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Name:Lidocaine Hcl And Hydrocortisone Acetate
Manufacturer:E. Fougera & Co. A Division Of Nycomed Us Inc.
Category:Prescription Marketed Drugs


Fougera Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% cream

LIDOCAINE HCL AND HYDROCORTISONE ACETATE   - lidocaine hydrochloride and hydrocortisone acetate cream 
E. Fougera & Co. A division of Nycomed US Inc.

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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Fougera Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% cream

DESCRIPTION: Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream contains lidocaine hydrochloride 3% and hydrocortisone acetate 0.5% microdispersed in an AcidMantle vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl) and has the following structure:

IMAGE


Hydrocortisone acetate has a chemical name pregn-4-ene-3,20-dione,21-(acetyloxy)-11,17-dihydroxy-(11β). It has the following structure formula:

IMAGE



INGREDIENTS: Each gram of Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% cream contains lidocaine hydrochloride 30mg and hydrocortisone acetate 5mg. Inactive ingredients include: aluminium sulfate, calcium acetate, cetyl alcohol, glycerin, hydrochloric acid, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, purifed water, sodium hydroxide, sorbitan stearate, stearic acid and stearyl alcohol.

CLINICAL PHARMACOLOGY:

MECHANISM OF ACTION: Lidocaine is released from an AcidMantle vehicle to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action.  Hydrocortisone acetate provides relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.  The AcidMantle base can help maintain the pH balance of the skin.

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 criculation because of biotransformation in 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 conjugation.  N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylide.  The pharmacological/toxicological actions of these metabolites  are similar to, but less potent than those 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 concentrations of 1 to 4g 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 lidocain 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 lidocain 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.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma protein in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.


INDICATIONS: Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.

CONTRAINDICATIONS: Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions of lidocaine or amide anesthetics, which usually do not cross-react with "caine" ester type of anesthetics.  If excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician.  Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream and topical lidocaine should be used cautiously in those with impaired liver function as well as the very ill or very elderly and those with significant liver disease.  Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream should be used with caution in patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic.  Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream is contraindicated for tuberculous  or fungal lesions or skin vaccinia, varicella and acute herpes simplex.  Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

WARNINGS: For external use only.  Not for ophtalmic use. Product and used applicators could harm small children if chewed or swallowed.  Individual tubes are NOT child resistant.  Keep the product inside the child resistant blister until ready to use.

KEEP PRODUCT AND USED APPLICATORS OUT OF THE REACH OF CHILDREN.

Topical formulations of lidocaine may be absorbed to a greater extent through mucous membranes and abraded, fissured or irritated skin than through intact skin.  Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream should not be ingested or applied into the mouth, inside of the nose or in the eyes.  Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream should not be used in the ears.  Any situation when lidocaine penetrates beyond the tympanic membrane into the middle ear is contraindicated because of ototoxicity associated with lidocaine observed in animals when instilled in the middle ear.  Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream should not come into contact with eye or be applied into the eye because of the risk of severe eye irritation and the loss of eye surface sensation which reduces protective reflexes and can lead the corneal irritation and possibly abrasion.  If eye contact occurs, rinse out the eye immediately with saline or water and protect the eye surface until sensation is restored.

PRECAUTIONS: If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy.  If extensive areas are treated, the possibility of systemic absorption exists.  Systemic absorption of topical steroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glycosuria in some patients.  Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use and the addition of occlusive dressings.  Therefore, patients receiving a large dose of  potent topical steroids applied to a large surface area,  or under an occlusive dressing, should be evaluated periodically for evidence of HPA axis suppression.  If noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid.  Recovery of the HPA axis function generally prompt and complete upon discontinuation of the drug.  Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.  Children may absorb proportionately larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.  If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.  In the presence of dermatological or antibacterial agent should be instituted.  If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Carcinogenesis, Mutagenesis adn Impairment of Fertility: Long term animal studies have not been performed to evaluate the carcinogenic potential or the affect on the fertility or topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential on the effect on fertility have not been conducted.

Use in Pregnancy: Teratogenic Effects: Pregnancy Category C.  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.  They 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.

Corticosteroids are generally teratogenic in laboratory animal  when administered systemically at relatively low dosage levels.  The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.  They are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids.  Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.  Drugs of this calss should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

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 administrated to a nursing mother.

ADVERSE REACTIONS: During or immediately following application of Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream, there may be transient stinging or burning from open areas of skin, or transient blanching (lightening), or erythema (redness) of the skin.

DOSAGE AND ADMINISTRATION: Apply Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream to the affected area(s) twice daily or as directed by a physician.  The cap should be removed form the tube of Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream and the applicator tip firmly screwed onto the and of the tube and tightened.  Do not over-tightnen.  While holding the tube, squeeze the tube to fill the applicator until a small amount of cream shows and lubricate the end of the tip with cream.  Gently insert the applicator tip with attached tube into anal area.  Continue squeezing the body of the tube as it is moved around the areas of discomfort, and lastly, around and in the anal opening (if directed by a physician).

Do not completely insert the applicator and tube into the anus or insert deep into the rectum.  Do not insert a loose applicator tip into the anus or rectum.  Once application is completed, the tube and applicator tip should be gently removed from the area and disposed.  Note that an adequate amount of Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream for an application to the anal and peri-anal area will be applied through the applicator tip by gently squeezing the tube during application.  Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream should not be used in excess of recommendations or for prolonged use in the anal canal.  If the condition does not respond to repeated courses of Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream, or should worsen, discontinue use and seek the advice of your physician.

HOW SUPPLIED:Lidocaine HCl and Hydrocortisone Acetate 0.5% Cream kit - NDC 0168-0479-14 contains 14 tubes, 1/4 oz (7g) each and 14 single-use applicators.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at 15-30°C (59-86°F) Protect from freezing.

Manufactured for:

E.FOUGERA AND CO.
A division of Nycomed US Inc.
Melville, New York 11747


Manufactured by: Groupe PARIMA, Inc.
Montreal, QC H4S 1X6 CANADA

Image tube label


LIDOCAINE HCL AND HYDROCORTISONE ACETATE  
lidocaine hydrochloride and hydrocortisone acetate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0479
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 30 mg  in 1 g
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM SULFATE  
CALCIUM ACETATE  
CETYL ALCOHOL  
GLYCERIN  
HYDROCHLORIC ACID  
METHYLPARABEN  
MINERAL OIL  
PETROLATUM  
POLYSORBATE 60  
PROPYLENE GLYCOL  
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:0168-0479-14 7 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/19/2010

Labeler - E. Fougera & Co. A division of Nycomed US Inc. (043838424)
Registrant - Nycomed US Inc. (043838424)
Establishment
Name Address ID/FEI Operations
Groupe Parima Inc. 252437850 manufacture, analysis

Revised: 01/2010 E. Fougera & Co. A division of Nycomed US Inc.



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


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