Betadine Shampoo Betasept Shampoo
Povidone Iodine 4.0 % w/v
Seborrhoeic conditions of the scalp associated with excessive dandruff, pruritus, scaling, exudation and erythema of the scalp; pityriasis capitis; infected lesions of the scalp - pyodermas (recurrent furunculosis, infective folliculitis and impetigo).
Route of administration: topical use.
1. Having first wetted the hair, apply 2 or 3 capfuls of Betadine Shampoo, use warm water to lather. Rinse.
2. Again, apply 2 or 3 capfuls of Betadine Shampoo and massage into the scalp with the tips of the fingers.
3. Work up to a golden lather using warm water.
4. Repeat treatment twice until improvement is noted. Afterwards, use Betadine
Shampoo once a week.
As for children over 12 years, substituting 1 or 2 capfuls of Betadine Shampoo.
Known or suspected iodine hypersensitivity. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis).
Not for use in children under 2 years.
Use of this preparation may interfere with tests of thyroid function. Iodine is absorbed through burns and broken skin and to a lesser extent through intact skin and may lead to toxic levels of iodine in the blood, particularly in patients with renal insufficiency. If used for long periods thyroid function tests should be performed. Particular care should be taken when treating patients with excessive burns. Use of this preparation In patients with renal impairment may possibly result in the development of toxic levels of iodine" Therefore, iodine levels should be monitored in these patients. Particular care should also be taken when treating neonates and very low birth weight infants.
Betadine Surgical Scrub can permanently discolour white gold jewellery and it is recommended that this type of jewellery should be removed before using Betadine Alcoholic Solution.
Avoid contact with eyes. In case of contact with the eyes, immediately flush the eyes liberally with water for at least 15 minutes and seek medical attention. If easy to do, remove contact lenses.
Use with concurrent lithium therapy has been shown to exhibit additive hypothyroidic effects. Absorption of iodine from povidone iodine through either intact skin 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.
Iodine freely crosses the placenta and is secreted in breast milk. Therefore it is recommended that breastfeeding should stop during treatment, unless no alternative is possible. Thyroid function disorders have been reported in the offspring of mothers exposed to pharmacological doses of iodine. Povidone iodine should not be used regularly during pregnancy unless there is no alternative treatment available.
Local irritation, skin burns and sensitivity reactions have been reported rarely. Anaphylactic reactions, anaphylactoid reactions and anaphylactic shock have been reported uncommonly with products containing povidone-iodine or povidone.
Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Such effects have occasionally been seen with extensive or prolonged use of povidone iodine. Other effects that have been reported are metabolic acidosis and acute renal failure.
Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns may lead to a number of adverse effects: Metallic taste in mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia and renal impairment.
Deliberate or accidental ingestion of large quantities of povidone iodine will result in high blood levels of iodine and gastrointestinal toxicity including vomiting and diarrhoea. Symptomatic and supportive treatment should be started with special attention to monitoring electrolyte balance, renal function, thyroid function and liver function. Iodine can be removed by dialysis.
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.
The product is intended for topical application.
Sulphated nonylphenoxypoly (Oxyethylene) ammonium salt (NPPE) Lauric diethanolamide Ethoxylated lanolin 50%
Natrasol HXR HSE Perfume vah floral no 2 Potassium iodate Sodium hydroxide Purified water
24 months unopened.
Store in a dry place at or below 25oC, and protected from light.
White polypropylene containers fitted with white polypropylene lids, containing 125ml or 250ml of product.
Ayrton Saunders Ltd 9 Arkwright Road,
Astmoor Industrial Estate,
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16th September 1993 / 26th November 1998.
DATE OF REVISION OF THE TEXT