Tazorac (Tazarotene) - Complete Drug Information

Tazorac (Tazarotene) is a synthetic retinoid derivative that has got immunological and anti-inflammatory properties.

It is used to treat patients with the following conditions:

Acne (Fabior, Tazorac 0.1% cream, Tazorac 0.1% gel):
- It is used in the topical treatment of acne vulgaris in patients 12 years and older.
Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines (Avage):
- Tazorac is used in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients older than 17 years of age ( who use sunlight avoidance programs and comprehensive skin care programs) as an adjunct to other therapies.
Psoriasis:
- Tazorac 0.05% and 0.1% cream:
  - It is used in the topical treatment of plaque psoriasis in patients 18 years and older.
- Tazorac 0.05% and 0.1% gel:
  - It is used in the topical treatment of stable plaque psoriasis of up to 20% body surface area involvement in patients 12 years and older.
    - It does not eliminate or prevent wrinkles, repair sun-damaged skin, reverse photoaging, or restore more youthful or younger skin.
    - A mitigating effect on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, keratinocytic atypia, tactile roughness, telangiectasia, skin laxity, melanocytic atypia, or dermal elastosis has not been demonstrated.
    - Safety and effectiveness for the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna have not been seen.
    - Beyond 52 weeks, its safety and efficacy are not known.
    - The safety of gel use on more than 20% body surface area has not been established.

Tazarotene (Tazorac) Dose in Adults

In patients having excessive pruritus, burning, skin redness, or peeling, stop until the integrity of the skin is restored, or reduce dosing to an interval the patient is able to tolerate.

Dose in Acne: Topical:

Fabior:
- Apply a small amount to the affected area once daily in the evening.
Tazorac cream/gel 0.1%:
- Apply a thin layer (2 mg/cm ) to the affected area once daily in the evening.

Dose in the treatment of Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines:

Topical: Avage:
- Apply a small amount (pea-sized) to the entire face once daily at bedtime.

Dose in the treatment of Psoriasis:

Topical: Tazorac cream/gel: Initial: 0.05%:
- Apply once daily to psoriatic lesions that are enough (2 mg/cm² ) to cover only the lesion with a thin film.
- May increase strength to 0.1% if tolerated and required.

Tazarotene (Tazorac) Dose in Childrens

Patients with excessive burning, pruritis, skin redness, or peeling, treatment may be discontinued until integrity of the skin is restored or reduce dosing to an interval the patient is able to tolerate.

Dose in the treatment of Acne vulgaris:

Children ≥12 years and Adolescents: Topical:
- Cream or gel: Tazorac (0.1%):
  - Apply as a thin film (2 mg/cm ) to affected areas once daily in the evening
- Foam: Fabior (0.1%):
  - Apply a small amount to the affected area once daily in the evening.

Dose in the treatment of Psoriasis: Topical:

Cream: Adolescents ≥18 years:
- Tazorac (0.05%): Initial:
  - Apply a thin film (2 mg/cm ) to affected area once daily in the evening
  - may increase strength to 0.1% if tolerated and required
Gel: Children ≥12 years and Adolescents:
- Tazorac (0.05%): Initial:
  - Apply a thin film (2 mg/cm ) to affected area once daily in the evening
  - may increase strength to 0.1% if tolerated and required
  - apply to no more than 20% of the body surface area

Dose in the treatment of Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines:

Adolescents ≥17 years:
- Topical: Cream: Avage (0.1%):
  - Apply a pea-sized amount once daily at bedtime & lightly cover entire face including eyelids if desired

Tazarotene (Tazorac) Pregnancy Risk Category: X

It is strictly against the law to use during pregnancy.
Premarketing studies showed that a small number of pregnant women were accidentally exposed to the drug. However, these data are not sufficient to assess outcomes.
As an initial treatment for acne and psoriasis, topical products are highly recommended.
Before using females with reproductive potential, it is important to determine if you are pregnant.
You should have a negative pregnancy test within two weeks of starting treatment. Treatment should start during normal menstrual periods.
Females with reproductive potential should be advised to use contraception.

Tazarotene (Tazorac) use during breastfeeding:

It is unknown if breast milk contains tazarotene or not.
The formulation and the size of the surface area are key factors in systemic absorption.
Topical agents are preferred to systemic treatments for facial acne or psoriasis for breastfeeding women.
To reduce the risk of systemic absorption, avoid applying large quantities over a prolonged period of time.
Breastfeeding females should not be given tazarotene. The area of treatment should not exceed 20% of their body surface.
After breastfeeding, apply any topical psoriasis agent to the chest and remove before the next session

Tazarotene (Tazorac) Dose in Renal Disease:

There are no dosage adjustments given in the manufacturer's labeling.

