Lidocaine Hydrochloride And Hydrocortisone Acetate

Seton Pharmaceuticals
Human Prescription Drug
NDC 13925-164

Lidocaine Hydrochloride And Hydrocortisone Acetate is a human prescription drug labeled by 'Seton Pharmaceuticals'. National Drug Code (NDC) number for Lidocaine Hydrochloride And Hydrocortisone Acetate is 13925-164. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Lidocaine Hydrochloride And Hydrocortisone Acetate drug includes Hydrocortisone Acetate - 25 mg/g Lidocaine Hydrochloride - 30 mg/g . The currest status of Lidocaine Hydrochloride And Hydrocortisone Acetate drug is Active.

Drug Information:

Drug NDC:	13925-164
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Lidocaine Hydrochloride And Hydrocortisone Acetate
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Lidocaine Hydrochloride And Hydrocortisone Acetate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Seton Pharmaceuticals
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	HYDROCORTISONE ACETATE - 25 mg/g LIDOCAINE HYDROCHLORIDE - 30 mg/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	RECTAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	17 Jun, 2011
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Seton Pharmaceuticals
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1012223
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	3X7931PO74 V13007Z41A
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Amide Local Anesthetic [EPC] Amides [CS] Antiarrhythmic [EPC] Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC] Local Anesthesia [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
13925-164-20	20 TUBE in 1 KIT (13925-164-20) / 7 g in 1 TUBE (13925-164-07)	17 Jun, 2011	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Product Elements:

Lidocaine hydrochloride and hydrocortisone acetate lidocaine hydrochloride and hydrocortisone acetate lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous hydrocortisone acetate hydrocortisone aluminum sulfate calcium acetate cetyl alcohol anhydrous citric acid glyceryl stearate se peg-100 stearate methylparaben mineral oil peg-150 distearate petrolatum polycarbophil propylene glycol propylparaben water sodium citrate sodium hydroxide stearyl alcohol xanthan gum

Drug Interactions:

Drug interactions: patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: class examples nitrates/nitrites nitroglycerin, nitroprusside, nitric oxide, nitrous oxide local anesthetics benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine antineoplastic agents cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea antibiotics dapsone, sulfonamides, nitrofurantoin, para-aminosalicylic acid antimalarials chloroquine, primaquine anticonvulsants phenytoin, sodium valproate, phenobarbital other drugs acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), quinine

Warnings:

Warnings: for external use only. not for ophthalmic use. product, applicators and moist wipes could harm small children if chewed or swallowed. keep product, moist wipes and applicators out of the reach of children. methemoglobinemia cases of methemoglobinemia have been reported in association with local anesthetic use. although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. if local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal colorat Read more...

ion of the blood. methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. discontinue [the use of this product] and any other oxidizing agents. depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. more severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

Dosage and Administration:

Dosage and administration: apply product to the affected area(s) twice daily or as directed by a physician. product should not be used in excess of recommendations or for prolonged use in the anal canal. if the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advice of your physician. patient directions for rectal administration: remove moist wipe from box, tear open the package, gently clean the affected area and discard moist wipe. (note: the moist wipe does not contain any of the prescribed active ingredients.) the cap and foil seal should be removed from the tube and the applicator tip firmly screwed onto the end of the tube and tightened. (do not over tighten.) while holding the tube, gently squeeze the tube until a small amount of cream/gel comes out of the applicator openings. this will lubricate the applicator tip. gently insert the applicator tip into anal area. continue squeezing the body of the tube as you move it aroun Read more...

d the areas of discomfort, and lastly, around and in the anal opening (if directed by physician). do not completely insert the applicator and tube into the anus or insert deep into the rectum. do not insert a loose applicator tip into the anus or rectum. once application is completed, the tube and applicator tip should be gently removed and discarded.

Contraindications:

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 âcaineâ 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.

Adverse Reactions:

Adverse reactions: during, immediately, or following application of product, there may be transient stinging or burning from open areas of skin, or transient blanching (lightening), or erythema (redness) of the skin. call your doctor about side effects. you may report side effects to the fda at 1-800-fda-1088.

Drug Interactions:

Use in Pregnancy:

Use in pregnancy: teratogenic effects: 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 us Read more...

ed 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.

Pediatric Use:

Pediatric use: safety and efficacy in children have not been established.

Description:

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.

Clinical Pharmacology:

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-(11Ã)-. it has the following structural formula: lidocaine structure hydrocortisone structure

Mechanism of Action:

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-(11Ã)-. it has the following structural formula: lidocaine structure hydrocortisone structure

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, and impairment of fertility: long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted.

How Supplied:

How supplied: lidocaine 3% - hydrocortisone 2.5% gel kit 20 count kit, ndc 13925-164-20 containing: 20 single use Â¼ oz (7g) tubes (ndc 13925-164-07) of lidocaine 3% - hydrocortisone 2.5% gel (a white gel), 20 applicators and 20 moist wipes

Package Label Principal Display Panel:

Package label.principal display panel: rx only ndc-13925-164-20 lidocaine 3% hydrocortisone 2.5% gel kit contents: 20 single-use 1/4 oz. (7 g) tubes, applicators and moist wipes. for external use only. not for ophthalmic use. seton pharmaceuticals carton

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.