1. Name Of The Medicinal Product
Warticon
2. Qualitative And Quantitative Composition
Podophyllotoxin 5 mg/ml (0.5% w/v). The quality of podophyllotoxin fulfills in-house specification.
3. Pharmaceutical Form
Topical solution
4. Clinical Particulars
4.1 Therapeutic Indications
For the topical treatment of condylomata acuminata affecting the penis and the external female genitalia.
4.2 Posology And Method Of Administration
The affected area should be thoroughly washed with soap and water, and dried prior to application.
Warticon is applied twice daily for 3 days. If residual warts persist, this 3-day treatment may be repeated weekly, if necessary, for a total of 4 weeks of treatment.
Where lesions are greater than 4 cm2, it is recommended that treatment takes place under the direct supervision of medical staff.
4.3 Contraindications
Open wounds following surgical procedures should not be treated with podophyllotoxin.
Hypersensitivity to podophyllotoxin is a contra-indication.
Use in children.
Concomitant use with other podophyllotoxin containing preparations.
Pregnancy and lactation.
4.4 Special Warnings And Precautions For Use
Avoid contact with eyes. Should the solution accidentally come into contact with the eye, the eye should be thoroughly rinsed with water.
The hands should be thoroughly washed after each application. Prolonged contact with healthy skin must be avoided since the solution contains an active pharmaceutical substance which could be harmful on healthy skin.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None presently known.
4.6 Pregnancy And Lactation
The product is not for use in pregnancy or lactation.
Reproduction toxicity studies in animals have not given evidence of an increased incidence of foetal damage or other deleterious effects on the reproductive process. However, since podophyllotoxin is a mitosis inhibitor, Warticon Solution should not be used during pregnancy or lactation.
It is not known if the substance is excreted into breast milk.
Observations in man indicate that podophyllin, a crude mixture of lignans, can be harmful to pregnancy. Such observations have not been reported in patients treated with podophyllotoxin.
4.7 Effects On Ability To Drive And Use Machines
None presently known.
4.8 Undesirable Effects
Local irritation may occur on the second or third day of application associated with the start of wart necrosis. In most cases the reactions are mild. Tenderness, itching, smarting, erythema, superficial epithelial ulceration and balanoposthitis have been reported. Local irritation decreases after treatment.
4.9 Overdose
There have been no reported overdosages with Warticon Solution. However, excessive use of podophyllotoxin 0.5% solution has been reported as causing two cases of severe local reactions. In cases of excessive use of Warticon Solution resulting in severe local reaction, the treatment should be stopped, the area washed and symptomatic treatment introduced. No specific antidote is known. In the event of accidental ingestion, give emetic or stomach washout. Treatment should be symptomatic and in severe oral overdose ensure the airway is clear and give fluids. Check and correct electrolyte balance, monitor blood gases and liver function. Blood count should be monitored for at least 5 days.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmaco-therapeutic group: D06B B Antivirals
Podophyllotoxin is a metaphase inhibitor in dividing cells binding to at least one binding site on tubulin. Binding prevents tubulin polymerisation required for microtubule assembly. At higher concentrations podophyllotoxin also inhibits nucleoside transport through the cell membrane.
The chemotherapeutic action of podophyllotoxin is assumed to be due to inhibition of growth and the ability to invade the tissue of the viral infected cells.
5.2 Pharmacokinetic Properties
Topical Administration of a 0.5% solution of ethanolic podophyllotoxin in the majority of cases only requires volumes in the range of 0.1 ml to 0.2 ml. Studies monitoring serum drug level reveal that topical application of a twice daily dose of 100MCL to the penile preputial cavity in 10 patients resulted in a maximum serum concentration of 0.25 ng/ml.
5.3 Preclinical Safety Data
No relevant findings
6. Pharmaceutical Particulars
6.1 List Of Excipients
Phosphoric acid Ph Eur
Ethanol BP
Purified Water Ph Eur
Patent Blue V (E131)
6.2 Incompatibilities
None known.
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Should be stored below 25oC.
6.5 Nature And Contents Of Container
An amber glass bottle with plastic child-proof cap. Each bottle contains 3 ml of Warticon Solution. The outer carton also includes a tube containing plastic applicators. Each loop will carry approximately 5μl Warticon Solution.
6.6 Special Precautions For Disposal And Other Handling
The solution is applied by the plastic applicators provided.
7. Marketing Authorisation Holder
Stiefel Laboratories (UK) Ltd
Eurasia Headquarters
Concorde Road
Maidenhead
SL6 4BY
UK
8. Marketing Authorisation Number(S)
PL0174/0211
9. Date Of First Authorisation/Renewal Of The Authorisation
21st June 1999 / 8th October 2003
10. Date Of Revision Of The Text
August 2009
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