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Name:Lidocaine Hcl
Manufacturer:Puretek Corporation
Category:Prescription Marketed Drugs


Prescribing Information

LIDOCAINE HCL   - lidocaine hydrochloride cream 
PureTek Corporation

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.

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Prescribing Information

DESCRIPTION

Contains lidocaine HCl 3% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl).

Lidocaine structure

INGREDIENTS: Each gram of PharmaPure Rx Lidocaine HCl 3% Cream contains Lidocaine HCl USP 3%, Inactive ingredients include: Aluminum Sulfate, Calcium Acetate, Cetyl Alcohol, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Purified Water, Sodium Hydroxide, Sorbitan Stearate, Stearic Acid, Stearyl Alcohol.

CLINICAL PHARMACOLOGY

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MECHANISM OF ACTION

PharmaPure Rx Lidocaine HCl 3% Cream releases lidocaine 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.

PHARMACOKINETICS

Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon the specific site of application, duration of exposure, concentration, and total dosage. In general, the rate of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug appears in the circulation because of biotransformation of the liver.

Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjungation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexlidide. The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline. The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentration of 1 to 4 g of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid-glycoprotein. Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion. Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2 hours. Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics. The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6 g free base per mL. In the rhesus monkey arterial blood levels of 18-21 g/mL have been shown to be threshold for convulsive activity.

INDICATIONS

Indications: For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.

CONTRAINDICATIONS

Tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

WARNINGS

For external use only. Not for ophthalmic use.
Keep out of reach of children.

PRECAUTIONS

If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Pharmapure Rx Lidocaine HCl 3% Cream should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine.

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:

Teratogenic Effects; Pregnancy Category B. Reproduction studies have been performed for lidocaine 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. 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 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 this drug is administered to a nursing mother.

PEDIATRIC USE:

Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.

ADVERSE REACTIONS:

During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.

DOSAGE AND ADMINISTRATION:

Apply a thin film to the affected area two or three times daily or as directed by a physician.

HOW SUPPLIED:

PharmaPure Rx Lidocaine HCl 3% Cream


1 oz (28.3g) tube - NDC 59088-997-03

3 oz (85 g) tube -  NDC 59088-997-07

STORAGE AND HANDLING

Store at controlled room temperature 150 - 300C (590 -860F). Protect from freezing.

1 oz CARTON LABEL

image of 1 oz carton

LIDOCAINE HCL  
lidocaine hcl cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59088-997
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 30 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM SULFATE  
CALCIUM ACETATE  
CETYL ALCOHOL  
METHYLPARABEN  
MINERAL OIL  
PETROLATUM  
POLYSORBATE 60  
PROPANEDIOL  
PROPYLPARABEN  
WATER  
SODIUM HYDROXIDE  
SORBITAN MONOSTEARATE  
STEARIC ACID  
STEARYL ALCOHOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59088-997-03 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 28.3 g in 1 TUBE This package is contained within the CARTON (59088-997-03)
2 NDC:59088-997-07 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
2 85 g in 1 TUBE This package is contained within the CARTON (59088-997-07)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/13/2011

Labeler - PureTek Corporation (785961046)
Establishment
Name Address ID/FEI Operations
PureTek Corporation 785961046 manufacture, label, pack, outsourcing human drug compounding, relabel, repack

Revised: 06/2011 PureTek Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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