Halonate 0.0005

INDICATIONS

0.05% cream or ointment is a super-high potent corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 gm/week ... Read more0.05% cream or ointment is a super-high potent corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 gm/week because of the potential for the drug to suppress the Hypothalamic-Pituitary-Adrenal (HPA) axis.0.01% lotion is a super-high potent corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses including plaque psoriasis. It can be continuously use for up to 8 weeks.

PHARMACOLOGY

Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2 .

DOSAGE & ADMINISTRATION

0.05% Halobetasol Propionate: Apply a thin layer of Halobetasol Cream or Ointment to the affected skin once or twice daily, as directed by the physician, and rub in gently and completely. Halobetasol 0.05% is a super-high potency corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 gm/week should not be used. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Halobetasol should not be used with occlusive dressings.0.01% Halobetasol Propionate: Apply a thin layer of Halobetasol Propionate Lotion to affected areas once daily. Rub in gently. Wash hands after each application, unless Halobetasol Propionate Lotion is for treatment of the hands. This Lotion treatment beyond 8 weeks is not recommended, and the total dosage should not exceed approximately 50 g per week. Discontinue treatment if control is achieved before 8 weeks. Do not use with occlusive dressings unless directed by a physician. This Lotion should not be used on the face, groin, or in the axillae. This Lotion is not for oral, ophthalmic, or intravaginal use.

SIDE EFFECTS

The following adverse effects have been reported infrequently with topical corticosteroids. These reactions include burning, itching, dryness, folliculitis acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin atrophy, secondary infections, striae and miliaria.

PREGNANCY & LACTATION

Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore caution should be exercised when topical corticosteroids are administered to a nursing woman.

PRECAUTIONS & WARNINGS

Systemic absorption of topical corticosteroids may cause reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression, manifestations of cushing's syndrome, hyperglycemia, and glucosuria. Patients receiving 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.

USE IN SPECIAL POPULATIONS

Use in children under 12 years of age is not recommended. Safety and effectiveness of Halobetasol Propionate cream & ointment in paediatric patients have not been established. Paediatric patients are at greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids.

THERAPEUTIC CLASS

Other Topical corticosteroids

STORAGE CONDITIONS

Store below 30°C. Keep all medicines out of reach of children.