NDC 59088-819 Lidocaine Hcl - Hydrocortisone Acetate

Lidocaine Hcl And Hydrocortisone Acetate

NDC Product Code 59088-819

NDC CODE: 59088-819

Proprietary Name: Lidocaine Hcl - Hydrocortisone Acetate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Lidocaine Hcl And Hydrocortisone Acetate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat hemorrhoids and itching/swelling in the rectum and anus. It is also used with other medications to treat certain intestinal problems (such as ulcerative colitis of the rectum and other rectal/anal inflammatory conditions). Hydrocortisone suppositories help to relieve rectal pain, itching, bloody diarrhea, and bleeding by reducing swelling (inflammation) directly in the rectum and anus. Hydrocortisone belongs to a class of drugs called corticosteroids.

NDC Code Structure

NDC 59088-819-03

Package Description: 1 TUBE in 1 CARTON > 28.3 g in 1 TUBE

NDC 59088-819-07

Package Description: 1 TUBE in 1 CARTON > 85 g in 1 TUBE

NDC 59088-819-14

Package Description: 14 TUBE in 1 KIT > 7 g in 1 TUBE (59088-819-01)

NDC 59088-819-20

Package Description: 20 TUBE in 1 KIT > 7 g in 1 TUBE (59088-819-01)

NDC Product Information

Lidocaine Hcl - Hydrocortisone Acetate with NDC 59088-819 is a a human prescription drug product labeled by Puretek Corporation. The generic name of Lidocaine Hcl - Hydrocortisone Acetate is lidocaine hcl and hydrocortisone acetate. The product's dosage form is cream and is administered via rectal; topical form.

Labeler Name: Puretek Corporation

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Lidocaine Hcl - Hydrocortisone Acetate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LIDOCAINE HYDROCHLORIDE 30 mg/g
  • HYDROCORTISONE ACETATE 5 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALUMINUM SULFATE (UNII: 34S289N54E)
  • CALCIUM ACETATE (UNII: Y882YXF34X)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Rectal - Administration to the rectum.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Amide Local Anesthetic - [EPC] (Established Pharmacologic Class)
  • Amides - [CS]
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
  • Local Anesthesia - [PE] (Physiologic Effect)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Puretek Corporation
Labeler Code: 59088
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 07-01-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Lidocaine Hcl - Hydrocortisone Acetate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

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 biotransformation of the liver.


Lidocaine
is metabolized rapidly by the liver, and metabolites and unchanged drug
are excreted by the kidneys. Biotransformation includes oxidative
N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and
conjungation. N-dealkylation, a major pathway of biotransformation,
yields the metabolites monoethylglycinexylidide and glycinexylidide. The
pharmacological/toxicological actions of these metabolites are similar
to, but less potent than, those of lidocaine. Approximately 90% of
lidocaine administered is excreted in the form of various metabolites,
and less than 10% is excreted unchanged. The primary metabolite in
urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline.


The
plasma binding of lidocaine is dependent of drug concentration, and the
fraction bound decreases with increasing concentration. At
concentrations of 1 to 4 g of free base per mL, 60 to 80 percent of
lidocaine is protein bound. Binding is also dependent on the plasma
concentration of the alpha-1-acid-glycoprotein.


Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion.


Studies
of lidocaine metabolism following intravenous bolus injections have
shown that the elimination half-life of this agent is typically 1.5 to
2 hours. Because of the rapid rate at which lidocaine is metabolized,
any condition that affects liver function may alter lidocaine kinetics.
The half-life may be prolonged two-fold or more in patients with liver
dysfunction. Renal dysfunction does not affect lidocaine kinetics but
may increase the accumulation of metabolites.


Factors such as
acidosis and the use of CNS stimulants and depressants affect the CNS
levels of lidocaine required to produce overt systemic effects.
Objective adverse manifestations become increasingly apparent with
increasing venous plasma levels above 6 g free base per mL. In the
rhesus monkey arterial blood levels of 18-21 g/mL have been shown to be
the threshold for convulsive activity.


The extent of percutaneous
absorption of topical corticosteroids is determined by many factors
including the vehicle, the integrity of the epidermal barrier, and the
use of occlusive dressings.


