as defined in the USP/NF.SHAKE WELL BEFORE USE.Distr. by: Pharmaceuticals Corp. Eatontown, NJ 077244055408//10Revised September 2017Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)The 2% oral topical solution is supplied as a clear, colorless, viscous solutionNDC 0054-0548-44: Squeeze Bottle of 20 mLNDC 0054-3500-49: Squeeze Bottle of 100 mLStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a child-resistant container as defined in the USP/NF.SHAKE WELL BEFORE USE.Distr. by: Pharmaceuticals Corp. Eatontown, NJ 077244055408//10Revised September 2017Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)The 2% oral topical solution is supplied as a clear, colorless, viscous solutionNDC 0054-0548-44: Squeeze Bottle of 20 mLNDC 0054-3500-49: Squeeze Bottle of 100 mLStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a child-resistant container as defined in the USP/NF.SHAKE WELL BEFORE USE.Distr. by: Pharmaceuticals Corp. Eatontown, NJ 077244055408//10Revised September 2017Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)The 2% oral topical solution is supplied as a clear, colorless, viscous solutionNDC 0054-0548-44: Squeeze Bottle of 20 mLNDC 0054-3500-49: Squeeze Bottle of 100 mLStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a child-resistant container as defined in the USP/NF.SHAKE WELL BEFORE USE.Distr. by: Pharmaceuticals Corp. Eatontown, NJ 077244055408//10Revised September 2017Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)The 2% oral topical solution is supplied as a clear, colorless, viscous solutionNDC 0054-0548-44: Squeeze Bottle of 20 mLNDC 0054-3500-49: Squeeze Bottle of 100 mLStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a child-resistant container as defined in the USP/NF.SHAKE WELL BEFORE USE.Distr. by: Pharmaceuticals Corp. Eatontown, NJ 077244055408//10Revised September 2017Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)The 2% oral topical solution is supplied as a clear, colorless, viscous solutionNDC 0054-0548-44: Squeeze Bottle of 20 mLNDC 0054-3500-49: Squeeze Bottle of 100 mLStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a child-resistant container as defined in the USP/NF.SHAKE WELL BEFORE USE.Distr. by: Pharmaceuticals Corp. Eatontown, NJ 077244055408//10Revised September 2017Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)The 2% oral topical solution is supplied as a clear, colorless, viscous solutionNDC 0054-0548-44: Squeeze Bottle of 20 mLNDC 0054-3500-49: Squeeze Bottle of 100 mLStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a child-resistant container as defined in the USP/NF.SHAKE WELL BEFORE USE.Distr. by: Pharmaceuticals Corp. Eatontown, NJ 077244055408//10Revised September 2017Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)The 2% oral topical solution is supplied as a clear, colorless, viscous solutionNDC 0054-0548-44: Squeeze Bottle of 20 mLNDC 0054-3500-49: Squeeze Bottle of 100 mLStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a child-resistant container as defined in the USP/NF.SHAKE WELL BEFORE USE.Distr. by: Pharmaceuticals Corp. Eatontown, NJ 077244055408//10Revised September 2017Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)The 2% oral topical solution is supplied as a clear, colorless, viscous solutionNDC 0054-0548-44: Squeeze Bottle of 20 mLNDC 0054-3500-49: Squeeze Bottle of 100 mLStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a child-resistant container as defined in the USP/NF.SHAKE WELL BEFORE USE.Distr. by: Pharmaceuticals Corp. Eatontown, NJ 077244055408//10Revised September 2017Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)The 2% oral topical solution is supplied as a clear, colorless, viscous solutionNDC 0054-0548-44: Squeeze Bottle of 20 mLNDC 0054-3500-49: Squeeze Bottle of 100 mLStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a child-resistant container as defined in the USP/NF.SHAKE WELL BEFORE USE.Distr. by: Pharmaceuticals Corp. Eatontown, NJ 077244055408//10Revised September 2017Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)The 2% oral topical solution is supplied as a clear, colorless, viscous solutionNDC 0054-0548-44: Squeeze Bottle of 20 mLNDC 0054-3500-49: Squeeze Bottle of 100 mLStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a child-resistant container as defined in the USP/NF.SHAKE WELL BEFORE USE.Distr. by: Pharmaceuticals Corp. Eatontown, NJ 077244055408//10Revised September 2017Lidocaine Viscous 2% (Lidocaine Hydrochloride Oral Topical Solution USP)The 2% oral topical solution is supplied as a clear, colorless, viscous solutionNDC 0054-0548-44: Squeeze Bottle of 20 mLNDC 0054-3500-49: Squeeze Bottle of 100 mLStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a child-resistant container as defined in the USP/NF.SHAKE WELL BEFORE USE.Distr. by: Pharmaceuticals Corp. Eatontown, NJ 077244055408//10Revised September 2017

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.

Non-Clinical Toxicology

Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of the solution.

EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS. PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS.

Lidocaine should be used with extreme caution if the mucosa in the area of application has been traumatized, since under such conditions there is the potential for rapid systemic absorption.

Life-threatening and fatal events in infants and young children

Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Viscous 2% when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Viscous 2% 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.

MAO inhibitors should be used with caution in patients receiving hydrALAZINE

When other potent parenteral antihypertensive drugs, such as diazoxide, are used in combination with hydrALAZINE, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide injection and hydrALAZINE are used concomitantly.

Administration of hydrALAZINE with food results in higher plasma levels.

Parents and caregivers should be cautioned about the following:

All patients should be aware that when topical anesthetics are used in the mouth or throat, the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, food should not be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating.

Numbness of the tongue or buccal mucosa may increase the danger of biting trauma. For this reason food and/or chewing gum should not be used while the mouth or throat area is anesthetized.

Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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