Fluocinonide by Macleods Pharmaceuticals Limited / OXALIS LABS FLUOCINONIDE solution

Fluocinonide by

Drug Labeling and Warnings

Fluocinonide by is a Prescription medication manufactured, distributed, or labeled by Macleods Pharmaceuticals Limited, OXALIS LABS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Fluocinonide Topical Solution USP, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α, 11β, 16α)-. It has the following chemical structure:

Fluocinonide topical solution USP, 0.05% contains fluocinonide 0.5 mg/mL in a solution of citric acid, ethyl alcohol (35%), diisopropyl adipate, propylene glycol and purified water. In this formulation, the active ingredient is totally in solution.

CLINICAL PHARMACOLOGY

Topical corticosteroids share anti-inflammatory, anti-pruritic 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. A significantly greater amount of fluocinonide is absorbed from the solution than from the cream or gel formulations.

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.

INDICATIONS & USAGE

Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS

GENERAL PRECAUTIONS

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, the addition of occlusive dressings, and dosage form.

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. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS - Pediatric Use).

This preparation is not for ophthalmic use. Severe irritation is possible if fluocinonide solution contacts the eye. If that should occur, immediate flushing of the eye with a large volume of water is recommended.

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use.

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

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 external use only. Avoid contact with the eyes. If there is contact with the eyes and severe irritation occurs, immediately flush with a large volume of water.
2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
5. 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.

LABORATORY TESTS

The following tests may be helpful in evaluating the HPA axis suppression:

Urinary free cortisol test
ACTH stimulation test

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 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.

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 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 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.

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 an approximate decreasing order of occurrence:

Burning	Hypertrichosis	Maceration of the skin
Itching	Acneiform eruptions	Secondary infection
Irritation	Hypopigmentation	Skin atrophy
Dryness	Perioral dermatitis	Striae
Folliculitis	Allergic contact dermatitis	Miliaria

OVERDOSAGE

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

DOSAGE & ADMINISTRATION

Fluocinonide Topical Solution USP, 0.05% is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

Fluocinonide Topical Solution USP, 0.05% is supplied in 20 mL (NDC: 33342-320-84) and 60 mL(NDC: 33342-320-85) bottles.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat, above 40°C (104°F).

Manufactured for:
Macleods Pharma USA, Inc.
Plainsboro, NJ 08536

Manufacturer
Macleods Pharmaceuticals Limited
At Oxalis Labs
Baddi, Himachal Pradesh, INDIA

Revised: May, 2018

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx

0.05%: Carton label of 20 mL Bottle
NDC: 33342-320-84

Rx

0.05%: Carton label of 60 mL Bottle
NDC: 33342-320-85

Rx

0.05%: Container label of 20 mL Bottle
NDC: 33342-320-84

Rx

0.05%: Carton label of 60 mL Bottle
NDC: 33342-320-85

INGREDIENTS AND APPEARANCE

FLUOCINONIDE 
fluocinonide solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 33342-320
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLUOCINONIDE (UNII: 2W4A77YPAN) (FLUOCINONIDE - UNII:2W4A77YPAN)	FLUOCINONIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALCOHOL (UNII: 3K9958V90M)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33342-320-84	1 in 1 CARTON	04/24/2018
1		20 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 33342-320-85	1 in 1 CARTON	04/24/2018
2		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209283	04/24/2018

Labeler - Macleods Pharmaceuticals Limited (862128535)

Establishment
Name	Address	ID/FEI	Business Operations
OXALIS LABS		860120472	ANALYSIS(33342-320) , LABEL(33342-320) , MANUFACTURE(33342-320) , PACK(33342-320)