How To Use Urojet For Foley Insertion

DESCRIPTION

Lidocaine Hydrochloride Jelly USP, ii% 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 equally acetamide, two-(diethylamino)-Northward-(2,half dozen-dimethylphenyl)-, monohydrochloride and has the following structural formula:

STRUCTURE

Composition of Lidocaine Hydrochloride Jelly USP, two%

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

CLINICAL PHARMACOLOGY

Mechanism of activeness

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

Onset of action

The onset of activity is 3–5 minutes. It is ineffective when applied to intact pare.

Hemodynamics

Excessive blood levels may cause changes in cardiac output, full peripheral resistance, and mean arterial pressure. These changes may be attributable to a direct depressant event of the local anesthetic amanuensis on diverse components of the cardiovascular system.

Pharmacokinetics and metabolism

Lidocaine may be captivated following topical assistants to mucous membranes, its rate and extent of absorption varies depending upon concentration and total dose administered, the specific site of application and duration of exposure. In full general, the charge per unit of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract, just footling intact drug may appear in the apportionment because of biotransformation in the liver.

Lidocaine is metabolized rapidly past the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative Due north-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation. North-dealkylation, a major pathway of biotransformation, yields the metabolites mono-ethylglycinexylidide and glycinexylidide. The pharmacological / toxicological deportment of these metabolites are like to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is excreted in the grade of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a cohabit of four-hydroxy-2,6-dimethylaniline.

The plasma binding of lidocaine is dependent on drug concentration, and the fraction jump decreases with increasing concentration. At concentrations of 1 to 4 µg of free base of operations per mL, sixty to 80 pct of lidocaine is protein bound. Binding is as well dependent on the plasma concentration of the alpha-I-acid glycoprotein.

Lidocaine crosses the blood-encephalon and placental barriers, presumably by passive diffusion.

Studies of lidocaine metabolism post-obit intravenous bolus injections have shown that the elimination one-half-life of this agent is typically i.5 to two hours. Because of the rapid rate at which lidocaine is metabolized, whatever condition that affects liver function may modify lidocaine kinetics. The half-life may exist prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does non touch on lidocaine kinetics just may increase the accumulation of metabolites.

Factors such every bit acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic furnishings. Objective adverse manifestations get increasingly credible with increasing venous plasma levels above half dozen µg free base per mL. In the rhesus monkey arterial blood levels of xviii–21 µg / mL have been shown to be the threshold for convulsive activity.

INDICATIONS & USAGE

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

CONTRAINDICATIONS

Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide blazon or to other components of Lidocaine Hydrochloride Jelly USP, 2%.

WARNINGS

EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, Tin RESULT IN High PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS. PATIENTS SHOULD BE INSTRUCTED TO STRICTLY Attach TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT.

THE Management OF SERIOUS Agin 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 awarding, since under such atmospheric condition at that place is the potential for rapid systemic absorption.

When used for endotracheal tube lubrication, intendance should be taken to avoid introducing the product into the lumen of the tube. Exercise not use the jelly to lubricate the endotracheal stylettes. lf immune 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 accept been rare reports in which this residue has acquired the lumen to occlude. See also ADVERSE REACTIONS and DOSAGE & ADMINISTRATION.

PRECAUTIONS

Full general

The safe and effectiveness of lidocaine depend on proper dosage, correct technique, acceptable precautions, and readiness for emergencies. (See WARNINGS and ADVERSE REACTIONS). The lowest dosage that results in effective anesthesia should exist used to avoid loftier plasma levels and serious adverse furnishings. Repeated doses of lidocaine may cause meaning increases in blood levels with each repeated dose because of wearisome accumulation of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients, acutely sick patients, and children should be given reduced doses commensurate with their age and physical status. Lidocaine should likewise be used with caution in patients with severe daze or heart block.

Lidocaine Hydrochloride Jelly USP, 2% should exist used with caution in patients with known drug sensitivities. Patients allergic to para-aminobenzoic acrid derivatives (procaine, tetracaine, benzocaine, etc.) take not shown cross sensitivity to lidocaine.

Many drugs used during the conduct of anesthesia are considered potential triggering agents for familial cancerous hyperthermia. Since information technology is not known whether amide-type local anesthetics may trigger this reaction and since the need for supplemental full general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for direction should exist available. Early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may precede temperature peak. Successful event is dependent on early on diagnosis, prompt discontinuance of the suspect triggering agent(southward) and establishment of treatment, including oxygen therapy, indicated supportive measures and dantrolene (consult dantrolene sodium intravenous package insert before using).

