Halog

Halcinonide


E.r. Squibb & Sons, L.l.c.
Human Prescription Drug
NDC 0003-0249
Halog also known as Halcinonide is a human prescription drug labeled by 'E.r. Squibb & Sons, L.l.c.'. National Drug Code (NDC) number for Halog is 0003-0249. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Halog drug includes Halcinonide - 1 mg/mL . The currest status of Halog drug is Active.

Drug Information:

Drug NDC: 0003-0249
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: Halog
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: Halcinonide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: E.r. Squibb & Sons, L.l.c.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Solution
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:HALCINONIDE - 1 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
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: NDA
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: 01 Jan, 2009
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 Mar, 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.
Application Number: NDA017823
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.
Listing Expiration Date: 16 Mar, 2025
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:E.R. Squibb & Sons, L.L.C.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
NUI:N0000175576
N0000175450
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:SI86V6QNEG
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 MOA:Corticosteroid Hormone Receptor Agonists [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:Corticosteroid [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:Corticosteroid Hormone Receptor Agonists [MoA]
Corticosteroid [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0003-0249-1520 mL in 1 BOTTLE, PLASTIC (0003-0249-15)01 Jan, 2009N/ANo
0003-0249-2060 mL in 1 BOTTLE, PLASTIC (0003-0249-20)01 Jan, 2009N/ANo
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.

Product Elements:

Halog halcinonide halcinonide halcinonide edetate disodium polyethylene glycol 300 water butylated hydroxytoluene

Indications and Usage:

Indications and usage halog solution (halcinonide topical solution, usp) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

General 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 any 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, and for impairment of thermal homeostasis. if hpa axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, substitute a less potent steroid, or use a sequential approach when utilizing the occlusive technique. recovery of hpa axi
s function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. occasionally, a patient may develop a sensitivity reaction to a particular occlusive dressing material or adhesive and a substitute material may be necessary. children 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. this preparation is not for ophthalmic use.

Dosage and Administration:

Dosage and administration apply halog solution (halcinonide topical solution, usp) 0.1% to the affected area two to three times daily. occlusive dressing technique occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. apply the solution to the lesion, cover with a pliable nonporous film, and seal the edges. if needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. the frequency of changing dressings is best determined on an individual basis. it may be convenient to apply halog solution under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). when utilizing the 12-hour occlusion regimen, additional solution should be applied, without occlusion, during the day. reapplication is essential at each dressing change.
if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Contraindications:

Contraindications topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

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 (reactions are listed in an 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.

Use in Pregnancy:

Pregnancy teratogenic effects: 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 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.

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. hpa axis suppression, cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children 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 children should be limited to the least amount compatible with an effective therapeutic regimen. chronic corticosteroid therapy may interfere with the growth and development of children.

Geriatric Use:

Geriatric use clinical studies of 0.1% halog solution did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. other 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, usually starting at the low end of the dosing range.

Overdosage:

Overdosage topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see precautions: general ).

Description:

Description the topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. the steroids in this class include halcinonide. halcinonide is designated chemically as 21-chloro-9-fluoro-11β,16α, 17-trihydroxypregn-4-ene-3,20-dione cyclic 16,17-acetal with acetone. graphic formula: c 24 h 32 clfo 5 , mw 454.96, cas-3093-35-4 each ml of 0.1% halog solution (halcinonide topical solution, usp) contains 1 mg halcinonide, edetate disodium, polyethylene glycol 300, and purified water with butylated hydroxytoluene as an antioxidant. halcinonide solution chemical structure

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. 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 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 (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.

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 showed negative results.

How Supplied:

How supplied halog ® solution (halcinonide topical solution, usp) 0.1% is supplied in plastic squeeze bottles containing 20 ml (ndc 0003-0249-15) and 60 ml (ndc 0003-0249-20) of solution. storage store at room temperature; avoid freezing and temperatures above 104° f.

Information for Patients:

Information for the patient patients using topical corticosteroids should receive the following information and instructions: this medication is to be used as directed by the physician. it is for dermatologic use only. avoid contact with the eyes. patients should be advised not to use this medication for any disorder other than for which it was prescribed. the treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. patients should report any signs of local adverse reactions especially under occlusive dressing. parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Package Label Principal Display Panel:

----------------------------------------- representative packaging not applicable - no longer marketed pdp not applicable


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.