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

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:

PureTek Corporation

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 30 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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. 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 t

Product summary:

PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream 1 oz (28.3g) tube - NDC 59088-819-03 PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream 3 oz (85g) tube - NDC 59088-819-07 PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream KIT contains 14 Single-Use 1/4 oz (7 g) Tubes and Applicators. NDC 59088-819-14. PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream KIT contains 20 Single-Use 1/4 oz (7 g) Tubes, Applicators and Cleansing Wipes. NDC 59088-819-20.

Authorization status:

unapproved drug other

Summary of Product characteristics

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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LIDOCAINE HCI 3% - HYDROCORTISONE ACETATE 0.5% CREAM
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:
PHARMAPURE RX LIDOCAINE HCL 3% - HYDROCORTISONE ACETATE 0.5% CREAMEach
gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 5 mg.
ACTIVE INGREDIENTS:
LIDOCAINE HCl 3%
HYDROCORTISONE ACETATE 0.5%
INACTIVE INGREDIENTS:
ALUMINUM SULFATE, CALCIUM ACETATE, CETYL ALCOHOL, METHYLPARABEN,
MINERAL
OIL, POLYSORBATE 60, PROPYLENE GLYCOL, PROPYLPARABEN, PURIFIED WATER,
SODIUM HYDROXIDE, SORBITAN STEARATE, STEARIC ACID, STEARYL ALCOHOL.
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-absorbed from the
gastrointestinal tract, but little
intact drug appears in the circulation because of biotransformat