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
4.1
CLINICAL PARTICULARS
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
5.1
PHARMACOLOGICAL PROPERTIES
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
6.1
PHARMACEUTICAL PARTICULARS
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 25C 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
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
4.1
CLINICAL PARTICULARS
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
5.1
PHARMACOLOGICAL PROPERTIES
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
6.1
PHARMACEUTICAL PARTICULARS
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 25C 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
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
