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Lido Rx
Overview
What is Lido Rx?
Lidocaine HCL USP, 3% contains a local anesthetic agent and is administered topically. See for specific uses.
Lidocaine HCL USP, 3% contains lidocaine, which is chemically designated as acetamide, 2-(diethylamino)--(2,6-dimethylphenyl)-, and has the following structural formula:
Composition of Lidocaine HCL USP, 3%: Each gram contains lidocaine hydrocloride USP, 3% in a water soluble base containing AQUA (DEIONIZED WATER), CARBOMER, ISOPROPYL ALCOHOL, PETROLATUM, POLYSORBATE-20,
TRIETHANOLAMINE.
What does Lido Rx look like?
What are the available doses of Lido Rx?
Sorry No records found.
What should I talk to my health care provider before I take Lido Rx?
Sorry No records found
How should I use Lido Rx?
Each pump of the LidoRx 3% bottle in 30mL Airless Pumps (NDC:35781-0300-3) will deliver 0.25 mL of LidoRx 3% enough to cover a 2 x 2 inch area of skin. A single application should not exceed 10 g of LidoRx 3%, containing 300 mg of Lidocaine Hydrochloride USP; This would equal 40 pumps of the 30mL Airless bottle. In a 70 kg adult this dose equals 4.3 mg/kg (1.9 mg/lb) Lidocaine Hydrochloride USP. No more than one 30mL Airless Pump bottle, approximately 30g of LidoRx 3% or 900 mg Lidocaine Hydrochloride USP, should be administered in any one day.
Although the incidence of adverse effects with LidoRx 3% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.
What interacts with Lido Rx?
Lidocaine Hydrochloride USP is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of LidoRx 3%.
Do not use LidoRx 3% on traumatized mucosa or in the presence of secondary bacterial infection of the area of proposed application.
What are the warnings of Lido Rx?
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.
LidoRx 3% 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.
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What are the precautions of Lido Rx?
If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. LidoRx 3% Gel should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of Lidocaine Hydrochloride USP. In case of accidental ingestion get medical help or contact poison control center right away.
CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY
Studies of lidocaine in animals to evaluate the carcinogenic potential of the effect on fertility have not been conducted.
USE IN PREGNANCY
Teratogenic Effects. Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by Lidocaine Hydrochloride USP. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering Lidocaine Hydrochloride USP to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.
NURSING MOTHERS:
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lidocaine Hydrochloride USP. is administered to a nursing woman.
PEDIATRIC USE:
Dosage in children should be reduced, commensurate with age, body weight and physical condition. Caution must be taken to avoid over dosage when applying LidoRx 3% to large areas of injured or abraded skin, since the systemic absorption of Lidocaine Hydrochloride USP may be increased under such conditions.
What are the side effects of Lido Rx?
Adverse experiences following the administration of Lidocaine Hydrochloride USP are similar in nature to those observed with 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:
Central Nervous System:
CNS manifestations are excitatory and/or depressant and may be 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 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 to 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.
What should I look out for while using Lido Rx?
Lidocaine Hydrochloride USP is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of LidoRx 3%.
Do not use LidoRx 3% on traumatized mucosa or in the presence of secondary bacterial infection of the area of proposed application.
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.
LidoRx 3% 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.
What might happen if I take too much Lido Rx?
Sorry No Records found
How should I store and handle Lido Rx?
Store at 20°C to 25°C (68°F to 77°F). Excursion permitted between 15°C to 30°C (59°F to 86°F). See USP controlled room temperature.Discard any unused EMFLAZA Oral Suspension remaining after 1 month of first opening the bottle.Store at 20°C to 25°C (68°F to 77°F). Excursion permitted between 15°C to 30°C (59°F to 86°F). See USP controlled room temperature.Discard any unused EMFLAZA Oral Suspension remaining after 1 month of first opening the bottle.Product: 50090-1352NDC: 50090-1352-0 28.5 g in a TUBE Product: 50090-1352NDC: 50090-1352-0 28.5 g in a TUBE
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
LidoRx 3% releases Lidocaine Hydrochloride USP from a mild acidic vehicle to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. A mild acidic vehicle lowers pH to increase protection against alkaline irritations and to provide a favorable environment for healing.
Non-Clinical Toxicology
Lidocaine Hydrochloride USP is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of LidoRx 3%.Do not use LidoRx 3% on traumatized mucosa or in the presence of secondary bacterial infection of the area of proposed application.
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.
LidoRx 3% 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.
Although Timolol Maleate Ophthalmic Solution used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with Timolol Maleate Ophthalmic Solution and epinephrine has been reported occasionally.
Beta-adrenergic blocking agents:
Calcium antagonists:
Catecholamine-depleting drugs:
Digitalis and calcium antagonists:
CYP2D6 inhibitors:
Clonidine:
If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. LidoRx 3% Gel should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of Lidocaine Hydrochloride USP. In case of accidental ingestion get medical help or contact poison control center right away.
Adverse experiences following the administration of Lidocaine Hydrochloride USP are similar in nature to those observed with 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:
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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