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BETADINE OINTMENT

Active substance: POVIDONE-IODINE

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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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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