A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tazorac Indications, Dosage, Storage, Stability - Tazarotene
Tazorac Indications, Dosage, Storage, Stability - Tazarotene
INDICATIONS AND USAGE
TAZORAC® (tazarotene) Gel, 0.05% and 0.1% are
indicated for the topical treatment of patients with stable plaque psoriasis
of up to 20% body surface area involvement. TAZORAC® (tazarotene)
Gel) 0.1% is also indicated for the topical treatment of patients with facial
acne vulgaris of mild to moderate severity. The efficacy of TAZORAC®
Gel in the treatment of acne previously treated with other retinoids or resistant
to oral antibiotics has not been established.
DOSAGE AND ADMINISTRATION
General:
Application may cause excessive irritation in the skin of certain
sensitive individuals. In cases where it has been necessary to temporarily discontinue
therapy, or the dosing has been reduced to a lower concentration (in patients
with psoriasis) or to an interval the patient can tolerate, therapy can be resumed,
or the drug concentration or frequency of application can be increased as the
patient becomes able to tolerate the treatment. Frequency of application should
be closely monitored by careful observation of the clinical therapeutic response
and skin tolerance. Efficacy has not been established for less than once daily
dosing frequencies.
For psoriasis: It is recommended that treatment start
with TAZORAC® Gel, 0.05%, with strength increased to 0.1% if tolerated and
medically indicated. Apply TAZORAC® Gel once a day, in the evening,
to psoriatic lesions, using enough (2 mg/cm2) 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 TAZORAC® Gel. Because unaffected skin may be more susceptible to irritation,
application of tazarotene to these areas should be carefully avoided. TAZORAC®
Gel was investigated for up to 12 months during clinical trials for psoriasis.
For acne: Cleanse the face gently. After the skin is dry, apply a thin
film of TAZORAC® Gel 0.1% (2 mg/cm2) once a day, in
the evening, to the skin where acne lesions appear. Use enough to cover the
entire affected area. TAZORAC® Gel was investigated for up to
12 weeks during clinical trials for acne.
HOW SUPPLIED
TAZORAC® (tazarotene) Gel is 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 and a white propylene screw cap, in 30 gm
and 100 gm sizes.
| |
TAZORAC® Gel 0.05%
|
TAZORAC® Gel 0.1%
|
|
30 gm
|
NDC 0023-8335-03
|
NDC 0023-0042-03
|
|
100 gm
|
NDC 0023-8335-10
|
NDC 0023-0042-10
|
NOTE: TAZORAC® (tazarotene) Gel should be stored at 25oC
(77o F): excursion permitted to 15-30 C (59-86°
F).
® Marks owned by Allergan, Inc., U.S.
Patent Numbers 5,089,509; 5,914,334 and 6,258,830 ALLERGAN, Irvine,
California 92612, USA, December 2003, ©2003 Allergan, Inc., Printed in
USA
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