TAZORAC Gel (2018)
Βιβλιογραφική αναφορά
Συγγραφείς
Allergan, Inc.
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1. Indications and Usage
1.1 Plaque Psoriasis TAZORAC (tazarotene) Gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. 1.2 Acne Vulgaris TAZORAC ...
2. Dosage and Administration
TAZORAC Gel is for topical use only. TAZORAC Gel is not for ophthalmic, oral, or intravaginal use. Avoid accidental transfer of TAZORAC Gel into eyes, mouth, or other mucous membranes. If contact with ...
3. Dosage Forms and Strengths
Gel, 0.05% and 0.1%, in 30 g and 100 g tubes. Each gram of TAZORAC Gel, 0.05% and 0.1% contains 0.5 mg and 1 mg of tazarotene, respectively in a translucent, aqueous gel.
4. Contraindications
TAZORAC Gel is contraindicated in: Pregnancy. Retinoids may cause fetal harm when administered to a pregnant female <em>[see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)]</em> ...
5. Warnings and Precautions
5.1 Embryofetal Toxicity Based on data from animal reproduction studies, retinoid pharmacology and the potential for systemic absorption, TAZORAC Gel may cause fetal harm when administered to a pregnant ...
6. Adverse Reactions
The following serious adverse reactions are discussed in more detail in other sections of the labeling: Embryofetal toxicity <em>[see Warnings and Precautions (5.1)]</em> Photosensitivity and Risk of Sunburn ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. ...
7. Drug Interactions
No formal drug-drug interaction studies were conducted with TAZORAC Gel. In a trial of 27 healthy female subjects between the ages of 20–55 years receiving a combination oral contraceptive tablet containing ...
8.1. Pregnancy
Risk Summary Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, TAZORAC Gel may cause fetal harm when administered to a pregnant female and ...
8.2. Lactation
Risk Summary There is no information regarding the presence of tazarotene in human milk, the effects on the breastfed infant, or the effects on milk production. After single topical doses of <sup>14</sup> ...
8.3. Females and Males of Reproductive Potential
Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential within 2 weeks prior to initiating TAZORAC Gel therapy which should begin during a menstrual period. Contraception ...
8.4. Pediatric Use
The safety and efficacy of TAZORAC Gel have not been established in pediatric patients with psoriasis or acne under the age of 12 years.
8.5. Geriatric Use
Of the total number of subjects in clinical trials of TAZORAC Gel for plaque psoriasis, 163 were over the age of 65. Subjects over 65 years of age experienced more adverse events and lower treatment success ...
10. Overdosage
Excessive topical use of TAZORAC Gel, 0.05% and 0.1% may lead to marked redness, peeling, or discomfort <em>[see Warnings and Precautions (5.2)]</em>. TAZORAC Gel 0.05% and 0.1% are not for oral use. Oral ...
11. Description
TAZORAC (tazarotene) Gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of TAZORAC Gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in ...
12.1. Mechanism of Action
Tazarotene is a retinoid prodrug which is converted to its active form, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor ...
12.2. Pharmacodynamics
The pharmacodynamics of TAZORAC Gel in the treatment of plaque psoriasis and facial acne vulgaris are unknown.
12.3. Pharmacokinetics
Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Little parent compound could be detected in the plasma. Tazarotenic acid was highly ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
A long-term study of tazarotene following oral administration of 0.025, 0.050, and 0.125 mg/kg/day to rats showed no indications of increased carcinogenic risks. Based on pharmacokinetic data from a shorter-term ...
14. Clinical Studies
Psoriasis In two large vehicle-controlled clinical trials, TAZORAC Gel, 0.05% and 0.1% applied once daily for 12 weeks was significantly more effective than vehicle in reducing the severity of the clinical ...
16.1. How Supplied
TAZORAC (tazarotene) Gel is a translucent, aqueous gel, available in concentrations of 0.05% and 0.1%. It is available in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening ...
16.2. Storage and Handling
Store at 20ºC to 25ºC (68ºF to 77ºF). Excursions permitted from 15ºC to 30ºC (59ºF to 86ºF).
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Embryofetal Toxicity Inform females of reproductive potential of the potential risk to a fetus. Advise these patients ...