HALCINONIDE (Page 2 of 2)
Geriatric Use
Of approximately 3000 patients included in clinical studies of 0.1% halcinonide cream, 14% were 60 years or older, while 4% were 70 years or older. No overall differences in safety were observed between these patients and younger patients. Efficacy data have not been evaluated for differences between elderly and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
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.
OVERDOSAGE
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS: General).
DOSAGE AND ADMINISTRATION
Apply the 0.1% halcinonide cream, USP, to the affected area two to three times daily. Rub in gently.
Occlusive Dressing Technique
Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream into the lesion until it disappears. Reapply the preparation leaving a thin coating on 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 halcinonide cream 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 cream 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.
HOW SUPPLIED
Halcinonide cream, USP, 0.1 % is smooth, soft homogeneous white to off-white cream, essentially free of foreign matter and is supplied as:
- NOC 57664-698-36 Tube containing 60 g
Storage
Store at room temperature; avoid excessive heat (104° F).
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured by:
DPT Laboratories Inc.
San Antonio, TX 78215
Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
141012
Issued September 2019
Halcinonide 60g Carton Label
| HALCINONIDE halcinonide cream | ||||||||||||||||||||
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| Labeler — Sun Pharmaceutical Industries, Inc. (146974886) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| DPT Laboratories, Ltd | 832224526 | MANUFACTURE (57664-698), PACK (57664-698) | |
Revised: 05/2021 Sun Pharmaceutical Industries, Inc.
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