INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo WARTEC™ Solution

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

WARTEC™ Solution

COMPOSITION:
An acidic ethanolic solution containing 0,5%
podophyllotoxin.

PHARMACOLOGICAL CLASSIFICATION:
A 13.9 Dermatological preparations - special combinations

PHARMACOLOGICAL ACTION:
Podophyllotoxin binds to microtubules and causes mitotic arrest in metaphase. It acts as a corrosive agent.

INDICATIONS:
For the treatment of penile warts (condylomata acuminata), located in the preputial space, and for the treatment of external genital warts (condylomata acuminata) in women.

CONTRA-INDICATIONS:
Treatment of open wounds, for example, after surgical procedures. Hypersensitivity to podophyllotoxin. Children. Pregnancy and lactation.

WARNINGS:
Podophyllotoxin is intended for topical use only. Podophyllotoxin is strongly irritant to the skin, eyes and mucous membranes and requires careful handling. In the event of the preparation accidentally entering the eye, the eye should be thoroughly bathed in water, and a doctor must be consulted. The recommended method of application, frequency of application, and duration of treatment should not be exceeded. Relapses may occur. Where lesions are more than 4 cm² it is recommended that the treatment takes place under the direct supervision of medical staff.

DOSAGE AND DIRECTIONS FOR USE:
The affected area should be thoroughly washed with soap and water, and dried prior to application.
Using the applicator provided, dip the loop end into the solution. The warts should be painted twice daily for 3 days. The treated area should be allowed to dry.
If residual warts persist, further treatment may be repeated after 7 days. Patients may require up to 4 topical treatment courses to achieve a complete cure/response. If there is an incomplete response after 4 treatment courses alternative treatment should be considered.
Ensure that the solution is applied to the warts only.
Avoid contact with healthy skin or mucous membranes. The majority of patients will not require in excess of 30 application loops for each application, however a maximum of 50 loops per application (equivalent to 250 µJ Wartec Solution) may be applied.

WARTEC APPLICATOR. {illustrated here}
loop end for treatment of separate warts
spatula end for treatment of large or fused warts.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local irritation may occur after the 2nd or 3rd day in connection with the onset of wart necrosis. Pruritis, tenderness, erythema, burning, superficial epithelial ulceration and balanoposthitis have been observed.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The risk of systemic toxicity after topical apllication is increased by the treatment of large areas with excessive amounts for prolonged periods, by the treatment of friable, bleeding, or recently biopsied warts and by the inadvertent application to normal skin or mucous membranes.
Symptoms of toxicity include nausea, vomiting, abdominal pain and diarrhoea. Central effects include hallucinations, confusion, dizziness, stupor, convulsions, ataxia, hypotonia, and coma.
EEG changes may persist for several days. Peripheral and autonomic neuropathies are delayed in onset and prolonged in duration and may result in paraesthesia, reduced reflexes, muscle weakness, tachycardia, apnoea, orthostatic hypotension, paralytic ileus and urinary retention. There may be thrombocytopenia, leucopenia, renal failure and hepatotoxicity. Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear colourless solution.

PRESENTATION:
Screw-capped amber glass bottles of 10 mL capacity containing 3 mL solution. Plastic applicators are provided with each pack.

STORAGE INSTRUCTIONS:
Store below 25°C
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
28/13.9/0142

NAME AND BUSINESS ADDRESS OF APPLICANT:
PHARMAFRICA PTY LTD
33 Hulbert Road
New Centre
Johannesburg

DISTRIBUTED UNDER LICENCE FROM:
Conpharm AB Sweden

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 March 1996

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