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Lidocaine Hydrochloride
Overview
What is Sx1 Medicated Post-Operative System?
Lidocaine HCI 2% Jelly is a sterile, aqueous product that contains a local anesthetic agent and is administered topically. (See 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 CHNO • 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.
What does Sx1 Medicated Post-Operative System look like?
What are the available doses of Sx1 Medicated Post-Operative System?
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What should I talk to my health care provider before I take Sx1 Medicated Post-Operative System?
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How should I use Sx1 Medicated Post-Operative System?
First aid to help prevent infection in:
clean the affected areas
apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
may be covered with a sterile bandage
What interacts with Sx1 Medicated Post-Operative System?
Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine HCI 2% Jelly.
What are the warnings of Sx1 Medicated Post-Operative System?
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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 and .)
What are the precautions of Sx1 Medicated Post-Operative System?
General:
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:
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
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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/m 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/m on a body surface area basis). Treatment of rabbits with 25 mg/kg (300 mg/m) 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/m) 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/m); however, the number of surviving pups was reduced at 50 mg/kg (300 mg/m), 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/m and 180 mg/m 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:
Nursing Mothers:
Pediatric Use:
DOSAGE AND ADMINISTRATION
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What are the side effects of Sx1 Medicated Post-Operative System?
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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 and .)
Central Nervous System:
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:
Allergic:
What should I look out for while using Sx1 Medicated Post-Operative System?
Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of Lidocaine HCI 2% Jelly.
For external use only
What might happen if I take too much Sx1 Medicated Post-Operative System?
ADVERSE REACTIONS
WARNINGS
PRECAUTIONS
How should I store and handle Sx1 Medicated Post-Operative System?
Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F). Lidocaine HCI 2% Jelly is supplied in the listed dosage forms.NDC 17478-840-30 30 mL aluminum tubeNDC 17478-840-05 5 mL aluminum tubeA detachable applicator cone and a key for expressing the contents are included in the 30 mL carton.Lidocaine HCI 2% Jelly is supplied in the listed dosage forms.NDC 17478-840-30 30 mL aluminum tubeNDC 17478-840-05 5 mL aluminum tubeA detachable applicator cone and a key for expressing the contents are included in the 30 mL carton.Lidocaine HCI 2% Jelly is supplied in the listed dosage forms.NDC 17478-840-30 30 mL aluminum tubeNDC 17478-840-05 5 mL aluminum tubeA detachable applicator cone and a key for expressing the contents are included in the 30 mL carton.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mechanism of 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 Lidocaine HCI 2% Jelly.For external use only
Mineral oil interferes with the absorption of fat-soluble vitamins, including vitamin D preparations. Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with ergocalciferol may cause hypercalcemia.
General:
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).
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 and .)
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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