LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Seton Pharmaceuticals

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 30 mg in 1 g

Administration route:

RECTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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.

Product summary:

Lidocaine 3% - Hydrocortisone 2.5% Gel Kit 20 Count Kit, NDC 13925-164-20 Containing: 20 single use ¼ oz (7g) Tubes (NDC 13925-164-07) of Lidocaine 3% - Hydrocortisone 2.5% Gel (a white gel), 20 Applicators and 20 Moist Wipes

Authorization status:

unapproved drug other

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE- LIDOCAINE
HYDROCHLORIDE AND HYDROCORTISONE ACETATE GEL
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._
----------
LIDOCAINE 3% - HYDROCORTISONE 2.5% GEL KIT
RX ONLY
ANTI-INFLAMMATORY ANESTHETIC FOR RELIEF OF HEMORRHOID PAIN, SWELLING
AND
INFLAMMATION
DESCRIPTION:
Lidocaine 3% - Hydrocortisone 2.5% Gel 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 2.5% GEL KIT
lidocaine hydrochloride 3% (30mg) and hydrocortisone acetate 2.5% (25
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:
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 anestheti