Data for Patients

When topical anesthetics are used in the mouth, the patient should be aware that the product of topical anesthesia may impair swallowing and thus raise the danger of aspiration. For this reason, food should non be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat expanse. This is particularly important in children because of their frequency of eating.

Numbness of the natural language or buccal mucosa may enhance the danger of unintentional biting trauma. Food and chewing gum should not exist taken while the oral fissure or throat surface area is anesthetized.

Carcinogenesis

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of lidocaine.

Mutagenesis

The mutagenic potential of lidocaine has been tested in the Ames Salmonella reverse mutation assay, an in vitro chromosome aberrations assay in human being lymphocytes and in an in vivo mouse micronucleus assay. There was no indication of any mutagenic event in these studies.

Impairment of Fertility

The effect of lidocaine on fertility was examined in the rat model. Assistants of xxx mg/kg, s.c. (180 mg/m2) to the mating pair did not produce alterations in fertility or general reproductive performance of rats. In that location are no studies that examine the consequence of lidocaine on sperm parameters. There was no evidence of altered fertility.

Employ in Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies for lidocaine have been performed in both rats and rabbits. There was no evidence of impairment to the fetus at subcutaneous doses of up to 50 mg/kg lidocaine (300 mg/m2 on a body surface expanse basis) in the rat model. In the rabbit model, at that place was no prove of harm to the fetus at a dose of 5 mg/kg, s.c. (threescore mg/m2 on a body surface area ground). Treatment of rabbits with 25 mg/kg (300 mg/m2) produced evidence of maternal toxicity and prove of delayed fetal development, including a non-significant decrease in fetal weight (seven%) and an increase in pocket-sized skeletal anomalies (skull and sternebral defect, reduced ossification of the phalanges). The effect of lidocaine on post-natal development was examined in rats by treating pregnant female rats daily subcutaneously at doses of two, 10, and 50 mg/kg (12, 60, and 300 mg/m2) from day 15 of pregnancy and upwardly to twenty days post partum. No signs of adverse effects were seen either in dams or in the pups upward to and including the dose of 10 mg/kg (threescore mg/m2); however, the number of surviving pups was reduced at 50 mg/kg (300 mg/m2), both at nativity and the duration of lactation catamenia, the effect nearly likely being secondary to maternal toxicity. No other furnishings on litter size, litter weight, abnormalities in the pups and physical developments of the pups were seen in this written report.

A second written report examined the effects of lidocaine on post-natal evolution in the rat that included cess of the pups from weaning to sexual maturity. Rats were treated for eight months with ten or 30 mg/kg, s.c. lidocaine (lx mg/m2 and 180 mg/m2 on a body surface area footing, respectively). This fourth dimension period encompassed 3 mating periods. In that location was no evidence of altered mail-natal development in any offspring; nevertheless, both doses of lidocaine significantly reduced the average number of pups per litter surviving until weaning of offspring from the first 2 mating menstruation.

There are, however, no acceptable and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human being response, this drug should be used during pregnancy just if clearly needed.

Labor and Delivery

Lidocaine is not contraindicated in labor and delivery. Should Lidocaine Hydrochloride Jelly USP, 2% be used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in listen.

Nursing mothers

Lidocaine is secreted in human milk. The clinical significance of this observation is unknown. Caution should be exercised when lidocaine is administered to a nursing woman.

Pediatric use

Although, the safe and effectiveness of Lidocaine Hydrochloride Jelly USP, ii% in pediatric patients have non been established, a study of 19 premature neonates (gestational age <33 weeks) constitute no correlation between the plasma concentration of lidocaine or monoethylglycinexylidide and babe body weight when moderate amounts of lidocaine (i.e. 0.3 mL/kg of lidocaine gel 20 mg/ml) were used for lubricating both intranasal and endotracheal tubes. No neonate had plasma levels of lidocaine to a higher place 750 mcg/L. Dosages in children should be reduced, commensurate with age, body weight, and concrete status. (Encounter DOSAGE & Administration)

ADVERSE REACTIONS

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 full general, dose-related and may result from high plasma levels caused by excessive dosage or rapid assimilation, or may effect from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are mostly systemic in nature. The following types are those most commonly reported:

At that place have been rare reports of endotracheal tube apoplexy associated with the presence of dried jelly residue in the inner lumen of the tube. Encounter also WARNINGS and DOSAGE & ADMINISTRATION.

