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LIDOCAINE HCL - HYDROCORTISONE ACETATE
lidocaine hydrochloride and
hydrocortisone acetate gel
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.
DESCRIPTION:Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation.
Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:
Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:
INGREDIENTS: PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 2.5% Gel
Each gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 25 mg.
LIDOCAINE HCl 3%
HYDROCORTISONE ACETATE 2.5%
INACTIVE INGREDIENTS:ALUMINUM SULFATE, CALCIUM ACETATE, CARBOMER, CETYL ALCOHOL, CITRIC ACID, DIAZOLIDINYL UREA, GLYCERIN, GLYCERYL STEARATE, METHYLPARABEN, MINERAL OIL, PEG-100 STEARATE, PETROLATUM, PROPYLENE GLYCOL, PROPYLPARABEN, PURIFIED WATER, SODIUM CITRATE, SODIUM HYDROXIDE, SORBITAN STEARATE, STEARIC ACID, STEARYL ALCOHOL.
MECHANISM OF ACTION:
Product releases lidocaine 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.
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.
INDICATIONS:Product 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:Product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics. If excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. Product 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. Product should be used with caution in patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic. Product is contraindicated for tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any components of the preparation.
For external use only. Not for ophthalmic use. Product and used applicators could harm small children if chewed or swallowed.
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, manifestation 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 is 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 steroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal 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, AND IMPAIRMENT OF FERTILITY:Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of 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 of the effect on fertility have not been conducted.
USE IN PREGNANCY:
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. 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. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There 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 class should not be used extensively on pregnant patients, in large amounts or for prolonged periods of time.
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.
ADVERSE REACTIONS:During or immediately following application of product, 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 product to the affected area(s) twice daily or as directed by a physician. The cap and foil seal should be removed from the tube and the applicator tip firmly screwed onto the end of the tube and tightened. Do not over tighten. While holding the tube, squeeze the tube to fill the applicator until a small amount of cream/gel shows and lubricates the end of the tip with cream/gel. 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 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 product for an application to the anal and peri-anal area will be applied through the applicator tip by gently squeezing the tube during application. Product 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 product or should worsen, discontinue use and seek the advice of your physician.
PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 2.5% Gel KIT
contains 20 Single-Use 1/4 oz (7 g) Tubes, Applicators and Cleansing
Wipes. NDC 59088-838-20.
KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.
Store at controlled room temperature 15°-30°C (59°-86°F).
Revised: 06/2011 PureTek Corporation
Reproduced with permission of U.S. National Library of Medicine
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