BETADINE ALCOHOLIC SOLUTION

Active substance: POVIDONE-IODINE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Betadine Alcoholic Solution.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone iodine 10% w/v.

3

PHARMACEUTICAL FORM
Alcoholic solution.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For use as an antiseptic skin cleanser for major and minor surgical procedures
where a quick drying effect is desired.

4.2

Posology and method of administration
Topical administration.

4.3

Contraindications
Hypersensitivity to iodine, polyvinylpyrrolidine or to any excipient. History
of abnormal thyroid function or goitre (in particular nodular colloid goitre,
endemic goitre and Hashimoto's thyroiditis). 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 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.

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. 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.

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
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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
The active ingredient, povidone iodine slowly liberates iodine when in contact
with skin and mucous membranes. The activity of iodine as a microbicide is
then governed by a series of dissociations.
I2 ↔ I+ + II2 + H2O ↔ H2O I+ + II2 + I- ↔ I3The microbicidal species H2O I+ preferentially displaces O2 as the end electron
acceptor in the micro organisms respiratory cycle. H2O I+ similarly interacts
within the electron transport chain and reacts with the amino acids of the
microbial cell membrane.

5.2

Pharmacokinetic properties
Betadine alcoholic solution is for topical application and therefore a
consideration of the ADME of povidone iodine is largely without relevance.

5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Nonoxynol 9
Dibasic sodium phosphate (anhydrous)
Citric acid, monohydrate
Glycerol
Industrial methylated spirit
Sodium hydroxide
Purified water.

6.2

Incompatibilities
None.

6.3

Shelf life
36 months unopened.

6.4

Special precautions for storage
To be stored at or below 25ºC and protected from light.

6.5

Nature and contents of container
High density polyethylene containers with steran lined white polypropylene
caps. Pack sizes: 500m1 and 5 litres.

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
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 16431/0187

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14th March 2005

10

DATE OF REVISION OF THE TEXT
28/06/2012

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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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