Halog Cream (Halcinonide)

HALOG® Preparations



Topical Corticosteroid

Indications And Clinical Uses: Halcinonide, a synthetic fluorinated corticosteroid, is indicated for topical application for the relief of the inflammatory manifestations of acute or chronic corticosteroid responsive dermatoses; under occlusion, in the management of recalcitrant cases of psoriasis and neurodermatitis.

Contra-Indications: Tuberculous, fungal and most viral lesions of the skin (including herpes simplex, vaccinia, and varicella). Patients with history of hypersensitivity to any of the components. Not intended for use in the eye nor in the external auditory canal of patients with perforated eardrums.

Precautions: Adrenal suppression and other systemic adverse effects may occur and must be kept in mind, particularly during use over large areas or over an extended period of time. Occasionally, symptoms of steroid withdrawal may develop when the medication is stopped after prolonged use.

Pregnancy and Lactation: Safety in pregnancy and lactation has not yet been established. Weigh potential benefit against potential hazard to the fetus or nursing infant.

In cases of bacterial skin infections, use appropriate antibacterial agents as primary therapy. If necessary, halcinonide may be used as an adjunct to control inflammation, erythema and itching. If a symptomatic response is not noted within a few days to a week, discontinue the local application of corticosteroid until the infection is controlled.

If local irritation or sensitization develops, discontinue halcinonide and institute appropriate therapy.

Use topical corticosteroids with caution on lesions close to the eye.

Advise patients to inform subsequent physicians of the prior use of corticosteroids.

Prolonged use of topical corticosteroid products may produce atrophy of the skin and of subcutaneous tissues, particularly on flexor surfaces and on the face. If this is noted, discontinue the use of topical corticosteroids.

Topical corticosteroids should be used with caution in patients with stasis dermatitis and other skin diseases associated with impaired circulation.

Use of occlusive dressings increases the percutaneous absorption of corticosteroids; their extensive use increases the possibility of systemic adverse effects. For patients with extensive lesions, it may be preferable to use a sequential approach. Prolonged occlusive therapy necessitates close observation of the patient. Impairment of thermal homeostasis may occur if large areas of the body are occluded. Discontinue use of the occlusive dressing if elevation of the body temperature occurs.

Plastic films, commonly used as occlusive dressings, are often flammable; warn patients when using such materials. Employ extreme caution when such films are used on children to avoid the possibility of suffocation.

Occasionally, a patient may develop a sensitivity reaction to a particular occlusive dressing material or adhesive. If infection develops, discontinue the use of the occlusive dressings and institute appropriate antimicrobial therapy.

Adverse Reactions: Significant local irritation is uncommon; a transient burning sensation may occur in some patients. The use of corticosteroids under occlusive dressings is known to produce miliaria, folliculitis, pyoderma, maceration of the skin or localized cutaneous atrophy. Striae occasionally may develop when used extensively in intertriginous areas or under occlusive dressings. Erythema, dryness, itching, hypertrichosis and change in skin pigmentation have been reported with topical steroids.

Adrenal suppression has also been reported following topical corticosteroid therapy. Posterior subcapsular cataracts have been reported following systemic use of corticosteroids.

Symptoms And Treatment Of Overdose: Symptoms: Mild, reversible suppression of adrenal function, ecchymoses of the skin, peptic ulceration, hypertension, aggravation of infection, hirsutism, acne, edema and muscle weakness due to protein depletion are all toxic symptoms when large amounts of corticosteroids are absorbed. Animal studies suggest that overdosage in females may result in swollen breasts or lactation.

Treatment: No specific antidote available. Treatment should be chiefly symptomatic. Discontinue corticosteroid administration.

Dosage And Administration: Apply to the affected area 2 or 3 times daily. Rub in gently.

Occlusive dressing technique: Gently rub a small amount of cream or ointment into the lesion until the cream or ointment disappears. Then re-apply the cream or ointment, leaving a thin coating on the lesion and cover with a pliable nonporous film. Good results have been obtained by applying the cream or ointment under occlusion in the evening and reapplying it without occlusion in the morning (i.e. 12 hour occlusion). Reapplication of the cream or ointment is essential at each dressing change.

Availability And Storage: Cream: Each g contains: halcinonide 0.1%. Nonmedicinal ingredients: cetyl alcohol, dimethicone, glyceryl monostearate, isopropyl palmitate, polysorbate, propylene glycol, titanium dioxide and water. Tubes of 15, 30 and 60 g.

Ointment: Each g contains: halcinonide 0.1%. Nonmedicinal ingredients: butylated hydroxytoluene, mineral oil, polyethylene, polyethylene glycol and polyethylene glycol distearate. Tubes of 30 and 60 g.

Solution: Each mL contains: halcinonide 0.1%. Nonmedicinal ingredients: butylated hydroxytoluene, disodium edetate dihydrate, polyethylene glycol 300 and water. pH adjusted with sodium hydroxide. Plastic bottles of 60 mL.

Store at room temperature. Avoid freezing. Avoid storage at temperatures exceeding 30°C.

HALOG® Preparations Westwood-Squibb Halcinonide Topical Corticosteroid

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