Monday, October 10, 2016

Warticon Cream (Stiefel)





1. Name Of The Medicinal Product



Warticon 0.15% w/w Cream


2. Qualitative And Quantitative Composition



Podophyllotoxin 1.5 mg/g (0.15% w/w).



The cream also contains the following excipients:



Methyl parahydroxybenzoate E218



Propyl parahydroxybenzoate E216



Sorbic acid



Stearyl alcohol



Cetyl alcohol



Butylhydroxyanisole (BHA) E320



For a full list of excipients, see section 6.1



3. Pharmaceutical Form



Topical cream



A homogenous white cream.



4. Clinical Particulars



4.1 Therapeutic Indications



Route of administration: Topical



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.



Using a fingertip, the cream is applied twice daily for 3 days using only enough cream to just cover each wart.



Residual warts should be treated with further courses of twice daily applications for three days at weekly intervals, 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



Known hypersensitivity to any of the ingredients



Open wounds eg. Following surgical procedures.



Use in children.



Hypersensitivity to podophyllotoxin.



Concomitant use with other podophyllotoxin containing preparations.



Pregnancy and lactation.



4.4 Special Warnings And Precautions For Use



Avoid contact with eyes. Should the cream accidentally come into 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 cream contains an active pharmaceutical substance which could be harmful on healthy skin.



This cream contains:



• methyl and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).



• sorbic acid, stearyl alcohol and cetyl alcohol which may cause local skin reactions, (e.g. contact dermatitis).



• butylhydroxyanisole which may cause local skin reactions (e.g.contact dermatitis), or irritation to the eyes and mucous membranes.



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 Cream 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 cream. 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 cream 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, D06BB 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 nucleo side 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



Systemic absorption of podophyllotoxin after topical application with a higher strength, 0.3% is low. Thus no study was performed on the present strength, 0.15%. The Cmax (1.0 – 4.7 ng/ml) and Tmax (0.5 – 36 hrs) are comparable for the 0.3% cream and 0.5% solution in both males and females.



5.3 Preclinical Safety Data



No relevant findings



6. Pharmaceutical Particulars



6.1 List Of Excipients



Purified Water



Methyl parahydroxybenzoate E218



Propyl parahydroxybenzoate E216



Sorbic acid



Phosphoric acid



Stearyl alcohol



Cetyl alcohol



Isopropyl myristate



Paraffin, liquid



Fractionated coconut oil



Butylhydroxyanisole (BHA) E320



Macrogol –7 stearyl ether



Macrogol – 10 stearyl ether



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



3 years



6.4 Special Precautions For Storage



This medicinal product does not require any special storage conditions.



6.5 Nature And Contents Of Container



A collapsible aluminium tube with imperforate nozzle membrane and internally coated with a protective lacquer. Tube cap of polyethylene with a spike on the upper end aimed to perforate the membrane when opening the tube for the first time. Size 5g and 10g.



6.6 Special Precautions For Disposal And Other Handling



No special requirements.



7. Marketing Authorisation Holder



GlaxoSmithKline UK Limited



980 Great West Road



Brentford



Middlesex



TW8 9GS



Trading as Stiefel



Stockley Park West



Uxbridge



Middlesex



UB11 1BT



8. Marketing Authorisation Number(S)



PL 19494/0073



9. Date Of First Authorisation/Renewal Of The Authorisation



Date of first authorisation: 26th April 1999



Date of last renewal: 17th January 2010



10. Date Of Revision Of The Text



5th February 2011




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