Tazorac (Tazarotene) - Complete Drug Information

Tazarotene is a topical medication primarily used to treat acne and psoriasis. It belongs to a class of drugs called retinoids, which are derivatives of vitamin A. Tazarotene works by affecting the growth of skin cells and reducing inflammation.

In addition to treating acne and psoriasis, tazarotene is sometimes prescribed for other skin conditions such as photoaging (skin aging caused by exposure to sunlight) and certain types of dermatitis.

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):
  • 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

  • Tazarotene is a cream used to treat acne and psoriasis.
  • It's made from vitamin A and helps control skin cell growth and inflammation.
  • You put it on your skin once a day.
  • But if your skin gets too itchy, burns, turns red, or peels too much, stop using it until your skin feels better. Or your doctor might suggest using it less often.

Tazarotene Dose in Acne: Topical:

  • If you're using Fabior, put a little on the area with acne once a day at night.
  • If you're using Tazorac cream or gel, put a thin layer on the acne area once a day at night.

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

  • For treating fine wrinkles, skin discoloration, and spots with tazarotene, like Avage, use a small amount, about the size of a pea, for your whole face once a day before bedtime. Just apply it gently all over your face and you're good to go!

Tazarotene Dose in the treatment of Psoriasis:  

  • When using tazarotene like Tazorac cream or gel for psoriasis, start with the 0.05% strength.
  • Put it on the psoriasis spots once a day, using just enough to cover the spot thinly.
  • If it's okay for you and you need stronger treatment, your doctor might suggest increasing the strength to 0.1%.

Tazarotene (Tazorac) Dose in Children

  • Tazarotene is a cream used to treat acne and psoriasis.
  • It's made from vitamin A and helps control skin cell growth and inflammation.
  • You put it on your skin once a day.
  • But if your skin gets too itchy, burns, turns red, or peels too much, stop using it until your skin feels better. Or your doctor might suggest using it less often.

Tazarotene Dose in the treatment of Acne vulgaris:

Children ≥12 years and Adolescents: Topical:

  • When using tazarotene for acne in children aged 12 years and above and adolescents, you can use Tazorac cream or gel with a strength of 0.1%.
  • Apply a thin layer covering the affected areas once a day in the evening.
  • Alternatively, you can use Fabior foam, applying a small amount to the acne-affected area once daily in the evening.

Tazarotene Dose in the treatment of Psoriasis: Topical:

Cream: Adolescents ≥18 years:

  • For treating psoriasis with tazarotene, adolescents aged 18 years and older can use Tazorac cream with a strength of 0.05%.
  • Apply a thin layer covering the affected area once a day in the evening, and if needed and tolerated, the strength may be increased to 0.1%.

Gel: Children ≥12 years and Adolescents:

  • For children aged 12 years and older and adolescents, Tazorac gel with a strength of 0.05% can be used.
  • Apply a thin layer to the affected area once daily in the evening, and if necessary, the strength can be increased to 0.1%.
  • However, make sure not to apply the gel to more than 20% of the body surface area.

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

Adolescents ≥17 years:

  • For teenagers aged 17 years and above treating fine facial wrinkles, skin discoloration, and spots with tazarotene like Avage cream with a strength of 0.1%, apply a pea-sized amount once daily at bedtime.
  • Gently cover your whole face, including eyelids if you want.
  • Just remember to use it lightly and only once a day before sleeping.

Tazarotene (Tazorac) Pregnancy Risk Category: X

  • Tazarotene is not safe to use during pregnancy and should be avoided.
  • Although there were instances of accidental exposure to pregnant women during studies, there isn't enough data to assess potential risks.
  • For pregnant women needing treatment for acne or psoriasis, topical products are recommended as the first choice.
  • Before using tazarotene, make sure to confirm that you're not pregnant through a pregnancy test taken within 2 weeks before starting treatment.
  • It's also advised to start treatment during a normal menstrual period and to use effective contraception if you're of reproductive age.

Tazarotene (Tazorac) use during breastfeeding:

  • The presence of tazarotene in breast milk is not confirmed, as absorption into the bloodstream varies depending on the formulation and the area of application.
  • However, it's generally preferred to use topical treatments over oral medications for facial acne and psoriasis in breastfeeding women.
  • To minimize the potential for absorption into the bloodstream, avoid using large amounts of tazarotene for extended periods.
  • When tazarotene treatment is necessary while breastfeeding, limit the application area to less than 20% of the body surface.
  • For topical psoriasis treatments on the chest area, apply them after breastfeeding and remove them before the next feeding session to minimize exposure to the baby.

Tazarotene (Tazorac) Dose in Renal Disease:

  • The manufacturer's labeling for tazarotene does not specify any dosage adjustments for individuals with renal impairment.

Tazarotene (Tazorac) Dose in Liver Disease:

  • The manufacturer's labeling for tazarotene does not indicate any dosage adjustments for individuals with hepatic impairment.

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:

  • Tazarotene should not be used by individuals with a known hypersensitivity to tazarotene itself or any other component of the formulation.
  • Additionally, it is contraindicated in women who are pregnant or may become pregnant due to potential risks to the fetus.
  • While documentation of allergenic cross-reactivity for retinoids is limited, due to similarities in chemical structure and pharmacologic actions, there is a possibility of cross-sensitivity.
  • Therefore, caution should be exercised, and individuals with known hypersensitivity to other retinoids should use tazarotene with care, as cross-reactivity cannot be ruled out with certainty.

