NDC 0037-6822 Proctofoam HC

Pramoxine Hydrochloride Hydrocortisone Acetate

NDC Product Code 0037-6822

NDC CODE: 0037-6822

Proprietary Name: Proctofoam HC 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: Pramoxine Hydrochloride 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

  • 0037 - Meda Pharmaceuticals

NDC 0037-6822-10

Package Description: 1 CANISTER in 1 CARTON > 10 g in 1 CANISTER

NDC Product Information

Proctofoam HC with NDC 0037-6822 is a a human prescription drug product labeled by Meda Pharmaceuticals. The generic name of Proctofoam HC is pramoxine hydrochloride hydrocortisone acetate. The product's dosage form is aerosol, foam and is administered via topical form.

Labeler Name: Meda Pharmaceuticals

Dosage Form: Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.

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.

Proctofoam HC 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.

  • PRAMOXINE HYDROCHLORIDE 100 mg/10g
  • HYDROCORTISONE ACETATE 100 mg/10g

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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • LAURETH-23 (UNII: N72LMW566G)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • WATER (UNII: 059QF0KO0R)
  • ISOBUTANE (UNII: BXR49TP611)
  • PROPANE (UNII: T75W9911L6)

Administration Route(s)

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

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

  • 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: Meda Pharmaceuticals
Labeler Code: 0037
FDA Application Number: ANDA086195 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 08-15-2014 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: 12-31-2020 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’.

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Information for Patients

Hydrocortisone Topical

Hydrocortisone Topical is pronounced as (hye droe kor' ti sone)

Why is hydrocortisone topical medication prescribed?
Hydrocortisone is available with or without a prescription. Low-strength preparations (0.5% or 1%) are used without a prescription for the temporary relief of (1) minor s...
[Read More]
Pramoxine

Pramoxine is pronounced as (pra mox' een)
Why is pramoxine medication prescribed?
Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation...
[Read More]

* Please review the disclaimer below.

Proctofoam HC 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

Other

Topical aerosolRx OnlyIN-682210-01CIA71190CRev. 9/2013

Hydrocortisone acetateMolecular weight: 404.50. Solubility of hydrocortisone acetate in water: 1 mg/100 mL.Chemical name: pregn-4-ene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11β)-.

Pramoxine hydrochlorideMolecular weight: 329.86. Pramoxine hydrochloride is freely soluble in water. Chemical name: morpholine, 4-[3-(4-butoxyphenoxy) propyl]-, hydrochloride.

Directions for Use.1. Place cap on top of container. Shake foam container vigorously for 5 — 10 seconds before each use. Do not remove container cap during use of the product.2. Hold container upright on a level surface and gently place the tip of the applicator onto the nose of the container cap. CONTAINER MUST BE HELD UPRIGHT TO OBTAIN PROPER FLOW OF MEDICATION.3. Pull plunger past the fill line on the applicator barrel.4. Hold the container and applicator at eye level. Place the index and middle fingers on the container cap flanges and the thumb beneath the container. Support the applicator with your other hand. Prime the container by pressing down firmly on flanges and then release. With initial priming, a burst of air may come out of the container. It usually requires 1 — 2 pumps for foam to appear.5. To fill applicator barrel, press down firmly on cap flanges, hold for 1 — 2 seconds, and release. Wait 5 — 10 seconds to allow foam to expand in applicator barrel. Repeat until foam reaches fill line. It usually requires 3 — 4 pumps for foam to reach fill line. Remove applicator from container cap. Note: If foam goes beyond fill line, it will continue to expand and flow backwards resulting in foam build-up under cap.6. Hold applicator firmly by barrel, making sure thumb and middle finger are positioned securely underneath and resting against barrel wings. Place index finger over the plunger. Gently insert tip into anus. Once in place, push plunger to expel foam, then withdraw applicator. CAUTION: Do not insert any part of the aerosol container directly into the anus. Apply to anus only with enclosed applicator. Do not insert any part of the applicator past the anus into rectum.7. After each use, applicator parts should be pulled apart for thorough cleaning with warm water. Since some foam will appear under the cap, the cap and underlying tip should be pulled apart and rinsed to help prevent build-up of foam and possible blockage.

Description

DESCRIPTION: Proctofoam®-HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam for anal use containing hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a hydrophilic base containing cetyl alcohol, emulsifying wax, methylparaben, polyoxyethylene-10-stearyl ether, propylene glycol, propylparaben, purified water, trolamine and inert propellants: isobutane and propane. Proctofoam®-HC contains a synthetic corticosteroid used as an anti-inflammatory/antipruritic agent and a local anesthetic.

Clinical Pharmacology

CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.Pramoxine hydrochloride is a surface or local anesthetic which is not chemically related to the "caine" types of local anesthetics. Its unique chemical structure is likely to minimize the danger of cross-sensitivity reactions in patients allergic to other local anesthetics.