Tazarotene (Tazorac) Dose in Liver Disease:

There are no dosage adjustments given in the manufacturer's labeling.

Common Side Effects of Tazarotene (Tazorac) Include:

Dermatologic:
- Desquamation
- Erythema
- Burning Sensation Of Skin
- Xeroderma
- Skin Irritation
- Exacerbation Of Psoriasis
- Skin Pain

Less Common Side Effects of Tazarotene (Tazorac) Include:

Cardiovascular:
- Peripheral Edema
Dermatologic:
- Pruritus
- Contact Dermatitis
- Stinging Of The Skin
- Skin Rash
- Cheilitis
- Dermatitis
- Skin Photosensitivity
- Eczema
- Skin Discoloration
- Skin Fissure
Endocrine & Metabolic:
- Hypertriglyceridemia
Local:
- Application Site Pain
- Local Hemorrhage
Ophthalmic:
- Ocular Irritation

Rare side effects of Tazarotene (Tazorac):

Hypersensitivity:
- Hypersensitivity reaction
- Local hypersensitivity reaction

Contraindication to Tazarotene Include:

Hypersensitivity to tazarotene and any part of the formulation
Women who may or are pregnant
Limited documentation exists on cross-reactivity between allergenic retinoids and retinoids.

Warnings and precautions

Photosensitivity
- It can cause photosensitivity. Avoid exposure to ultraviolet radiation (including sunlamps/sunlight) unless it is absolutely necessary for your health.
- Concurrent therapy with photosensitizers such as thiazides or tetracyclines, fluoroquinolones and phenothiazines can increase the risk.
- Patients with a family history or personal history of skin cancer should be cautious.
- It is recommended to use sunscreen daily and take other precautions.
- Sunburn patients should not use sunblock until it has completely healed.
Skin irritation:
- Local tolerability reactions, including skin desquamation or blistering, or local hypersensitivity reactions (including the urticaria), might occur. Extreme burning, pruritus and peeling may also occur, particularly in the first weeks of treatment.
- The skin may be more sensitive to extremes of cold or wind.
- Avoid using concomitant medications such as medicated or abrasive soaps or cleansers or cosmetics that have a strong drying impact.
- Reduce frequency of use or stop using until irritation disappears.

Monitor:

Monitor disease severity in plaque psoriasis (reduction in scaling, erythema, and induration)
clinical response and skin tolerance
pregnancy test prior to treatment in childbearing-aged females.

How to administer Tazarotene (Tazorac)?

For topical use only
not for oral, ophthalmic, or intravaginal use.
Avoid eyes, mouth, or other mucous membranes
rinse thoroughly with water if contact occurs.
Do not cover treated areas with dressings or bandages.
Do not apply to eczematous, abraded, broken, or sunburned skin.
Effective sunscreen and protective clothing should be used during treatment.
Wash hands after use.

Acne:

Apply in the evening after gently cleansing and drying face
apply enough to cover the entire affected area.

Foam:

A small amount of foam should be dispensed into the palm of the hand.
Use fingertips to lightly cover the entire affected area of the face and/or upper trunk with a thin layer
massage into skin until foam disappears.
Moisturizer can be used if necessary.

Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines:

Apply to clean dry face at bedtime
lightly cover the entire face including eyelids if desired.
Emollients or moisturizers may be applied before or after
Before applying tazarotene, ensure the cream or lotion has absorbed into the skin and has dried completely.

Psoriasis:

Apply in the evening.
Dry the skin before applying.
If emollients are used, apply them at least 1 hour prior to application.
Unaffected skin may be more susceptible to irritation, avoid application to these areas.

Mechanism of action of Tazarotene (Tazorac):

Tazarotene, a synthetic, acetylenic-retinoid that modulates differentiation and proliferation of epithelial tissues and has some anti-inflammatory and immunological activities, is known as Tazarotene.

The onset of action: Psoriasis:

1 week

Duration: Therapeutic: Psoriasis:

Effects have been observed for up to 3 months after a 3-month course of topical treatment

Absorption:

Minimal after cutaneous application (≤6% of the dose)

Distribution:

Retained in the skin for prolonged periods after topical application

Protein binding:

>99% (tazarotenic acid)

Metabolism:

The prodrug is rapidly metabolized via esterase hydrolysis to an active metabolite (tazarotenic acid) following topical application and systemic absorption; tazarotenic acid undergoes further hepatic metabolism

Half-life elimination: Cream, gel: ~18 hours (tazarotenic acid) Foam: 8.1 ± 3.7 hours

Excretion: