CONTRAINDICATIONS/PRECAUTIONS:
There are NO known absolute contraindications
to the use of Condylox Gel, but Condylox Gel use has not been thoroughly
evaluated in a number of situations:
-
Condylox Gel 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 Papilloma
virus (HPV). Condylox Gel can only be used on external skin and NEVER on
mucous membranes.
-
There is NO clinical experience with
Condylox Gel used immediately following the treatment of the genital/perianal
warts with other cutaneously applied drugs, therefore DO NOT use
Condylox Gel along with any other topical treatments to the genital/perianal
area. Condylox Gel 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 Condylox
Gel under the foreskin need to retract the foreskin daily and thoroughly
wash and dry the area. When applying Condylox Gel make sure the area
is completely dry before allowing the return of opposing skin surfaces
to their normal positions. 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 Condylox Gel 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 Condylox Gel.
-
Hypersensitivity to any ingredient of
Condylox Gel contraindicates usage: to Podofilox
or any of the inactive ingredients: alcohol, glycerin, lactic acid,
hydroxypropyl cellulose, sodium lactate and butylated hydroxytoluene.
-
Absolutely no one under the age of 18
should use Condylox Gel.
-
Pregnant women and nursing mothers should
NOT use Condylox Gel, there are no adequate studies to guarantee safety,
and whether the active ingredients may get into breast milk.
IMPORTANT
WARNING:
Condylox Gel is
approved for the treatment of acute outbreaks of genital warts in
ADULTS with NORMAL immune systems only!
There are no
adequate studies of Condylox Gel during pregnancy
or breast feeding, therefore Condylox Gel
should not be used by pregnant women or nursing woman.
The safety
of Condylox Gel in patients under 18 has not
been established, therefore it is not recommended that anyone under age
18 should use Condylox Gel cream.
Condylox Gel
is approved for external genital warts and external anal warts only.
Therefore it is crucial that one has a correct diagnosis of genital warts
by their own physician. Genital warts can sometimes be confused with squamous
cell carcinoma, "Bowenoid papulosis," and Condylox Gel does NOT treat squamous
cell carcinoma.
Condylox Gel
should only be applied externally to the genital and perianal area. Condylox
Gel 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. Condylox
Gel is to be used externally, topically only!
If contact with eyes occur immediately flush the eyes with copious quantities
of water and seek medical advice. If ingested by mistake call 911
immediately or your local poison center for emergency treatment.
IMPORTANT
PRECAUTIONS - SIDE EFFECTS:
When using Condylox
Gel as directed, local skin reactions such as burning,
erythema (redness), erosion, flaking and edema (swelling) along with some
discomfort, itching are very common and does not mandate discontinuance
of treatment. If you should develop a more severe local skin reaction,
you should contact your physician for a physical examination to determine
whether treatment needs to be discontinued Condylox Gel can
be absorbed systemically and the most common systemic side effect is headache.
If too much
Condylox is absorbed through the skin it could cause symptoms such as abnormally
fast breathing, blood in the urine, changes in mental attitude, comma,
diarrhea, fever, kidney failure, lethargy(sluggishness), nausea, respiratory
failure, seizures and vomiting. If you accidentally apply too much
Condylox Gel to your skin, wash the skin thoroughly with water and call
our doctor and seek medical attention.
IMPORTANT
PATIENT INFORMATION:
Condylox Gel 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.
Condylox
Gel does not alter the need for precaution in spreading
the disease to others.
This medication
is to be used as directed by a physician. It is for external use
only. Eye contact should be avoided.
-
This medication
is to be used as directed by a physician. It is for external use
only. Patients must wash their hands thoroughly before and after
each application. Eye contact should be avoided.
-
The area being
treated must not exceed one and one-half square inches of skin and a maximum
of 0.5 grams per day of Condylox Gel can be applied. Condylox Gel
treatment is twice a day for 3 consecutive days, then no treatment for
4 consecutive days. This cycle can only be repeated for a maximum
of 4 weeks. If genital warts not cleared after a 4 week treatment
cycle, you must contact your physician and seek alternative treatment.
Increasing dosage or frequency or duration of treatment does NOT increase
efficacy and only increase adverse side effects. Condylox Gel can be systemically
absorbed and over usage can have serious systemic side effects.
-
Sexual (genital,
anal, oral) contact should be avoided while the gel on the skin.
-
After applying
the gel allow treated area to thoroughly dry before allowing opposing skin
to touch treated areas..
-
It is common for
patients to experience local skin reactions such as burning, 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, Condylox Gel is
NOT a cure.
|