Lido Rx

LIDO RX- lidocaine gel
Gensco Laboratories, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Indications

Anesthetic for relief of pain at site of injury; relief of musculoskeletal pain
and soreness; pain from neuropathy; local medical procedures,
injections and vaccines; relief of pruritis, pruritic eczema, abrasions,
minor burns, insect bites, pain, soreness and discomfort due to pruritis
ani, pruritis vulvae, hemorrhoids, anal fissures and similar conditions of
the skin and mucous membranes.

2. Dosage and Administration

Each pump of the LiDORx® 3% bottle (30mL Airless Pump bottle — NDC:35781-0300-3) will deliver 0.25 mL of LiDORx® 3% enough to cover
a 2 inch by 2 inch area of skin. A single application should not exceed 4 pumps of the Airless bottle, equal to 1 gram of LiDORx® 3%, (30 mg of
Lidocaine Hydrochloride USP).


No more than 16 pumps of the Airless Pump bottle, approximately 4 grams of LiDORx® 3% (120 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.

2.1 Dosage for children

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children less
than ten 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 (e.g., Clark’s rule). For example a child of five years weighing 50 lbs., the
dose of lidocaine should not exceed 75-100 mg when calculated according to Clark’s rule. In any case, the maximum amount of
Lidocaine Hydrochloride USP administered should not exceed 4.3 mg/kg (2.0 mg/lb) of body weight.

2.2 Administration

Apply 1-4 pumps to the affected area three or four times daily not to exceed 16 pumps in twenty-four hours (24 Hrs) or as directed by a
physician. As a topical anesthesic, apply an adequate amount for the desired procedure to the target area 10 minutes prior to initiation
of procedure.

3. Dosage Form and Strength

LiDORx® 1% is a Topical Gel. Each gram of LiDORx® 1% contains 1% Lidocaine Hydrochloride USP (10mg). Lid10ml

LiDORx® 3% is a Topical Gel. Each gram of LiDORx® 3% contains 3% Lidocaine Hydrochloride USP (30mg). Lid30ml

LiDORx® 9% is a Topical Gel. Each gram of LiDORx® 9% contains 9% Lidocaine Hydrochloride USP (90mg). Lid90ml

CONTRAINDICATIONS

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.

5. Warnings and Precautions

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.

Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients
are at risk for methemoglobinernia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia,
cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites
are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close
monitoring for symptoms and signs of methemoglobinemia is recommended. Signs and symptoms of methemoglobinemia may
occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal
coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious
central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue LiDORx® and
any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen
therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen

6. Adverse Reactions

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:

6.1 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 Hydrochloride USP is usually an early sign of a high blood level of the drug and may occur as a
consequence of rapid absorption.

6.2 Cardiovascular system

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

6.3 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 Hydrochloride USP are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

7. Drug Interactions

7.1 Serious interactions:

Antiarrhythmic Drugs: LiDORx® 3% should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.

Bupivacaine liposome: Lidocaine Hydrochloride USP increases toxicity of Bupivacaine by increasing the free (unencapsulated)bupiacaine.
Dofetilide: Lidocaine Hydrochloride USP increases effects of dofetilide thru pharmacodynamic synergism.
Lomitapide: Lidocaine Hydrochloride USP increases levels of lomitapide by affecting hepatic/intestinal enzymes CYP3A4 metabolism.

7.2 General interactions:
DRUG INTERACTIONS:
Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents:

Class Examples
Nitrates/Nitrites Nitroglycerin, Nitroprusside, nitric oxide, nitrous oxide
Local anesthetics Benzocaine, Lidocaine, Bupivacaine, Mepivacaine, Letracaine, prilocaine, procaine, articaine, ropivacaine
Antincoplastic agents cyclophosphosphamide,flutamide, rasburicase, ifosfamide, hydroxyurea
Antibiotics Dapsone, sulfonamides, nitrofurantoin,paraaminosalicylic acid
Antimalarials Chloroquine,primaquine
Anticonvulsants phenytoin,sodium valproate,phenobarbital
Other drugs acetaminophen, metoclopramide, sulfa drugs (i.e, Sulfasalazine), quinine

Drugs metabolized via CYP3A4 enzyme: (ex. Antipsychotics, SSRIs, TCAs, many chemotherapeutics, calcium channel bockers, benzodiazopines) Lidocaine Hydrochloride USP may increase serum levels of many drugs metabolized by hepatic / intestinal CYP3A4 enzymes.

Drugs that affect hepatic CYP1A2 enzyme: (ex. Quinoline antibiotics, cimetidine, barbiturates, benzodiazepines, erythromycin) May increase serum Lidocaine Hydrochloride USP levels by decreasing Lidocaine Hydrochloride USP metabolism by CYP1A2 enzyme.

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