1. Name Of The Medicinal Product
Standardised Betadine Antiseptic Solution.
2. Qualitative And Quantitative Composition
Povidone Iodine 10.00% w/v.
3. Pharmaceutical Form
Aqueous solution.
4. Clinical Particulars
4.1 Therapeutic Indications
For use as a pre-operative and post-operative antiseptic skin cleanser for major and minor surgical procedures.
4.2 Posology And Method Of Administration
Route of administration: Topical. Adults, the elderly and children: Apply full strength as a pre-operative and post-operative antiseptic skin cleanser. Avoid pooling both under the patient and in the skin folds. Wash off excess solution before using occlusive dressings. Povidone iodine is not recommended for regular use in neonates and is contraindicated in very low birth weight infants (below 1500 grams).
4.3 Contraindications
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). Standardised Betadine Antiseptic Solution is not recommended for body cavity irrigation.
4.4 Special Warnings And Precautions For Use
Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Absorption of iodine from povidone iodine through either intact or damaged 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 Pregnancy And Lactation
Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption on foetal thyroid function and development.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Povidone iodine may produce local skin reactions although it is considered to be less irritant than iodine. The application of povidone iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function.
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.
In the case of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Standardised Betadine Antiseptic Solution 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. Standardised Betadine Antiseptic Solution kills bacteria, viruses, fungi, spores and protozoa.
5.2 Pharmacokinetic Properties
The product is intended for topical application.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Glycerol; nonoxynol 9; dibasic sodium phosphate (anhydrous); citric acid monohydrate; sodium hydroxide; potassium iodate; purified water.
6.2 Incompatibilities
None.
6.3 Shelf Life
36 months unopened.
6.4 Special Precautions For Storage
Store at a temperature not exceeding 25oC.
6.5 Nature And Contents Of Container
High-density polyethylene bottle containing 500ml of product, fitted with a white polypropylene cap with a steran-lined wad.
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.
8. Marketing Authorisation Number(S)
PL 21248/0002.
9. Date Of First Authorisation/Renewal Of The Authorisation
30th March 2005.
10. Date Of Revision Of The Text
March 2005.
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