Betasept Ointment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine Ointment Betasept Ointment.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone-Iodine 10 % w/w.
3 PHARMACEUTICAL FORM
Ointment.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Betadine ointment is a broad spectrum antiseptic for the topical treatment or prevention of infection in minor cuts and abrasions, minor surgical procedures and small areas of burns. Treatment of mycotic and bacterial skin infections pyodermas. Treatment of infections in decubitus and stasis ulcers.
4.2 Posology and method of administration
Route of administration: Topical
For the treatment of infection: Apply once or twice daily for a maximum of 14 days.
For the prevention of infection: Apply once or twice a week, for as long as necessary.
The affected skin should be cleaned and dried. Apply Betadine ointment to the affected area. May be covered with a dressing or bandage.
Not for use in children under two years of age.
4.3 Contraindications
Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient. History of abnormal thyroid function or goitre (in particular nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis). Use in children under two years of age. Regular use should be avoided in patients on concurrent lithium therapy.
4.4 Special warnings and precautions for use
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 symptoms occur suggesting changes in thyroid function, these should be investigated. In patients with impaired renal function, blood levels of iodine should be monitored.
If local irritation and hypersensitivity develop, then discontinue treatment. Refer to section 4.8 for further information.
Betadine Ointment can permanently discolour white gold jewellery and it is recommended that this type of jewellery should be removed before using Betadine
4.5 Interaction with other medicinal products and other forms of interaction
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.
4.6 Fertility, Pregnancy and lactation
Iodine freely crosses the placenta and is secreted in breast milk. 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.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
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.
4.9 Overdose
Deliberate or accidental ingestion of large quantities of povidone iodine will result in high blood concentrations of iodine and gastrointestinal corrosive effects including vomiting, diarrhoea and abdominal pain. Systemic toxicity may result in shock, hypotension, tachycardia, fever, metabolic acidosis and renal impairment. Symptomatic and supportive treatment should be started with special attention to monitoring electrolyte balance, renal function, thyroid function and liver function. Haemodialysis effectively clears iodine and should be employed in severe cases of iodine poisoning particularly if renal failure is present. Continuous venovenous haemodiafiltration is less effective than haemodialysis.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Povidone-iodine is a complex of Iodine which retains the broad-spectrum germicidal activity of elemental iodine without its disadvantages. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue.
5.2 Pharmacokinetic properties
Betadine Ointment is applied topically to the affected area.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Polyethylene Glycol 4000
Polyethylene Glycol 1000 Polyethylene Glycol 1500 Purified Water Sodium Bicarbonate Polyethylene Glycol 400.
6.2 Incompatibilities
None.
6.3 Shelf life
36 months unopened.
6.4 Special precautions for storage
Store at or below 25°C.
6.5 Nature and contents of container
Triple epoxy lacquered aluminium tubes with polyethylene closures containing 20, 40 or 80g of product.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd 9 Arkwright Road,
Astmoor Industrial Estate,
Runcorn,
Cheshire,
WA7 1NU,
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0192
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
7th July 1993 / 30th November 1998.
10 DATE OF REVISION OF THE TEXT
24/05/2012