Halobetasol Propionate + Tazarotene

Uses

This Lotion is a combination of halobetasol propionate and tazarotene used for the topical treatment of plaque psoriasis in adults.
Safety and effectiveness of this lotion in pediatric patients under the age of 18 years have not been evaluated.

Halobetasol Propionate + Tazarotene is also used to associated treatment for these conditions: Psoriasis Vulgaris (Plaque Psoriasis), Benign facial lentigines, Facial fine wrinkling, Facial hyperpigmentation, Facial hypopigmentation, Mild Acne vulgaris, Moderate Acne vulgaris

How Halobetasol Propionate + Tazarotene works

Although the exact mechanism of tazarotene action is not known, studies have shown that the active form of the drug (tazarotenic acid) binds to all three members of the retinoic acid receptor (RAR) family: RARa, RARb, and RARg, but shows relative selectivity for RARb, and RARg and may modify gene expression. It also has affinity for RXR receptors.

Dosage

Halobetasol Propionate + Tazarotene dosage

Apply a thin layer of this lotion once daily to cover only affected areas and rub in gently. If a bath or shower is taken prior to application, the skin should be dry before applying the lotion. The total dosage should not exceed approximately 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Do not use with occlusive dressings unless directed by a physician. Discontinue treatment when control is achieved. Avoid the application of this lotion on the face, groin, or in the axillae. This lotion is not for oral, ophthalmic, or intravaginal use.

Side Effects

The most common side effects are redness, itching, swelling, burning, stinging, application site pain, inflamed hair follicles (folliculitis), thinning of the skin (atrophy), peeling and rash.

Toxicity

Excessive topical use may lead to marked redness, peeling, or discomfort. Oral ingestion of the drug may affect liver function causing hypertriglyceridemia. Other symptoms may include conjunctival irritation, hair loss, headache, edema, fatigue, dermatitis, nausea, and visual disturbances. Oral administration of this material to rats and rabbits at doses of 0.20 mg/kg/day (rabbits) and 0.25 mg/kg/day (rats) resulted in developmental toxicity. A no effect level of 0.05 mg/kg/day was established. Similar teratogenic effects have been reported for other retinoid compounds.

Precaution

• This lotion contains tazarotene, which is a teratogenic substance. In females of reproductive potential, obtain a negative pregnancy test within 2 weeks prior to initiating treatment and advise patients to use an effective method of contraception during treatment.
• Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment.
• Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria.
• Systemic absorption may require evaluation for HPA axis suppression.
• Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure.
• Local Adverse Reactions: Local adverse reactions may include atrophy, striae, telangiectasias, and folliculitis. If these effects occur, discontinue at least until the integrity of the skin has been restored. DUOBRII Lotion should not be used on eczematous skin, as it may cause severe irritation.
• Photosensitivity and Risk for Sunburn: Avoid exposure to sunlight, sunlamps, and weather extremes. DUOBRII Lotion should be administered with caution if the patient is also taking drugs known to be photosensitizers.
• Ophthalmic Adverse Reactions: Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist

Interaction

Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is also advisable to "rest" a patient’s skin until the effects of such preparations subside before use of Tazarotene cream is begun. Topical steroid may be hazardous in psoriasis; careful patient supervision is important. Consider if infection spreads. Do not use near a naked flame.

Elimination Route

Minimal systemic absorption of tazarotene occurs due to its rapid metabolism in the skin to the active metabolite, tazarotenic acid, which can be systemically absorbed and further metabolized. Gender had no influence on the systemic bioavailability of tazarotenic acid.

Half Life

The half-life of the active form of the drug, tazarotenic acid, is approximately 18 hours in normal and psoriatic patients.

Elimination Route

Tazarotene and tazarotenic acid were metabolized to sulfoxides, sulfones and other polar metabolites which were eliminated through urinary and fecal pathways.

Pregnancy & Breastfeeding use

Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, This Lotion may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established. There are no data on the presence of tazarotene, halobetasol propionate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after treatment with This Lotion.

Contraindication

This lotion is contraindicated in pregnancy.

Special Warning

Use in children under 12 years of age is not recommended. Halobetasol Propionate Cream should not be used with occlusive dressings. 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.

Use in pediatric patients: 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.

Pediatric Use: Studies of this medicine have been done only in adult patients, and there is no specific information comparing use of Tazarotene in children up to 12 years of age (gel) and up to 18 years of age (cream) with use in other age groups.

Elderly Use (Over 65 year): There is no specific information comparing the use of Tazarotene in the elderly with use in other age groups.

Acute Overdose

Topically applied Halobetasol propionate Cream can be absorbed in sufficient amounts to produce systemic effects.

Excessive topical use cause marked redness, peeling or discomfort. Accidental oral ingestion produces similar adverse effects as those associated with excessive oral intake of Vitamin A or other retinoids. Monitor and take supportive measures as necessary.

Storage Condition

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

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