Warnings and precautions

Photosensitivity

  • Tazarotene may cause photosensitivity, making your skin more sensitive to sunlight and sunlamps.
  • It's best to avoid unnecessary exposure to ultraviolet rays, such as sunlight, unless it's medically necessary.
  • If you do need to be in the sun, try to minimize your exposure.
  • Be cautious if you're using other medications known to increase photosensitivity, like certain antibiotics and diuretics, and avoid using them together with tazarotene if possible.
  • If you have a personal or family history of skin cancer, use tazarotene with care.
  • It's recommended to use sunscreen daily and take other protective measures against the sun.
  • If you get sunburned, stop using tazarotene until your sunburn heals.

Skin irritation:

  • Tazarotene may cause skin irritation, including blistering or peeling, and local hypersensitivity reactions like hives.
  • You might also experience excessive burning, itching, or redness, especially in the first few weeks of treatment.
  • Your skin might become more sensitive to extreme weather conditions like wind or cold.
  • Avoid using harsh soaps, cleansers, or cosmetics that dry out your skin while using tazarotene, as they can increase irritation.
  • If you experience irritation, consider reducing how often you use tazarotene or stop using it until the irritation goes away.

Monitor:

Monitoring Plaque Psoriasis Treatment

  • Reduced Symptoms: Tazarotene helps lessen redness, scaling, and hardening of the skin in plaque psoriasis.
  • Check Progress: Keep an eye on how well your skin responds and how well you tolerate the treatment.
  • Pregnancy Check: If you're of childbearing age, take a pregnancy test before starting tazarotene treatment.

How to administer Tazarotene (Tazorac)?

General Usage Guidelines:

  • Topical Use Only: Do not swallow, put in your eyes, mouth, or vagina. If it accidentally gets in your eyes, rinse with water.
  • Avoid Certain Areas: Don't apply on broken, irritated, or sunburned skin.
  • Sun Protection: Wear sunscreen and protective clothing during treatment.
  • No Bandages: Don't cover the treated area with dressings or bandages.

Acne Treatment:

  • Evening Application: Apply after gently cleaning and drying your face in the evening.
  • Sufficient Amount: Use enough to cover the whole affected area.

Foam Usage:

  • Application Technique: Dispense a small amount onto your palm and lightly cover the affected area with a thin layer.
  • Massage In: Gently massage until the foam disappears into the skin.
  • Moisturizer: You can use moisturizer if needed.

Palliation of Skin Issues:

  • Bedtime Application: Apply to a clean, dry face at bedtime, covering the entire face.
  • Optional Eyelid Application: You can apply it to your eyelids too, if desired.
  • Moisturizer Use: You can use moisturizer before or after application, ensuring it's fully absorbed and dried.

Psoriasis Treatment:

  • Evening Application: Apply in the evening, preferably after bathing and drying the skin.
  • Precaution with Emollients: If using emollients, apply them at least 1 hour before applying tazarotene.
  • Avoid Unaffected Skin: Don't apply on areas of the skin not affected by psoriasis to avoid irritation.

Mechanism of action of Tazarotene (Tazorac):

  • Tazarotene is a synthetic retinoid that influences how epithelial tissue (like skin cells) grow and develop. It helps regulate their differentiation and proliferation, essentially how they mature and multiply.
  • Additionally, it possesses anti-inflammatory properties and can affect the immune system to some extent.

Onset of Action:

  • Psoriasis: Improvement can be seen as early as one week after starting treatment.

Duration of Action:

  • Therapeutic Effects: In psoriasis, the effects of topical treatment may last for up to 3 months after completing a 3-month course of treatment.

Absorption:

  • Cutaneous Absorption: After applying to the skin, only a small amount (less than or equal to 6% of the dose) is absorbed into the body.

Distribution:

  • Skin Retention: Tazarotene remains in the skin for extended periods after topical application.

Protein Binding:

  • Tazarotenic Acid: More than 99% of the active form of tazarotene (tazarotenic acid) binds to proteins in the body.

Metabolism:

  • Prodrug: Tazarotene is initially a prodrug and is quickly converted into its active form (tazarotenic acid) through enzymatic action, both on the skin's surface and after absorption into the bloodstream.
  • Further Metabolism: Tazarotenic acid undergoes additional metabolism primarily in the liver.

Half-life Elimination:

  • Cream, Gel: The half-life of tazarotenic acid is approximately 18 hours.
  • Foam: The half-life of tazarotenic acid in foam formulation is around 8.1 ± 3.7 hours.

Excretion:

  • Elimination: Metabolites of tazarotene are excreted from the body mainly through urine and feces.

International Brands of Tazarotene:

  • Avage
  • Fabior
  • Tazorac
  • Acniswab
  • Aguder
  • Avage
  • Evitar
  • Ful Lee
  • Glentaz
  • Le Wei
  • Marzoten
  • Psorix Gel
  • Pzoret
  • Que Wei
  • Rantric
  • Regava
  • Soritene
  • Sumaytene
  • Suretin
  • Tarac
  • Tazaro
  • Tazmeral
  • Tazoderm Forte
  • Tazorac
  • Tazoskin
  • Tazoten
  • Tazret
  • Zaroten
  • Zarotex
  • Zorac

Tazarotene (Tazorac) Brands in Pakistan:

Tazarotene [Cream 0.1 %w/w]

Azoten

Danas Pharmaceuticals (Pvt) Ltd

Tazarotene [Gel 0.1 %w/w]

Trazene

Pharmevo (Pvt) Ltd.

Tazarotene [Gel 0.05 %w/w]

Trazene

Pharmevo (Pvt) Ltd.

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