LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE cream

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Seton Pharmaceuticals

INN (International namn):

LIDOCAINE HYDROCHLORIDE

Sammansättning:

LIDOCAINE HYDROCHLORIDE 30 mg in 1 g

Administreringssätt:

RECTAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 on patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive and generally synergistic. These products are contraindicated for tuberculous or fungal lesions or skin vaccinia, varicella and acute herpes simplex. Topical corticosteroids are contraindica

Produktsammanfattning:

Lidocaine 3% - Hydrocortisone 0.5% Cream Kit 14 Count Kit, NDC 13925-157-14 Containing: 14 single use ¼ oz (7g) Tubes (NDC 13925-157-07) of Lidocaine 3% - Hydrocortisone 0.5% Cream (a white cream), 14 Applicators and 14 Moist Wipes

Bemyndigande status:

unapproved drug other

Produktens egenskaper

LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE- LIDOCAINE
HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM
SETON PHARMACEUTICALS
_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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LIDOCAINE 3% - HYDROCORTISONE 0.5% CREAM KIT
RX ONLY
ANTI-INFLAMMATORY ANESTHETIC FOR RELIEF OF HEMORRHOID PAIN, SWELLING
AND
INFLAMMATION
DESCRIPTION:
Lidocaine 3% - Hydrocortisone 0.5% Cream Kit are indicated 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.
ACTIVE INGREDIENTS:
LIDOCAINE 3% - HYDROCORTISONE 0.5% CREAM KIT
lidocaine hydrochloride 3% (30mg) and hydrocortisone acetate 0.5% (5
mg) per gram.
INACTIVE INGREDIENTS:
aluminum sulfate, calcium acetate, cetyl alcohol, citric acid,
glyceryl stearate (and) PEG-
100 stearate, methylparaben, mineral oil, PEG-150 distearate,
petrolatum, polycarbophil,
propylene glycol, propylparaben, purified water, sodium citrate,
sodium hydroxide,
stearyl alcohol, xanthan gum.
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. 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-(11ß)-. It has the following structural formula:
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 dosag