Pharmacokinetics

Pharmacokinetics: 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 through normal intact skin. Inflammation and/or other disease processes in the skin increase the percutaneous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION.)Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins 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 & Usage

INDICATIONS AND USAGE: Proctofoam®-HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.

Contraindications

CONTRAINDICATIONS: Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Warnings

WARNINGS: Do not insert any part of the aerosol container directly into the anus. Avoid contact with the eyes. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). If there is no evidence of clinical improvement within two or three weeks after starting Proctofoam®-HC therapy, or if the patient's condition worsens, discontinue the drug. Keep this and all medicines out of the reach of children.

General Precautions

PRECAUTIONS:General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria 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 a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is 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 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. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (see PRECAUTIONS - Pediatric Use.)If irritation develops, topical corticosteroids 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.

Information For Patients

Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for anal or perianal use only. Avoid contact with eyes.2. Be advised not to use this medication for any disorder other than for which it has been prescribed.3. Report any signs of adverse reactions.

Laboratory Tests

Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression:Urinary free cortisol testACTH stimulation test

Carcinogenesis & Mutagenesis & Impairment Of Fertility

Carcinogenesis, Mutagenesis, 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.

Pregnancy

Pregnancy: Teratogenic Effects. Pregnancy Category C.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, well-controlled studies of teratogenic effects from topically applied corticosteroids in pregnant women. 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

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Geriatric Use

Geriatric Use: Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious using the least amount compatible with an effective therapeutic regimen and reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 866-210-5948 or FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.

Overdosage

OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

Dosage & Administration

DOSAGE AND ADMINISTRATION: Apply to affected area 3 to 4 times daily. Use the applicator supplied for anal administration. For perianal use, transfer a small quantity to a tissue and rub in gently.

How Supplied

HOW SUPPLIED: Proctofoam®-HC is supplied in an aerosol container with a special anal applicator. When used correctly, the aerosol container will deliver a minimum of 14 applications.NDC 0037-6822-10                10 gStore upright at controlled room temperature 20°-25°C (68°-77°F). DO NOT REFRIGERATE.

Storage And Handling

  • Distributed by: MEDA PHARMACEUTICALS® Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120©2013 Meda Pharmaceuticals Inc.  PROCTOFOAM and MEDA PHARMACEUTICALS are registered trademarks of Meda AB or a related entity. IN-682210-01    CIA71190C     Rev. 9/2013

Spl Patient Package Insert

  • PLEASE READ CAREFULLY BEFORE USING  PATIENT INSTRUCTIONS FORproctofoam® HC(hydrocortisone acetate 1% and pramoxine hydrochloride 1%)TOPICAL AEROSOLKeep this insert. It contains important information about the use of proctofoam® HC. •Place cap on top of container. Shake foam container vigorously for 5-10 seconds before each use. Do not remove container cap during use of the product. •Hold container upright on a level surface and gently place the tip of the applicator onto the nose of the container cap. CONTAINER MUST BE HELD UPRIGHT TO OBTAIN PROPER FLOW OF MEDICATION. •Pull plunger past the fill line on the applicator barrel. Steps 4-7 are continued on the other side •Hold the container and applicator at eye level. Place the index and middle fingers on the container cap flanges and the thumb beneath the container. Support the applicator with your other hand. Prime the container by pressing down firmly on flanges and then release. With initial priming, a burst of air may come out of the container. It usually requires 1-2 pumps for foam to appear. •To fill applicator barrel, press down firmly on cap flanges, hold for 1-2 seconds, and release. Wait 5-10 seconds to allow foam to expand in applicator barrel. Repeat until foam reaches fill line. It usually requires 3-4 pumps for foam to reach fill line. Remove applicator from container cap. Note: If foam goes beyond fill line, it will continue to expand and flow backwards resulting in foam build-up under cap. •Hold applicator firmly by barrel, making sure thumb and middle finger are positioned securely underneath and resting against barrel wings. Place index finger over the plunger. Gently insert tip into anus. Once in place, push plunger to expel foam, then withdraw applicator. CAUTION: Do not insert any part of the aerosol container directly into the anus. Apply to anus only with enclosed applicator. Do not insert any part of applicator past the anus into rectum. •After each use, applicator parts should be pulled apart for thorough cleaning with warm water. Since some foam will appear under the cap, the cap and underlying tip should be pulled apart and rinsed to help prevent build-up of foam and possible blockage.Distributed by: MEDA PHARMACEUTICALS® Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120©2013 Meda Pharmaceuticals Inc.PROCTOFOAM and MEDA PHARMACEUTICALS are registered trademarks of Meda AB or a related entity.To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 866-210-5948 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.IS-682210-01CIA71191B Rev. 09/2013

* Please review the disclaimer below.