Lidocaine Hydrochloride Jelly

Lidocaine Hydrochloride Jelly

Lidocaine Hydrochloride Jelly Recall

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Questions & Answers

Side Effects & Adverse Reactions

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 Hydrochloride Jelly USP, 2% should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.

When used for endotracheal tube lubrication, care should be taken to avoid introducing the product into the lumen of the tube. Do not use the jelly to lubricate the endotracheal stylettes. lf allowed into the inner lumen, the jelly may dry on the inner surface leaving a residue which tends to clump with flexion, narrowing the lumen. There have been rare reports in which this residue has caused the lumen to occlude. See also ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Lidocaine Hydrochloride Jelly USP, 2% is indicated for prevention and control of pain in procedures involving the male and female urethra for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).

History

There is currently no drug history available for this drug.

Other Information

Lidocaine Hydrochloride Jelly USP, 2% is a sterile aqueous product that contains a local anesthetic agent and is administered topically. See INDICATIONS for specific uses.

Lidocaine Hydrochloride Jelly USP, 2% contains lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula:

Chemical Structure
Composition of Lidocaine Hydrochloride Jelly USP, 2%

Each mL contains 20 mg of lidocaine hydrochloride, and sodium carboxymethylcellulose as a viscosity-increasing agent. Sodium hydroxide may have been added to adjust pH to meet USP limits of 6 to 7. Carboxymethylcellulose sodium adjusts the resulting mixture to a suitable consistency, to enhance contact with mucosa and provide lubrication for instrumentation. This product contains no preservative and any unused portion should be discarded after initial use.

Lidocaine Hydrochloride Jelly Manufacturers


  • Amphastar Pharmaceuticals, Inc.
    Lidocaine Hydrochloride Jelly [Amphastar Pharmaceuticals, Inc.]
  • Hi-tech Pharmacal Co., Inc.
    Lidocaine Hydrochloride Jelly [Hi-tech Pharmacal Co., Inc.]
  • General Injectables & Vaccines, Inc
    Lidocaine Hydrochloride Jelly [General Injectables & Vaccines, Inc]
  • General Injectables & Vaccines, Inc
    Lidocaine Hydrochloride Jelly [General Injectables & Vaccines, Inc]
  • General Injectables & Vaccines, Inc
    Lidocaine Hydrochloride Jelly [General Injectables & Vaccines, Inc]
  • General Injectables & Vaccines, Inc
    Lidocaine Hydrochloride Jelly [General Injectables & Vaccines, Inc]
  • General Injectables & Vaccines, Inc
    Lidocaine Hydrochloride Jelly [General Injectables & Vaccines, Inc]
  • Cardinal Health
    Lidocaine Hydrochloride Jelly [Cardinal Health]
  • General Injectables & Vaccines, Inc
    Lidocaine Hydrochloride Jelly [General Injectables & Vaccines, Inc]
  • International Medication Systems, Limited
    Lidocaine Hydrochloride Jelly [International Medication Systems, Limited ]
  • Cardinal Health
    Lidocaine Hydrochloride Jelly [Cardinal Health]

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