CONTRAINDICATIONS/PRECAUTIONS:
There are NO known absolute contraindications
to the use of ALDARA cream, but Aldara cream use has not been thoroughly
evaluated in a number of situations:
-
Aldara cream should ONLY be used in
the treatment of EXTERNAL genital warts on the genital and perianal area.
It has NOT been evaluated for the treatment of internal genital/anal disease
such as urethral, intravaginal, cervical, rectal, or intraanal Human Papillomavirus
(HPV).
-
There is NO clinical experience with
Aldara Cream used immediately following the treatment of the genital/perianal
warts with other cutaneously applied drugs, therefore DO NOT use
Aldara cream along with any other topical treatments to the genital/perianal
area. Aldara has the potential to exacerbate inflammatory conditions
of the skin, and one must WAIT until the genital/perianal tissue is healed
from any previous drug or surgical treatment.
-
Uncircumcised males who apply Aldara
cream under the foreskin need to retract the foreskin daily and thoroughly
wash and dry the area. FAILURE TO DO SO CAN LEAD TO PAINFUL STRICTURING
AND SCARRING OF THE FORESKIN AND MAY EVEN NECESSITATE CIRCUMCISION!
-
Anyone with a severely compromised immune
system or advanced HIV disease should not use Aldara unless prescribed-by
and under the direct supervision of their regular primary-care physician.
If you have any questions about your medical condition, consult your primary
care physician before using Aldara cream.
-
Hypersensitivity to any ingredient of
Aldadra cream contraindicates usage: to Imiquimod
or any of the inactive ingredients: isotearic acid, cetyl alcohol,
stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate,
purified water, benzyl alcohol, , glycerin, xanthan gum, methylparaben,
and propylparaben..
-
Absolutely no one under the age of 18
should use Aldara cream.
-
Pregnant women and nursing mothers should
NOT use Aldara cream, there are no adequate studies to guarantee safety,
and whether the active ingredients may get into breast milk.
IMPORTANT
WARNING:
Aldara is
approved for the treatment of acute outbreaks of genital warts in
ADULTS with NORMAL immune systems only! There are no adequate studies of
Aldara during pregnancy or breast feeding, therefore Aldara should not
be used by pregnant women or nursing woman. The safety of Aldara
in patients under 18 has not been established, therefore it is not recommended
that anyone under age 18 should use Aldara cream.
Aldara should
only be applied externally to the genital and perianal area. Aldara should
NEVER be applied internally to mucous membranes inside the vagina or cervical
area or inside the rectal or urethral area . Use caution
and do not get in eyes. Aldara is to be used externally, topically
only! If ingested by mistake call 911 immediately or your local poison
center for emergency treatment.
IMPORTANT
PRECAUTIONS - SIDE EFFECTS:
When using Aldara
cream as directed, local skin reactions such as erythema (redness), erosion,
flaking and edema (swelling) along with some discomfort, burning, itching
are very common and does not mandate discontinuance of treatment.
If you should develop a more severe local skin reaction, you should remove
the cream by washing treated area with mild soap and water. After
the skin reaction has subsided in several days, you can resume treatment
with Aldara Cream.
IMPORTANT
PATIENT INFORMATION:
Aldara cream is
not a cure for genital warts and transmission of infection to others can
occur during asymptomatic viral shedding even when there are no lesions
present. ALDARA does not alter the need for precaution in spreading the
disease to others. Aldara 5% cream may weaken condoms and vaginal diaphragms.
Therefore, concurrent use is not recommended.
-
This medication
is to be used as directed by a physician. It is for external use
only. Eye contact should be avoided.
-
The treatment
area should not be bandaged or otherwise covered or wrapped as to be occlusive.
White cotton underwear is recommended.
-
Sexual (genital,
anal, oral) contact should be avoided while the cream is on the skin.
-
It is recommended
that 6 - 10 hours following Aldara 5% cream application the treatment area
be washed with mild soap and water. One must wash their hands before
and after applying the cream.
-
It is common for
patients to experience local skin reactions such as erythema, erosion,
flaking and edema at the site of application or surrounding areas.
Most skin reactions are mild to moderate. Severe skin reactions can
occur and should be reported promptly to your own regular primary care
physician.
-
Uncircumcised
males treating warts under the foreskin should retract the foreskin and
clean the area daily. Failure to do so can lead to stricturing of the foreskin
or scarring and could even necessitate circumcision!
-
Patients need
to be aware that new warts may develop during therapy, Aldara is NOT a
cure.
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