Domina

Composition:
Each 100g gel contains 50mg Tazarotene.

Mechanism of Action:
Tazarotene is a retinoid prodrug which is converted to its active form.

Psoriasis:

Topical tazarotene blocks induction of epidermal ornithine decarboxylase activity , which is associated with cell profileration and hyperplasia . Tazarotene suppresses expression of MRP8, amarker of inflammation present in the epiermis of psoriasis patients at high levels . it inhibits cornified envelope formation . Tazarotene also induces the expression of a gene which may be a growth suppressor in human heratinocytes and which may inhibit epidermal hyperproliferation in treated plaques.

Pharmacokinetics:

Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite acid .
Tazarotene is highly bound to plasma proteins (greater than 99%(.
Tazarotene and tazarotenic acid metabolized to sulfoxides, sulfones and other polar metabolites which eliminated through urinary and fecal pathways.
The half-life of tazarotenic acid is approximately 18hours, following topical application of tazarotene to normal, acne or psoriatic skin.
the Cmax for tazarotenic acid occurring 9 hours after the last dose.

Indications:
Tazarotene Domina Gel are indicated for the topical treatment of patients with stable plaque psoriasis up to 20%body surface area involvement .

Dosage and Administration

For Psoriasis
It is recommended that treatment start with tazarotene 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 tazarotene gel. Unaffected skin should be avoided carefully.
For Acne

face should be cleansed gently, and after the skin is dry, a thin film of Tazarotene Domina Gel (2mg/cmf) should be applied once a day, in the evening to the skin where acne lesion appear. Enough quantity should be used to cover affected area.

Pediatric Use :The safety and efficacy of tazarotene 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 tazarotene Gel compared with those 65 years of age and younger.

Contraindications
Tazaroten Domina may cause fetal harm when administered to a pregnant woman.
Tazarotene Gel is contraindicated in women who are or may become pregnant. It is contraindicated in individuals who have shown hypersensitivity to any of its components.

Warnings and Precautions:

Application of Tazarotene Domina Gel may cause excessive irritation in the skin of certain sensitive individuals. If these adverse reactions occur, consider discontinuing the medication or reducing the dosing frequency, asappropriate, until the integrity of the skin is restored.
Concomitant topical 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 treatment with Tazarotene Domina Gel is initiated.
Tazarotene Domina Gel, should not be used on eczematous skin, as it may cause severe irritation.
Weather extremes, such as wind or cold, may be more irritating to patients using Tazarotene Domina Gel.
Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided, and in such cases, exposure should be minimized during the use of Tazarotene Domina Gel.
Patients must be warned to use sunscreens and protective clothing when using Tazarotene Domina Gel. Patients with sunburn should be advised not to use Tazarotene Domina Gel until fully recovered.
Tazarotene Domina Gel should be administered with caution if the patient is also taking drugs known to bephotosensitizers (e.g. thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity.

Adverse Reactions
Tazarotene Domina Gel did not induce allergic contact sensitization, phototoxicity photoallergy.
Psoriasis: The most frequent adverse events are: pruritus ,burning/stinging, erythema, worsening of psoriasis, irritation, skin pain , rash, desquamation, irritant contact dermatitis, skin inflammation, fissuring, bleeding, and dry skin.
Acne: The most frequent adverse events are: desquamation ,burning/stinging ,dry skin ,erythema and pruritus, irritation, skin pain, fissuring, localized edema and skin discoloration.
The following adverse reactions have been identified during post marketing use of Tazarotene Domina Gel including blister ,rash ,skin discoloration and pain.

Drug Interactions
Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. Concomitant use of tazarotene did not affect the pharmacokinetics of norethindrone and ethenyl estradiol over a complete cycle.

Pregnancy:

Teratogenic Effects: Pregnancy Category X
Tazarotene Gel may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established. The potential risk to the fetus outweighs the potential benefit to the mother from Tazarotene Gel during pregnancy; therefore, Tazarotene Gel should be discontinued as soon as pregnancy is recognized.
For females who can become pregnant: Your doctor will order a pregnancy test for you within 2 weeks before you begin treatment with Tazarotene Gel to be sure that you are not pregnant.
- Begin treatment with Tazarotene Gel during a normal menstrual period
- Use an effective form of birth control during treatment with Tazarotene Gel.

lactation:
There is no information regarding the presence of tazarotene in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tazarotene Gel and any potential adverse effects on the breastfed child from Tazarotene Gel or from the underlying maternal condition

Overdose:
Excessive topical use of tazarotene Gel may lead to marked redness, peeling, or discomfort. Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. If oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary.