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  • Xylocaine Jelly
    (Lidocaine HCl) - Akorn

    THERAPEUTIC CLASS

    Acetamide local anesthetic

    DEA CLASS

    RX

    INDICATIONS

    Prevention and control of pain in procedures involving the male and female urethra. Topical treatment of painful urethritis. Anesthetic lubricant for endotracheal intubation (oral/nasal).

    ADULT DOSAGE

    Adults: Dosage varies and depends on area to be anesthetized, vascularity of tissues, individual tolerance, and technique of anesthesia. Administer lowest effective dose. Max: 600mg/12 hrs. Surface Anesthesia of Male Urethra: Slowly instill approximately 15mL (300mg) into the urethra or until a feeling of tension exists. Instill an additional dose of not >15mL (300mg) for adequate anesthesia. Prior to Sounding or Cystoscopy: Usual: Total Dose: 30mL (600mg). Prior to Catheterization: Usual: 5-10mL (100-200mg) for adequate lubrication. Surface Anesthesia of Female Urethra: Slowly instill 3-5mL (60-100mg) into the urethra. Lubrication for Endotracheal Intubation: Apply a moderate amount to the external surface of endotracheal tube shortly before use. Elderly/Debilitated/Acutely Ill: Reduce dose.

    PEDIATRIC DOSAGE

    Pediatrics: Determine max dose of children <10 yrs (normal lean body mass and development) using standard pediatric drug formulas (eg, Clark's rule). Max: 4.5mg/kg (2mg/lb).

    HOW SUPPLIED

    Jelly: 2% (20mg/mL) [5mL, 30mL]

    WARNINGS/PRECAUTIONS

    Safety and effectiveness depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Management of serious adverse reactions may require the use of resuscitative equipment, oxygen, and other resuscitative drugs. Use with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application; risk of rapid systemic absorption. Repeated doses may cause significant increases in blood levels. Elderly, debilitated, acutely ill, and children should be given reduced doses commensurate with their age, weight, and physical condition. Tolerance to elevated blood levels varies with the status of the patient. Caution in patients with severe shock or heart block. Caution with known drug sensitivities. Avoid introducing product into lumen of endotracheal tube; the jelly may dry on the inner surface leaving a residue that narrows or occludes the lumen. Do not use to lubricate the endotracheal stylettes. May trigger familial malignant hyperthermia; have standard protocol for management available. Acidosis affects the CNS levels of lidocaine required to produce overt systemic effects.

    ADVERSE REACTIONS

    Lightheadedness, nervousness, confusion, euphoria, dizziness, drowsiness, blurred vision, tremors, convulsions, respiratory depression, bradycardia, hypotension, urticaria, edema, anaphylactoid reactions.

    DRUG INTERACTIONS

    CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects.

    PREGNANCY

    Category B, caution in nursing.

    MECHANISM OF ACTION

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

    PHARMACOKINETICS

    Absorption: Well-absorbed from GI tract. Rate and extent of absorption depends on concentration and total dose administered, the specific site of application, and duration of exposure. Distribution: Plasma protein binding (60-80%); crosses placenta, found in breast milk. Metabolism: Liver (rapid), oxidative N-dealkylation, ring hydroxylation, cleavage of amide linkage, conjugation; monoethylglycinexylidide and glycinexylidide (metabolites). Elimination: Urine (90% metabolites, <10% unchanged); T1/2=1.5-2 hrs (IV).

    ASSESSMENT

    Assess for hypersensitivity to local anesthetics of the amide type or to other components of the drug, sepsis, presence of severely traumatized mucosa in the area of application, debilitation or acute illness, severe shock or heart block, known drug sensitivities, acidosis, pregnancy/nursing status, and possible drug interactions.

    MONITORING

    Monitor for signs/symptoms of hypersensitivity reactions, familial malignant hyperthermia, and other adverse reactions.

    PATIENT COUNSELING

    Inform that therapy may impair swallowing and enhance danger of aspiration if used in the mouth. Instruct not to ingest food for 60 min following use in mouth or throat area. Inform that numbness of tongue or buccal mucosa may enhance danger of unintentional biting trauma.

    ADMINISTRATION/STORAGE

    Administration: Topical route. Storage: 20-25°C (68-77°F).