LIDOCAINE HCL - HYDROCORTISONE ACETATE- lidocaine hcl and hydrocortisone acetate cream

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Доступно од:

PureTek Corporation

Пут администрације:

RECTAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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. 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 or skin vaccinia, varicella and acute herpes simplex. Topical corticosteroids are contraindicated in t

Резиме производа:

PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 1% Cream KIT contains 20 Single-Use 1/4 oz (7 g) Tubes, Applicators and Cleansing Wipes. NDC 59088-771-20.

Статус ауторизације:

unapproved drug other

Карактеристике производа

LIDOCAINE HCL - HYDROCORTISONE ACETATE - LIDOCAINE HCL AND
HYDROCORTISONE
ACETATE 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:
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:
NGREDIENTS: PHARMAPURE RX LIDOCAINE HCL 3% - HYDROCORTISONE ACETATE 1%
CREAMEach
gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 10 mg.
ACTIVE INGREDIENTS:
LIDOCAINE HCl 3%
HYDROCORTISONE ACETATE 1%
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, SODIUM LAURYL
SULFATE,
SORBITAN STEARATE, STEARIC ACID, STEARYL ALCOHOL, TROLAMINE.
CLINICAL PHARMACOLOGY:
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.
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-abso