Topical corticosteroids can be
absorbed from normal intact skin. Inflammation and/or other disease
processes in the skin increase percutaneous absorption. Occlusive
dressings substantially increase the percutaneous absorption of topical
corticosteroids. Thus, occlusive dressings may be a valuable
therapeutic adjunct for treatment of resistant dermatoses.


Once
absorbed through the skin, topical corticosteroids are handled through
pharmacokinetic pathways similar to systemically administered
corticosteroids. Corticosteroids are bound to plasma protein in varying
degrees. Corticosteroids are metabolized primarily in the liver and are
then excreted by the kidneys. Some of the topical corticosteroids and
their metabolites are also excreted into the bile.

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.

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 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 those patients with a history of hypersensitivity to any components of the preparation.

Warnings:

For external use only. Not for ophthalmic use. Product and used applicators could harm small children if chewed or swallowed.


Keep out of reach of children.Topical
formulations of lidocaine may be absorbed to a greater extent through
mucous membranes and abraded, fissured or irritated skin than through
intact skin. Product should not be ingested or applied into the mouth,
inside of the nose or in the eyes. Product should not be used in the
ears. Any situation where lidocaine penetrates beyond the tympanic
membrane into the middle ear is contraindicted because of ototoxicty
associated with lidocaine observed in animals when instilled in the
middle ear. Product should not come into contact with the eye or be
applied into the eye because of the risk of severe eye irritation and
the loss of eye surface sensation, which reduces protective reflexes and
can lead to corneal irritation and possibly abrasion. If eye contact
occurs, rinse out the eye immediately with saline or water and protect
the eye surface until sensation is restored.

Precautions:

If
irritation or sensitivity occurs or infection appears, discontinue use
and institute appropriate therapy. If extensive areas are treated, the
possibility of systemic absorption exists. Systemic absorption of topical
steroids has produced reversible hypothalamic-pituitary-adrenal (HPA)
axis suppression, manifestation of Cushing’s syndrome, hyperglycemia,
and glycosuria in some patients. Conditions which augment systemic
absorption include the application of the more potent steroids, use over
large surface areas, prolonged use, and the addition of occlusive
dressings. Therefore, patients receiving a large dose of potent topical
steroids applied to a large surface area, or under an occlusive
dressing, should be evaluated periodically for evidence of HPA axis
suppression. If noted, an attempt should be made to withdraw the drug,
to reduce the frequency of application, or to substitute a less potent
steroid. Recovery of the HPA axis function is generally prompt and complete
upon discontinuation of the drug. Infrequently, signs and symptoms of
steroid withdrawal may occur, requiring supplemental systemic
corticosteroids. Children may absorb proportionately larger amounts of
topical corticosteroids and thus be more susceptible to systemic
toxicity. If irritation develops, topical steroids should be
discontinued and appropriate therapy instituted. In the presence of
dermatological infections, the use of an appropriate antifungal or
antibacterial agent should be instituted. If a favorable response does
not occur promptly, the corticosteroid should be discontinued until the
infection has been adequately controlled.

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.

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 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.

Nursing Mothers:

It is not
known whether this drug is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when this drug
is administered to a nursing mother.

Pediatric Use:

Safety and efficacy in children have not been established.

Adverse Reactions:

During or immediately 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.

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 used in the anal canal. If the condition does not respond to repeated courses of product or should worsen, discontinue use and seek the advise of your physician. 


Products without applicators:


Remove the child-resistant cap and foil seal from the tube.


Apply a thin film to the affected area. Replace the cap after use. 


Products with Single-Use Tubes and Applicators: Tear open one cleansing wipe packet (if the product kit contains such item), gently clean the affected area and discard the used cleansing wipe. Remove the child-resistant cap and foil seal from one tube and firmly screw one applicator onto the tube. Do not over tighten. Squeeze the tube to fill the applicator until a small amount of cream/gel comes out of and lubricates the applicator openings. Gently insert the applicator tip with attached tube into anal area. Continue squeezing the body of the tube as it is moved around 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, both the tube and applicator should be gently removed and discarded.

How Supplied:

PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream 1 oz (28.3g) tube - NDC 59088-819-03PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 0.5% Cream 3 oz (85g) tube - NDC 59088-819-07PharmaPure 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.

Keep This And All Medications Out Of Reach Of Children.

Store at 20°-25°C (68°-77°F) [see USP Controlled Temperature].Protect from freezing.

* Please review the disclaimer below.