Central nervous organization

CNS manifestations are excitatory and/or depressant and may exist 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 abort. The excitatory manifestations may be very brief or may not occur at all, in which case the commencement manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.

Drowsiness post-obit the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur equally a issue of rapid absorption.

Cardiovascular system

Cardiovascular manifestations are ordinarily depressant and are characterized past bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.

Allergic

Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur every bit a result of sensitivity either to the local coldhearted agent or to other components in the conception. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by peel testing is of doubtful value.

OVERDOSAGE

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

Management of local coldhearted emergencies

The commencement consideration is prevention, best achieved past careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic administration. At the start sign of change, oxygen should be administered.

The beginning step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting firsthand positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such every bit thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should exist familiar, prior to utilise of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may crave administration of intravenous fluids and when advisable, a vasopressor as directed past the clinical situation (east.yard. ephedrine).

If not treated immediately, both convulsions and cardiovascular depression tin can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac abort should occur, standard cardiopulmonary resuscitative measures should be instituted.

Dialysis is of negligible value in the handling of astute overdosage with lidocaine.

The oral LD50 of lidocaine hydrochloride in non-fasted female person rats is 459 (346–773) mg / kg (as the table salt) and 214 (159–324) mg / kg (as the salt) in fasted female rats.

DOSAGE & Assistants

When Lidocaine Hydrochloride Jelly USP, two% is used concomitantly with other products containing lidocaine, the full dose contributed by all formulations must be kept in listen.

The dosage varies and depends upon the surface area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should exist administered. Dosages should be reduced for children and for elderly and debilitated patients. Although the incidence of adverse effects with Lidocaine Hydrochloride Jelly USP, 2% is quite depression, caution should exist exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local coldhearted agent administered.

For surface anesthesia of the male adult urethra

The outer orifice is washed and disinfected. The plastic tip is introduced into the orifice, where it is firmly held in position. The jelly is instilled past an easy syringe-like activity, until the patient has a feeling of tension or until about xv mL (i.east., 300 mg of lidocaine hydrochloride) is instilled. A penile clench is and so applied for several minutes at the corona and and then boosted jelly (about 15 mL) is instilled. To save time, the injection is performed against the resistance of the sphincter, possibly assisted by request the patient to strain every bit for defecation or to press as in voiding. The jelly will then pass into the posterior urethra. Prior to sounding or cystoscopy, a penile clamp should be applied for 5 to 10 minutes to obtain adequate anesthesia. If the instrument is introduced immediately, a lubricant is unnecessary. Otherwise some jelly can exist expressed from the vial and applied to the instrument tip. Well-nigh 30 mL (i.e., 600 mg) may be required to fill and dilate the male urethra. When it is desired to hypnotize only the inductive male person urethra, as prior to catheterization, considerably smaller volumes, such as the contents from a five mL (i.e., 100 mg) or 10 mL (i.e., 200 mg) size vial, are normally adequate for lubrication.

For surface anesthesia of the female developed urethra

iii to v mL of the jelly is instilled slowly into the urethra by gently expressing the contents of the vial. If desired, some jelly may be deposited on a cotton swab and introduced into the urethra. In order to obtain adequate anesthesia, several minutes should be allowed prior to performing urological procedures.

Lubrication for endotracheal intubation

Employ a moderate amount of jelly to the external surface of the endotracheal tube presently before use. Intendance should be taken to avert introducing the production into the lumen of the tube. Do not apply the jelly to lubricate endotracheal stylettes. See WARNINGS and ADVERSE REACTIONS concerning rare reports of inner lumen occlusion. It is besides recommended that utilise of endotracheal tubes with dried jelly on the external surface be avoided for lack of lubricating effect.

MAXIMUM DOSAGE

No more than 600 mg of lidocaine hydrochloride should exist given in any 12 60 minutes period.

Children

It is difficult to recommend a maximum dose of any drug for children since this varies every bit a role of historic period and weight. For children less than 10 years who have a normal lean body mass and a normal lean body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (due east.g., Clark'south dominion). For example, in a child of five years weighing 50 lbs., the dose of lidocaine hydrochloride should non exceed 75–100 mg when calculated co-ordinate to Clark'south rule. In any example, the maximum corporeality of lidocaine administered should not exceed 4.five mg / kg (2 mg / lb) of body weight.