Information about Tazoderm
Composition:
Tazarotene 0.05% or 0.1% W/W
Excipients:
Benzyl alcohol, butylated hydroxyanisole, butylated hydroxy toluene, hexylene glycol, poloxamer 407, tween 80, Triethanolamine, edetate disodium, Macrogol 400, Carbomer, Ascorbic acid, nitrogen gas, purified water.
Indications:
Tazoderm Gel 0.05% and 0.1% are indicated for the topical treatment of patients with stable plaque psoriasis up to 20%bodysurface area involvement.
Tazoderm Gel 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity.
Dose and Drug Administration:
-For psoriasis:
It is recommended that treatment start with Tazoderm gel 0.05% with strength increased to 0.1% If tolerated and medically indicated. It is applied once a day in the evening to psoriatic lesions, using enough (2mg/cmf) to cover only the lesion with a thin film to no more than 20% of body surface area. If a bath or shower is taken prior to application, the skin should be dry before applying the gel.
If emollients are used, they should be applied at least an hour before application of Tazoderm gel. Unaffected skin should be avoided carefully
-For Acne:
face should be cleansed gently, and after the skin is dry, a thin film of Tazoderm gel 0.1% (2mg/cmf) should be applied once a day, in the evening to the skin where acne lesion appears. Enough quantity should be used to cover affected area.
*Pediatric Use: The safety and efficacy of Tazoderm have not been established in pediatric patients under the age of 12 years.
*Geriatric Use: Subjects over 65 years of age experienced more adverse events and lower treatment success rates after 12 weeks of use of Tazoderm Gel compared with those 65 years of age and younger.
Pregnancy and breastfeeding:
Teratogenic Effects: Pregnancy Category X
Women of child-bearing potential should use adequate birth-control measures when Tazoderm Gel is used
Although there may be less systemic exposure in the treatment of acne of the face alone due to less surface area for application, Tazoderm is a teratogenic substance, and it is not known what level of exposure is required for teratogenicity in human.
-Nursing Mothers:
It is not known whether this drug is excreted in human milk. Caution should be exercised when Tazoderm is administered to a nursing woman.
Storage conditions:
Store at 25°.
Packaging:
Aluminum tube of 15g or 30g.