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
Olux Indications, Dosage, Storage, Stability - Clobetasol propionate
Olux Indications, Dosage, Storage, Stability - Clobetasol propionate
INDICATIONS
AND USAGE
OLUX Foam is a super-potent topical corticosteroid indicated
for short-term topical treatment of the inflammatory and pruritic manifestations
of moderate to severe corticosteroid-responsive dermatoses of the scalp.
In a controlled pharmacokinetic study
3 of 13 patients experienced reversible suppression of the adrenal following
14 days of OLUX Foam therapy.
Treatment beyond 2 consecutive weeks is not recommended, and
the total dosage should not exceed 50 g per week because of the potential for
the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children
under 12 years of age is not recommended.
DOSAGE AND ADMINISTRATION
Note: For proper dispensing of foam, hold the can upside down
and depress the actuator.
OLUX Foam should be applied to the affected scalp area twice
daily, once in the morning and once at night. Invert the can and dispense a
small amount of OLUX Foam (up to a maximum of a golf-ball-size dollop) into
the cap of the can, onto a saucer or other cool surface, or directly on the
lesion, taking care to avoid contact with the eyes. Dispensing directly onto
hands is not recommended, as the foam will begin to melt immediately upon contact
with warm skin. Move the hair away from the affected area of the scalp so that
the foam can be applied to each affected area. Gently massage into affected
scalp area until the foam disappears. Repeat until entire affected scalp area
is treated.
OLUX Foam is a super-high-potency topical corticosteroid; therefore,
treatment should be limited to 2 consecutive weeks and amounts greater than
50 g/week should not be used. Use in pediatric patients under 12 years of age
is not recommended.
Unless directed by a physician, OLUX Foam should not be used
with occlusive dressings.
HOW SUPPLIED
OLUX Foam is supplied in a 100-gram aluminum can; box of one
(NDC 63032-031-00).
Store at controlled room temperature 68-77°F (20-25°C).
WARNING
FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY
FOLLOWING APPLICATION. Keep out of reach of children. Contents under pressure.
Do not puncture or incinerate container. Do not expose to heat
or store at temperatures above 120°F (49°C).
Manufactured for: Connetics Corporation Palo
Alto, CA 94303 USA
By: CCL Pharmaceuticals Runcorn WA7 1NU United
Kingdom
LB-0190/L00702, May 26, 2000
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