Sx1 Medicated Post-Operative System

Name: Sx1 Medicated Post-Operative System

Sx1 Medicated Post-Operative System Description

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

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

Its molecular formula is C14H22N2O • HCI and its molecular weight is 270.80.

Lidocaine HCI 2% Jelly also contains hypromellose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation. The unused portion should be discarded after initial use.

Composition of Lidocaine HCI 2% Jelly 30 mL and 5 mL tubes: Each mL contains 20 mg of lidocaine HCI. The formulation also contains methylparaben, propylparaben, hypromellose, and sodium hydroxide and/or hydrochloric acid to adjust pH between 6.0 to 7.0.

Warnings

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 HCI 2% Jelly should be used in 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. If 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.)

Precautions

General: The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. (See WARNINGS and ADVERSE REACTIONS.) 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 or its metabolites. Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical status. Lidocaine should also be used with caution in patients with severe shock or heart block.

Lidocaine HCI 2% Jelly should be used with caution in patients with known drug sensitivities. Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine.

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

Information for Patients: When topical anesthetics are used in the mouth, the patient should be aware that 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 enhance the danger of unintentional biting trauma. Food or chewing gum should not be taken while the mouth or throat 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, and in vitro chromosome aberrations assay in human lymphocytes and in an in vivo mouse micronucleus assay. There was no indication of any mutagenic effect in these studies.

Impairment of Fertility – The effect of lidocaine on fertility was examined in the rat model. Administration of 30 mg/kg, s.c. (180 mg/m2) to the mating pair did not produce alterations in fertility or general reproductive performance of rats. There are no studies that examine the effect of lidocaine on sperm parameters. There was no evidence of altered fertility.

Use in Pregnancy:

Teratogenic Effects: Pregnancy Category B.

Reproduction studies for lidocaine have been performed in both rats and rabbits. There was no evidence of harm to the fetus at subcutaneous doses of up to 50 mg/kg lidocaine (300 mg/m2 on a body surface area basis) in the rat model. In the rabbit model, there was no evidence of harm to the fetus at a dose of 5 mg/kg, s.c. (60 mg/m2 on a body surface area basis). Treatment of rabbits with 25 mg/kg (300 mg/m2) produced evidence of maternal toxicity and evidence of delayed fetal development, including a non-significant decrease in fetal weight (7%) and an increase in minor 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 2, 10, and 50 mg/kg (12, 60, and 300 mg/m2) from day 15 of pregnancy and up to 20 days post partum. No signs of adverse effects were seen either in dams or in the pups up to and including the dose of 10 mg/kg (60 mg/m2); however, the number of surviving pups was reduced at 50 mg/kg (300 mg/m2), both at birth and the duration of lactation period, the effect most likely being secondary to maternal toxicity. No other effects on litter size, litter weight, abnormalities in the pups and physical developments of the pups were seen in this study.

A second study examined the effects of lidocaine on post-natal development in the rat that included assessment of the pups from weaning to sexual maturity. Rats were treated for 8 months with 10 or 30 mg/kg, s.c. lidocaine (60 mg/m2 and 180 mg/m2 on a body surface area basis, respectively). This time period encompassed 3 mating periods. There was no evidence of altered post-natal development in any offspring; however, both doses of lidocaine significantly reduced the average number of pups per litter surviving until weaning of offspring from the first 2 mating period.

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

Labor and Delivery: Lidocaine is not contraindicated in labor and delivery. Should Lidocaine HCl 2% Jelly be used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.

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 safety and effectiveness of Lidocaine 2% Jelly in pediatric patients have not been established, a study of 19 premature neonates (gestational age <33 weeks) found no correlation between the plasma concentration of lidocaine or monoethylglycinexylidide and infant 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 above 750 mcg/L. Dosages in children should be reduced, commensurate with age, body weight, and physical condition. (See DOSAGE AND ADMINISTRATION.)

Adverse Reactions

Adverse experiences following the administration of lidocaine are similar in nature to those observed in 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:

There have been rare reports of endotracheal tube occlusion associated with the presence of dried jelly residue in the inner lumen of the tube. (See also WARNINGS and DOSAGE AND ADMINISTRATION.)

Central Nervous System: CNS manifestations are excitatory and/or depressant and may be characterized by light headedness, 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.

Cardiovascular System: Cardiovascular manifestations are usually depressant and are characterized by 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 as a result of sensitivity either to the local anesthetic agent or other components in the formulation. 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 skin testing is of doubtful value.

Other information

  • store at controlled room temperature 15°-30° C (59°-86° F)
  • avoid excessive heat and humidity

Do Not Use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

  • Stop use and ask a doctor if condition persists or gets worse, or if a rash or other allergic reaction occurs

Packaging-System Components Labeling

Sx1 Medicated Post-Operative System 
lidocaine hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70529-941
Packaging
# Item Code Package Description
1 NDC:70529-941-01 1 KIT in 1 PACKAGE
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 5 mL
Part 2 1 PACKET 0.9 g
Part 1 of 2
LIDOCAINE 
lidocaine hydrochloride jelly
Product Information
Item Code (Source) NDC:17478-840
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES  
METHYLPARABEN  
PROPYLPARABEN  
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:17478-840-05 1 TUBE in 1 CARTON
1 5 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040433 08/01/2013
Part 2 of 2
BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE 
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
Product Information
Item Code (Source) NDC:67777-217
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN 400 [iU]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 5000 [iU]  in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM  
Packaging
# Item Code Package Description
1 NDC:67777-217-07 0.9 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 12/01/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040433 05/01/2016
Labeler - IT3 Medical LLC (079971231)
Revised: 10/2016   IT3 Medical LLC
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