Friday, 31 August 2012

Betadine Shampoo (Molnlycke Health Care )





1. Name Of The Medicinal Product



Betadine Shampoo.


2. Qualitative And Quantitative Composition



Povidone Iodine 4.00% w/v.



3. Pharmaceutical Form



Shampoo for cutaneous use.



4. Clinical Particulars



4.1 Therapeutic Indications



Seborrhoeic conditions of the scalp associated with excessive dandruff, pruritis, scaling, exudation and erythema of the scalp, pityriasis capitis; infected lesions of the scalp - pyodermas (recurrent furunculosis, infective folliculitis and impetigo).



4.2 Posology And Method Of Administration



Route of administration: topical use. Adults and children over 12 years: Having first wetted the hair, apply 2 or 3 capfuls of Betadine Shampoo, use warm water to lather. Rinse. Again, apply 2 or 3 capfuls of Betadine Shampoo and massage into the scalp with the tips of the fingers. Work up to a golden lather using warm water. Repeat treatment twice weekly until improvement is noted. Afterwards, use Betadine Shampoo once a week. Children aged 2 to 12 years: As for children over 12 years, substituting 1 or 2 capfuls of Betadine Shampoo. Children under 2 years: Contraindicated.



4.3 Contraindications



Known or suspected iodine hypersensitivity. Regular use is contra-indicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis). Not for use in children under two years.



4.4 Special Warnings And Precautions For Use



Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Absorption of iodine from povidone iodine through either intact or broken skin may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.



4.6 Pregnancy And Lactation



Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption of iodine on foetal thyroid function and development.



4.7 Effects On Ability To Drive And Use Machines



None known.



4.8 Undesirable Effects



Povidone iodine may produce local skin reactions although it is considered to be less irritant than iodine.



4.9 Overdose



Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. In the case of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Betadine Shampoo contains povidone iodine, a complex of iodine which shows all the broad-spectrum germicidal activity of elemental iodine. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue. Povidone iodine kills bacteria, viruses, fungi, spores and protozoa.



5.2 Pharmacokinetic Properties



The product is intended for topical application.



5.3 Preclinical Safety Data



None stated.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Sulphated nonylphenoxypoly (oxyethylene) lauric diethanolamide; ethoxylated lanolin 50%; Natrosol HXR; perfume Vah Floral No 2; potassium iodate; sodium hydroxide; purified water.



6.2 Incompatibilities



None.



6.3 Shelf Life



24 months unopened.



6.4 Special Precautions For Storage



Store in a dry place at or below 25oC and protected from light.



6.5 Nature And Contents Of Container



White polypropylene containers fitted with white polypropylene lids, containing 250ml of product.



6.6 Special Precautions For Disposal And Other Handling



None stated.



7. Marketing Authorisation Holder



Medlock Medical Limited, Tubiton House, Oldham, OL1 3HS.



8. Marketing Authorisation Number(S)



PL 21248/0013.



9. Date Of First Authorisation/Renewal Of The Authorisation



19th July 2006.



10. Date Of Revision Of The Text



July 2006.




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