LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE- lidocaine hydrochloride and hydrocortisone acetate cream

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Seton Pharmaceuticals

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Product is used for the anti-inflammatory and anesthetic relief of pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritus ani, pruritus vulvae, hemorrhoids, anal fissures and similar conditions of the skin and mucous membranes. 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. This product 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. 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. Safety and efficacy in children have not been established.

Proizvod sažetak:

Lidocaine 3% - Hydrocortisone 0.5% Cream is supplied as a white cream in: 1 oz (28.35 g) tubes NDC 13925-160-01 3 oz (85 g) tubes NDC 13925-160-03 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-77°F). See USP Controlled Room Temperature. Protect from freezing.

Status autorizacije:

unapproved drug other

Svojstava lijeka

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
RX ONLY
ANTI-INFLAMMATORY ANESTHETIC FOR RELIEF OF HEMORRHOID PAIN SWELLING
AND
INFLAMMATION
DESCRIPTION:
Lidocaine 3% - Hydrocortisone 0.5% Cream is 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: Each gram of Lidocaine 3% - Hydrocortisone 0.5%
Cream
contains lidocaine hydrochloride 3% (30mg) and hydrocortisone acetate
0.5% (5 mg).
INACTIVE INGREDIENTS: aluminum sulfate, calcium acetate, cetyl
alcohol,
hydrochloric acid, methylparaben, mineral oil, polysorbate 60,
propylene glycol,
propylparaben, purified water, sodium hydroxide, sorbitan stearate,
stearic acid, stearyl
alcohol, and white petrolatum.
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 dosage. In general, the rate of
absorption of l