HALOG Ointment (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Sun Pharmaceutical Industries, Inc.

Λέξεις κλειδιά

10631-096

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1. 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 ...

2. 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, ...

3. Indications and Usage

HALOG OINTMENT (Halcinonide Ointment, USP) 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

4. Contraindications

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

6.1. General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushings syndrome, hyperglycemia, and glucosuria in some ...

6.2. Information for Patients

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 ...

6.3. Laboratory Tests

A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis suppression.

6.6. 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 ...

6.7. Pregnancy

Teratogenic Effects Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be ...

6.9. 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 ...

6.10. Pediatric Use

<b>Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushings syndrome than mature patients because of a larger skin surface area to body ...

6.11. Geriatric Use

Clinical studies of 0.1% HALOG OINTMENT did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical ...

7. 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 ...

9. Overdosage

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

10. Dosage and Administration

Apply a thin film of 0.1% HALOG OINTMENT (Halcinonide Ointment, USP) to the affected area two to three times daily. Occlusive Dressing Technique Occlusive dressings may be used for the management of psoriasis ...

11. How Supplied

HALOG OINTMENT (Halcinonide Ointment, USP) 0.1% is translucent white to off-white, smooth, soft homogeneous ointment type material, essentially free of foreign matter and is supplied as: NDC 10631-096-30 ...

12. Storage and Handling

Store at room temperature; avoid excessive heat (104º F).